Source: https://patents.google.com/patent/EP2475328B1/en
Timestamp: 2019-04-18 22:51:33
Document Index: 672798965

Matched Legal Cases: ['Application No. 10', 'Application No. 11', 'Application No. 11', 'Application No. 11', 'Application No. 11', 'Application No. 12', 'Application No. 10', 'Application No. 11', 'Application No. 11']

EP2475328B1 - Anchors with open heads - Google Patents
EP2475328B1
EP2475328B1 EP10754838.0A EP10754838A EP2475328B1 EP 2475328 B1 EP2475328 B1 EP 2475328B1 EP 10754838 A EP10754838 A EP 10754838A EP 2475328 B1 EP2475328 B1 EP 2475328B1
EP10754838.0A
EP2475328A1 (en
2012-07-18 Publication of EP2475328A1 publication Critical patent/EP2475328A1/en
2014-08-27 Publication of EP2475328B1 publication Critical patent/EP2475328B1/en
Endoscopically delivered gastrointestinal implants, such as those described in commonly assigned U.S. Patent Nos. 7,025,791 and 7,608,114 to Levine et al. , provide the benefits of gastric bypass without the hazards of surgery. For example, an implant may include a thin-walled, floppy sleeve that is secured in the stomach or intestine with a collapsible anchor. The sleeve extends into the intestine and channels partially digested food, or chyme, from the stomach through the intestine in a manner that may cause weight loss and improve diabetes symptoms. The sleeve and anchor can be removed endoscopically when treatment is over or if the patient desires.
WO2004/087014 discloses an anchoring ring and a drum membrane that are collapsible. WOO2004/041133 discloses a fastener system comprising an annular shaped member having a surface having hooks. US2005/0102024 discloses a staple with helical shaped hooks. WO2006/002492 discloses a valve constriction device comprising a plurality of filaments, each having an engaging portion for engaging annular tissue of the valve being treated. US5630829 discloses a high hoop strength intraluminal stent. EP0701800 discloses a self-expanding anchor carrying hooks. Closest prior art is US2005/0085923 disclosing in figures 40A and 40B a gastrointestinal implant with a collapsible anchor with protrusions with a looped end.
The present invention provides an implant, according to claim 1. Embodiments of the present invention provide improved anchoring of an implant in the gastrointestinal tract and can increase the duration that an implant can be anchored in the intestine by encouraging stable tissue reactions to the implant. The collapsible anchor, which may, for example, be a wave anchor or a stent comprising a network of struts, is configured to be deployed within a lumen of the gastrointestinal tract in a mammalian body. Upon deployment, the collapsible anchor expands within the lumen, and the protrusion expands away from the anchor, pushing the loop against a wall of the lumen. Over time, the protrusion and the loop may penetrate the luminal wall, and the loop may project through the far side of the luminal wall. A pocket of scar tissue may form about the loop and through an opening in the loop, securing the anchor within the lumen. The implant may have additional protrusions, each of which is connected to the anchor and includes a loop. Each additional loop may also include an opening and may be adapted to penetrate the luminal wall upon deployment of the collapsible anchor.
Each loop may have an inner opening with a width of between 1 mm and 13 mm, or, more preferably, an inner diameter of 3 mm. Typically, the protrusion extends along a total length of between 6 mm and 13 mm from the collapsible anchor upon full deployment from the collapsible anchor. The protrusion and the loop may be formed of wire (e.g., nitinol wire) with a preferred diameter of 0.25 mm (0.010 inch) to 1.02 mm (0.040 inch), and more preferably 0.51 mm (0.020 inch).
The loop can be formed of a loop of wire, and the protrusion can be formed of a straight length of wire extending from the loop of wire. The loop may be oriented in a variety of directions with respect to the collapsible anchor. For example, the loop may define a plane that is perpendicular to the lumen wall when the protrusion is deployed. Alternatively, the loop may define a plane that is parallel to the lumen wall when the protrusion is deployed. When the protrusion is in a collapsed state, it may fold against or along a side of the collapsible anchor. When relaxed, straight protrusions typically extend outwards from the collapsible anchor at an angle of between about 45 degrees and about 135 degrees, or, more preferably, to an angle of about 80 degrees or about 90 degrees. At these angles, the expanded straight protrusion pushes the loop outward, causing an edge of the loop to engage the luminal wall.
