Patent Application
20150374522
This invention relates to a system and method for endoscopic deliver of a stent. More particularly, this invention relates to an endoscope having a preloaded or preloadable stent, including a radially distensible, polymeric and/or non-polymeric stent.
An intraluminary stent is a medical device used in the treatment of diseased bodily lumens, such as in the coronary or peripheral vasculature, esophagus, trachea, bronchi colon, biliary tract, urinary tract, prostate, brain, as well as in a variety of other applications in the body. Contemporary endoscopy practitioners increasingly often require visualization of the damaged vessel while delivering the stent. In some cases an endoscope and a stent delivery catheter are separately advanced to the damaged vessel to allow for visualization of the delivery of the stent from the stent delivery catheter. Such a procedure has size limitation, especially for smaller bodily lumens, as both the endoscope and the stent delivery catheter must be navigated to the damaged vessel.
To avoid the need or disadvantage of intraluminally advancing two separate and independent devices, endoscopes and stent delivery systems have been combined. One technique may have a stent disposed within a stent delivery catheter and an endoscope which is slidable within an inner tube of the catheter. For example, U.S. Patent Application Publication No. 2006/0184224 A1 to Angel and U.S. Pat. No. 6,033,413 to Mikus et al. describe stent delivery systems having a catheter holding a stent between two tubes of the catheter and an endoscope being positioned within the inner shaft of the catheter. The combining of a stent delivery catheter and an endoscope in such a manner, however, limits the diameter of the contracted or loaded stent to a diameter larger than that of the endoscope. In other words, the overall profile of the delivery system is constrained by the size of the endoscope.
Another technique used to avoid the need for separately advancing independent endoscopes and stent delivery catheters, is to have a stent constrained within a stent delivery catheter where the stent delivery catheter is slidably disposed within a lumen of the endoscope. For example, U.S. Patent Application Publication Nos. 2002/0143387 A1 to Soetikno et al.; 2004/0098105 A1 to Stinson et al.; 2005/0090889 A1 to Yanuma et al. and 2005/0125050 A1 to Carter et al. and U.S. Pat. No. 6,162,231 Mikus et al.; U.S. Pat. No. 6,093,194 to Mikus et al. and U.S. Pat. No. 6,620,570 to Stinson et al. describe a stent delivery catheter having a stent disposed between two tubes where the catheter is fittable through a working channel of an endoscope. Again, the overall profile of the endoscope is limited to a relatively large size as the endoscope must be sized for accenting the stent delivery catheter.
Other approaches include the endoscopic systems as described in U.S. Pat. No. 6,176,873 to Ouchi and U.S. Pat. No. 6,146,389 to Geitz, and International PCT Patent Application Publication No. WO 2005/122953 A2 to Selden. Ouchi describes an endoscope having a mesh stent disposed within the endoscope. The stent has includes rings or tubes at both ends of the stent where the rings or tubes restrict the diameter of the stent ends. A pusher tube within the endoscope is described as being pushed to engage the ring or tube at the distal end of the stent to radially contract the stent and to urge the contracted stent out from a working channel of the endoscope. Such a system makes stent placement difficult as the stent is pushed away from the distal end of the endoscope. Further, the need of rings or tubes at the ends of the stent which are smaller in diameter than the diameter of the expanded stent, limits the use of such a stent as the smaller ends of the stent will tend to restrict flow through the stent. Geitz describes an endoscope having a distal cap. A stent may be disposed over the distal cap and held there via an overlying sheath. For delivery the sheath is removed to deploy the stent. Selden describes a stent radially compressed against the sidewall of the distal portion of an endoscope. The stent is pushed out of the endoscope by a slidable release disposed within the endoscope that engages over the proximal end of the stent. The stent of Seldon is a highly flared stent with outwardly flared ends. Again the pushing of the stent out of the endoscope is problematic as accurate stent placement is difficult. Further, the device of Seldon is apparently limited to a particular stent design, i.e., a highly flared configuration with only the very terminal end portions of the stent being engageable with the wall to the endoscope such that the longitudinal expanse of the stent does not engage the wall of the endoscope as the stent is being pushed out of the endoscope.
Thus, despite the efforts of the prior art, there is a need for an improved endoscopic stent delivery system. In particular, there is a need for an endoscopic stent delivery system which allows for accurate placement and delivery of the stent and which is not limited or constrained to particular stent designs or sizes as with the prior art devices.
