Medical device base with rotatable post

Abstract

A medical device comprising a substrate (10) defining a major surface (9) defining a plane, a plurality of first struts (14) extending in a first direction, the plurality of first struts being interconnected with a plurality of second struts (12) extending in a second direction that is non-parallel to the first direction, wherein a width (11) of the second struts, measured along the major surface, is greater than a thickness of the second struts, measured perpendicular to the major surface, such that when the substrate is stretched in the first direction, a mid-section (15) of the second struts (12) rotates relative to the first struts (14) and the mid-section of the second struts bends out of the plane of the major surface. The medical device is operable to stretch and / or retract elements adapted for a particular purpose. In response to stresses applied by means of stretching and / or retracting devices and other methods, the elements are extended and / or retracted. Once the force is removed, the elements remain elongated and / or retracted, or can spring back to an initial position. In various embodiments, the elements are used to treat a target site in the body or to deliver a therapeutic to a target site in the body.

Description

[0001] This application is a divisional application of application number 201880058449.X filed on March 9, 2020, entitled “Medical device substrate with rotatable struts”. TECHNICAL FIELD

[0002] The present disclosure relates generally to medical devices. SUMMARY

[0003] Various aspects of the present disclosure are directed to a medical device including a substrate defining a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along a first direction, the plurality of first struts being interconnected with a plurality of second struts, the plurality of second struts extending along a second direction, the second direction being non-parallel to the first direction along the major surface. A width of the second struts, measured along the major surface, is greater than a thickness of the second struts, measured perpendicular to the major surface, such that when the substrate is stretched in the first direction, a middle section of the second struts rotates relative to the first struts, and the middle section of the second struts is bent out of the plane of the major surface prior to stretching.

[0004] In some embodiments, the medical device further includes a plurality of protrusions extending from the middle sections of the plurality of second struts. When the substrate is stretched in the second direction, the plurality of protrusions rotate with the middle sections of the plurality of second struts to protrude outward relative to the plurality of first struts.

[0005] The plurality of protrusions can optionally include an anchor. In various embodiments, such an anchor can be operable to perform one or more of the following: anchor into tissue, deliver a drug to tissue, stimulate tissue, conceal tissue, expose tissue, secure tissue together, and secure tissue to a medical device, such as a graft or other component of an implantable medical device. In the same or different embodiments, such a protrusion can represent a protrusion including a micro-needle operable to deliver a therapeutic fluid or collect a sample.

[0006] Various aspects of the present disclosure are also directed to a medical system including the medical device of the preceding paragraph and a delivery device configured to cause stretching of the substrate. Deployment of the medical device includes stretching the substrate such that the second struts rotate relative to the first struts.

[0007] Various aspects of the present disclosure are also directed to a medical system including the medical device of the preceding paragraph and a delivery device configured to deliver the medical device within a closed orifice of a patient. The base is a flat sheet that is crimped (rolled up) within the delivery device. The delivery device is operable to unroll the base within the closed orifice such that the flat sheet is at least partially uncrimped within the closed orifice. The medical device is configured to function as a hernia patch, with the plurality of protrusions configured to contact or penetrate tissue of the patient adjacent an opening in the tissue at which a hernia is formed.

[0008] Various aspects of the present disclosure are also directed to a medical system including the medical device of the preceding paragraph and a delivery device configured to deliver the medical device within a closed orifice of a patient. The base is a flat sheet that is crimped (rolled up) within the delivery device. The delivery device is operable to unroll the base within the closed orifice such that the flat sheet is at least partially uncrimped within the closed orifice. The medical device is configured to function as a hernia patch, with the plurality of protrusions configured to contact or penetrate tissue of the patient adjacent an opening in the tissue at which a hernia is formed.

[0009] Various aspects of the present disclosure are also directed to a method of manufacturing the medical device of the preceding paragraph, the method including cutting a sheet of base material to form a base including a plurality of first struts and a plurality of second struts. In the cut sheet of base material, the plurality of first struts are interconnected with the plurality of second struts. BRIEF DESCRIPTION OF DRAWINGS

[0010] The accompanying drawings are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification, illustrate embodiments and together with the description serve to explain the principles of the application.

[0011] Figure 1 An exemplary base according to an embodiment is shown, the base defining longitudinal and lateral struts in a major surface, with barbed protrusions extending from intermediate sections of the lateral struts.

[0012] Figures 2A-2D An exemplary base according to an embodiment is shown, the base defining longitudinal and lateral struts in a major surface, with barbed protrusions extending from intermediate sections of the lateral struts. Figure 1 Rotation of barbed protrusions of an exemplary base after stretching in a longitudinal direction from an initial state.

[0013] Figure 3A And 3B An exemplary base according to an embodiment is shown, the base defining longitudinal and lateral struts in a major surface, with barbed protrusions extending from intermediate sections of the lateral struts.

[0014] Figures 4A-4K Exemplary protrusion configurations according to various embodiments are shown, suitable for use with a base provided with rotatable struts having protrusions.

[0015] Figure 5A And 5BAn exemplary base defining serpentine longitudinal and lateral struts in a major surface with protrusions extending from rotatable intermediate sections of the lateral struts is shown, according to an embodiment.

