WO2009143227A1 - Implants transperçant les tissus et autres dispositifs de traitement de défauts septaux - Google Patents

Implants transperçant les tissus et autres dispositifs de traitement de défauts septaux Download PDF

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Publication number
WO2009143227A1
WO2009143227A1 PCT/US2009/044647 US2009044647W WO2009143227A1 WO 2009143227 A1 WO2009143227 A1 WO 2009143227A1 US 2009044647 W US2009044647 W US 2009044647W WO 2009143227 A1 WO2009143227 A1 WO 2009143227A1
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WO
WIPO (PCT)
Prior art keywords
implantable device
clip
end portion
deflectable
implantable
Prior art date
Application number
PCT/US2009/044647
Other languages
English (en)
Inventor
Dean Carson
Ronald J. Jabba
Richard S. Ginn
Original Assignee
Ovalis, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ovalis, Inc. filed Critical Ovalis, Inc.
Publication of WO2009143227A1 publication Critical patent/WO2009143227A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00668—Type of implements the implement being a tack or a staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00982—General structural features
    • A61B2017/00986—Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0419—H-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals

Definitions

  • the subject matter described herein relates generally to the treatment of septal defects and more particularly, to low profile trans-septal implantable devices and low profile delivery systems and methods for using the same.
  • blood that is oxygenated via gas exchange with the placenta may travel through the vena cava into the right atrium, through the foramen ovale into the left atrium, and from there into the left ventricle for delivery to the fetal systemic circulation.
  • the increased left atrial blood flow and pressure causes the functional closure of the foramen ovale and, as the heart continues to develop, this closure allows the foramen ovale to grow completely sealed.
  • a PFO is generally defined herein as an opening existing between two flaps of atrial tissue, the septum primum and the septum secundum.
  • a PFO can pose serious health risks for the individual, including strokes and migraines.
  • the presence of PFO's have been implicated as a possible contributing factor in the pathogenesis of migraines.
  • Two current hypothesis that link PFO's with migraine include the transit of vasoactive substances or thrombus/emboli from the venous circulation directly into the left atrium without passing through the lungs where they would normally be deactivated or filtered respectively.
  • PFO's diseases that have been associated with PFO's (and which could benefit from PFO closure) include but are not limited to depression and affective disorders, personality and anxiety disorders, pain, stroke, TIA, dementia, epilepsy, sleep disorders, high- altitude pulmonary edema (HAPE), hypoxemia, chronic obstructive pulmonary disease (COPD) and decompression illness.
  • HAPE high- altitude pulmonary edema
  • COPD chronic obstructive pulmonary disease
  • Implantable devices can be deployed trans-septally, i.e., through a man-made, i.e., iatrogenic, opening in the septal tissue.
  • Devices that are deployed trans-septally are typically deployed from the inner lumen of a needle, although some devices are themselves capable of piercing the septal tissue, such as those described in U.S. Patent No. 6,702,835 entitled “Needle Apparatus For Closing Septal Defects and Methods For Using Such Apparatus” and U.S. Patent No. 6,776,784 entitled “Clip Apparatus For Closing Septal Defects and Methods For Use,” each of which are fully incorporated by reference herein.
  • trans-septal closure devices are typically much smaller than "through-the-tunnel" devices since they can be used to close the PFO tunnel by merely pulling the opposing septal flaps together without the need for large occlusive anchors that must block the entire native PFO tunnel. Regardless of whether the trans-septal closure device is deployed from a needle or includes a tissue-piercing structure, there is a desire and need to use these device with smaller delivery systems.
  • trans-septal closure devices include a tissue-piercing structure that can be used to pierce the septal tissue without the aid of a separate tissue-piercing member. Additional embodiments include trans-septal closure devices that are delivered with a
  • FIG. IA is an exterior/interior view depicting an example human heart.
  • FIG. IB is an enlarged side view of the septal wall depicting a PFO taken from the right atrium.
  • FIG. 1C is an enlarged side view of the septal wall depicting a PFO taken from the left atrium.
  • FIG. ID is a cross-sectional view depicting an example PFO region taken along line ID- ID of FIGs. IB-C.
  • FIG. 2A is a perspective view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 2B is a side view depicting an exemplary embodiment of a treatment system.
  • FIG. 2C is an end-on view depicting an exemplary embodiment of a treatment system.
  • FIG. 2D is a partial cross-sectional view depicting an exemplary embodiment of a PFO closure device implanted within septal tissue.
  • FIG. 2E is a perspective view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 2F is a perspective view depicting an exemplary embodiment of a treatment system.
  • FIG. 2G is an end-on view depicting an exemplary embodiment of a treatment system.
  • FIG. 2H is a perspective view depicting an exemplary embodiment of a treatment system.
  • FIG. 3 A is a perspective view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 3B is a cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIG. 3C is an end-on view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 3D is a partial cross-sectional view depicting an exemplary embodiment of a PFO closure device implanted within septal tissue.
  • FIG. 4A is a cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIG. 4B is an end-on view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIGs. 4C-D are perspective views depicting exemplary embodiments of an implantable PFO closure device.
  • FIG. 4E is an end-on view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 4F is a perspective view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 4G is an end-on view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 4H is a side view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIGs. 4I-J are top views depicting exemplary embodiments of an implantable PFO closure device.
  • FIG. 5 A is a perspective view depicting an exemplary embodiment of a treatment system.
  • FIGs. 5B-6B are end-on views depicting exemplary embodiments of an implantable PFO closure device.
  • FIG. 6C is a side view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 6D is an end-on view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIGs. 7A-C are side views depicting exemplary embodiments of an implantable PFO closure device.
  • FIG. 8 A is an end-on view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 8B is a partial cross-sectional view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIGs. 9A- 1 IA are side views depicting exemplary embodiments of an implantable PFO closure device.
  • FIGs. 1 IB-C are cross-sectional views depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 1 ID is a side view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIGs. 1 IE-G are cross-sectional views depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 12B is a partial cross-sectional view depicting an exemplary embodiment of a PFO closure device within septal tissue.
  • FIG. 13A is a perspective view depicting an exemplary embodiment of a treatment system.
  • FIG. 13B is a longitudinal cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIG. 13C is a radial cross-sectional view taken along line 13C-13C of FIG. 13B.
  • FIG. 13D is a longitudinal cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIG. 13E is a radial cross-sectional view taken along line 13E-13E of FIG. 13D.
  • FIGs. 14A-C are perspective views depicting exemplary embodiments of a treatment system.
  • FIG. 15A is a side view depicting an exemplary embodiment of a treatment system.
  • FIG. 15B is a longitudinal cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIG. 16A is a side view depicting an exemplary embodiment of a treatment system.
  • FIG. 16B is a longitudinal cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIGs. 16C-E are partial cross-sectional views depicting an exemplary embodiment of the treatment system during deployment.
  • FIG. 17A is a side view depicting an exemplary embodiment of a treatment system.
  • FIG. 17B is a longitudinal cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIG. 17C is a radial cross-sectional view of taken along line 17C-17C of FIG. 17A.
  • FIG. 17D is a radial cross-sectional view depicting an exemplary embodiment of an implantable PFO closure device.