In one aspect, the present invention is directed to an endoscopic stent delivery device. The device may include an endoscope having an elongate shaft, which includes a proximal end, a distal end, an outer wall and a longitudinal working channel through the elongate shaft defining an inner wall of the elongate shaft; a stent juxtaposingly disposed to a distal portion of the inner wall; and an inner tubular member slidably disposed within the working channel and having a stent holding member engaging an interior portion of the stent for releasably securing the stent to the distal portion of the inner wall. The device may further include a viewing device disposed at the distal end of the endoscope and/or an illuminating device disposed at the distal end of the endoscope.
The device, in particular the inner tubular member, may further include inner and outer telescoping members, where the stent may be disposed over the inner telescoping member. The outer telescoping member has a larger outer diameter than an outer diameter of the inner telescoping member, where exterior wall portions of the outer telescoping member juxtaposing may abut the inner wall of the elongate shaft. Further, the stent may be a radially distensible stent having a radially contracted state and a larger radially expanded state, and the outer telescoping member may abut a proximal end of the stent in the radially contracted state of the stent.
The device may further include a suture thread having a portion securably attached to a proximal portion of the stent. The inner tubular member may farther include a longitudinally extending channel, and the suture thread may longitudinally extend through the longitudinal channel of the inner tubular member, whereby a pulling force proximally applied on the suture thread extending through the inner member may proximally move the stent within the working channel. The device may further include a stent loading member for radially compressing the stent into the working channel.
Packaging, kits and methods of use are also provided.
The present invention relates to an endoscopic assembly and method for transporting and deploying a stent or other intraluminary member, as described herein, in a bodily passageway. The assembly is useful for medical applications in, but not limited to, the gastrointestinal tract, the biliary, tract, the urinary tract, and the respiratory tract. In particular, a preferred embodiment of the present invention is directed to an endoscopic delivery system having a stent loaded into a working channel. The stent may be loaded into the working channel of the endoscope either by a manufacturer of the assembly or by a practitioner of the assembly prior to use. The endoscope may be a disposable endoscope or a non-disposable endoscope. The endoscopic assembly and method of the present invention is particularly suitable for delivering a self-expanding esophageal stent. The endoscopic assembly in accordance with the present invention, however, could also be used in the neurological system (e.g., in the brain), the vascular system (e.g., in arteries or veins), in the cardiovascular system (e.g., in the heart) and in the like. Reference to bodily passageways may be to passageways in any of the aforementioned tracts and systems or elsewhere in the body.
References herein to the term “distal” and variants thereof refer to a direction away from an operator of the subject invention, while references to the term “proximal” and variants thereof refer to a direction towards the operator of the subject invention. Accordingly, when the terms “distal” and “proximal” are used herein in the context of an assembly device that is being deployed within a body, such as a human body, by an operator, the term “distal” refers to a location within or near the body that is further within the body than a location that is “proximal” to the operator.
The illumination device or channel 20 provides light for the operation of the endoscope 10 within a bodily lumen. The illumination channel or channel 20 may include, but is not limited to, a light emitting diode or a number of light emitting diodes, a fiber optic illumination guide for providing light from a light source, such as a laser or a white light source, and the like. Further a lens (not shown) may also be provided at the distal end of illumination channel or channel 20 to focus the illumination on the bodily lumen or tissue. The visualization device or channel 22 may be used to optically or electrically transmit images through the flexible tubular member 12 of the system 10 of the present invention. The visualization device or channel 22 may include, but is not limited to, an objective lens and fiber optic imaging light guide communicating with a practitioner, a camera, a video display, a cathode ray tube (CRT), a liquid crystal display (LCD), digital light processing (DLP) panel, a plasma display panel (PDP), a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, a sensor, such as a charge-coupled device (CCD) sensor or a complementary metal oxide semiconductor (CMOS) sensor, and the like for use with computer displays, video monitors, televisions and the like.
The endoscopic system 10 of the present invention is depicted in a partial cross-sectional view in
In
The endoscopic system 10 of the present invention may further, and optionally, include an intermediate tubular member 36. As described further below, the intermediate tubular member 36 may be useful for loading the stent 26 within the working channel 18 by, for example, a practitioner or user, where the stent 26 has not been preloaded into the working channel 18 by, for example, the manufacturer of the endoscopic system 10. Additionally, as described below, the intermediate tubular member 36 may also be useful for deploying, repositioning and/or retrieving the stent 26.