[0016] Figure 6 An exemplary base defining longitudinal and lateral struts in a major surface with micro-needle-like protrusions extending from rotatable intermediate sections of the lateral struts, the struts including internal lumens in fluid communication with the micro-needle-like protrusions, is shown, according to an embodiment.

[0017] Figure 7A and 7B A balloon-inflatable vascular drug delivery system including a base defining circumferential and lateral struts in a tubular major surface with protrusions extending from rotatable intermediate sections of the lateral struts, is shown, according to an embodiment.

[0018] Figures 8A-8D A barbed sleeve deployed from protrusions operable to secure two tissue layers together is shown, according to an embodiment.

[0019] Figures 9A-9D A medical device suitable for endoluminal delivery including a diameter-adjustable tubular base with rotatable struts mounted on an elongate member is shown, according to an embodiment.

[0020] Figures 10A-10C A medical device is shown, according to an embodiment, for removing a thrombus from a vessel of a patient using Figures 9A-9D DETAILED DESCRIPTION

[0021] Those skilled in the art will readily understand that the aspects of the present application can be implemented by any number of methods and devices constructed to perform the intended functions. It should also be noted that the figures referred to herein are not necessarily drawn to scale, but that certain aspects of the application can be shown exaggerated or enlarged for illustrative purposes, and that the drawings are therefore not to be considered limiting in scope.

[0022] Embodiments presented herein include a medical device operable to extend and / or retract elements adapted for a particular purpose. These elements are extended and / or retracted in response to stresses applied by means of stretching and / or retracting devices, among other methods. These elements can remain extended and / or retracted, or can spring back to an initial position once the force is removed. In various embodiments, these elements are used to treat a target site in the body or to deliver a therapeutic to a target site in the body. In the same or different embodiments, these elements can provide fixation for a medical device.

[0023] Figure 1 ​An exemplary base 10 is shown, defining a main surface 9 comprising a plurality of lateral struts 12 and a plurality of longitudinal struts 14. The lateral struts 12 extend along a first direction and interconnect with the longitudinal struts 14, which extend along a second direction that is not parallel to the first direction along the main surface 9. In some, but not all, embodiments, the first direction may be approximately perpendicular to the second direction. The base 10 is configured such that when the base 10 is stretched along a longitudinal direction, i.e., a direction perpendicular to the first direction, the lateral struts 12 rotate relative to the longitudinal struts 14 and bend out of (bend away from) the plane defined by the main surface 9 prior to stretching. As indicated herein, stretching along a direction means that at least a portion of the stretch is within the dimension of that direction; that is, the stretch does not need to be perpendicular to that direction overall.

[0024] Because the width 11 of the lateral support 12 measured along the main surface 9 is greater than the thickness of the lateral support 12 measured perpendicular to the main surface 9 ( Figure 1 (Not shown in the diagram), the rotation of the lateral strut 12 occurs in response to tension in the longitudinal direction. Since rotation occurs once the bending resistance across the thickness is less than the bending resistance across the width of the strut, the width only needs to be slightly greater than the thickness; however, the width and thickness should be designed to account for any manufacturing tolerances to ensure reliable rotation of all lateral struts in response to tension in the base 10. When the base 10 is exposed to tensile forces, at least the intermediate segment 15 of the lateral strut 12 is configured to rotate relative to the longitudinal strut 14 and bend out of the plane of the main surface 9, which is defined before tension. As the intermediate segment 15 of the lateral strut 12 rotates or after its rotation, the intermediate segment 15 of the lateral strut 12 bends in a plane parallel to the width of the lateral strut 12 as the base 10 elongates, for example, as... Figure 2C and 2D As shown. A plane parallel to the width of the lateral support 12 is included on the main surface 9 at the lateral support 12 and is generally parallel to the plane defined by the directions 30, 32 of the planar base 10.

[0025] In some examples, all or substantially all of the lateral struts 12 are configured to rotate relative to the longitudinal strut 14 and bend outwards from the plane of the main surface 9 when exposed to tensile forces. In such cases, Figures 3A-3BIn examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1. Figures 1-3B In examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1.

[0026] In examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1. Figure 1 In examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1. Figure 2A In examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1.

[0027] In examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1. Figure 1 In examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1.

[0028] In examples of the exemplary base 40, the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12 is curved to allow rotation of substantially all of the lateral strut 12. In other examples, the lateral strut 12 can be twisted to facilitate rotation of the middle section 15 of the lateral strut. In such examples, the strut interconnection 13 can be reinforced to resist bending of the longitudinal strut 14 or the strut interconnection 13 between the longitudinal strut 14 and the lateral strut 12. Such reinforcement can include a widening of the longitudinal strut 14 relative to the lateral strut 12 (e.g., in the plane of the directions 30, 32), as compared to the example of FIG. 1. Such reinforcement can also include a stiffening of the strut interconnection 13, as compared to the example of FIG. 1. Figure 1In embodiments, barbed protrusions 16 extend along major surface 9 in a direction that is approximately parallel to longitudinal strut 14. Base 10, including major surface 9, can be approximately planar. As such, base 10, which defines lateral struts 12, longitudinal strut 14, and optionally all or a portion of barbed protrusions 16, can be cut from a flat sheet of material. In alternative embodiments, base 10, including major surface 9, can be tubular, such that base 10, which defines lateral struts 12, longitudinal strut 14, and optionally all or a portion of barbed protrusions 16, can be cut from a tubular piece of material. In either embodiment, the medical device can be fabricated using relatively simple manufacturing techniques, and the medical device can be operable to provide protrusions 16 to rotatable lateral struts 12 that are configured to rotate relative to longitudinal strut 14 and relative to initial major surface 9 in response to longitudinal stretching of the base material.