  • FIG. 18A is a longitudinal cross-sectional view depicting an exemplary embodiment of a treatment system.
  • FIG. 18B is a radial cross-sectional view taken along line 18B- 18B of FIG. 18A.
  • FIG. 18C is a perspective view depicting an exemplary embodiment of an implantable PFO closure device. DETAILED DESCRIPTION
  • these devices, systems and methods will be described with reference to closure of a PFO.
  • these devices, systems and methods can be used in treatment of any type of septal defect including ASD's, VSD's and the like, as well as PDA's, pulmonary shunts or other structural cardiac or vascular defects or non-vascular defects, and also any other tissue configuration having overlapping tissue layers including non-defect tissue configurations, non-septal tissue defects and left-atrial appendages (LAA).
  • ASD septal defect
  • VSD's and the like as well as PDA's, pulmonary shunts or other structural cardiac or vascular defects or non-vascular defects, and also any other tissue configuration having overlapping tissue layers including non-defect tissue configurations, non-septal tissue defects and left-atrial appendages (LAA).
  • LAA left-atrial appendages
  • FIG. IA is an exterior/interior view depicting an example human heart 200 with a portion of the IVC 202 and the SVC 203 connected thereto. Outer tissue surface 204 of heart 200 is shown along with the interior of right atrium 205 via cutaway portion 201. Depicted within right atrium 205 is septal wall 207, which is placed between right atrium 205 and the left atrium located on the opposite side (not shown). Also depicted is fossa ovalis 208, which is a region of septal wall 207 having tissue that is relatively thinner than the surrounding tissue. PFO region 209 is located beyond the upper portion of the fossa ovalis 208.
  • FIG. IB is an enlarged view of septal wall 207 depicting PFO region 209 in more detail as viewed from right atrium 205.
  • PFO region 209 includes septum secundum 210, which is a first flap-like portion of septal wall 207. The edge of this flap above fossa ovalis 208 is referred to as the limbus 21 1.
  • FIG. 1C is also an enlarged view of septal wall 207, instead depicting septal wall 207 as viewed from left atrium 212.
  • PFO region 209 is seen to include septum primum 214, which is a second flap-like portion of septal wall 207.
  • Septum primum 214 and septum secundum 210 partially overlap each other and define a tunnel-like opening 215 between sidewalls 219 (indicated as dashed lines in FIGs. IB-C) that can allow blood to shunt between right atrium 205 and left atrium 212 and is commonly referred to as a PFO.
  • FIG. I D is a cross-sectional view depicting an example PFO region 209 taken along line ID- ID of FIGs. IB-C.
  • septum secundum 210 is thicker than septum primum 214.
  • the blood pressure within left atrium 212 is higher than that within right atrium 205 and tunnel 215 remains sealed.
  • conditions can occur when the blood pressure within right atrium 205 becomes higher than the blood pressure within left atrium 212 and blood shunts from right atrium 205 to left atrium 212 (e.g., due to a valsalva condition).
  • PFO' s Many different variations can occur. For instance, thickness 220 of septum primum 214, thickness 221 of septum secundum 210, overlap distance 222 and the flexibility and distensibility of both septum primum 214 and septum secundum 210 can all vary.
  • the openings to the PFO tunnel 215 are depicted as being relatively the same size, with the width of tunnel 215, or the distance between sidewalls 219, remaining relatively constant. However, in some cases, one opening can be larger than the other, resulting in an tunnel 215 that converges or diverges as blood passes through.
  • septum primum 214 and septum secundum 210 are depicted as relatively planar tissue flaps, but in some cases one or both of septum primum 214 and septum secundum 210 can have folded, non-planar, or highly irregular shapes.
  • the devices, systems and methods described herein will be done so with regard to a catheter-based intravascular delivery system routed through the IVC into the right atrium of the heart.
  • a trans-septal piercing is performed from the right atrium to the left atrium ("right-to-left"), typically through both the secundum and primum.
  • the devices, systems and methods can also be used when approaching from the SVC into the right atrium, in left-to-right procedures, and in procedures that involve the piercing of either the primum, secundum or both (in either order).
  • FIG. 2A is a perspective view of an exemplary embodiment of implantable closure device 103.
  • implantable closure device 103 is configured to close the native PFO tunnel via trans-septal implantation, preferably through both the septum secundum and septum primum.
  • Implantable closure device 103 is configured in a clip-like manner, and for ease of discussion herein, will be referred to as clip 103.
  • the concepts described herein can be likewise applied to other devices, such as coils and suture-based closure devices.
  • Clip 103 preferably includes a left atrial (LA) anchor portion 303, a right atrial (RA) anchor portion 304 and an intermediate, centrally located portion 305.
  • LA portion 303 is preferably located in left atrium 212 and RA portion 304 is preferably located in the right atrium 205.
  • RA portion 304 is preferably located in the right atrium 205.
  • Located on the LA portion 303 are three deflectable LA anchor members 306-1, 306-2 and 306-3 and, located on the opposite RA portion are three deflectable RA anchor members 307-1, 307-2 and 307-3.
  • clip 103 is depicted in an exemplary at-rest state.
  • Each of the members 306 and 307 are preferably biased (i.e., self-deflecting) towards this or a similar at-rest state.
  • members 306 and 307 are preferably deflected to a relatively straight, or elongate, configuration as depicted in the side view of FIG. 2B.
  • FIG. 2B depicts this exemplary embodiment of treatment system 100 with clip 103 housed within inner lumen 121 of an elongate tubular member 120, which is referred to herein as sheath 120 and is shown in cross- section to allow the components within to be seen.
  • FIG. 2C is an end-on view of treatment system 100 showing the distal end of clip 103.
  • FIG. 2D is a partial cross-sectional view depicting clip 103 implanted within the iatrogenic, septal opening 206 in septal wall 207.
  • LA members 306 are preferably relatively longer than RA members 307 to apply a closure force to a relatively wider region of septal tissue. It should be noted that the respective lengths of LA members 306 and RA members 307 can be the same or can vary. If desired, RA members 307 can be relatively longer than LA members 306 and/or each LA member 306 (or RA member 307) can have a different length, etc.
  • clip 103 is preferably biased to transition from the elongate configuration towards the at-rest configuration, the presence of the septal tissue can prevent members 306 and 307 from fully transitioning to the at-rest state, instead entering only an intermediate, partially deflected state. This may be preferred to ensure that members 306 and 307 continue to exert a compressive force on the septum secundum 210 and septum primum 214 to close the native PFO tunnel 215 existing therebetween. In such an instance, it is generally desirable for each of members 306 and 307 to be deflected greater than 90 degrees from the central longitudinal axis of the clip when in the at-rest state.
  • Clip 103 (or at least the portions thereof biased to deflect) is preferably formed from a shape memory material such as a nickel-titanium alloy (e.g., nitinol) and the like.
  • nitinol can be heat-treated to instill a bias towards the heat-treated configuration.
  • the configuration in which clip 103 is heat-treated will become the at-rest configuration that the members 306 and 307 of clip 103 are biased towards.
  • the thermally dependent shape memory characteristics of nitinol can also be used to initiate any of the various deflections of the clip body.
  • Other materials can also be used, such as elgiloy, stainless steel and various polymers, including biodegradable polymers.