As depicted in
Moreover, as depicted in
Further, as depicted in
Alternatively, the stent 26 may be disposed within a loading cartridge (not shown) for facilitating storage and delivery of the stent 26 into the working channel 18. The stent 26 may suitably be loaded in its radially contracted or radially expanded or quiescent state. Desirably, when the stent 26 is a polymeric stent, the stent is stored in the expanded or quiescent state within a loading cartridge or other holding device (not shown). In such a case the stent may be slightly contracted, i.e., less than about five percent radial contraction, so that the stent does not slip or substantially move during transport of handling of the stent holder or stent loading cartridge. The loading cartridge may contain a piston or other axially movable member to facilitate stent movement. Details of suitable stent loading cartridges are further described in U.S. Pat. No. 6,068,635 and/or U.S. Patent Application Publication 2003/0083730 A1, the contents of which are incorporated herein by reference.
As discussed above, the endoscopic system 10 of the present invention may optionally include the intermediate tubular member 36. For example, as depicted in
The flexible tubular endoscopic member 12, the intermediate tubular member 36, and the inner tubular member 32 may also have respective handles 48, 50, 52 to allow the practitioner or user to control the movement of each member. The handles 48, 50, 52 may be moved or manipulated independently of each other or in concert as a pair while keeping the third or non-paired handle fixed or relatively fixed to allow concurrent movement of two tubular members while keeping the third tubular member fixed or relatively fixed. Further, the handles 48, 50, 52 may be lockable and/or unlockable in unison or in any combination of the handles 48, 50, 52. Moreover, the handles 48, 50, 52 of the endoscopic system 10′ may be activated by sliding a button (not shown) on one of the handles or otherwise disposed on the endoscopic system 10′. Such activation may move any or all of the tubular members 12, 36, 32 and/or handles 48, 50, 52.
Furthermore, as depicted in
The tubular members 12, 32, 36 are formed of a body compatible material. Desirably, the biocompatible material is a biocompatible polymer. Examples of suitable biocompatible polymers include, but are not limited to, polyolefins such as polyethylene (PE), high density polyethylene (HDPE) and polypropylene (PP), polyolefin copolymers and terpolymers, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyesters, polyamides, polyurethanes, polyurethaneureas, polypropylene and, polycarbonates, polyvinyl acetate, thermoplastic elastomers including polyether-polyester block copolymers and polyamide/polyether/polyesters elastomers, polyvinyl chloride, polystyrene, polyacrylate, polymethacrylate, polyacrylonitrile, polyacrylamide, silicone resins, combinations and copolymers thereof, and the like. Desirably, the biocompatible polymers include polypropylene (PP), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), high density polyethylene (HDPE), combinations and copolymers thereof, and the like. Materials for the tubular members 12, 32, 36 may be the same or different.