[0029] With respect to embodiments that include a base 10 that is cut from a tubular piece of material, referred to herein as a tubular base 10a, the pattern of cuts that form lateral struts 12, longitudinal strut 14, and optionally all or a portion of barbed protrusions 16 can be oriented in any direction about the major surface, such that, for example, as shown in FIGS. 1 1 A and 1 1 B, radial stretching, stretching along the length of the tubular base 10a, or a combination thereof can result in rotation of barbed protrusions 16. Figure 7A and 7B As shown in FIGS. 1 1 A and 1 1 B, radial stretching, stretching along the length of the tubular base 10a, or a combination thereof can result in rotation of barbed protrusions 16.

[0030] Tubular base 10a, which defines lateral struts 12 and longitudinal strut 14, forms a tubular major surface that defines a longitudinal axis. In such embodiments, protrusions 16 can extend approximately parallel to the longitudinal axis when the tubular base 10a is in an unstretched state, and protrusions 16 can extend radially outward when the tubular base 10a is stretched in a longitudinal direction that is parallel to the longitudinal axis. Some or all of protrusions 16 can also be oriented to extend inward when the tubular base 10a is stretched in the longitudinal direction.

[0031] Example steps for manufacturing a medical device that includes a base 10 can include cutting a sheet of base material to form base 10, which includes longitudinal struts 14 and lateral struts 12 having strut interconnections 13, and barbed protrusions 16 or base portions of barbed protrusions 16, i.e., portions that are connected to intermediate sections 15. As described above, longitudinal struts 14 can be interconnected with lateral struts 12 in the cut sheet of base material according to a cutting pattern to provide strut interconnections 13. Additionally, barbed protrusions 16 extend from intermediate sections 15 of lateral struts 12 in the cut sheet of base material, again according to a cutting pattern. In various embodiments, the sheet of base material can be a tubular sheet of base material or a flat (planar) sheet of base material. In a tubular sheet of base material, lateral struts 12 and / or longitudinal struts 14 can form a tubular or generally helical ring according to the cutting pattern.

[0032] The method can further include stretching the base 10 along a direction perpendicular to the longitudinal direction, i.e., along a direction that is not parallel to the longitudinal direction, to rotate the lateral strut 12 relative to the longitudinal strut 14 and to rotate the protrusion 16 relative to the longitudinal strut 14. With or after rotation of the middle section 15 of the lateral strut 12, the middle section 15 of the lateral strut 12 bends in a plane parallel to the width of the lateral strut 12 as the base 10 is elongated, e.g., as shown in Figure 2C and 2D Such stretching can be reversible in that it results in elastic deformation of the base 10 or irreversible in that it results in plastic deformation of the base 10.

[0033] The material of the base 10 can include one or more metals such as stainless steel, a plastic, a super-elastic metal such as Nitinol, and / or a shape memory material such as Nitinol. In embodiments in which the base 10 includes Nitinol or another elastic material, the base 10 can be configured to self-expand to elongate the base 10 and rotate the lateral strut 12 relative to the major surface 9 of the longitudinal strut 14, e.g., such that the protrusion 16 is biased to protrude relative to the longitudinal strut 14. As another example, the elastic base 10 can be configured to self-contract to retract the base 10, e.g., such that the protrusion 16 is biased to lie flat relative to the major surface 9 of the longitudinal strut 14. Although in some examples, a Nitinol base can be temperature activated, such stretching can be at least primarily due to mechanical energy rather than thermal energy.

[0034] Barbed protrusions 16 represent anchors that include a pointed tip with barbs that are adapted to resist retraction of the protrusion 16 once deployed within tissue. Barbed protrusions 16 and other such anchors are operable to penetrate at least one of a patient's tissue and a graft material of an implantable medical device, such graft material of a heart valve device as part of a valve-in-valve implantation procedure. In some embodiments, the protrusions 16 are deployable by stretching the base 10 and retractable by compressing the base 10 or by removing the stretching force from the base 10.

[0035] In different configurations, the protrusions 16 configured as anchors are operable to perform one or more of: anchoring into tissue, delivering a drug to tissue (e.g., as discussed in further detail with respect to Figure 7A and 7B

[0036] Figures 2A-2D ​It is shown that the barbed protrusion 16 of the base 10 is rotated by stretching the base 10 along the longitudinal direction 30, for example in a direction that is not perpendicular to the longitudinal direction 30. Figure 2A This is a top view of a base 10 with a flat pattern cut out from a flat sheet of base material, the flat pattern including longitudinal struts 14, lateral struts 12, and barbed protrusions 16. A longitudinal direction 30 and a lateral (width) direction 32 are shown, and a main surface 9 is indicated, including the longitudinal struts 14, lateral struts 12, and protrusions 16.