The implant can be collapsed, for removal from the lumen, with the drawstring that may run through an opening in the loop or through additional retaining hooks or loops connected to the loop or the protrusion. Pulling on the drawstring collapses the protrusion towards the collapsible anchor, and away from the luminal wall. Collapsing an implanted helix may cause coils in the helix to shear fibrotic tissue formed about the helix depending on the spacing and orientation of the coils that make up the helix.
An implant with a protrusion and a loop can also include an unsupported, thin-walled sleeve coupled to the collapsible anchor and configured to extend into the lumen (e.g., the intestine) upon deployment of the collapsible anchor. The implant may also include a restrictor plate instead of or in addition to the thin-walled sleeve.
An anchor may be used to secure a sleeve in the intestine of a patient for treating obesity and/or type-2 diabetes as described in commonly assigned U.S. Patent No. 7,025,791 ; U.S. Patent No. 7,608,114 ; U.S. Patent No. 7,476,256 ; U.S. Patent Application No. 10/858,852, filed on June 1, 2004, by Levine et al. ; U.S. Patent Application No. 11/330,705, filed on January 11, 2006, by Levine et al. ; U.S. Patent Application No. 11/827,674 filed on July 12, 2007, by Levine et al. .
Protrusions with open loops (also called open heads), on the other hand, can secure an implant for longer periods of time while minimizing the risk of damage to nearby organs. In one embodiment, the protrusion, which is relatively narrow (e.g., about 1.52 mm (0.060 inch) wide) and relatively long (e.g., about 13 mm long), connects a relatively broad open loop (e.g., about 3 mm in diameter) to a collapsible anchor. Upon deployment, the protrusion pushes the open loop against the intestinal wall. Without being bound by any particular theory, initial research suggests that the muscle layer in the intestine stretches across the loop, and it eventually thins out or erodes enough to allow the loop to penetrate the luminal wall. A chronic inflammation response causes scar tissue to form around the loop and through the opening formed by the loop; this scar tissue can hold the loop securely. Because the loop is rounded or otherwise shaped to promote erosion through the muscle wall, the protrusion and the loop are less likely to pierce the scar tissue or surrounding organs.
The implant 100 includes a collapsible wave anchor 102 that includes a plurality of protrusions 110, each of which extends outward from the wave anchor 102 when the implant 100 is in a relaxed state. The anchor 102 may have a relaxed diameter of about 40 mm or greater, e.g., about 45 mm, about 50 mm, or about 55 mm. Each protrusion 110 includes a rounded loop 112 at the end of a narrow, straight neck 114, and each loop 112 includes an opening whose inner width D is within the range (inclusive) of between about 1 mm and about 13 mm, and preferably a diameter D within a range of about 1 mm and about 6 mm, or, more preferably, about 3 mm. The outer diameter can be within a range of about 2 mm to about 8 mm, and the diameter of the wire used to form each protrusion 110 can be within a range of about 0.25 mm (0.010 inch) to about 0.76 mm (0.030 inch). Typically, the minimum bend radius of the wire limits the minimum inner diameter (it can be difficult to bend the wire too tightly), and the minimum desired pressure exerted by the loop 112 against the tissue limits the maximum inner diameter (bigger loops 112 may not exert enough pressure on the tissue to penetrate the tissue). The straight neck 114 has a length l of between about 6 mm and about 10 mm, for a total projection length L of between about 7 mm and about 13 mm. A crimp 116 or other suitable connection fixes the neck 114 to the wave anchor.
Each protrusion 110 folds down along the side of the wave anchor 102 when compressed for delivery, then springs up to extend nearly perpendicularly from the wave anchor 102 when released from the compressed state to the relaxed state. Specifically, the angle ϕ formed by the protrusion 110 and a leg of the wave anchor 102 may be between about 45° and about 135°, or, more preferably, between about 75° and 105°, e.g., about 80° or about 90°.