The tubular members 12, 32, 36, may also have a surface treatment and/or coating on their inner surface, outer surface or portions thereof. A coating need not be applied to all of the tubular members 12, 32, 36, and individual members may be coated, uncoated, partially coated, and the like. Useful coating materials include any suitable biocompatible coating. Non-limiting examples of suitable coatings include polytetrafluoroethylene, silicone, hydrophilic materials, hydrogels, and the like. Useful hydrophilic coating materials include, but are not limited to, alkylene glycols, alkoxy polyalkylene glycols such as methoxypolyethylene oxide, polyoxyalkylene glycols such as polyethylene oxide, polyethylene oxide/polypropylene oxide copolymers, polyalkylene oxide-modified polydimethylsiloxanes, polyphosphazenes, poly(2-ethyl-2-oxazoline), homopolymers and copolymers of (meth)acrylic acid, poly(acrylic acid), copolymers of maleic anhydride including copolymers of methylvinyl ether and maleic acid, pyrrolidones including poly(vinylpyrrolidone) homopolymers and copolymers of vinyl pyrrolidone, poly(vinylsulfonic acid), acryl amides including poly(N-alkylacrylamide), poly(vinyl alcohol), poly(ethyleneimine), polyamides, poly(carboxylic acids), methyl cellulose, carboxymethylcellulose, hydroxypropyl cellulose, polyvinylsulfonic acid, water soluble nylons, heparin, dextran, modified dextran, hydroxylated chitin, chondroitin sulphate, lecithin, hyaluranon, combinations and copolymers thereof, and the like. Non-limiting examples of suitable hydrogel coatings include polyethylene oxide and its copolymers, polyvinylpyrrolidone and its derivatives; hydroxyethylacrylates or hydroxyethyl(meth)acrylates; polyacrylic acids; polyacrylamides; polyethylene maleic anhydride, combinations and copolymers thereof, and the like. Additional details of suitable coating materials and methods of coating medical devices with the same may be found in U.S. Pat. Nos. 6,447,835 and 6,890,348, the contents of which are incorporated herein by reference. Such coatings and/or surface treatment is desirably disposed on the inside or a portion thereof of the outer tubular member 12 to aid, if desired, in loading and/or deploying of the stent 26. Further, the outer tubular member 12, and/or other tubular members 32, 36, may also have see-through portions to aid the stent delivery procedure. Such portions may be transparent, substantially transparent, translucent, substantially translucent and the like. Additional details of delivery devices having such transparent and or translucent portions may be found in U.S. Patent Application Publication No. 2003/0050686 A1 to Raeder-Devens et al., the contents of which are incorporated herein by reference.
Any stent that is capable of radial expansion may be used in accordance with the present invention. For example, a radially distensible stent 26 which does not substantially longitudinally elongate upon radial contraction is useful. A non-limiting example of such a stent 26 is one formed from zig-zag or undulating wires or wire as depicted in
As depicted in
The stent 26, 60 may also include inwardly and/or outwardly tapered portions (not shown) and/or inwardly or outwardly flared portions (not shown), such as inwardly or outwardly flared stent end portions. The stent 26, 60 may also be a branched stent (not shown), such as, but not limited to, a bifurcated stent (not shown). The stent 26, 60 may also include apertures and/or discontinuities (not shown) along portions of the stent wall. Furthermore, the ends of the stent 26, 60 may be atraumatic, i.e., ends being free or substantially free of loose wire ends or of other sharp projections.
While the stent 26, 60 may be formed of metals, plastics or other materials, it is preferred that a biocompatible material or construction is employed. Useful biocompatible materials include, but are not limited to, biocompatible metals, biocompatible alloys, biocompatible polymeric materials, including synthetic biocompatible polymeric materials and bioabsorbable or biodegradable polymeric materials, materials made from or derived from natural sources and combinations thereof. Useful biocompatible metals or alloys include, but not limited to, nitinol, stainless steel, cobalt-based alloy such as Elgiloy, platinum, gold, titanium, tantalum, niobium, polymeric materials and combinations thereof. Useful synthetic biocompatible polymeric materials include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalane dicarboxylene derivatives, silks and polytetrafluoroethylenes. The polymeric materials may further include a metallic, a glass, ceramic or carbon constituent or fiber. Useful and nonlimiting examples of bioabsorbable or biodegradable polymeric materials include poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), poly(glycolide) (PGA), poly(L-lactide-co-D,L-lactide) (PLLA/PLA), poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), polydioxanone (PDS), Polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly(phosphazene) poly(D,L-lactide-co-caprolactone) PLA/PCL), poly(glycolide-co-caprolactone) (PGA/PCL), polyphosphate ester) and the like. Further, the stent 26, 60 may include materials made from or derived from natural sources, such as, but not limited to collagen, elastin, glycosaminoglycan, fibronectin and laminin, keratin, alginate, combinations thereof and the like.