[0037] Figure 2B It is a top view of the base 10 stretched along the longitudinal direction 30 by applying force 20 along the longitudinal direction 30. Figure 2C It is shown that an additional force 20 is applied along the longitudinal direction 30 to further stretch the base 10. Figure 2D Is it like this? Figure 2C The side view shown is of the base 10 stretched along the longitudinal direction 30. (See figure) Figure 2D As shown, due to the stretching of the base 10 along the longitudinal direction 30, the lateral struts 12 and protrusions 16 are rotated 22 relative to the longitudinal struts 14, such that protrusions 16 point in direction 24, which is outward relative to the unstretched plane of the base 10, including the lateral struts 12 and protrusions 16. This rotation occurs because the width 11 of the lateral struts 12, measured along the main surface 9, is greater than the thickness of the lateral struts 12, measured perpendicular to the main surface 9 along direction 34. This causes the lateral struts 12 to bend in the thickness direction 34 rather than in the width direction 32. As the base 10 is stretched along the longitudinal direction 30, the middle section 15 of the lateral struts 12 bends in a plane parallel to the width of the lateral struts 12.

[0038] Rotation is increased by the geometry of the lateral struts 12, since each of the lateral struts 12 is non-linear along the main surface 9, such that the middle segment 15 of the lateral struts 12 is offset from the strut interconnection 13 between the lateral struts 12 and the longitudinal struts 14, to enhance the rotation of the protrusions 16 caused by the stretching of the base 10 in the longitudinal direction 30.

[0039] When the base 10 is stretched along the longitudinal direction 30, the middle section 15 of the lateral strut 12 rotates relative to the longitudinal strut 14 and bends out of the plane of the main surface 9. In some examples, only a portion of the lateral strut 12 rotates relative to the longitudinal strut 14, while other portions of the lateral strut 12 twist to allow rotation. In other examples, the longitudinal strut 14 may be bent to allow most or all of the lateral strut 12 to rotate relative to the longitudinal strut 14. As the middle section 15 of the lateral strut 12 rotates, or after rotation, the middle section 15 of the lateral strut 12 bends in a plane parallel to the width of the lateral strut 12 as the base 10 elongates along the longitudinal direction 30, for example, as...Figure 2C and 2D As shown. The magnitude of rotation can be controlled by the magnitude of stretching along the longitudinal direction.

[0040] The substrate 10 shown represents examples of various features of the substrate, and although combinations of those features shown are clearly within the scope of the invention, such examples and examples are not intended to imply that the inventive concept provided herein is limited to fewer features, additional features, or alternative features. Figure 1 and 2A – One or more of those features shown in 2D. For example, in various embodiments, the main surface of the substrate 10 may instead be a tubular main surface instead of a planar main surface 9.

[0041] Example

[0042] Example 1

[0043] Figure 3A and Figure 3B An exemplary stainless steel substrate 40 is shown, which defines longitudinal struts 44 and lateral struts 42 in a main surface 39, having barbed protrusions 46 extending from a central segment 45 of the lateral struts 42. In some embodiments, the substrate 40 may be a stainless steel substrate. The substrate 40 is shown stretched in the longitudinal direction. In an unstretched configuration (not shown), the width 41 of the lateral struts 42, measured along the main surface 39, is greater than the thickness 43 of the lateral struts 42, measured perpendicular to the main surface 39.

[0044] exist Figure 3A and 3B In this embodiment, when the base 40 is exposed to tensile forces, substantially all portions of the lateral strut 42 (including the intermediate segment 45 of the lateral strut 42) are configured to rotate relative to the longitudinal strut 44 and bend out of the plane of the main surface 39. As the intermediate segment 45 of the lateral strut 42 rotates, or after rotation, the intermediate segment 45 of the lateral strut 42 bends in a plane parallel to the width of the lateral strut 12 as the base 40 elongates. The plane parallel to the width of the lateral strut 42 includes the main surface 39 at the lateral strut 42.

[0045] Base 40 is substantially similar to base 10, except that base 40 is configured to facilitate a near-perpendicular orientation of protrusions 46 relative to major surface 39 of longitudinal strut 44 when stretched. Barbed protrusions 46 and other such anchors are operable to penetrate a patient's tissue. As with barbed protrusions 16, barbed protrusions 46 represent anchors that are adapted to resist retraction and potentially prevent protrusions 46 from being pulled out once deployed within a patient's tissue. In some embodiments, protrusions 16, 46 can be deployed by stretching base 40 and can be retracted by compressing base 40 or by removing the stretching force from base 40. The size of the rotation can be controlled by the size of the stretch in the longitudinal direction.

