Source: http://www.google.ca/patents/US8579954
Timestamp: 2017-12-16 03:47:43
Document Index: 234311827

Matched Legal Cases: ['Application No. 04758233', 'Application No. 06802753', 'Application No. 2004226464', 'Application No. 2005050976', 'Application No. 2006', 'Application No. 04758233', 'Application No. 04758233', 'Application No. 06802753', 'Application No. 2005050976']

Patent US8579954 - Untwisting restraint implant delivery system - Google Patents
Medical devices and methods for delivery or implantation of prostheses within hollow body organs and vessels or other luminal anatomy are disclosed. The subject technologies may be used in the treatment of atherosclerosis in stenting procedures or be used in variety of other procedures. The systems may...http://www.google.ca/patents/US8579954?utm_source=gb-gplus-sharePatent US8579954 - Untwisting restraint implant delivery system
Publication number US8579954 B2
Application number US 11/342,316
Also published as CN101365401A, CN101365401B, EP1959862A2, EP1959862A4, EP2340790A1, EP2340790B1, US7862602, US8273116, US8900285, US8974509, US20070100414, US20070100415, US20070100416, US20070100417, US20070100418, US20070100419, US20110160835, WO2007055780A2, WO2007055780A3
Publication number 11342316, 342316, US 8579954 B2, US 8579954B2, US-B2-8579954, US8579954 B2, US8579954B2
Inventors David Licata
Original Assignee Biosensors International Group, Ltd.
Patent Citations (389), Non-Patent Citations (25), Referenced by (14), Classifications (9), Legal Events (3)
Untwisting restraint implant delivery system
US 8579954 B2
1. A method of maintaining a self-expanding stent on a delivery guide, the method comprising:
twisting a stent, which comprises a lattice of closed cells, to a reduced profile, wherein the stent comprises a plurality of near end projections and a plurality of far end projections, wherein the stent is releaseably secured to a delivery guide through said projections, and wherein twisting the stent comprises rotating the near end projections or the far end projections relative to other; and
holding the stent twisted by maintaining at least one rotatable seat in a fixed position, wherein the at least one rotatable seat is secured to the delivery guide and coupled to the near end projections or the far end projections the stent.
2. The method of claim 1, wherein maintaining the at least one rotatable seat in a fixed position comprises maintaining the at least one rotatable seat in a fixed rotational position relative to the delivery guide.
3. The method of claim 2, wherein maintaining the at least one rotatable seat in a fixed position comprises maintaining the at least one rotatable seat in a fixed position with a member having an electrolytically erodable sacrificial section.
4. The method of claim 3, wherein the far end projections are coupled to said at least one rotatable seat and said near end projections are releasably secured to another seat coupled to the delivery guide and a second member is wrapped around the another seat and at least a portion of the near mating portion.
5. The method of claim 1, wherein the delivery guide has a crossing profile in the range of about 1 French to about 2 French.
6. The method of claim 1, wherein allowing the stent to untwist and expand causes the length of the stent to shorten.
7. The method of claim 1, wherein the delivery guide is a guidewire.
8. The method of claim 1, wherein each closed cell comprises a plurality of struts including a first pair of axially adjacent and interconnected struts and a second pair of axially adjacent and interconnected struts, one strut of the first pair being connected to the one strut of the second pair through a strut junction.
9. The method of claim 1, wherein each closed cell consists of four interconnected struts.
Various stent designs have been developed and used clinically, but self-expandable and balloon-expandable stent systems and their related deployment techniques are now predominant. Examples of self-expandable stents currently in use are the Magic WALLSTENT® stents and Radius stents (Boston Scientific). A commonly used balloon-expandable stent is the Cypher® stent (Cordis Corporation). Additional self-expanding stent background is presented in: “An Overview of Superelastic Stent Design,” Min. Invas Ther & Allied Technol 2002: 9(3/4) 235-246, “A Survey of Stent Designs,” Min. Invas Ther & Allied Technol 2002: 11(4) 137-147, and “Coronary Artery Stents: Design and Biologic Considerations,” Cardiology Special Edition, 2003: 9(2) 9-14, “Clinical and Angiographic Efficacy of a Self-Expanding Stent” AM Heart J 2003: 145(5) 868-874.
Another class of retainers or retaining and release means or releaseable means comprises an overriding means or covering including at least one electrolytically erodable section that releasably secures ends of an implant in association with a seating portion or portions of a delivery guide. In one variation, the means comprises a-wrap or band or plurality of bands. Upon release of one or more sections, the band opens or wrap loosens. In another variation, the radial retention member comprises a sleeve or casing with one or more electrolytically erodable sections that allow (or upon release, cause) the structure to open. Such a “flower petal” type design may be soldered or welded together in a pre-stressed state in order that it self expands upon eroding connecting webbing, solder, weld point(s), etc.
