Source: http://www.google.com/patents/US8221390?dq=5636223
Timestamp: 2017-02-22 11:20:16
Document Index: 129831860

Matched Legal Cases: ['§119', '§119', '§119', '§119', '§119', '§119', '§119']

Patent US8221390 - Medical device delivery system having a sheath with a flared strain relief ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA flared strain relief member for medical device delivery systems for stents, prosthetic valve devices, and other implantable articles inside a patient's body are provided. An elongate outer sheath has proximal and distal end portions defining a passageway, and the proximal end portion having an outer...http://www.google.com/patents/US8221390?utm_source=gb-gplus-sharePatent US8221390 - Medical device delivery system having a sheath with a flared strain relief member operatively coupled by a unidirectional handleAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS8221390 B2Publication typeGrantApplication numberUS 11/787,376Publication dateJul 17, 2012Filing dateApr 16, 2007Priority dateApr 20, 2006Fee statusPaidAlso published asUS20070250150Publication number11787376, 787376, US 8221390 B2, US 8221390B2, US-B2-8221390, US8221390 B2, US8221390B2InventorsDharmendra Pal, Jeffry S. MelsheimerOriginal AssigneeCook Medical Technologies LlcExport CitationBiBTeX, EndNote, RefManPatent Citations (30), Non-Patent Citations (4), Referenced by (2), Classifications (48), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetMedical device delivery system having a sheath with a flared strain relief member operatively coupled by a unidirectional handle
The present patent document claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Ser. No. 60/793,709, filed on Apr. 20, 2006, which is hereby incorporated by reference.
This disclosure relates generally to medical device delivery systems, and in particular, to a flared strain relief member disposed about a proximal end portion of an elongate sheath. More particularly, the disclosure relates to a flared strain relief member operatively coupled to a medical device delivery system that employs a unidirectional handle. These systems have a host of uses, including for example, the deployment of rapid insertion self-expanding devices such as stents, prosthetic valve devices, and other implantable articles inside a patient's body (individually and collectively, “stent” or “stents”). Exemplary embodiments of medical device delivery systems have been described in the U.S. Provisional Patent Application filed on Apr. 20, 2005 entitled, “Delivery System and Devices for the Rapid Insertion of Self-Expanding Devices” and having an application Ser. No. 60/673,199, and the non-provisional application filed on Apr. 20, 2006 by the same title and claiming the benefit of the filing date application Ser. No. 60/673,199 under 35 U.S.C. §119(e), the disclosures of which are incorporated in its entirety. The strain relief member may also be used, however, with balloon expandable and non-expanding stents. In addition to being used with a rapid insertion delivery system, the strain relief member may be used in an “over-the-wire” delivery system, so both systems will be described below.
The outer sheath 50 for use with the middle section delivery device 14, and the outer guide channel member 80 (FIGS. 4-7) and/or the inner guide channel member 70 (FIGS. 4-7) for use with the system distal portion 13, are available for purchase from Cook Incorporated, of Bloomington, Ind. under the trade name of “Flexor®.” Examples of the Flexor® sheath devices, materials, and methods of manufacturing them are found in U.S. Pat. Nos. 5,700,253 and 5,380,304, the contents of which are incorporated herein by reference. The Flexor® sheath is particularly suited for the outer sheath 50 of the middle section delivery device 14 and/or the outer guide channel member 80 of the system distal portion 13 due to its thin PTFE liner on the inside wall of the inner layer 44, thin flat wire coil 43, and Nylon and/or PEBA overcoat 42 that captures the coil 43 and PTFE liner 44 and binds the structure together. The PTFE inner layer 44 of the Flexor® sheath resists an expansile inner object from protruding or becoming embedded into the inner layer 44 and, thereby, provides a slick, smooth surface that slides (e.g., across the surface of a stent if the Flexor® sheath is used with the system distal portion 13 or across the surface of an inner compression member 41 if the Flexor® sheath is used with the middle section delivery device 14) relatively easily when retracted to expose, release, and deploy the stent or allow the outer sheath 50 to move relative to the inner compression member 41, and the outer guide channel member 80 to move relative to the inner guide channel member 70, during deployment of the stent.
It should be understood that the diameter, width, and/or cross-section of the inner compression member 41 may taper. For example, the inner compression member 41 may taper toward the distal end as taught in the U.S. Provisional Patent Application filed on Jan. 23, 2006 entitled, “Tapered Inner Compression Member and Tapered Inner Guide Channel Member for Medical Device Delivery Systems,” and having an application Ser. No. 60/761,676, and the non-provisional application filed-on Apr. 20, 2006 by the same title and claiming the benefit of the filing date application Ser. No. 60/761,676 under 35 U.S.C. §119(e), the disclosures of which are incorporated in its entirety.