  • Clip 103 can also be configured without any bias, if desired. As will be described later, clip 103 can also comprise one or more of numerous types of coatings.
  • Clip 103 is capable of being modified and configured in a host of different ways.
  • the number of LA and RA members can be one or more on each end of the clip, and the degree to which each LA and RA member deflects from the central axis of the clip body, the degree of overlap between the LA and RA members when in the at-rest state, the location or offset of each LA and RA member on the ends of the clip body, the thickness, width and length of each LA and RA member, the number of bodies that can be used to form central portion 305 and/or LA and RA members 306 and 307, the profile shape of each LA and RA member, the placement of radiopaque and other visualization enhancement markers, the constituent materials used to form the clip body or other components of the treatment system, coatings on any portion of the clip and the configuration of the clip center portion 305 (e.g., compressible/expandable as opposed to rigid, tubular as opposed to solid, etc.) can all be varied according to the needs of the particular implementation and/or application.
  • implant 103 is configured to pierce septal tissue when in the housed configuration depicted in the partial cross-sectional view of FIG. 2B.
  • clip 103 is releasably coupled with pusher member 128, which is slidably received within sheath inner lumen 121.
  • End tips 315 of RA members 307 each can include an aperture 316 configured to securely engage with one or more corresponding abutments 129 on pusher member 128, which allows pusher 128 to control the movement of clip 103 within sheath 120.
  • RA end tips 315 are preferably configured to be atraumatic and substantially dull.
  • Sheath 120 can be any elongate, preferably flexible, tubular member.
  • the rim of the open distal end 122 is preferably tapered or sloped to facilitate the passage through the tissue.
  • the open distal end 122 also preferably fits closely over the clip or other underlying member to minimize the transition to the sheath outer diameter.
  • sheath 120 can be configured as the tubular off-axis delivery member, the configuration and preferred operation of which can be referenced in the incorporated '814 application.
  • LA members 306 each have a substantially sharp end tip 314 configured to pierce septal tissue.
  • LA distal ends 314 preferably come together to form a needle tip having a single distal point formed by each of the sharp distal ends 314.
  • each distal end 314 can be seen to have a circular sector (i.e., pie-piece shape) that is complementary to the other distal ends 314.
  • Each end 314 has a complementary circular sector shape when three or more LA members 306 are present (accordingly, each distal end 314 is preferably half-circular when only two LA members 306 are present.
  • distal end 314 can be configured in any manner that will pierce septal tissue. Furthermore, the use of complementary shapes are not required, since the formation of a single sharp distal point itself can pierce septal tissue. Other multi-pointed or blade-like configurations can be used.
  • clip 103 When advanced through the patient's vasculature, clip 103 is preferably placed in a position proximal to the one shown in FIG. 2B, fully housed within inner lumen 121. However, once in proximity with the PFO, clip 103 can be advanced such that the LA distal ends 314 are exposed from the open distal end 122 of sheath 120. A relatively close fit between LA members 306 and the inner surface of sheath 120 is preferable to keep LA distal ends 314 in close contact to form the single tissue-piercing tip as shown. Sheath 120 and clip 103 are preferably kept in a fixed position in relation to each other, while both are advanced through the septal tissue (either or both of the septum primum and septum secundum, in either order). As mentioned, the distal surface of sheath 120 is preferably tapered to provide minimal resistance as it is passed through the septal tissue.
  • sheath 120 and clip 103 are preferably both advanced through the septal tissue while in the configuration shown in FIG. 2B, it should be noted that clip 103 can be advanced on its own and sheath 120 can be advanced only partially into the iatrogenic opening or can be left entirely outside of the septal tissue. If clip 103 is advanced without sheath 120, then preferably LA members 306 are long enough such that they are still partially retained within sheath 120, and hence kept in the elongate configuration while doing so. Whether sheath 120 passes into the iatrogenic opening and, if so, the amount by which it passes into the opening, is dependent upon the needs of the individual application.
  • FIG. 2D is a partial cross-sectional view of septal wall 207 with clip 103 implanted within iatrogenic opening 206. Members 306 and 307 are deflected over the septal tissue and maintain secundum 210 and primum 214 in close contact to preferably fully close PFO tunnel 215.
  • FIGs. 2E-G depict additional exemplary embodiments of a tissue-piercing clip 103.
  • FIG. 2E is a perspective view depicting clip 103 in the at-rest state.
  • clip 103 has a configuration similar to that described in the incorporated '710 application, to which further reference can be made regarding this clip's configuration and modifications, additions, subtractions thereto and all other possible modifications.
  • Clip 103 includes two wire-like bodies 301-1 and 301-2 coupled together by a tubular coupling device 302.
  • Wire-like bodies 301 preferably have a generally, semi-circular, D-shaped cross-sectional profile, with a relatively flat surface contacting the adjacent wire-like body and a curved surface contacting coupling device 302.
  • each wire-like body 301 has a substantially sharp LA distal end 314 and a substantially atraumatic RA distal end 315.
  • Neck regions 309 are also shown on RA members 307. These regions 309 can be used to securely engage with pusher 128.
  • FIG. 2F is a perspective view and FIG. 2G is an end-on view of the distal end tips 314-1 and 314-2 of LA members 306-1 and 306-2, respectively, while clip 103 is housed within sheath 120.
  • each wire-like body 301 has a semi-conical shape (FIG. 2F) and a semi-circular, D-shaped radial cross-sectional profile (FIG. 2G).
  • System 100 can be used in a similar manner as described with respect to FIGs. 2A-D to create the iatrogenic piercing in the septal tissue.
  • FIG. 2F semi-conical shape
  • FIG. 2G semi-circular, D-shaped radial cross-sectional profile
  • 2H is a perspective view depicting another exemplary embodiment where LA distal ends 314 are staggered and come together to form a single sloped surface terminating in a substantially sharp distal end of one of the wire-like bodies, which in this case is distal end 314-1.
  • FIG. 3A is a perspective view of another exemplary embodiment of clip 103, specifically depicting LA end portion 303 and a segment of central portion 305.
  • LA member 306-1 has a substantially sharp end tip 314-1 configured to penetrate septal tissue.
  • LA member 306-2 has a enlarged end portion 320 and a rounded end tip 314-2.
  • FIG. 3B is a cross-sectional view of this embodiment of clip 103 within sheath 120.
  • clip 103 is partially extended from sheath 120, the side walls of which maintain clip 103 in the relatively elongate configuration.
  • LA member 306-1 is relatively longer than member 306-2 allowing the tissue -piercing end tip 314-1 to extend past rounded end tip 314-2 in a position suitable for piercing the septal tissue.
  • LA members 306-1 and 306-2 are preferably deflected toward each other such that end tip 314-2 makes contact with LA member 306-1 for added support during piercing. This results in a tapered profile that also reduces the resistance of member 306-2 to entry during septal piercing by member 314-1.
  • LA members 306-1 and 306-2 are preferably biased to deflect to the same side of clip 103 after deployment.
  • FIG. 3C is a end-on view of LA portion 303 with LA members 306- 1 and 306-2 deflected to the right after deployment (RA members are not shown).
