AU2014202338B2 - Medical device fixation anchor suited for balloon expandable stents - Google Patents

Medical device fixation anchor suited for balloon expandable stents Download PDF

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Publication number
AU2014202338B2
AU2014202338B2 AU2014202338A AU2014202338A AU2014202338B2 AU 2014202338 B2 AU2014202338 B2 AU 2014202338B2 AU 2014202338 A AU2014202338 A AU 2014202338A AU 2014202338 A AU2014202338 A AU 2014202338A AU 2014202338 B2 AU2014202338 B2 AU 2014202338B2
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expansion
medical device
barb
anchor
expandable
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AU2014202338A1 (en
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John R. Daugherty
Edward E. Shaw
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WL Gore and Associates Inc
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WL Gore and Associates Inc
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Priority claimed from AU2010260540A external-priority patent/AU2010260540A1/en
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Priority to AU2014202338A priority Critical patent/AU2014202338B2/en
Publication of AU2014202338A1 publication Critical patent/AU2014202338A1/en
Assigned to W. L. GORE & ASSOCIATES, INC. reassignment W. L. GORE & ASSOCIATES, INC. Request for Assignment Assignors: GORE ENTERPRISE HOLDINGS, INC.
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Abstract

A medical fixation device, comprising a balloon expandable anchor having a device attachment portion to couple said balloon expandable anchor to an expandable medical device having a first compacted profile and a second expanded profile, an expansion bearing portion, and a barb portion; the anchor expansion bearing portion being positioned between the anchor device attachment portion and the anchor barb portion; the expandable anchor being positioned within the first compacted profile; and the expandable anchor being deformed by internal balloon pressure to extend the anchor barb portion outside the second expanded profile.