In one embodiment, the Flexor® sheath, manufactured and sold by Cook Incorporated of Bloomington, Ind., may be adapted for use with the system distal portion 13 and/or the middle section delivery device 14. Otherwise stated, the Flexor® sheath, as shown in FIG. 3 and described above, may be provided for the system distal portion 13 and/or the middle section delivery device 14. For instance, the system distal portion 13 may be constructed as comprising an integral Flexor® sheath tube with the middle section delivery device 14. Alternatively, a Flexor® tubing may be used for either the middle section delivery device 14 or the system distal portion 13, or both. Then, the separable middle section delivery device 14 and system distal portion 13 may be attached, adjoined, joined, or combined as taught in the U.S. Provisional Patent Application filed on Apr. 20, 2005 entitled, “Delivery System and Devices for the Rapid Insertion of Self-Expanding Devices” and having an application Ser. No. 60/673,199, and the non-provisional application filed on Apr. 20, 2006 by the same title and claiming the benefit of the filing date application Ser. No. 60/673,199 under 35 U.S.C. §119(e), the disclosures of which are incorporated in its entirety, and/or the U.S. Provisional Patent Application filed on Jan. 23, 2006 entitled, “Melt-Bonded Joint for Joining Sheaths Used in Medical Devices, and Methods of Forming the Melt-Bonded Joint” and having an application Ser. No. 60/761,594, and the non-provisional application filed on Apr. 20, 2006 by the same title and claiming the benefit of the filing date application Ser. No. 60/761,594 under 35 U.S.C. §119(e), the disclosures of which are incorporated in its entirety.
The Flexor® sheath has a PTFE inner lining 44 that provides a slick, smooth surface for sliding the outer sheath 50 and/or the outer guide channel member 80 proximally. With regard to the system distal portion 13, the outer guide channel member 80 slides relative to the inner guide channel member 70, and the outer guide channel member inner surface 92 would be the inner layer 44 described above, thereby resulting in minimal friction to a stent 17 on the stent platform 91. The slidable inner surface 92 of the Flexor® sheath exhibits a second benefit of minimizing damage or misalignment to the stent. Indeed, because self-expanding stents continuously exert an expanding force against the inside surface 92 of the outer guide channel member 80, any substantial friction or drag between the stent and the inner surface 92 of the outer guide channel member 80 as the outer guide channel member 80 withdraws may damage the stent or cause the stent to be deployed slightly off of the target site.
The thin flat wire reinforcing coil 43 of the Flexor® sheath provides the outer guide channel member 80 with the necessary radial strength to constrain the stent over long periods of storage time. In contrast, where the inner surface 92 of an outer guide channel member 80 does not comprise the Flexor® sheath inner layer 44 or equivalent, the stent over time may tend to become imbedded in the inner surface 92 and, as a result, interfere with retraction of the outer guide channel member 80 at the time of deployment. In an outer guide channel member 80 that comprises a Flexor® sheath, in addition to the inner layer 44 and the reinforcing coil 43, the outer guide channel member 80 has a Flexor® sheath outer layer 42. The outer layer 42 comprises nylon and/or PEBA to provide the necessary stiffness for pushability, retraction, and control of the outer guide channel member 80 to facilitate proper deployment of the constrained self-expanding stent. Therefore, the Flexor® sheath is one non-limiting example of an embodiment of an outer sheath 50 and/or an outer guide channel member 80.
Furthermore, the outer guide channel member 80 has a stepped 84, 85 profile, whereby the outer guide channel member 80 comprises a first outer diameter 84 intermediate the outer guide channel member first and second end portions 88, 87, respectively, and a second smaller outer diameter 85 located at or near the outer guide channel member second end portion 87 in the vicinity of the transition region 60 and the breech position opening 65. The stepped 84, 85 profile includes an embodiment where the outer guide channel member 80 transitions to the distal end portion 58 of the outer sheath 50 of the middle section delivery device 14. In describing embodiments, however, the stepped 84, 85 profile shall be discussed in reference to the outer guide channel member 80 in particular, but it should be understood as including a stepped 84, 85 profile in reference to the transition region 60 of the system distal portion 13 relative to the middle section delivery device 14 where the middle section delivery device 14 and system distal portion 13 are formed from separate units such as, by way of example only and not by way of limitation, separate “Flexor®” sheaths where one comprises a first outer diameter 84 and the other comprises a second smaller outer diameter 85.
In one embodiment, the inner compression member outer engaging surface 48′ may form a melt bond 47 to an inner surface 101 of the inner guide channel member second end portion 77. Alternatively, the inner compression member outer engaging surface 48′ may form a melt bond 47 to the outer surface 102 of the inner guide channel second end portion 77. In yet another embodiment, the distal mating end portion 48 of a solid inner compression member 41 as shown in FIG. 4 is implanted 49 between (and/or melt bonded 47 to one or both of the) inner and outer surfaces 101, 102, respectively, of the inner guide channel member second end portion 77, as taught in U.S. Provisional Patent Application filed on Jan. 23, 2006 entitled, “Internal Joint for Medical Devices, and Methods of Making the Internal Joint,” and having an application Ser. No. 60/761,313, and the non-provisional application filed on Apr. 20, 2006 by the same title and claiming the benefit of the filing date application Ser. No. 60/761,313 under 35 U.S.C. §119(e), the disclosures of which are incorporated in its entirety. In still another embodiment, an insert body operatively couples the inner compression member 41 and the second end portion 77 of the inner guide channel member 70, as taught in U.S. Provisional Patent Application filed on Jan. 23, 2006 entitled, “Internal Cannulated Joint for Medical Delivery Systems,” and having an application Ser. No. 60/761,565, and the non-provisional application filed on Apr. 20, 2006 by the same title and claiming the benefit of the filing date application Ser. No. 60/761,565 under 35 U.S.C. §119(e), the disclosures of which are incorporated in its entirety.