Further, the stent 26, 60 may be made from polymeric materials which may also include radiopaque materials, such as metallic-based powders or ceramic-based powders, particulates or pastes which may be incorporated into the polymeric material. For example, the radiopaque material may be blended with the polymer composition from which the polymeric wire is formed, and subsequently fashioned into the stent as described herein. Alternatively, the radiopaque material may be applied to the surface of the metal or polymer stent. Various radiopaque materials and their salts and derivatives may be used including, without limitation, bismuth, barium and its salts such as barium sulfate, tantalum, tungsten, gold, platinum and titanium, to name a few. Additional useful radiopaque materials may be found in U.S. Pat. No. 6,626,936, which is herein incorporated in its entirely by reference. Metallic complexes useful as radiopaque materials are also contemplated. The stent 26, 60 may be selectively made radiopaque at desired areas along the stent or made be fully radiopaque, depending on the desired end-product and application. Further, portions of the stent 26, 60, for example stent filaments, may have an inner core of tantalum, gold, platinum, iridium or combination of thereof and an outer member or layer of nitinol to provide a composite filament for improved radiocapicity or visibility. Alternatively the stent 26, 60 may also have improved external imaging under magnetic resonance imaging (MRI) and/or ultrasonic visualization techniques. MRI is produced by complex interactions of magnetic and radio frequency fields. Materials for enhancing MRI visibility include, but not be limited to, metal particles of gadolinium, iron, cobalt, nickel, dysprosium, dysprosium oxide, platinum, palladium, cobalt based alloys, iron based alloys, stainless steels, or other paramagnetic or ferromagnetic metals, gadolinium salts, gadolinium complexes, gadopentetate dimeglumine, compounds of copper, nickel, manganese, chromium, dysprosium and gadolinium. To enhance the visibility under ultrasonic visualization the stent 26, 60 of the present invention may include ultrasound resonant material, such as but not limited to gold.
Other features, which may be included with the stent 26, 60 of the present invention, include radiopaque markers: surface modification for ultrasound, cell growth or therapeutic agent deliver; varying stiffness of the stent or stent components; varying geometry, such as tapering, flaring, bifurcation and the like; varying material; varying geometry of stent components, for example tapered stent filaments; and the like. The stent struts or filaments may also have any suitable geometry, such as, but not limited to a round cross-sectional geometry, an elliptical cross-sectional geometry, a flat cross-sectional geometry, a square cross-sectional geometry, a triangular cross-sectional geometry, and the like. Such different geometries may be congruent, i.e., substantially the same, or may be varied, for example, having a varying cross-sectional area, e.g., flared. Further, the stent struts and/or filaments may be multifilament members, where the multiple filaments may be the same or different and include, in any combination, any of the above-described biocompatible materials. Moreover, radiopaque markers may be disposed on the stent and/or components of the stent delivery device.
Also, the stent 26, 60 may have coverings, films, coatings, and the like disposed over, under or throughout or embedding the stent 26, 60. For example, as depicted in
Moreover, the stent 60 may include braided polyester filaments, such as PET polyester filaments. Further, in some applications, the stent 60 is desirably embedded in a coating of silicone. Additional details of such desirable stents are described in U.S. Pat. No. 6,162,244, the contents of which are incorporated herein by reference.
Further, the stent 26, 60 may be repositionable, removable and/or reconstrainable, and/or may include multiple interconnected or non-interconnected stents. For example, the stent 26, 60 may include a loop or element such as a suture loop or element, a polymeric loop or element, metallic or element, and combinations thereof which may be accessible to a user or practitioner, for example by the use of forceps, to reposition, remove and/or reconstrain the stent 26, 60 after it has been delivered, partially or totally, to a bodily lumen. Moreover, a loop or element may be integrally formed as part of the stent 26, 60. Further details of useful repositioning, removing and/or reconstraining loops or elements may be found in U.S. patent application Ser. No. 11/341,540, filed Jan. 7, 2006 and entitled “Stent Retrieval Member And Devices And Methods For Retrieving Or Repositioning A Stent” and in U.S. patent application Ser. No. 11/432,065, filed May 11, 2006, attorney docket 792-32, and entitled “Integrated Stent Repositioning And Retrieval Loop”, the contents of both of which are incorporated herein by reference.
Further, the stent 26, 60 may be treated with a therapeutic agent or agents, such as, but not limited to, anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone); anti-proliferative agents (such as enoxaparin, angiopeptin, or monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-miotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides); vascular cell growth promotors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promotors); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.