  • sharp end tip 314-1 when deflected, is located adjacent to enlarged portion 320 of LA member 306-2.
  • enlarged portion 320 is situated between sharp tip 314-1 and any underlying septal tissue.
  • enlarged portion 320 is preferably large enough to surround and prevent sharp end tip 314-1 from making contact with the septal tissue, which can be undesirable in some applications.
  • 3D is a partial cross-sectional view showing this embodiment of clip 103 implanted within septal wall 207.
  • LA members 306 and RA members 307 are deflected over the septal tissue to hold secundum 210 and premum 214 together to (at least partially) close PFO tunnel 215.
  • FIGs. 4A-J depict additional exemplary embodiments of a tissue-piercing clip 103.
  • a tissue-piercing-portion of an LA member is preferably biased to deflect into a generally atraumatic position.
  • FIG. 4A is a cross-sectional view of the preferred placement of any of these embodiments of clip 103 within sheath 120 during the tissue-piercing procedure.
  • LA member 306-1 is relatively longer than LA member 306-2, although here, LA member 306- 1 is configured with a hinge or hinge region 322.
  • Hinge 322 can be a mechanized hinge or can be formed as a bendable region of the LA member itself (shown in FIGs. 4B-I).
  • LA member 306-1 is preferably used to pierce the septal tissue when in the distally-facing, elongate state shown here.
  • FIG. 4B is an end-on view of an exemplary embodiment of clip 103 showing LA portion 303 with LA members 306 in the deflected, at-rest state (RA members are not shown).
  • LA member 306-1 is biased to bend, fold or deflect back toward central portion 305 of clip 103 as shown.
  • sheath 120 is retracted to allow LA member to deflect in this manner.
  • sharp end tip 314-1 is less likely to irritate or injure the septal tissue during and after deployment.
  • FIGs. 4C-E depict additional exemplary embodiments of tissue-piercing clips.
  • LA member 306-1 includes an enclosed open region 321 configured to receive a deflectable elongate tissue-piercing portion 310 of LA member 306-1.
  • FIGs. 4C-D are perspective views depicting alternate embodiments of clip 103 in the generally elongate configuration for housing as well as piercing septal tissue (LA member 306-2 is not shown for clarity).
  • elongate tissue-piercing portion 310 deflects along a bent or curved portion, while in the embodiment of FIG. 4D, elongate portion 310 deflects through rotation or twisting around intermediate strut portion 31 1.
  • Elongate tissue-piercing portion 310 is preferably biased to deflect back such that sharp end tip 314-1 is received within open region 321, as shown in the end-on view of FIG. 4E.
  • FIGs. 4F-G are depict yet another exemplary embodiment of a tissue-piercing clip 103.
  • FIG. 4F is a perspective view depicting clip 103 and LA member 306-1 in the generally elongate state (LA member 306-2 is not shown).
  • hinge region 322 includes aperture 323 between struts 319-1 and 319-2.
  • Struts 319 preferably have a width less than that of the portions of LA member 306-1 above and below aperture 323 to facilitate bending in hinge region 322.
  • Hinge region 322 is configured to allow elongate tissue-piercing portion 310 to deflect backwards once unrestrained.
  • FIG. 4G is an end-on view showing LA member 306-1 in the deployed configuration after deflection.
  • FIG. 4H is a side view depicting clip 103 in this deployed configuration.
  • elongate portion 310 is again shown deflected back upon itself such that end tip 314-1 contacts clip 103 and overlies central portion 305.
  • FIGs. 4I-J are top-down views depicting exemplary embodiments of an LA member 306 having a slotted hinge region 322.
  • LA member 306 can include one or more elongate slots 345. Each slot can include an relatively wider aperture or open region 346 to allow the alleviation of stress during bending. Slots 345 can be oriented generally perpendicular to the longitudinal axis of LA member 306 (see FIG. 41) or at a non-perpendicular angle (see FIG. 4J) or any combination thereof.
  • FIG. 5 A is a perspective view of another exemplary embodiment of a tissue- piercing clip 103.
  • clip 103 is configured to releasably couple with pusher member 128.
  • pusher member 128 are both slidably housable within sheath 120 (not shown).
  • LA member 306-1 includes a tubular distal portion 325 having substantially sharp end tip 314-1 and an inner lumen 326.
  • Pusher member 128 preferably extends within inner lumen 326 to maintain tubular portion 325 in the elongate position.
  • FIGs. 5B-C are an end-on views of exemplary embodiments of clip 103 showing LA members 306-1 and 306-2 in the deployed state (RA members are not shown).
  • LA member 306-1 is shown with portion 325 deflected backwards into proximity with central body portion 305.
  • LA member 306-1 includes an intermediate portion 327 adjacent to tubular portion 325.
  • LA member 306-1 deflects in two locations into a generally triangular profile where sharp end tip 314-1 is in relatively closer proximity with, and directed towards, central body portion 305. This configuration places end tip 314-1 in a position that is even less likely to cause injury or irritation to the septal tissue.
  • FIG. 6A is an end-on view of another exemplary embodiment of a tissue-piercing clip 103 (RA members are not shown).
  • clip 103 has two LA members 306-1 and 306-2 configured to overlap when deflected.
  • LA member 306-1 is again biased to deflect into a generally triangular configuration.
  • LA member 306-2 has a curved configuration and is biased to deflect into a position overlapping with LA member 306-1.
  • LA member 306-2 is allowed to deflect before LA member 306-1 such that LA member 306-2 lies underneath LA member 306-1 to prevent contact of sharp end tip 314-1 with the septal tissue.
  • FIG. 6B is an end-on view of another exemplary embodiment of clip 103 having LA member 306-1 deflected in a generally triangular configuration (RA members are again not shown).
  • LA member 306-1 is configured to receive sharp end tip 314-1 in a recess or slot 324 located in the member's base portion. By retaining end tip 314-1 in slot 324, LA member 306-1 attains a generally low profile (i.e., flatter or more planar) configuration that will minimize any hemodynamic impact as well as any thrombogenic response.
  • slot 324 can be omitted and member 314-1 can reside on top of the base portion of 306-1.
  • FIG. 6C is a side view depicting another exemplary embodiment of clip 103 having tissue-piercing capability.
  • LA member 306-1 is shown prior to delivery and deployment over the septal tissue (LA member 306-2 is not shown for clarity).
  • LA member 306-1 includes a pivotable distal portion 339 connected to a proximal portion 340 by a pivot section 341.
  • Pivotable distal portion 339 has an atraumatic end tip 318 and a tissue-piercing end tip 317.
  • tip 317 is distally-facing while atraumatic tip 318 is deflected into a generally more proximal position.
  • Clip 103 can be restrained in this configuration by a tubular sheath.
  • atraumatic end tip 318 is oriented relatively more distally than tissue-piercing end tip 317 so that tissue-piercing end tip 317 is less likely to cause injury to the septal tissue.
  • FIGs. 7A-C depict another exemplary embodiment of clip 103 having tissue- piercing capability.
  • FIG. 7 A is a side view of clip 103 and
  • FIG. 7B is a side view with clip 103 rotated by 90° from the orientation of FIG. 7A.
  • LA members 306-1 and 306-2 cooperate to form a tissue-piercing end portion of clip 103.