Description

TITLE OF THE INVENTION MEDICAL DEVICE FIXATION ANCHOR SUITED FOR BALLOON EXPANDABLE STENTS Cross Reference To Related Applications This application is a divisional application of Australian patent application no. 2010260540 filed on 17 June 2010, which is incorporated herein by reference. BACKGROUND OF THE INVENTION Field of the Invention The invention relates to a medical device fixation anchor and in particular with an anchor that is suitable for use with a balloon expandable stent. Discussion of the Related Art Various medical devices require some form of fixation or anchoring to a targeted site. Common anchoring means include barbs, hooks, sutures, or other features used to attach a device to the surrounding anatomy. Some examples of devices requiring a means to anchor include vena-cava filters, stents, stent grafts, bile/urinary duct stents, intestinal/gastro stents and liners, occluders, electrophysiological leads, various monitors or diagnostic devices, central venous catheters, and other devices. Many of these devices incorporate a balloon expandable component that is expanded to bear against the surrounding anatomy, thus providing an anchoring means. The degree of positional anchoring of the medical device is normally dependent upon the degree of "over-expansion" of the balloon expandable component. When over-expanded, the expandable portion is aggressively forced against the surrounding anatomy, affecting a frictional or "interference-fit" means of anchoring. If the degree of over- expansion is excessive, the surrounding anatomy can be damaged. Conversely, if the degree of over-expansion is 7518439_1 (GHMatters) P89104.AU.1 1 minimal, the device may dislodge due to poor anchoring. An improved means of anchoring a balloon expandable component incorporates expandable anchors or barbs. These expandable anchors eliminate the need for aggressive over-expansion and provide a degree of anchoring if the over-expansion is minimal. An improved, balloon expandable anchor can also improve the retention of the expandable component to the balloon. The improved balloon expandable anchors can be contained within the profile of the expandable device, so they do not interfere with the delivery of the device. SUMMARY OF THE INVENTION In one embodiment of the present invention there is provided a medical fixation device, comprising: an expandable anchor having a device attachment portion, a barb portion and an expansion bearing portion positioned therebetween; the device attachment portion being directly coupled to an expandable medical device with an outer surface and an inner surface, the expandable medical device having a first compacted profile and, upon application of an extrinsic expansion force, a second expanded profile; wherein prior to the application of the extrinsic expansion force the barb portion is positioned within the first compacted profile, and wherein the expansion bearing portion is configured, upon expansion by the extrinsic expansion force, to force the barb portion to expand such that the barb portion extends outside the second expanded profile. In another embodiment, there is provided an anchor for an expandable medical device, the anchor comprising: a device attachment portion directly coupling the anchor to the expandable medical device, the expandable medical device having an outer surface and an inner surface, a barb portion, and an expansion bearing portion, the expansion bearing portion being positioned between the device attachment portion and the barb portion, wherein the expandable medical device has a first compacted profile and, upon application of an extrinsic expansion force, a second expanded profile, wherein prior to the application of the extrinsic expansion force , the medical fixation device is configured such that the barb portion is positioned within the first compacted profile, and wherein the expansion bearing portion is configured, upon expansion by the extrinsic force, to 7518439_1 (GHMatters) P89104.AU.1 2 force the barb portion to expand such that the barb portion extends outside the second expanded profile. In another embodiment, there is provided an anchorable medical device for use with an expandable balloon, the anchorable medical device comprising: a medical device with an outer surface and an inner surface and including an anchor, the anchor including; a. a barb; and b. an expansion bearing portion connected to the barb, wherein the medical device has a first compacted profile and, upon application of an extrinsic expansion force, a second expanded profile, wherein prior to the application of the extrinsic expansion force the barb is positioned within the first compacted profile, and wherein the expansion bearing portion is configured, upon expansion by the extrinsic expansion force, to force the barb to expand such that the barb portion extends outside the second expanded profile. Additional features and advantages of the invention will be set forth in the description or may be learned by practice of the invention. These features and other advantages of the invention will be realised and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, to illustrate embodiments of the invention, and together with the description serve to explain the principles of the invention. Figure 1A is a partial side view of a medical device prior to implantation. The medical device shown is a balloon expandable stent surrounding a balloon and a delivery catheter. Figure 1 B is a partial side view of a medical device that has been balloon expanded. Figures 2A and 2B are partial side views of an improved balloon 7518439_1 (GHMatters) P89104.AU.1 3 expandable anchor showing the anchor barb contained within a first compacted device profile and shown outside of an expanded device profile. Figure 3 is a partial side view of a balloon expanded medical device having two anchor barbs extending outside of a device expanded profile. DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS The invention is directed to a medical device anchoring or fixation means that enhances the ease of initial compaction and subsequent device deployment. Figures 1A and 1B show a general example of a medical device delivery sequence. Shown in partial side view, Figure 1A is a compacted medical device 100. The specific medical device shown is a balloon expandable stent 102. The medical device is shown positioned within a lumen 104. The balloon expandable stent 102 is shown compacted onto a balloon (not shown) and delivery catheter 106.Shown in partial side view, Figure 11B is the medical device 100 in an expanded state. Shown are a balloon expandable stent 102 (shown in an expanded shape), an expanded balloon 108 and the delivery catheter 106. In a typical procedure, the internal balloon pressure expands a malleable stent (or other device), forcing the malleable stent into contact with the surrounding anatomy or lumen wall 104. The magnitude of balloon pressure normally dictates the outer profile of the stent and the degree of over-expansion or embedding into a vessel wall. Figures 2A and 2B are partial side views of an improved balloon expandable anchor. The expandable medical device 200 is shown within a lumen 104 and surrounding an inflatable balloon 202. The medical device has an expandable anchor 204 having a device attachment portion 206 (used to couple the anchor to a medical device), an expansion bearing portion 208 and a barb portion 210. As shown in Figure 2A, the medical device 200 is shown having a first compacted profile 212. As shown, the anchor barb portion 210 is contained within 214 the first compacted profile 212. An expansion bearing portion 208 can be configured in a variety of ways and may include curved, protruding, flat, or any other profile that will result in the barb portion 210 being contained within the first compacted profile 212. As shown in Figure 2B, the internal balloon pressure 216 forces the medical device 200 to expand to a second expanded profile 218. Upon expansion, the balloon 202 contacts the expansion bearing portion 208 forcing 7518439_1 (GHMatters) P89104.AU.1 4 the expandable anchor 204 to expand, so that the barb portion 210 extends outside 220 of the second expanded profile 218. Shown in Figure 3 is a partial side view of a balloon expandable medical device 300, surrounding an expanded balloon 108 and a delivery catheter 106. The expanded medical device 300 is shown having a second expanded profile 302 and two anchor barb portions 210. The two anchor barb portions 210 are shown extending outside 304 of the second expanded profile 302. Although shown with expanding balloons, the expandable anchors of the present invention may also be used with other means to expand, such as mechanical bow-arms, expandable "Chinese lanterns", expandable baskets, or other expanding devices or materials. Balloon expandable anchors can comprise materials (or combinations of materials) used in the manufacture of balloon expandable stents. Typical materials include 316L stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy ("cobalt- chromium"), other cobalt alloys such as L605, tantalum, malleable Nitinol, or other bio-compatible malleable metals. Other suitable materials include specialised malleable polymers, malleable bio-absorbable materials, and the like. Typical methods used in the assembly of anchors to medical devices include techniques used to attach two or more components. Examples of permanent attachments include the use of glues, adhesives, welds, insert moulding, heavy press-fits, one-way snap or lock features, pressed pins, heat staking, and rivets. Examples of semi-permanent attachments or those that require a tool to separate the components include screws, threaded fasteners, snap-rings, and snap-fits. Examples of releasable attachments or those that can be separated by hand without the use of an additional tool include snap-fits, twist lock features, push to release features, squeeze to release features, slide levers, latches, and light press-fits. Anchors can have various cross-sectional profiles such as circular, oval, rectangular, or other polygon shapes. Anchors can also incorporate external lubricious layers, lubricious coatings, or lubricious wrappings to minimise friction. Anchors can also incorporate therapeutic agents tailored for specific biological results. Anchors can also include radiopaque markers or radiopaque intensifiers. While particular embodiments of the present invention have been 7518439_1 (GHMatters) P89104.AU.1 5 illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims. In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention. It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country. 7518439_1 (GHMatters) P89104.AU.1 6