As with the above variation of the invention in which retention members pass through one or more portions of the implant, those retention members that overlay one or more portions of the implant may secure the proximal and/or distal side the implant or point(s) between. They may be used in complimentary pairs or with other structures as is convenient. In the latter example, either one of the wrap-around or openable sleeve retainer may be set at the distal end of the stent with a mechanical release mechanism positioned at the proximal side of the stent. Examples of such mechanically-actuated systems including retractable mini-sheaths and wire or suture cut-down bands are presented in U.S. patent application Ser. No. 11/266,587, entitled, “Twist-Down Implant Delivery Technologies” filed on Nov. 2, 2005, which application is incorporated herein by reference in its entirety.
This unwinding of the spring is accomplished by releasing the pre-twist imparted to the adjoining implant. Until released, the spring is held twisted by the twisted implant interfacing with keys or ridge features underlying the sleeve.
When the twisted implant (be it a stent or another medical device) is released, the spring also untwists and is freed from its cinched-down configuration—thereby allowing its retraction from a stretched-out/preloaded state.
A “wire” as used herein generally comprises a common metallic member such as made of stainless steel or another material. The wire may be at least partially coated or covered by a polymeric material (e.g., with an insulating polymer such as Polyamide, or a lubricious material such as TEFLON®, i.e., PolyTetraFluoroEthelyne or PTFE). Still further, the “wire” may be a hybrid structure with metal and a polymeric material (e.g., Vectran™, Spectra™, Nylon, etc.) or composite material (e.g., carbon fiber in a polymer matrix). The wire may be in the form of a filament, bundle of filaments, cable, ribbon or in some other form. It is generally not hollow. The wire may comprise-different segments of material along an overall length.
FIGS. 22A and 22B show two states of a distal portion of a delivery system resembling that in FIGS. 21A and 21 B, where the auto-releasing member effects withdrawal of a restraint covering at least a portion of a body of an implant;
Before this discussion, however, it is noted that systems according to the present invention are advantageously sized to correspond to existing guidewire sizes. For example, the system may have about a 0.014 (0.36mm), 0.018 (0.46mm), 0.022 (0.56mm), 0.025 (0.64mm), 0.035 (0.89mm) inch crossing profile. Of course, intermediate sizes may be employed as well, especially for full-custom systems. Still further, it is contemplated that the system sizing may be set to correspond to French (FR) sizing. In that case, system sizes contemplated range at least from about 1 to about 2 FR, whereas the smallest known balloon-expandable stent delivery systems are in the size range of about 3 to about 4 FR. In instances where the overall device crossing profile matches a known guidewire size, they may be used with off-the-shelf components such as balloon and microcatheters.
At least when produced in the smallest sizes (whether in an even/standard guidewire or FR size, or otherwise), the system enables a substantially new mode of stent deployment in which delivery is achieved through an angioplasty balloon catheter or small microcatheter lumen. Further discussion and details of “through the lumen” delivery is presented in U.S. patent application Ser. No. 10/746,455 “Balloon Catheter Lumen Based Stent Delivery Systems” filed on Dec. 24, 823 and its PCT counterpart US824/008909 filed on Mar. 23, 824, each incorporated by reference in its entirety.
Turning to FIG. 4A, it shows a coronary artery 60 that is partially or totally occluded by plaque at a treatment site/lesion 62. Into this vessel, a guidewire 70 is passed distal to the treatment site. In Fig, 4B, a balloon catheter 72 with a balloon tip 74 is passed over the guidewire, aligning the balloon portion with the lesion (the balloon catheter shaft proximal to the balloon is shown in cross section with guidewire 70 therein).
However, it should be appreciated that such an exchange need not occur.
Rather, the original guidewire device inside the balloon catheter (or any other catheter used) may be that of item 80, instead of the standard guidewire 70 shown in FIG. 4A. Thus, the steps depicted in FIGS. 4E and 4F (hence, the figures also) may be omitted.
Now that stents as optionally used in the subject delivery systems have been described, an overview of an implant delivery system according to the invention is presented in FIG. 5. Here an implant delivery system 100 is shown as including a delivery guide 102 with a handle 104, an elongate body 106 with a distal implant carrying section 108 and terminating in an atraumatic coil tip 110.
The handle may incorporate a circuit board 112 and one or more batteries (e.g., lithium ion “coin” cells) to provide power to the system's electrolytic features.
Before describing these systems, however, it is noted that FIG. 5 also shows packaging 150 containing at least one coiled-up delivery guide 102. Packaging may include one or more of an outer box 152 and one or more inner trays 154, 156 with peel-away coverings as is customary in medical device product packaging. Naturally, instructions for use 158 may also be provided.
Such instructions may be printed product included within packaging 150 or be provided in connection with another readable (including computer-readable) medium. The instructions may include provision for basic operation of the subject devices and associated methodology. In cases where computer-readable media is provided, it may even include programming for a power supply for use in connection with a general purpose computer or more customized hardware to set and/or run the desired approach to powering activity of the delivery guide.
As for the specific example of loading, FIG. 6A shows stent 82 captured within a temporary restraint 160 and set over a delivery guide distal section 108.
Its placement therein causes the stent to lengthen to about its full extent. The stent 82 includes projections serving as near and far mating portions 92, 94 interfacing with proximal seat and distal seat features 200, 202, respectively. Further details of the seat features and associated features are discussed below. Suffice it to say, here, that each of the seats may—at first—be free to rotate.