The systems 10, 10′, 10″ of the present invention may be provided in or with packaging to contain and/or hermetically seal or contain the systems and devices of the present invention. As depicted in
The present invention, however, is not limited to separately a disposed stent engaging member 38 and/or a loading cartridge 84. For example, the engaging member 38 may be disposed at the distal end of the intermediate tubular member 36. In such a case the intermediate tubular member 36 may be formed of a thin polymeric film, for example, but not limited to, polyamide, such as polyamide 6-6 or nylon, PET or PTFE. The film is desirably compliant, so that the funnel is capable of alternatively assuming an open configuration as seen in
In one aspect of the present invention, an endoscopic stent delivery device 10, 10′, 10′″ is provided. The device 10, 10′, 10′″ includes an endoscope 10, 10′, 10″ comprising an elongate shaft 12 comprising a proximal end 14, a distal end 16, an outer wall portion 31 and a longitudinal working channel 18 through the elongate shaft 12 defining an inner wall 30 of the elongate shaft 12; a stent 26, 60 juxtaposingly disposed to a distal portion 14 of the inner wall 30; and an inner tubular member 32 slidably disposed within the working channel 18 and having a stent holding member 34 engaging an interior portion or portions 27, 63, 65 of the stent 26, 60 for releasably securing the stent 26, 30 to the distal portion 14 of the inner wall 30. The device 10, 10′, 10′″ may further include a viewing device 22 disposed at the distal end 14 of the endoscope 10, 10′, 10″ and/or an illuminating device 20 disposed at the distal end 14 of the endoscope 10, 10′, 10″.
The stent holding member 34 may include a tubular band; where the tubular band may partially or completely encompass a portion of the inner tubular member 32. Further, the stent holding member 34 may include elongate, desirably thin, members, which are sometimes referred to as prongs or whiskers that may engage the portions of the stent 26, 60 within the delivery device 10, 10′, 10″ of the present invention. Further details of a stent holding member having such elongate members may be found in U.S. Pat. No. 6,656,212 to Ravenscroft et al., the contents of which are incorporated herein by reference.
Desirably, the elongate shaft 12 is proximally slidable for releasing the stent 26, 60 from the working channel 18. The stent 26, 60 may be a radially distensible stent. Such a stent 26, 60 has a radially contracted state and a larger radially expanded state, where the stent 26, 60 is disposed within the working channel 18 in the radially contacted state. The radially distensible stent 26, 60 may be a polymeric stent, a self-expanding stent, a braided stent 60 and/or a zig-zag stent 26 having a plurality of undulating filament portions, or combinations thereof. The zig-zag stent 26 may further include struts 58 for interconnecting one undulating filament portion to another undulating filament portion.
Further, a graft 64, 66 disposed over at least a portion of the stent 26, 60. The graft 64, 66 may be selected from the group consisting of a covering 64, a liner 66, a film, a coating and combinations thereof. Desirably, the stent 60 is a braided polymeric stent and the graft 64, 66 comprises silicone.
Moreover, the inner tubular member 32 may further include inner and outer telescoping members 32, 36, where the stent 26, 60 is disposed over the inner telescoping member 32. The outer telescoping member 36 typically has a larger outer diameter than an outer diameter of the inner telescoping member 32, where exterior wall portions of the outer telescoping member 36 may juxtaposing abut the inner wall 30 of the elongate shaft 12. Further, the outer telescoping member 36 may abut a proximal end of the stent 26, 60 in the radially contracted state of the stent 26, 60.
The device 10, 10′, 10″ may further include a suture thread 40, 42 having a portion 40 securably attached to a proximal portion of the stent 26, 60, where the inner tubular member 32 further includes a longitudinally extending channel and further where the suture thread 42 longitudinally extends through the longitudinal channel of the inner tubular member 32, whereby a pulling force proximally applied on the suture thread 42 extending through the inner member 32 may proximally move the stent 26, 60 within the working channel 18. The device 10, 10′, 10″ may further include a stent loading member 38 for radially compressing the stent 26, 60 into the working channel 18.
The device 10, 10′, 10″ may further include a package 70, 74, 78, 82 for enclosing the device 10, 10′, 10″ and/or for hermetically sealing the device 10, 10′, 10″ within the package 70, 74, 78, 82.