FIGS. 2A-2D are elevation and plan views of a single protrusion 110 formed of a single piece of nitinol wire with a diameter of about 0.51 mm (0.020 inch). The wire is bent to form a pair of struts 124 that can be crimped, bonded, or welded onto a single-wire leg of an anchor (e.g., wave anchor 102 in FIGS. 1A-1D) such that the single wire of the anchor leg nestles between the struts 124. The wire is bent to form the narrow, straight neck 114 and coiled twice to create the loop 112. The two loops of coil form a broad, blunt edge 120 that can engage and erode the luminal wall such that the loop 112 eventually penetrates the luminal wall. In this case, the loops also form a face 122 that defines a plane perpendicular to the long axis of the struts 124. When affixed to an anchor and implanted in a lumen, the face 122 is perpendicular to the long axis of the lumen and parallel to a cross section of the lumen. Alternatively, the loop 112 may be formed such that the face 122 is parallel to the long axis of the struts 124. In this alternative orientation, the face 122 is near parallel to the lumen's long axis and near perpendicular to the lumen's cross section when implanted.
FIG. 4O shows an alternative protrusion 970 formed of a paddle with one or more openings 972, each of which is about 0.41 mm (0.016 inch) wide. Tissue can form through the openings 972 to secure the protrusion 970 within the lumen.
A drawstring (not shown) that runs through some or all of retrieval elements 442 can be used to withdraw the protrusions 440 from the luminal wall. Pulling on the drawstring applies a normal force directly to the loops 412, causing the loops 412 to collapse into the coils below to disengage the helix 414 from the surrounding tissue. As the coils collapse, one within the next, they act as a "cheese cutter": each coil helps to shear the surrounding tissue from the coil above it as the above coil passes through the lower coil, freeing the helical protrusion 440 from any scar tissue that may have grown through or around the wire in the loop 412 and the helix 414. Pulling on the drawstring also causes the anchor 102 to collapse for endoscopic withdrawal from the implantation site as described below.
The compliance of the helical neck 414 affects how quickly the loop 412 penetrates the luminal wall 601. Initial studies suggest that the top-most coils in the helical neck 414 continue to push through tissue after initial contact until the contacting tissue and helix 414 come to equilibrium. If the helical neck 414 is as compliant as the luminal wall, however, then the neck 414 will not be able to push the loop 412 through the luminal wall 601. Since the compliance of the helical neck 414 is largely a function of wire diameter and pitch, increasing either the wire diameter or the pitch the wire diameter generally increases the rigidity of helical neck 414. Increasing the wire diameter too much may make it difficult to form the wire into tight loops to shape the loop 412. Wire with a diameter in the range of about 0.41 mm (0.016 inch) to about 1.02 mm (0.040 inch) is generally suitable for helical protrusions 410. Nitinol wire with a diameter of about 0.48 mm (0.019") offers a balance: it can be formed into tight bends for the end of the helical neck 414 and the loop 412, yet forms a helix that is stiffer than the luminal wall 601. It can also be packed into a capsule for endoscopic delivery. The diameter of the helix 414 can also be varied to further customize the transition in stiffness and tissue response.
The compliance/stiffness of the protrusions disclosed herein can be characterized, in part, by the force required to deflect the protrusions from their respective relaxed (extended) states towards their respective collapsed states. For a protrusion with a straight neck (e.g., protrusion 110 of FIGS. 2A-2D), compliance may be defined, in part, by the normal force required to deflect the protrusion at room temperature by a given amount towards the strut of the collapsible anchor. Measurement shows that applying a force of at least about 0.44 N (0.1 lbf) normal to the head (i.e., parallel to the long axis of the lumen) completely collapses a straight-necked protrusion made of 0.25 mm (0.010-inch) diameter nitinol wire, with a total length of 13 mm, ending in a loop formed of two wraps of wire with an inner diameter of about 3 mm. Similar measurement shows that applying about 3.56 N (0.8 lbf) normal to the head deflects the head by about 6.35 mm (0.250 inch) for a straight-necked protrusion made of 0.51 mm (0.020-inch) diameter nitinol wire, with a total length of 11.5 mm, ending in a loop formed of two wraps of wire with an inner diameter of about 3 mm. Other straight-necked protrusions may be deflected by about 6.35 mm (0.250 inch) from their relaxed positions by forces within a range of about 3.56 N (0.80 lbf) to about 4.23 N (0.95 lbf).