[0046] As shown in FIG. 1, each protrusion 46 includes a base portion 47, a tip portion 48 distal from the base portion, and a body portion 49 between the base portion and the tip portion. At least base portion 47 is integral with lateral strut 42. However, one or both of tip portion 48 and body portion 49 can also be integral with lateral strut 42. Figure 3B

[0047] Bases 10, 40 are suitable for use in a variety of configurations of medical devices for any number of applications. In some embodiments, protrusions 46 can include a removable distal segment, such as a coating, a cap, or a distal tip. In various embodiments, the removable distal tip portion can include one or more of the following: an erodible portion, an absorbable portion, a fractured distal portion, a sticky distal portion, a barbed fractured distal tip, a cap or a barbed sleeve (as shown in FIG. 2), a biological moiety, or other removable distal segment. In any of these embodiments, the removable distal segment can include a therapeutic compound. Figures 8A-8C

[0048] In various embodiments, the shape of tip portion 48 can be pointed, configured as an arrowhead, a one-sided arrowhead, barbed, textured, rectangular, square, ovoid, circular, diamond, triangular, elliptical, polygonal, U-shaped, star-shaped, or other configuration suitable for the selected application. In Figure 4A Various different protrusion configurations suitable for use in tubular or flat (planar) bases 10, 40 are shown in FIGS. 4A-4K.

[0049] Figure 4A The protrusions of FIG. 4A provide a triangular profile.

[0050] Figure 4B The protrusions of FIG. 4B provide a pointed tip with a jagged edge.

[0051] Figure 4C The protrusions of FIG. 4C provide a symmetrical barbed tip, i.e., an arrowhead.

[0052] Figure 4D ​​The protrusions provide asymmetrical, barbed ends, i.e., one-sided arrowhead-shaped.

[0053] Figure 4E The protrusions provide a triangular profile arranged asymmetrically relative to the longitudinal struts.

[0054] Figure 4F The protrusion provides a pointed end.

[0055] Figure 4G The protrusion provides a series of barbed tips between the pointed end and the lateral support.

[0056] Figure 4H The protrusions include overlapping (aligned) protrusions extending on both sides of the lateral strut, such that the protrusions are configured to rotate relative to the longitudinal strut and point outwards relative to the opposite sides of the longitudinal strut when the base is stretched.

[0057] Figure 4I The protrusions include protrusions extending on opposite sides of alternating lateral struts, such that the protrusions are configured to rotate relative to the longitudinal struts and point outward relative to the opposite sides of the longitudinal struts when the base is stretched.

[0058] Figure 4J The protrusions include holes, which help to connect something or allow something to pass through the protrusion.

[0059] Figure 4K The protrusions include rotating paddles, which help to expose or conceal something through the rotation of the paddles.

[0060] Example 2

[0061] Figure 5A and 5B An exemplary substrate 100 is shown, defining a main surface 99 including a serpentine longitudinal strut 114 and lateral struts 112, having a protrusion 116 extending from a rotatable intermediate segment 115 of the lateral strut 112. Except for the serpentine longitudinal strut 114, substrate 100 is similar to substrates 10, 40, and the serpentine longitudinal strut 114 can be combined with the elements and features previously described with respect to substrates 10, 40 by replacing longitudinal strut 14 or longitudinal strut 44 with the serpentine longitudinal strut 114. Figure 5A The serpentine longitudinal strut 114 in the extended structure is shown, while Figure 5B The serpentine longitudinal strut 114 in a collapsed structure is shown.

[0062] The longitudinal struts 114 have a curved shape that is operable to allow the longitudinal struts 114 to be compressed and expanded along the longitudinal direction 130 prior to the lateral struts 112 rotating. For example, initially stretching the base 100 along the direction 130 can straighten the longitudinal struts 114 without the lateral struts 112 rotating. But after the longitudinal struts 114 are straightened or partially straightened, further stretching the base 100 along the direction 130 can cause the lateral struts 112 and the protrusions 116 to rotate, as previously described herein.

[0063] The base 100 is similar to the bases 10, 40, and the bases 10, 40 can be combined with elements and features relative to the base 100 by having the serpentine longitudinal struts include any of the features or elements described relative to the bases 10, 40.

[0064] Example 3

[0065] Figure 6 An exemplary base 200 is shown that defines longitudinal struts 214 and rotatable lateral struts 212 with micro-needle protrusions 216 extending from intermediate sections 215 of the lateral struts 212. The micro-needle protrusions 216 are operable to deliver therapeutic fluids or collect fluid samples, with at least some of the lateral struts 212 and longitudinal struts 214 being tubular structures and in fluid communication with the micro-needle protrusions 216.

[0066] As shown, the longitudinal struts 214 include lumens 224, while the lateral struts 212 include lumens 222. The lumens 222, 224 are in fluid communication with a fluid reservoir 220 and a central lumen 226 of the micro-needle protrusions 216 via a manifold 221. In various embodiments, the fluid reservoir 220 can be used to deliver and / or collect fluids via the central lumens 226 of the micro-needle protrusions 216. In addition to the lumens 222, 224 and the central lumens 226, the base 200 is similar to the bases 10, 40, and the micro-needle protrusions 216 can be combined with elements and features previously described relative to the bases 10, 40.