In another aspect of the invention, an endoscopic stent delivery kit 68, 72, 76, 80 is provided. The kit 72, 76, 80 may include an endoscope 10, 10′, 10″ comprising an elongate shaft 12 comprising a proximal end 14, a distal end 16, an outer wall 31 and a longitudinal working channel 18 through the elongate shaft 12 defining an inner wall 30 of the elongate shaft 12: a radially distensible stent 26, 60 having a radially contracted state and a radially expanded state; an inner tubular member 32 slidable disposed within the working channel 28 and having a stent holding member 34 engaging an interior portion or portions 27, 63, 65 of the stent 26, 60 for releasably securing the stent 26, 60 to the distal portion 14 of the inner wall 30; and a stent loading member 38, 44, 84 for loading the stent 26, 60 into a distal portion 14 of the working channel 18. The stent 26, 60 may be in a radially contracted state, where the stent 26, 60 is disposed within the stent loading member 44. Alternatively, the stent 26, 60 may be in the radially expanded state. Further, the radially expanded stent 26, 60 may be disposed within the stent loading member 84. The kit 68, 72, 76, 80 may further include a package 70, 74, 78, 82 for enclosing the device 10, 10′, 10″ for hermetically sealing the endoscope 10, 10′, 10″, the stent 26, 60, the inner tubular member 32 and the stent loading member within the package 38, 44, 84.
In another aspect of the invention, a method for delivering a stent 26, 60 into a bodily lumen 24 or a method of use is provided. The method or use includes providing an endoscopic stent delivery device 10, 10′, 10″, the device 10, 10′, 10″ includes an endoscope 10, 10′, 10″ including an elongate shaft 12 having a proximal end 14, a distal end 16, an outer wall 31 and a longitudinal working channel 18 though the elongate shaft 12 defining an inner wall 30 of the elongate shaft 12; a stent 26, 60 juxtaposingly disposed to a distal portion 14 of the inner wall 30; and an inner tubular member 32 slidably disposed within the working channel 18 and having a stent holding member 34 engaging an interior portion or portions 27, 63, 65 of the stent 26, 60 for releasably securing the stent 26, 60 to the distal portion 14 of the inner wall 30; and sliding the elongate shaft 12 relative to the inner tubular member 32 to release the stent 26, 60 from the device 10, 10′, 10″. The stent 26, 60 may be released from the endoscopic stent delivery device 10, 10′, 10″ by retracting the elongate shaft 12 to release the stent 26, 60 from the delivery device 10, 10′, 10″ and/or by advancing the inner tubular member 32 to push the stent 26, 60 out of the delivery device 10, 10′, 10′. The step of providing the endoscopic stent delivery device 10, 10′, 10″ may further include a step of loading the stent 26, 60 within the distal portion 14 of the inner wall 30 of the endoscope 10, 10′, 10″. The method may further include radially compressing the stent 26, 60 prior to loading the stent 26, 60 within the distal portion 14 of the inner wall 30 of the endoscope 10, 10′, 10″.
Moreover, some or all of the stent delivery components, such as, but not limited to, the flexible tubular endoscopic member 12, the intermediate tubular member 36, the inner tubular member 32, the stent engaging member 38, the stent holding member 44, and/or the loading cartridge 84, may be mechanically engageable, such as keyed, threaded and/or lockable together, to permit rotation and/or to prevent unwanted misalignment or mispositioning of the stent 20, 26. Furthermore, any of the above-described viewing devices and/or illuminating devices may be disposed on or within or in conjunction with any of the above-described any of the above-described components, for example, tubular members 12, 32, 36, of the endoscope 10, 10′, 10″. Further, the viewing device and the illuminating device may be disposed on different components of the present invention.
The following embodiments or aspects of the invention may be combined in any fashion and combination and be within the scope of the present invention, as follows:
An endoscopic stent delivery device, comprising: an elongate shaft comprising a proximal end, a distal end, an outer wall and a longitudinal working channel through the elongate shaft defining an inner wall of the elongate shaft; a stent juxtaposingly disposed to a distal portion of the inner wall; and an inner tubular member slidably disposed within the working channel and having a stent holding member engaging an interior portion of the stent for releasably securing the stent to the distal portion of the inner wall.
The device of embodiment 1, further comprising a viewing device disposed at the distal end of the elongate shaft.
The device of embodiment 1, further comprising an illuminating device disposed at the distal end of the elongate shaft.
The device of embodiment 1, wherein the stent holding member comprises a tubular band; wherein the tubular band may partially or completely encompass a portion of the inner tubular member.
The device of embodiment 1, wherein the elongate shaft is slidable for releasing the stent from the working channel.
The device of embodiment 1, wherein the stent is a radially distensible stent.