The compliance of a helical protrusion can be characterized, in part, by measuring the force required to (partially) collapse the helical protrusion at room temperature. Measurement shows that applying a force normal to the long axis of a helical protrusion within a range of about 0.85 N (0.19 lbf) to about 7.78 N (1.75 lbf), or, more preferably, about 1.42 N (0.32 lbf) to about 4.23 N (0.95 lbf), collapses the protrusion by about 6.35 mm (0.250 inch), depending on the wire diameter, coil pitch, and coil size: Table 1: Normal force applied to compress nitinol helical protrusions by 6.35 mm (0.250 inch) at room temperature
Protrusion Height Base Coil Diameter Top Coil Diameter Coil Spacing Wire Diameter Normal Force
10 mm 6mm 3 mm 2.4 mm 0.41mm (0.016") 0.85 N (0.19 lbf
6 mm 6 mm 3 mm 4.0 mm 0.58mm (0.023") 1.42 N (0.32 lbf)
10 mm 6 mm 3 mm 2.4 mm 0.71 mm (0.028") 4.23 N (0.95 lbf)
10 mm 6 mm 3 mm 2.4 mm 0.76mm (0.030") 7.78 N (1.75 lbf)
In addition to the compliance of the helix as measured in the normal force to compress the helix, resistance to bending must be considered. Helix stiffness can also be characterized by the force required to deflect the helix sideways, i.e., in the plane normal to the long axis of the helix. A balance must be struck between compressability and rigidity. Deflecting a nitinol helical protrusion with a 6 mm height, 6 mm base coil diameter, 3 mm top coil diameter, 4.0 mm coil spacing, and 0.51 mm (0.020-inch) wire diameter sideways by 6.35 mm (0.250 inch) at room temperature takes a force of at least about 0.15 N (0.033 lbf). Increasing the wire diameter to about 0.71 mm (0.028 inch) increases the force to about 0.60 N (0.135 lbf) for a 6.35 mm (0.250-inch) deflection at room temperature. A preferred balance can be defined within the specifications above.
Each of the aforementioned implants may be deployed in the intestine, preferably in the duodenum, and more preferably in the duodenal bulb just distal to the pylorus. Typically, a doctor or other qualified person inserts the implant into the intestine with an endoscopic delivery device. During insertion, the delivery device holds the implant in a compressed state. Once in position, the implant is released from the delivery device and allowed to self-expand, causing each neck coupled to the anchor to push its respective loop against the intestinal wall. Some implants may include a sleeve coupled to the anchor, which can be deployed within the intestine as described in U.S. Patent No. 7,122,058 ; U.S. Patent No. 7,329,285 ; U.S. Patent No. 7,678,068 ; and U.S. Patent Application No. 11/057,861, filed on February 14, 2005, by Levine et al. .
An implant secured with protrusions tipped with open loops may be removed laparoscopically, surgically, or, more preferably, endoscopically with an endoscope. For example, an implant may be collapsed using a drawstring, then withdrawn from the intestine using an endoscope. Further details on endoscopic removal can be found in U.S. Application No. 11/318,083, filed on December 22, 2005, by Lamport and Melanson ; and in U.S. Application No. 12/005,049, filed on December 20, 2007, by Levine et al. .
Typically, the sleeve 706 is floppy and conformable to the wall of the intestine when deployed. It also has a wall thickness of less than about 0.025 mm (0.001 inch) to about 0.13 mm (0.005 inch) and a coefficient of friction of about 0.2 or less. The polymer covering 704 and the sleeve 706 may be made of a fluoropolymer, such as ePTFE coated or impregnated with fluorinated ethylene polyethylene (FEP), or any other suitable material. The sleeve 706 and anchor covering 704 can be a single, integrally formed piece. They can also be separate pieces, depending on whether the anchor 702 is partially or wholly uncovered, as long as the anchor 702 forms a sufficiently good seal between the sleeve 706 and the stomach, pylorus, and/or intestine to funnel chyme through the sleeve 706. Each loop 712 remains uncovered or only partially covered to promote the in-growth of fibrotic tissue.