  • the distal ends 328-1 and 328-2 of LA members 306-1 and 306-2, respectively, when adjacent to each other in the elongate configuration, are configured to form a tubular, tapered needle-like end tip for clip 103.
  • LA member 306-1 is relatively longer than member 306-2 so that end tips 328-1 and 328-2 are staggered.
  • Each end tip 328-1 and 328-2 has a tapered edge that together form the needle-like tip of clip 103 when in the tissue-piercing configuration depicted in FIGS. 7A-B.
  • Clip 103 can be formed from nitinol tube stock giving each LA member 306 a C- shaped radial profile. It should be noted that the inner lumen of tubular clip 103 is preferably at least partially blocked to prevent blood from shunting therethrough. Of course, clip 103 can also be solid, for instance formed from a mandrel or wire-like material and the like.
  • Both LA members 306-1 and 306-2 can deflect into a relatively perpendicular configuration such as that described with respect to FIG. 2D.
  • LA members 306- 1 and 306-2 can deflect into a looped configuration such as that depicted in the side view of FIG. 7C.
  • each member 306 can include one or more radial slots 364.
  • end tips 328 are located adjacent to central portion 305 of clip 103 and are in a generally atraumatic orientation to the surrounding septal tissue. Because LA members 306 deflect proximally, clip 103 is preferably advanced through the iatrogenic opening in the septal wall far enough to allow members 306 to deflect into this looped configuration without again entering the septal tissue. Clip 103 can then be retracted proximally, pulling looped LA members 306 against the septal wall, to bring RA members 307 into the appropriate position to properly deflect and engage the opposite side of the septal wall.
  • RA members 307 can also be configured to deflect in a looped configuration like that shown in FIG. 7C.
  • the looped members can be oriented at 90 degrees from that depicted here, such that the entire loop (or the majority of the loop) lies flat against the septal tissue. This type of orientation is depicted in FIG. 12F of the incorporated '710 application.
  • FIGs. 8A-B depict another exemplary embodiment of clip 103 having tissue- piercing capability.
  • FIG. 8A is an end-on view of clip 103 having LA members 306 deflected into the deployed configuration (RA members not shown).
  • LA member 306-1 is relatively longer than LA member 306-2 and also has a bendable region 329, which is preferably configured to allow LA member 306-1 to bend and form a substantially sharp elbow 336 as depicted in the partial cross-sectional view FIG. 8B.
  • Clip 103 is preferably advanced through the septal tissue in the configuration depicted in FIG. 8B to create the iatrogenic opening. After piercing the septal tissue, sheath 120 can be proximally retracted with respect to clip 103 to expose LA members 306 and allow them to deflect into the configuration depicted in FIG. 8A.
  • FIGs. 9A-B depict yet another exemplary embodiment of clip 103 having tissue- piercing capability.
  • LA portion 303 of clip 103 includes a substantially sharp distal tip 330 configured for piercing septal tissue.
  • Clip 103 has a tubular body and LA members 306-1 and 306-2 are formed in the wall of the tubular body by the presence of slots 331-1 and 331-2, respectively.
  • FIG. 9A shows clip 103 in the undeployed configuration for housing within an outer sheath (not shown) and FIG. 9B depicts clip 103 in the deployed configuration.
  • clip 103 is preferably releasably coupled with a pusher member (not shown) and advanced through the septal tissue.
  • LA members 306 are proximally-facing and deflect distally after release. Because LA members 306 are proximally-facing, this embodiment of clip 103 can be advanced through the septal tissue from the outer sheath without actually advancing the outer sheath through the tissue. It should be understood that this arrangement can be reversed such that LA members 306 are connected to the clip body at the most proximal position to allow LA members 306 deflect in the opposite manner (proximally).
  • blocking material or another obstruction e.g., a radiopaque marker
  • deflectable tabs can be included that are biased to deflect into and occlude the inner lumen after removal of the member therein.
  • FIGS. 10A-B depict another exemplary embodiment of clip 103 configured for piercing septal tissue.
  • clip 103 includes a plurality of elongate slots 333 that define a plurality of adjacent, deformable, elongate struts 332 at the LA portion 303 of clip 103.
  • FIG. 1 OA depicts clip 103 in the configuration suitable for housing within an outer sheath (not shown) and
  • FIG. 1OB depicts clip 103 in the deployed configuration after implantation within the septal wall (septal tissue not shown).
  • an elongate pull member 334 having a distal end 335 is detachably coupled with clip 103 (such as with the clip sidewall or with a portion extending into the clip inner lumen) in a position distal to struts 332 to allow clip 103 to be deformed by the application of a force in a proximal direction by pull member 334.
  • pull member 334 is screwed into a threaded recess in clip 103.
  • pull member 334 can include a breakaway section that breaks at a specific load. This breakaway section can be in the form of an adhesive bond or a material of relatively lower tensile strength that the adjacent portions of the pull member. Examples include relatively fine polymeric or metal wire and the like.
  • pull member 334 preferably causes struts 332 to buckle outward as depicted in FIG. 1OB.
  • each strut 332 can have a central hinge region or an otherwise relatively more deformable section for facilitating buckling in the center of the strut 332. This buckling shortens clip 103 and also allows buckled struts 332 to act as the LA members.
  • pull member 334 is preferably unscrewed (detached) from clip 103.
  • clip 103 can be formed from a shape memory material and biased towards the configuration described with respect to FIG. 1OB, and housed within a delivery device in a stressed state as depicted in FIG. 1OA. In such an embodiment, pull member 334 can be omitted.
  • a clip having a substantially sharp portion configured for piercing septal tissue.
  • the substantially sharp portion can be configured such that it transitions to an atraumatic configuration over time, or is coupled with a device that is configured to shield the substantially sharp portion from the surrounding tissue, thereby rendering it atraumatic.
  • FIGs. 1 1-12 depict various embodiments for rendering atraumatic the substantially sharp portion of clip 103.
  • FIGs. 1 IA-C and 1 ID-F depict two exemplary embodiments of a substantially sharp portion 347 of clip 103 that can each be used as the sharp distal portion 330 described with respect to FIGs. 9-10, the various sharp end tips 314 described with respect to FIGs. 2A-H, 3A-D, 4A-J, 5A-C, 6A-B, 7A-C or as the sharp end tip 317 described with respect to FIGs. 6C-D.
  • sharp distal portion 347 is not limited to use with only these embodiments.
  • FIGs. 1 IA and 1 ID a substantially sharp portion 347 is formed, in part, from a dissolvable material 338.
  • FIGs. 1 IB and 1 IE depict cross-sections of FIGs. 1 IA and 1 ID, respectively.
  • the dissolvable material 338 is the shaded region and is shown to encompass a coil 337, which is embedded therein. After implantation, dissolvable material 338 dissolves and exposes coil 337 over time.
  • FIGs. 1 1C and 1 IF depict the cross-sectional view of exposed coil 337, which preferably is atraumatic or at least relatively more atraumatic than with the presence of dissolvable material 338.
  • FIG. 1 IG is a cross-sectional view depicting an embodiment where sharp portion 347 is tubular.