In one embodiment, PEEK material is used for the melt bonding material. PEEK melts at about 633° F., so the material may be heated from about 628° F. to about 638° F. For instance, a radiofrequency loop heater may be used for heating the melt bonding materials. Such a machine is available from Magnaforce, Incorporated and sold under the name and model Heatstation 1500. Another such machine is available from Cath-Tip, Inc. and is sold under the model and name Cath-Tipe II. There is a rise dwell and cool down time for the process. The total rise time is approximately 20 seconds and dwell time is approximately 10 seconds. During the dwell time the temperature is approximately 600° F. In one embodiment where nylon or PEBA are used, heating is at about 400° F., with dwell time of about 10 seconds.
FIGS. 4A and 4B present a schematic representation of a cross section 105 of components before and after melt bonding according to one embodiment. The cross section 105 of FIG. 4A, for example, represents an inner component 106, middle component 107, and outer component 108. While all components are shown having abutting interfaces in physical abutting contact, they need only be close enough to form a melt bond therebetween. Indeed, as previously explained in connection with the Flexor® sheath's outer layer 42 and inner layer 44, there may even be a middle layer comprising a coil 43 having spacings 43′ through which the melt bonding material of the outer layer 42 may move to be into contact with the inner layer 44.
FIG. 4B shows some of the first melt bonding material 109 of the middle component 107 moving into some of the second melt bonding material 109′ of the outer component 108. Likewise, some of the second melt bonding material 109′ of the outer component 108 moves into some of the first melt bonding material 109 of the middle component 107. It should be noted that both of the first and second materials 109, 109′ need not move into the other. Rather, the first and second materials 109, 109′ need only bond at an interface, with or without mixing and the like. By way of example, the Flexor® sheath's outer layer 42 may melt to the middle layer coil 43 (which has not melted) and bond to the outer surface of the inner layer 44 with or without the outer surface of the inner layer 44 melting into the outer layer 42.
Melt-bonding material(s) may, by way of example only and not by way of limitation, include one or combination of nylon, nylon natural tubing, polyether block amide (PEBA), polyetheretherketone (PEEK), thermoplastic, acrylonitrile-butadiene-styrene copolymer (ABS plastic), polypropylene, polyamide, ionomer, polycarbonate, polyphenylene oxide (PPO), polyphenylene sulphide (PPS), acrylic, liquid crystal polymer (LCP), polyolefin, polyethylene acrylate acid, polyvinylidene fluoride (PVDF), polyvinyl, and polyvinyl chloride (PVC) (collectively and individually, “nylon” and/or “PEBA”). Pebax® PEBA is one commercially available melt-bonding material, and is available from the Arkema Group.
In one embodiment where PEEK tubing is used for the strain relief member 29, because PEEK melts at about 633° F., the inner guide channel member second end portion 77 is heated from about 628° F. to about 638° F. There is a rise dwell and cool down time for the process. The total rise time is approximately 20 seconds and dwell time is approximately 10 seconds. During the dwell time the temperature is approximately 600 F. In one embodiment where nylon or PEBA are used for the strain relief member 29, heating step 212 is at about 400° F. The dwell time heating step 212 is about 10 seconds.
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2013Medtronic Vascular, Inc.Reconfigurable stent-graft delivery system and method of use* Cited by examinerClassifications U.S. Classification604/538, 623/1.12, 604/536, 606/108, 604/535, 623/1.11International ClassificationA61M25/18, A61M25/16Cooperative ClassificationB29C66/91411, B29C66/91933, B29C66/91931, B29C66/91935, B29C66/91445, B29K2027/16, B29K2023/00, B29K2009/06, B29K2027/06, B29C65/04, B29K2023/12, B29C66/0342, B29K2096/005, A61M2025/0098, B29C65/02, A61M25/005, A61M25/0097, A61F2/95, A61M25/0053, B29C66/919, B29K2071/12, B29K2101/12, B29K2069/00, B29C66/63, B29K2077/00, B29K2055/02, B29C57/04, B29L2031/605, B29C66/50, B29K2105/0079, B29B13/025, B29C66/949, B29K2081/04, B29C65/68, A61F2/2436, B29K2071/00European ClassificationA61F2/24H, A61M25/00V, B29B13/02D2B, A61F2/95Legal EventsDateCodeEventDescriptionJun 15, 2007ASAssignmentOwner name: COOK INCORPORATED, INDIANAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PAL, DHARMENDRA;MELSHEIMER, JEFFRY S.;REEL/FRAME:019437/0502Effective date: 20070524Jun 11, 2012ASAssignmentOwner name: COOK MEDICAL TECHNOLOGIES LLC, INDIANAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:COOK INCORPORATED;REEL/FRAME:028352/0908Effective date: 20120430Dec 29, 2015FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services