Anchors secured with loops and necks may also be used to secure restrictor plates within the gastrointestinal tract to treat obesity, such as the restrictor plates disclosed in U.S. Patent Application No. 10/811,293, filed on March 26, 2004, by Levine et al. ; U.S. Patent Application No. 11/330,705, filed on January 11, 2006, by Levine et al. ; and U.S. Patent Application No. 11/827,674, filed on July 12, 2007, by Levine et al. . An implant with a restrictor plate typically includes a restricting aperture that retards the outflow of food from the stomach to the intestine. The diameter of the aperture is less than 10 mm, is preferably less than 7 mm, and is more preferably initially in the range of about 3-5 mm. Alternatively, the aperture may be elastic and expandable under pressure from material flowing through the anchor and the aperture at elevated physiological pressures; as pressure increases, the aperture opens to greater diameters. The implant may include a sleeve that extends into the intestine.
An implant (100) comprising:
a collapsible anchor (102) configured to be deployed within a lumen of the gastrointestinal tract;
a protrusion (110) having a first end coupled to the collapsible anchor (102) between ends of the collapsible anchor (102) and a second end formed in a loop (112); characterised in that it also comprises
a drawstring configured to collapse the protrusion (110) towards the collapsible anchor (102).
The implant (100) of claim 1, wherein the anchor has a relaxed diameter of at least 40 mm, the protrusion (110) has a length of at least 5 mm, and the loop (112) defines an opening for tissue ingrowth.
The implant (100) of claim 1 or claim 2, wherein the protrusion (110) includes a straight neck (114) that connects the loop (112) to the collapsible anchor (102).
The implant (100) of claim 1 or claim 2, wherein the protrusion (410) includes a helix (414) that connects the loop (412) to the collapsible anchor (102).
The implant (100) of claim 4 wherein, in a collapsed state, the helix (414) collapses alongside the collapsible anchor (102).
The implant of claim 4 or claim 5 further including:
an end effect at a tip of the loop (412), the end effect being a post (462) to pierce tissue.
The implant (100) of any one of the preceding claims wherein the loop (112) defines an opening with an inner width within a range of 1 mm to 13 mm.
The implant (100) of any one of the preceding claims wherein the protrusion (110) extends between 6 mm and 13 mm from the collapsible anchor (102) upon full deployment from the collapsible anchor (102).
The implant (100) of any one of the preceding claims wherein the loop (112) is formed of wire with a diameter of 0.25 mm (0.010 inch) to 1.02 mm (0.040 inch).
The implant (100) of any one of the preceding claims wherein, in a collapsed state, the protrusion (110) folds against the collapsible anchor (102).
The implant (100) of any one of the preceding claims wherein the loop (112) defines a plane that is substantially perpendicular to the wall of the lumen.
The implant (100) of any one of claims 1 to 10 wherein the loop (112) defines a plane that is substantially parallel to the wall of the lumen.
The implant (100) of any one of the preceding claims wherein the loop (112) is formed of a wire loop at an end of the protrusion (110).
The implant (100) of any one of the preceding claims further including additional protrusions (110) connected to the collapsible anchor (102), each additional protrusion (110) having an end formed in a loop (112).
The implant (100) of any one of the preceding claims further including:
an unsupported, thin-walled sleeve (706) coupled to the collapsible anchor (702) and configured to extend into the lumen upon deployment of the collapsible anchor (702).
EP10754838.0A 2009-09-11 2010-09-10 Anchors with open heads Expired - Fee Related EP2475328B1 (en)
EP2475328A1 EP2475328A1 (en) 2012-07-18
EP2475328B1 true EP2475328B1 (en) 2014-08-27
EP10754838.0A Expired - Fee Related EP2475328B1 (en) 2009-09-11 2010-09-10 Anchors with open heads
US20070213763A1 (en) 2007-09-13 Intravascular Platforms And Associated Devices
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