  • dissolvable materials suitable for use as material 338 include dissolvable metals such as magnesium alloys and dissolvable polymers such as polyglycolide (PGA), polylactide (PLA), poly( ⁇ -caprolactone), poly(dioxanone) (a poly ether-ester), poly(lactide-co-glycolide), polyhydroxybutyrate (PHB), polyhydroxy valerate (PHV), polyanhydride, and polyorthoester.
  • PGA polyglycolide
  • PLA polylactide
  • PDA poly( ⁇ -caprolactone
  • poly(dioxanone) a poly ether-ester
  • poly(lactide-co-glycolide) polyhydroxybutyrate
  • PVB polyhydroxy valerate
  • polyanhydride and polyorthoester
  • FIG. 12A-B depict another embodiment of substantially sharp portion 347.
  • an expandable and compressible coil 342 is coupled with sharp portion 347 as shown at one or more proximal coiled segments 343.
  • coil 342 preferably compresses to expose sharp portion 347 and allow it to penetrate the septal wall 207 as depicted in FIG. 12B.
  • coil 342 is advanced through the opening to allow it to expand into the configuration depicted in FIG. 12A where coil 342 shields the septal tissue from sharp portion 347.
  • sharp portion 347 can also be made dissolvable like that described with respect to FIGs. 1 IA-G.
  • FIGs. 13A-E depict another exemplary embodiment of a treatment system 100 having a tissue-piercing implantable clip 103.
  • FIG. 13A is a perspective view showing clip 103 in its undeployed state over elongate pusher member 128.
  • FIG. 13B is an longitudinal cross- sectional view of this embodiment of treatment system 100 and
  • FIG. 13C is a radial cross- sectional view taken along line 13C-13C of FIG. 13B.
  • clip 103 includes a detachable, tissue-piercing distal end segment 350 (configured here as a needle) with a substantially sharp distal tip 351.
  • Detachable distal segment 350 has an elongate separation 352 running the entire longitudinal length of the distal end.
  • Needle segment 350 is preferably composed of a shape memory material (e.g., nitinol and the like) and is preferably biased to roll into a configuration having a smaller diameter such that distal segment 350 can be slidably retracted through inner lumen 358 of clip 103.
  • Clip 103 is configured in a manner partially similar to that described with respect to FIGS. 9A-B where each LA member 306 is formed in the side of the tubular clip body by a slot 331. Each RA member 307 is situated at the proximal end of the tubular clip body and extends proximal to the proximal end of the clip body in the manner shown. Clip 103 also includes two tab-like members 356-1 and 356-2 that are formed by slots 357-1 and 357-2 in the clip body. These tabs are preferably biased to deflect inwards to interface with recess 353 in the clip distal segment 350 and will be described in greater detail below.
  • an elongate sheath (not shown) would receive clip 103 and pusher member therein and retain clip 103 in the undeployed state depicted in FIG. 13 A.
  • the distal end region 125 of pusher 128 includes a tapered neck portion 126 located distal to a relatively wider proximal portion 127 having a diameter slightly smaller than the inner diameter of needle segment 350.
  • the relatively wider proximal portion 127 of pusher 128 acts to maintain needle segment 350 in the unrolled configuration depicted here.
  • one or more interface features are preferably included. As shown here, the interface features include a stepped portion 354 configured to slide within a similarly shaped recess 355 on needle segment 350.
  • FIG. 13D is a longitudinal cross-sectional view depicting needle segment 350 retained within clip 103.
  • FIG. 13E is a cross-sectional view taken along line 13E-13E of FIG. 13D.
  • pusher 128 is retracted proximally until only neck region 126 is situated within the inner lumen of needle segment 350. With proximal portion 127 no longer in a position to restrain segment 350, segment 350 separates at longitudinal separation 352 and deflects and rolls into the narrower state depicted here.
  • pusher 128 can be further retracted into lumen 358 of clip 103 until recessed portion 353 passes over tabs 356 thereby allowing tabs 356 to deflect inwards into recess 353 and to engage and retain segment 350. Once tabs 356 deflect into recess 353 distal end 350 becomes securely engaged to the clip body and pusher 128 can be withdrawn entirely from clip 103 leaving needle segment 350 locked in place.
  • This embodiment of system 100 allows the use of sharp tissue-piercing segment 350 on the clip 103 to create the passage through the septal tissue in which clip 103 will be implanted and at the same time allows that sharp tissue-piercing segment 350 to be detached and placed in a location with respect to clip 103 that will result in a reduced likelihood that the sharp portion will later come into contact with any of the patient's bodily tissue.
  • FIG. 14A is a perspective view depicting an exemplary embodiment of treatment system 100 having a tissue-piercing member 401 configured to slide through clip inner lumen 358.
  • tissue-piercing member 401 has a narrow blade-like configuration, although other configurations can be used.
  • Inner lumen 358 and blade-like member are shown obscured within clip 103 by the used of dashed lines.
  • tubular member 120 which restrains clip 103 in the undeployed state, is shown in cross-section to facilitate illustration of the components therein.
  • Tissue-piercing member 401 preferably includes a blade-like distal portion 402 with a substantially sharp cutting edge 403 on its distal end as well as a relatively wider, or larger diameter, portion 404 located proximal to distal blade portion 402.
  • FIG. 14A depicts delivery system 100 prior to the creation of a trans- septal piercing with blade-like distal portion 402.
  • tissue-piercing member 401 can be advanced distally to expose the sharp distal edge 403 from the open distal end 122 of sheath 120, as depicted in FIG. 14B.
  • system 100 including sheath 120, can then be advanced through the septal tissue to create the iatrogenic opening.
  • clip 103 can be configured with proximally-facing LA members 306.
  • sheath 120 is preferably withdrawn to allow members 306 and 307 to deploy over the septal tissue and at least partially close the native PFO tunnel.
  • Clip 103 is maintained in position relative to member 401 by the transition between the distal blade-like portion 402 and the proximal portion 404.
  • the proximal enlarged portion 404 has a diameter (or keyed shape) that will not travel into inner lumen 358 and thereby acts as a stop or abutment preventing further advancement of tissue- piercing member 401 within inner lumen 358 as well as preventing clip 103 from sliding proximal to this transition.
  • Abutments 124 can also be used to retain clip 103 as described in the earlier embodiments.
  • FIG. 14C is a perspective view depicting clip 103 in this state of deployment after sheath 120 has been withdrawn, but prior to the retraction of tissue-piercing member 401 (septal tissue not shown). Once clip 103 is fully deployed, blade-like portion 402 can be retracted into sheath 120 and members 120 and 401 can be withdrawn from the patient's vasculature.
  • FIGS. 15A-B depict another exemplary embodiment of treatment system 100 having a blade-like tissue-piercing member 401.
  • tissue-piercing member 401 includes an LA member retainer 406 configured to retain LA members 306-1 and 306-2 in the generally elongate, undeployed state.
  • FIG. 15A is a side view of this embodiment of treatment system 100 and
  • FIG. 15B is a longitudinal cross-sectional view depicting LA members 306 received within retainer 406.
  • Retainer 406 can have any desired configuration for retaining LA members 306.
  • retainer 406 includes a cup-like body 407 having an open proximal end 408 and an inner lumen 409 configured to receive LA members 306.