[0067] In some embodiments, the fluid reservoir 220 is located near a proximal end of a medical device that includes the base 200. In other embodiments, the fluid reservoir 220 is located near a proximal end of a delivery device adapted to facilitate delivery of a medical device that includes the base 200. Such a delivery device can be configured to cause stretching of the base 200. For example, the delivery device can include an elongate element to stretch the medical device in a longitudinal direction parallel to a primary axis of the delivery device. In the same or different embodiments, the delivery device can include a balloon to radially or longitudinally stretch the base 200 as or following release of the medical device from a distal end of a tubular delivery element of the delivery device. In such a balloon deployment embodiment, the base 200 can be a tubular base.

[0068] The base 200 is similar to the bases 10, 40, 100, and the bases 10, 40, 100 can be combined with elements and features relative to the base 200 by including any of the features or elements described with respect to the bases 10, 40, 100.

[0069] Example 4

[0070] Figure 7A And 7B A balloon expandable vascular drug delivery system 300 is shown. The vascular drug delivery system 300 includes a base 310 having rotatable lateral struts 312 with protrusions 316 and an expandable balloon 350, and is adapted for intravascular delivery to a target site within a vessel of a patient. Once at the target site, the vascular drug delivery system 300 facilitates deployment through remote expansion of the balloon 350. In particular, Figure 7A The vascular drug delivery system 300 is shown in a collapsed configuration, while Figure 7B The vascular drug delivery system 300 is shown in an expanded configuration.

[0071] For example, the vascular drug delivery system 300 can also include a therapeutic coating 360 including a therapeutic agent covering all or a portion of the base 310, rotatable lateral struts 312 with protrusions 316, and / or an expandable balloon 350. As previously described, protrusions such as the protrusions 316 extending from the rotatable struts can include a therapeutic compound, and / or present micro-needles configured to deliver a therapeutic fluid.

[0072] The vascular drug delivery system 300 can be operated to apply a therapeutic agent to surrounding tissue along a length thereof. For example, the therapeutic agent can be applied closely to at least a substantial portion of the surrounding tissue along the length.

[0073] In some embodiments, the vascular drug delivery system 300 can be configured to displace at least a portion of a fluid, such as blood, along a length of the vessel, and thus substantially occlude the vessel along the length. In fact, the close proximity to the surrounding tissue and displacement of blood can reduce the amount of therapeutic agent required for effective treatment and the amount of therapeutic agent that migrates away from the treatment site.

[0074] The base 310 defines a tubular major surface 309 comprising circumferential struts 314 and rotatable lateral struts 312 having a protrusion 316 extending from an intermediate section 315 of the lateral strut 312. The base 310 is configured such that when the base 310 is stretched in the circumferential direction by inflation of the balloon 350, the lateral strut 312 rotates relative to the circumferential strut 314 and bends out of the plane of the major surface 309 such that the barbed protrusion 316 rotates relative to the circumferential strut 314. The major surface 309 forms a tube, and the initial plane of the tubular major surface 309 is also tubular. Geometrically, bending out of the plane of the major surface 309 can mean bending inwardly and / or outwardly in the radial dimension.

[0075] The plane of a tubular major surface is a plane in which the tubular base is cut longitudinally and laid flat about the plane. In a tubular arrangement, a plane defined by a tangent to the tubular base major surface describes a protrusion moving (moving away) radially inwardly and / or outwardly out of the local plane.

[0076] In the contracted configuration of the stent 300, the protrusion 316 lies along the major surface 309 of the lateral strut 312 and the circumferential strut 314. In the expanded configuration of the stent 300, the lateral strut 312 with the protrusion 316 is rotated to point outwardly from the major surface 309 of the circumferential strut 314 and from the initial plane of the tubular major surface 309. Figure 7A Figure 7B In the expanded configuration shown, the lateral strut 312 with the protrusion 316 is rotated to point outwardly from the major surface 309 of the circumferential strut 314 and from the initial plane of the tubular major surface 309.

[0077] The tubular major surface 309 of the base 310, including the circumferential struts 314 and the lateral struts 312, defines a longitudinal axis 330. In both the stretched and unstretched configurations, the protrusion 316 lies around a line perpendicular to the longitudinal axis 330. As shown in Figure 7B When the base 310 is radially stretched, the protrusion 316 extends radially outwardly due to rotation of the intermediate section 315 of the lateral strut 312. When the tubular base 310 is not radially stretched, the protrusion 316 can remain coincident with respect to the tubular base 310, and can extend radially outwardly when radial stretching of the base causes the lateral strut 312 to rotate relative to the circumferential strut 314.

[0078] In a modified embodiment, the tubular base can include rotatable circumferential struts that rotate in response to longitudinal stretching of the base. In such an embodiment, the protrusion remains flat with respect to the base when the base is longitudinally stretched and not radially stretched, and can extend radially outwardly when longitudinal stretching of the base causes the circumferential strut to rotate relative to the lateral strut.

[0079] ​In various embodiments, the tubular base 310 can be radially self-expandable. In such embodiments, the tubular base 310 can be constrained within an elongate tubular catheter prior to expansion, and the balloon 350 can be optional. Alternatively, after the tubular base 310 is expanded to an intermediate diameter, the balloon 350 can be used to further radially expand the tubular base 310 to an expanded diameter, for example, to drive the barbed protrusions 316 into patient tissue or other material.