For use in such a system, various stent end receptacle 190 configurations are shown in FIGS. 8A-8C. In FIGS. 8A and 8B, the receptacle is integrated with the cell structure of the stent. In FIG. 8B, the struts include an additional relieved section 192 to relieve stress from the end of the crown. In FIGS. 8C and 8D, a separate aperture 194 is provided adjacent the strut ends to receive the elongate member that passes therethrough. While the implant may not be as compact (overall) if produced in such a manner, addition benefits in term of design flexibility or performance may be realized by such an approach. An example of which may be presented in FIG. 8D which combines the features shown in FIGS. 8B and 8C.
While in this variation of the invention at least one of the ends of the stent will be held by an electrolytically releasable latch, one side may be mechanically released. In the case shown in FIG. 10A, such release may be effected by withdrawal of the sleeve like a sheath. Further examples are provided below, in the above-referenced “Twist-Down Implant Delivery Technologies” case incorporated herein by reference. In any case, FIG. 10B shows the manner in which the body of the stent assumes an essentially cylindrical profile with no external confinement by virtue of the twist imparted thereto. FIG. 10C shows the far end of the stent with ribbon 206 neatly securing the keyed interface.
To release the stent-received within seat 202, sacrificial latch section 184 is eroded thereby untwisting assembly 266 rotates. The rotation causes the associated stent to untwist and expand. The expansion results in foreshortening that pulls the stent's distal projections out of capped slot 268.
In the present invention, a DC voltage component is likewise applied to effect corrosion/erosion of the implant release means. And while adding an AC voltage component for sensing purposes is known (e.g., as described U.S.Pat.No. 5,569,245 to Guglielmi, et al.; U.S. Pat. No. 5,643,254 to Scheldrup, et al.) the invention hereof does so and uses the AC voltage in a very different manner.
Regardless of how it is generated, FIG. 26 shows an exemplary power profile as may be used with the current invention. The Figure shows a square wave at about 110 kHz with a 10V peak to peak (10Vpp) AC component that is offset by a 2.2V DC signal.” This results in a square wave with a 7.2V peak and −3.8V trough. Through testing is has been appreciated that such a power profile erodes sacrificial material in an electrolytic solution much faster than would DC signal alone. Indeed, testing has shown that using DC voltage alone at steady state voltages below 2.5V results in very long erosion times (i.e., upwards of 2 minutes to erode 0.003 inch diameter wire) and providing power at 2V will often not erode stainless steel wire at all. With the addition of an AC profile of at least 4Vpp, however, the DC component could drop to as low as about 1V to about 1.5V giving a resulting waveform with a peak from 3 to 3.5V and a trough from −1 to −0.5V and still offer an acceptable rate of corrosion.
The impact of AC voltage on actual erosion/corrosion rates during bench tests of tensioned .002″ stainless steel wire was conducted. Setups were provided in which an insulated wire was equally tensioned and exposed along a 0.020 inch long section. The wires were placed in 38° porcine blood and power was applied. When applying 2V DC, it took 3-4 minutes to break the wire. When applying 2V DC and 10Vpp AC, time to separation ranged from 20-30 seconds. The setups tested under DC-only conditions were observed to generate roughly 0.040 inch balls of electrocoagulation on the ends of the wire opposite the eroded section. In marked contrast, the AC/DC power driven setups showed no visible electrocoagulation.
Tests were conducted to determine the improvement offered over the power supply provided by Target Therapeutics for detatching GDC® coils. First a comparative model was developed. The electrolytic “joint” in a GDC system was determined to be about a 0.005 inch long, 0.003 inch diameter stainless steel wire. In 38° porcine blood, with the Target Therapeutics power supply set at a 1mA currently delivery setting, voltage metered by the power supply initially showed at 3V, rose to 6.5V for the majority of the deployment time, and then rose to 8V. Over a deployment time measured at 40 seconds, the average voltage observed was about 6.5V. In addition, a ball of electrocoagulation having about a 1/32 inch diameter was observed.
A “test joint” model was developed to compare a number of samples in performance. It employed a roughly identically sized exposed wire extension as described above, but no occlusive coil attached thereto. In eroding the wire extension with the Target Therapeutics power supply set at a constant 1mA current, significant variability about the above referenced GDC test results was observed. Voltage varied over a greater range from 1.9V to 9V. Time to complete erosion ranged from 40-50 seconds irrespective of such variance. Average voltage was about 4V. Electrocoaguation was observed on all samples. In instances where voltage climbed to about 6V, similarly large 1/32 inch diameter balls of electrocoagulation were observed. When applying a 2.5V DC with 10Vpp AC signal to test joint systems, current floated between 0.5 and 0.75ma. Deployment times were consistently about 50 seconds. No electrocoagulation was visible upon inspection.
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US20120215152 * 21 Feb 2012 23 Aug 2012 Gi Dynamics, Inc. Bariatric sleeve
U.S. Classification 623/1.11, 623/1.12
Cooperative Classification A61F2002/9522, A61F2250/0071, A61F2/95, A61F2/88, A61F2002/9511, A61F2002/9505
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:LICATA, DAVID;REEL/FRAME:017883/0698