  • Retainer 406 also includes a closed distal end 410 that has a gradual, sloped transition from the sidewalls to the retainer base where it is coupled with blade-like portion 402. This sloped transition facilitates the passage of retainer 406 and clip 103 through the iatrogenic opening created by blade-like portion 402.
  • each LA member 306 includes a curved or angular portion 360 that offsets the elongate distal portion of each LA member 306 into a more centrally disposed location to allow receipt within inner lumen 409 of retainer 406.
  • Angular portion 360 also provides a gradual, sloped transition from the distal portion of LA members 306 to the outer sidewall of clip 103.
  • the outer diameter 41 1 of cup-like retainer body 407 is preferably slightly smaller than the inner diameter 412 of tubular clip 103. This allows retainer 406 to be withdrawn through clip inner lumen 358 after the deployment of clip 103.
  • RA members 307 can be maintained in the elongate position within the outer sheath 120 up to the point of deployment.
  • FIGS. 16A-B depict yet another exemplary embodiment of treatment system 100 configured to exhibit a reduced outer diameter or profile.
  • FIG. 16A is a side view of this embodiment and FIG. 16B is a longitudinal cross-sectional view taken along line 16B-16B.
  • an elongate needle 130 having a substantially sharp distal end 131 is configured to slidably retain clip 103 on the outer surface of needle 130.
  • Needle 130 includes slots 132-1 and 132-2 which provide access to needle inner lumen 133 for LA members 306-1 and 306-2, respectively.
  • LA members 306 can have angled or curved distal ends 314-1 and 314-2 that deflect inwardly as shown in FIG. 16B to facilitate the routing of members 306 into slots 132.
  • the distal ends 314 of members 306 can be biased towards a relatively elongate or straightened state such that they exert a expansive force on the outer walls of needle 130 and act to maintain clip 103 in the position depicted here.
  • FIGs. 16C-E are partial cross-sectional views depicting clip 103 with a cross-section of delivery device 104 and septal wall 207.
  • FIG. 16C depicts needle 130 after being advanced through septal wall 207.
  • Clip 103 is preferably retained on needle 130 during advancement through septal wall 207.
  • the surface friction between LA members 306 and needle 130 is sufficient to retain clip 103 in position on needle 130 during advancement.
  • RA members 307 each have outwardly deflected end tips 315 that are received within (and slidable within) slots 123 in the wall of outer sheath 120. RA member end tips 315 are maintained in slots 123 by their bias towards sheath 120 as well as by the presence of needle 130, as shown.
  • needle 130 is exposed from sheath 120 and clip 103 has been advanced to the distal end of slot 123.
  • needle 130 Prior to puncturing the septal wall 207, needle 130 is preferably housed within sheath 120, in which case RA member end tips 315 would be at or near the proximal end of slot 123.
  • needle 130 is preferably moved distally with respect to clip 103 (or vice- versa) after clip 103 has been advanced through the septal tissue and into (or near) the desired location for implantation. This allows LA members 306 to deflect into the deployed state over the septum primum 214. Needle 130 can then be withdrawn through the inner lumen of clip 103 and into a position proximal to clip 103, as depicted in FIG. 16D.
  • RA members 307 To deploy RA members 307, sheath 120 can be proximally retracted. LA members 306, which are preferably already deployed, resist the proximal movement of clip 103 and RA member end tips 315 are pulled from slots 123 as sheath 120 is retracted. RA members 307 are then free to deflect into the fully deployed configuration of FIG. 16E. It should be noted that, although RA members 307 and LA members 306 are shown at ninety degree offsets to each other, such an offset is not required.
  • FIGs. 17A-D depict another exemplary embodiment of treatment system 100 having a low profile.
  • clip 103 is retained on the outer surface of tissue-piercing member 140, which is configured in a trocar-like manner with a solid core.
  • FIG. 17A is a side view depicting clip 103 and trocar 140 and
  • FIG. 17B is an axial cross-sectional view showing clip 103, trocar 140 and sheath 120.
  • FIG. 17C is a cross-sectional view of trocar 140 and clip 103 taken along line 17C-17C of FIG. 17 A.
  • trocar 140 includes a substantially sharp distal end 141, a distal portion 142, a proximal portion 143 and an intermediate portion 144 located therebetween.
  • Trocar 140 has a circumferential recess 146 extending the length of intermediate portion 144, such that intermediate portion 144 has a smaller diameter than distal portion 142 or proximal portion 143.
  • This recess 146 constitutes a space in which clip 103 is retained.
  • Abutments 145- 1 and 145-2 are coupled with the intermediate portion 144 and are configured to releasably engage with apertures 316-1 and 316-2 of RA members 307-1 and 307-2, respectively. Abutments 145 can maintain the position of clip 103 on trocar 140 during deployment.
  • System 100 is preferably advanced through the septal tissue in the configuration depicted in FIG. 17B.
  • outer sheath 120 is proximally retracted to expose clip 103 and allow it to deflect over the septal tissue.
  • Clip 103 can be configured to expand to a larger diameter to allow trocar 140 to be withdrawn through clip inner lumen 358, in the case where distal portion 142 has an outer diameter that is too large to fit within lumen 358 when clip 103 is in the housed state of FIG. 17A.
  • clip 103 is biased to expand to a larger diameter.
  • Clip 103 has a longitudinal separation 362 and is housed in a rolled, compressed state within sheath 120, as shown in the cross-sectional view of FIG. 17C. Once exposed from sheath 120, clip 103 is free to expand to the unrolled, larger diameter state having a generally circular cross-section, as depicted in FIG. 17D, which is a radial cross-sectional view of clip 103 after its outer diameter has expanded (it should be noted that LA and RA members 306 and 307 are not shown). It should be noted that instead of rolling between the overlapping configuration of FIG. 17C and the generally circular configuration of FIG. 17D, clip 103 can be configured to uncurl from a generally circular configuration to a larger C-shaped or U-shaped configuration.
  • FIGs. 18A-B depict another embodiment of treatment system 100 having a recess 146 located in the trocar-like tissue -piercing member 140.
  • FIG. 18 A is a longitudinal cross- sectional view depicting this embodiment and
  • FIG. 18B is a radial cross-sectional view taken along line 18B-18B of FIG. 18 A.
  • recess 146 is not circumferential but instead is situated mainly to one side of trocar 140.
  • clip 103 is housed within recess 146 of intermediate portion 144 and is retained there by abutment 145, which preferably interfaces with an aperture on an elongate portion 308 of RA member 307-2.
  • FIG. 18C is a perspective view depicting RA member 307-2 in more detail.
  • elongate portion 308 extends to a position between RA members 307-1 and 307-2, where it is suitably positioned to interface with the abutment on the tissue-piercing member.
  • any portion of clip 103 can be coated with any material as desired.