[0080] For example, the tubular base 310 can be radially self-expanded from a collapsed diameter within an elongate tubular catheter to an intermediate diameter, and can be radially balloon expanded from the intermediate diameter to an expanded diameter. In some such embodiments, the intermediate sections 315 of the lateral struts 312 rotate relative to the circumferential struts 314 between the collapsed diameter and the expanded diameter. In some such embodiments, the intermediate sections 315 of the lateral struts 312 can not rotate significantly relative to the circumferential struts 314 between the collapsed diameter and the intermediate diameter during self-expansion, but rather do most of the rotating between the intermediate diameter and the expanded diameter during balloon expansion.

[0081] The base 310 is similar to the bases 10, 40, 100, 200, and the bases 10, 40, 100, 200 can be combined with elements and features relative to the system 300 by modifying or replacing the base 310 with any of the features or elements described relative to the bases 10, 40, 100, 200.

[0082] In embodiments where the protrusions 316 are microstaples (with or without central holes), the microstaples are covered with therapeutic material, and stretching of the base 310 breaks the therapeutic coating to help deliver the therapeutic coating to patient tissue adjacent the therapeutic coating. The microstaples can be used to create drug reservoir locations in a vessel wall, such as an arterial wall. Such a technique can not only provide a relatively high percentage of drug tissue concentration, but also a location to store (to prevent simple flushing of drug particles downstream after balloon therapy). In such embodiments, the microstaple protrusions 316 become exposed during balloon inflation to help break the internal elastic lamina of the vessel. The microstaple protrusions 316 retract prior to inflation, and can also be protected during delivery to the target site. In some embodiments, the therapeutic material 360 can include a combination of a solubilized formulation of a therapeutic compound and slowly dissolving paclitaxel crystals.

[0083] In some embodiments, the balloon 350 can be covered with therapeutic material 360, and the microstaple protrusions 316 can act to radially align the crystals to be directed into the internal elastic lamina of the vessel, rather than simply pressing up against the internal elastic lamina of the vessel during inflation of a similar system without the base 310. The microstaple protrusions 316 in the deployed state can be configured to be radially aligned with the internal elastic lamina of the vessel, and the balloon 350 can be configured to be radially aligned with the internal elastic lamina of the vessel. Figure 7B) disrupts the therapeutic material 360 and can produce a higher proportion of vertically oriented drug formulation particles and result in drug retention in the arterial wall after expansion and contraction. In contrast, a similar system without the base 310 can simply push flat formulation patches (mostly coplanar with the balloon surface and the thin vessel wall) against the wall with little mechanism for the formulation to adhere to the wall after balloon contraction and vessel blood restoration. Thus, the inclusion of the base 310 with microspiked protrusions in a drug delivery system can result in improved drug delivery efficiency and reduced amount of drug delivered to the patient's blood.

[0084] Generally, it can be preferable for the microspiked protrusions 316 to retract upon balloon contraction, such that the material of the base 310 should have sufficient elasticity to collapse upon balloon contraction. Such a material can include nitinol or other metals.

[0085] In some embodiments, the microspiked protrusions 316 can extend between 200 to 1000 microns, such as about 500 microns. Such a length can allow the drug formulation to penetrate from the endothelium through the media towards the adventitia of the artery, which is the target region and site of maximum drug retention. This can allow drug delivery through the fibrous cap on a plaque segment of the artery wall.

[0086] In the same or different embodiments, the vascular drug delivery system 300 can include about 25 to about 50 microspiked protrusions 316 for a balloon size of 5 millimeters diameter by about 40 millimeters long. The size and number of these microspiked protrusions 316 are merely examples, and other sizes and numbers of protrusions can be selected for various applications.

[0087] In the same or different embodiments, the microspiked protrusions 316 can deploy to about half of the final diameter once the balloon is inflated. Such a configuration can allow the fragments to align radially for delivery of various vessel diameters ranging from about half of the final diameter to the final diameter.

[0088] The balloon 350 can be selected according to the design requirements of a particular application, including the resistance to deployment provided by the base 310 and the therapeutic material 360, and the desired range of radial force to be applied to the vessel wall during deployment to improve delivery of the therapeutic material 360 without causing undesirable damage to the vessel wall.

[0089] For example, balloon formation can be carried out in any conventional manner using known extrusion, blow molding, and other molding techniques. Generally, the three main steps in the process include extruding a tubular preform, molding the balloon, and annealing the balloon. Depending on the balloon material employed, the preform can be axially stretched prior to blow molding.

[0090] The balloon can be attached to an elongated member (not shown) using various bonding techniques known to those skilled in the art to facilitate delivery within a blood vessel. Examples include, but are not limited to, solvent bonding, thermal adhesive bonding, and thermal shrinking or thermal sealing. The choice of bonding (adhesive) technique depends on the materials used to fabricate the expandable element and the tubular body.

[0091] According to this disclosure, any material with the desired physical properties known to those skilled in the art can be used to form the balloon. Commonly used materials include thermoplastic elastomers and non-elastomeric polymers, as well as thermosetting materials.