Claims (12)

1. An anchor for an expandable medical device, the anchor comprising: a device attachment portion directly coupling the anchor to the expandable medical device, the expandable medical device having an outer surface and an inner surface, a barb portion, and an expansion bearing portion, the expansion bearing portion being positioned between the device attachment portion and the barb portion, wherein the expandable medical device has a first compacted profile and, upon application of an extrinsic expansion force, a second expanded profile, wherein prior to the application of the extrinsic expansion force , the medical fixation device is configured such that the barb portion is positioned within the first compacted profile, and wherein the expansion bearing portion is configured, upon expansion by the extrinsic force, to force the barb portion to expand such that the barb portion extends outside the second expanded profile.
2. The anchor of claim 1, wherein the barb portion is metal.
3. The anchor of claim 1 or claim 2, wherein the expansion bearing portion is linear.
4. The anchor of claim 1 or claim 2, wherein the expansion bearing portion is non linear.
5. A medical fixation device, comprising: an expandable anchor having a device attachment portion, a barb portion and an expansion bearing portion positioned therebetween; 7 7518439_1 (GHMatters) P89104.AU.1 the device attachment portion being directly coupled to an expandable medical device with an outer surface and an inner surface, the expandable medical device having a first compacted profile and, upon application of an extrinsic expansion force, a second expanded profile; wherein prior to the application of the extrinsic expansion force the barb portion is positioned within the first compacted profile, and wherein the expansion bearing portion is configured, upon expansion by the extrinsic expansion force, to force the barb portion to expand such that the barb portion extends outside the second expanded profile.
6. The medical fixation device of claim 5, wherein the barb portion is metal.
7. The medical fixation device of claim 5 or claim 6, wherein the expansion bearing portion is linear.
8. The medical fixation device of claim 5 or claim 6, wherein the expansion bearing portion is non-linear.
9. An anchorable medical device for use with an expandable balloon, the anchorable medical device comprising: a medical device with an outer surface and an inner surface and including an anchor, the anchor including; a. a barb; and b. an expansion bearing portion connected to the barb, wherein the medical device has a first compacted profile and, upon application of an extrinsic expansion force, a second expanded profile, wherein prior to the application of the extrinsic expansion force the barb is positioned within the first compacted profile, and 8 7518439_1 (GHMatters) P89104.AU.1 wherein the expansion bearing portion is configured, upon expansion by the extrinsic expansion force, to force the barb to expand such that the barb portion extends outside the second expanded profile .
10. The anchorable medical device of claim 9, wherein the barb is metal.
11. The anchorable medical device of claim 9 or claim 10, wherein the expansion bearing portion is linear.
12. The anchorable medical device of claim 9 or claim 10, wherein the expansion bearing portion is non-linear. 9 7518439_1 (GHMatters) P89104.AU.1
AU2014202338A 2009-06-17 2014-04-30 Medical device fixation anchor suited for balloon expandable stents Active AU2014202338B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2014202338A AU2014202338B2 (en) 2009-06-17 2014-04-30 Medical device fixation anchor suited for balloon expandable stents

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US61/187,689 2009-06-17
AU2010260540A AU2010260540A1 (en) 2009-06-17 2010-06-17 Medical device fixation anchor suited for balloon expandable stents
AU2014202338A AU2014202338B2 (en) 2009-06-17 2014-04-30 Medical device fixation anchor suited for balloon expandable stents

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AU2010260540A Division AU2010260540A1 (en) 2009-06-17 2010-06-17 Medical device fixation anchor suited for balloon expandable stents

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AU2014202338A1 AU2014202338A1 (en) 2014-05-29
AU2014202338B2 true AU2014202338B2 (en) 2016-04-14

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6517573B1 (en) * 2000-04-11 2003-02-11 Endovascular Technologies, Inc. Hook for attaching to a corporeal lumen and method of manufacturing
US20040010312A1 (en) * 2002-07-09 2004-01-15 Albert Enayati Intervertebral prosthesis
US20090082847A1 (en) * 2007-09-26 2009-03-26 Boston Scientific Corporation System and method of securing stent barbs

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6517573B1 (en) * 2000-04-11 2003-02-11 Endovascular Technologies, Inc. Hook for attaching to a corporeal lumen and method of manufacturing
US20040010312A1 (en) * 2002-07-09 2004-01-15 Albert Enayati Intervertebral prosthesis
US20090082847A1 (en) * 2007-09-26 2009-03-26 Boston Scientific Corporation System and method of securing stent barbs

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Owner name: W. L. GORE & ASSOCIATES, INC.

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