  • Some exemplary coatings that can be used include coatings that are biodegradable, drug coatings (e.g., drugs can be released from hydrogels or polymer carriers where the polymer itself is a biodegradable material (e.g., poly(caprolactone), poly(D,L-lactic acid), polyorthoester, polyglycolides, polyanhydrides, erodable hydrogels and the like) or elastomers (e.g., polyurethane (PU), polydimethylsiloxane (PDMS) and the like), coatings that increase or decrease lubricity (e.g., hydrogels, polyurethane, parylene and the like), bioactive coatings (e.g., anti-platelet coatings, anti-microbial coatings and the like), coatings that inhibit thrombus formation or the occurrence an embolic events (e.g., heparin, pyrolytic carbon, phosphor
  • These coatings can be applied over the entire clip 103 or any portion thereof. Also, different portions of clip 103 can be coated with different coatings. For instance, because end portion 303 and LA members 306 lie within left atrium 212 in contact with the oxygenated arterial blood, it may be desirable to coat that region of clip 103 with a material designed to inhibit thrombus formation. On the other hand, end portion 304 and RA members 307 lie within right atrium 205 in contact with the oxygen-depleted venous blood, and it may therefore be desirable to coat that region of clip 103 with a material designed to accelerate or promote the healing response. Furthermore, the surface topography of the clip can be varied or configured to accelerate biodegradation of the clip (if including biodegradable materials) and/or to promote tissue encapsulation of the clip.
  • Clip 103 can also be coated in layers.
  • clip 103 has two coatings applied: a first, underlying coating and a second coating situated over the first coating and exposed to the surrounding environment.
  • the second, exposed coating can be a short term coating designed to dissolve over a desired time period.
  • the second coating eventually dissolves enough to expose the underlying first coating, which can itself be configured to dissolve or can be a long term, permanent coating. Any number of coatings having any desired absorption rate or drug elution rate can be used.
  • any portion of clip 103 can be made easier to view by an internal or external imaging device.
  • radiopaque markings are added to members 306 and 307 to make clip 103 viewable via fluoroscopy, while in another embodiment an echolucent coating is added to make clip 103 viewable with ultrasound devices.
  • Clip 103 can be configured for use with any internal or external imaging device such as magnetic-resonance imaging (MRl) devices, computerized axial tomography (CAT) scan devices, X-ray devices, fluoroscopic devices, ultrasound devices and the like.
  • MRl magnetic-resonance imaging
  • CAT computerized axial tomography
  • the devices, systems and methods described herein may be used in any part of the body, in order to treat a variety of disease states. Of particular interest are applications within hollow organs including but not limited to the heart and blood vessels (arterial and venous), lungs and air passageways, digestive organs (esophagus, stomach, intestines, biliary tree, etc.). The devices and methods will also find use within the genitourinary tract in such areas as the bladder, urethra, ureters, and other areas.
  • the devices and methods may also be used in any region of the body in which it is desirable to appose tissues. This may be useful for causing apposition of the skin or its layers (dermis, epidermis, etc), fascia, muscle, peritoneum, and the like.
  • the subject devices may be used after laparoscopic and/or thoracoscopic procedures to close trocar defects, thus minimizing the likelihood of subsequent hernias.
  • devices that can be used to tighten or lock sutures may find use in various laparoscopic or thoracoscopic procedures where knot tying is required, such as bariatric procedures (gastric bypass and the like) and Nissen fundoplication.
  • the subject devices and methods may also be used to close vascular access sites (either percutaneous, or cut-down). These examples are not meant to be limiting.
  • the devices and methods can also be used to apply various patch-like or non- patchlike implants (including but not limited to Dacron, Marlex, surgical meshes, and other synthetic and non-synthetic materials) to desired locations.
  • the subject devices may be used to apply mesh to facilitate closure of hernias during open, minimally invasive, laparoscopic, and preperitoneal surgical hernia repairs.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Rheumatology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne des systèmes, des dispositifs et des procédés de traitement de défauts des tissus internes, tels que des défauts septaux, à l’aide de dispositifs implantables (103). Dans certains modes de réalisation décrits à titre d’exemple, ces dispositifs implantables sont configurés de façon à transpercer le tissu septal pour créer une ouverture artificielle où le dispositif de fermeture peut être implanté. Les dispositifs peuvent comprendre des ancres déformables (306, 307) destinées à interagir avec le tissu septal. Dans d’autres modes de réalisation décrits à titre d’exemple, les dispositifs implantables sont configurés de façon à être mis en place à partir de systèmes de mise en place de faible encombrement dotés d’un organe séparé de percement des tissus.
PCT/US2009/044647 2008-05-20 2009-05-20 Implants transperçant les tissus et autres dispositifs de traitement de défauts septaux WO2009143227A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3542729A1 (fr) * 2018-03-21 2019-09-25 Medtronic Vascular Inc. Dispositif et procédé de migration d'endoprothèse
WO2022238844A1 (fr) * 2021-05-10 2022-11-17 Cilag Gmbh International Agrafe chirurgicale absorbable comprenant un revêtement

Citations (7)

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Publication number Priority date Publication date Assignee Title
WO2000007506A2 (fr) * 1998-08-03 2000-02-17 Anson Medical Ltd. Dispositifs et procedes pour reparer les arteres
WO2000035352A1 (fr) * 1998-12-16 2000-06-22 Scimed Life Systems, Inc. Dispositif d'ancrage pour dispositif implantable
US6913607B2 (en) * 2001-05-01 2005-07-05 Medtronic, Inc. Self-closing surgical clip for tissue
WO2007024615A1 (fr) * 2005-08-19 2007-03-01 Boston Scientific Limited Appareil, systeme et procede d'occlusion de defaut
US20070049970A1 (en) * 2005-09-01 2007-03-01 Ovalis Inc. Suture-based systems and methods for treating septal defects
WO2008024489A2 (fr) * 2006-08-24 2008-02-28 Boston Scientific Limited Dispositif de fermeture, système, et procédé
WO2008153872A2 (fr) * 2007-06-08 2008-12-18 St. Jude Medical, Inc. Dispositifs pour implantation de valvule cardiaque par transcathéter et fermeture d'accès

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000007506A2 (fr) * 1998-08-03 2000-02-17 Anson Medical Ltd. Dispositifs et procedes pour reparer les arteres
WO2000035352A1 (fr) * 1998-12-16 2000-06-22 Scimed Life Systems, Inc. Dispositif d'ancrage pour dispositif implantable
US6913607B2 (en) * 2001-05-01 2005-07-05 Medtronic, Inc. Self-closing surgical clip for tissue
WO2007024615A1 (fr) * 2005-08-19 2007-03-01 Boston Scientific Limited Appareil, systeme et procede d'occlusion de defaut
US20070049970A1 (en) * 2005-09-01 2007-03-01 Ovalis Inc. Suture-based systems and methods for treating septal defects
WO2008024489A2 (fr) * 2006-08-24 2008-02-28 Boston Scientific Limited Dispositif de fermeture, système, et procédé
WO2008153872A2 (fr) * 2007-06-08 2008-12-18 St. Jude Medical, Inc. Dispositifs pour implantation de valvule cardiaque par transcathéter et fermeture d'accès

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3542729A1 (fr) * 2018-03-21 2019-09-25 Medtronic Vascular Inc. Dispositif et procédé de migration d'endoprothèse
US10646325B2 (en) 2018-03-21 2020-05-12 Medtronic Vascular, Inc. Stent migration device and method
WO2022238844A1 (fr) * 2021-05-10 2022-11-17 Cilag Gmbh International Agrafe chirurgicale absorbable comprenant un revêtement

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