The device of embodiment 6, wherein the stent has a radially contracted state and a larger radially expanded state, and further wherein the stent is disposed within the working channel in the radially contacted state.
The device of embodiment 6, wherein the radially distensible stent is a polymeric stent.
The device of embodiment 6, wherein the radially distensible stent is a self-expanding stent.
The device of embodiment 1, wherein the stent is a braided stent.
The device of embodiment 1, wherein the stent is a zig-zag stent comprising a plurality of undulating filament portions.
The device of embodiment 11, wherein the stent further comprises struts for interconnecting one undulating filament portion to another undulating filament portion.
The device of embodiment 1, further comprising a graft disposed over at least a portion of the stent.
The device of embodiment 13, wherein the graft is selected from the group consisting of a covering, a liner, a film, a coating and combinations thereof.
The device of embodiment 13, wherein the stent is a braided polymeric stent and the graft comprises silicone.
The device of embodiment 1, wherein the inner tubular member comprises inner and outer telescoping members, and further wherein the stent is disposed over the inner telescoping member.
The device of embodiment 16, wherein the outer telescoping member has a larger outer diameter than an outer diameter of the inner telescoping member, and further wherein exterior wall portions of the outer telescoping member juxtaposing abut the inner wall of the elongate shaft.
The device of embodiment 17, wherein the stent is a radially distensible stent having a radially contracted state and a larger radially expanded state, and further wherein the outer telescoping member abuts a proximal end of the stent in the radially contracted state of the stent.
The device of embodiment 1, further comprising a suture thread having a portion securably attached to a proximal portion of the stent, whereby a pulling force applied on the suture thread moves the stent within the working channel.
The device of embodiment 19, further comprising a stent loading member for radially compressing the stent into the working channel.
The device of embodiment 1, further comprising a package for enclosing the device for hermetically sealing the device within the package.
An endoscopic stent delivery kit, comprising: an elongate shaft comprising a proximal end, a distal end, an outer wall and a longitudinal working channel through the elongate shaft defining an inner wall of the elongate shaft; a radially distensible stent having a radially contracted state and a radially expanded state; and an inner tubular member slidable disposed within the working channel and having a stent holding member engaging an interior portion of the stent for releasably securing the stent to the distal portion of the inner wall.
The kit of embodiment 22, further comprising a stent loading member for loading the stent into a distal portion of the working channel.
The kit of embodiment 22, wherein the stent is in the radially contracted state, and further wherein the stent is disposed within the stent loading member.
The kit of embodiment 22, wherein the stent is in the radially expanded state.
The kit of embodiment 25, wherein the radially expanded stent is disposed within the stent loading member.
The kit of embodiment 22, further comprising a package for enclosing the device for hermetically sealing the endoscope, the stent, the inner tubular member and the stent loading member within the package.
A method for delivering a stent into a bodily lumen, comprising (a.) providing an endoscopic stent delivery device, the device comprising: (i.) an elongate shaft comprising a proximal end, a distal end, an outer wall and a longitudinal working channel through the elongate shaft defining an inner wall of the elongate shaft; (ii.) a stent juxtaposingly disposed to a distal portion of the inner wall; and (iii.) an inner tubular member slidably disposed within the working channel and having a stent holding member engaging an interior portion of the stent for releasably securing the stent to the distal portion of the inner wall; and (b.) sliding the elongate shaft relative to the inner tubular member to release the stent from the device,
The method of embodiment 28, wherein the step of providing the endoscopic stent delivery device further comprises: loading the stent within the distal portion of the inner wall of the endoscope.
The method of embodiment 29, further comprising: radially compressing the stent prior to loading the stent within the distal portion of the inner wall of the endoscope.
While various embodiments of the present invention are specifically illustrated and/or described herein, it will be appreciated that modifications and variations of the present invention may be effected by those skilled in the art without departing from the spirit and intended scope of the invention. Further, any of the embodiments or aspects of the invention as described in the claims or in the specification may be used with one and another without limitation.
This application is a continuation of U.S. application Ser. No. 11/861,565, filed Sep. 26, 2007, which claims the benefit of U.S. Provisional Application No. 60/897,382, filed Jan. 25, 2007, the contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60897382 | Jan 2007 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11861565 | Sep 2007 | US |
| Child | 14814909 | US |