[0092] In example system 300, a 6 French collapse diameter allows for a 5 mm deployment diameter and a 40 mm balloon length, representing 250 percent balloon inflation. This example can be adjusted to accommodate other vessel sizes, including but not limited to 4-8 mm diameters, 40-200 mm lengths, 6 French guide sheath sizes, or 7 French guide sheath sizes, to deliver balloons with a 7 or 8 mm deployment diameter.

[0093] In applications below the knee: diameters of 2.0–4.0 mm, lengths of 40–200 mm, and guide profiles of 4–5 French are available.

[0094] In any of these examples, the formulation of the therapeutic material 360 may be somewhat fragile to facilitate disintegration and release from the micro-staples 316 and the balloon 350 upon deployment.

[0095] System 300 facilitates a variety of coating options. As an example, the treatment material 360 can be on the balloon 350 but beneath the substrate 310. This embodiment allows the micro-studs 316 to deploy without interference from the treatment material 360. Similarly, in this embodiment, the substrate 310 protects the treatment material 360 during tracking and primary lesioning. In a variation of this embodiment, the balloon 350 can be dip-coated, and then the substrate 310 can be loaded onto the balloon 350.

[0096] In another example, such as Figure 7A As shown, the therapeutic material 360 can be on the balloon 350 and the base 310. In this example, deployment allows the micro-staples 316 to force the therapeutic material 360 to rupture. In a variation of this embodiment, after the base 310 is loaded onto the balloon 350, all of the base 310 and the balloon can be impregnated.

[0097] In another example, the therapeutic material 360 can be coated on all or a portion of the substrate 310, such as on the microspike protrusions 316. This example would allow the therapeutic material 360 to penetrate the vessel wall. This example can result in the highest proportion of therapeutic material 360 being delivered to the vessel wall. In a variation of this embodiment, the entire substrate 310 can be dip coated and then loaded onto the balloon 350.

[0098] Embodiments in which the balloon 350 is covered with therapeutic material 360 and the microspikes 316 are used to radially align the crystals to be directed into the internal elastic lamina of the vessel can provide one or more advantages over similar drug delivery systems without the substrate 310. For example, the applied technology can improve patient safety due to: reduced paclitaxel drug content / device, reduced procedure time (primary angioplasty force) due to not requiring pre-dilation balloon inflation prior to deployment, reduced inflation time, reduced particulate delivery distally via blood flow, and reduced incidence of segmental drug overdosing, reduced dissection of the vessel, and reduced vessel recoil requiring implantation of a stent due to forced concentric dilation during angioplasty, enhanced clinical outcomes due to improved drug uptake consistency, and improved drug delivery efficiency, reduced incidence of segmental drug underdosing, and / or forced concentric inflation from the substrate 310 resulting in reduced vessel dissection and vessel recoil. The microspike protrusions 316 can also protect the drug formulation during the crossing and tracking of the introducer valve to the treatment site, which can mitigate loss of the formulation in tortuous arteries prior to inflation and can perform primary angioplasty. Such advantages can provide an effect over similar drug delivery systems without the substrate 310, resulting in greater treatment success, more consistent patient success, and across a greater patient population (i.e., reduced number of clinical "non-responders").

[0099] Embodiment 5

[0100] Figures 8A-8C A barbed sleeve deployed from a protrusion is shown to secure two tissue layers together. In particular, Figure 8A A blood vessel 460 is shown having tissue layers 462, 464 separated from one another. As an example, Figure 8A A blood vessel dissection can be represented, where the tissue layer 462 is a vessel wall and the tissue layer 464 is an intimal flap.

[0101] Figure 8B A balloon-inflatable vessel delivery system 400 is shown. The vessel delivery system 400 includes a substrate 410 having rotatable lateral struts 412 with protrusions 416, circumferential struts 414, and a balloon 420. Figure 8BThe vessel delivery system 400 also can include a delivery device (not shown). Once at the target site, the vessel drug delivery system 400 facilitates deployment by remote inflation of the balloon 450.

[0102] The vessel delivery system 400 and variations thereof are the same or similar to those described with respect to the vessel delivery system 300, except that a cap 420 is added on the distal end of the protrusion 416. The cap 420 can represent a coating or a releasable sheath on the protrusion 416.

[0103] Because the protrusion 416 lies flat against the balloon 450 (lays flat on the balloon) in the un-deployed state, the cap 420 can be deployed by the vessel delivery system 400 inside a patient's vessel. Once at the target treatment site, the balloon 450 can be remotely inflated, and as previously described, for example, with respect to the delivery system 300, the protrusion 416 will rotate into place during deployment. Inflation of the balloon 450 can cause the protrusion 416 and cap 420 to embed into the vessel wall including tissue layers 462, 464, as shown in the enlarged portion of Figure 8B In the particular embodiment shown, the cap 420 can represent a barbed sleeve that is adapted to pin the tissue layers 462, 464 together, for example, to repair an intimal flap. As shown in the enlarged portion of Figure 8B Figure 8D The cap 420 includes barbs 426 on the wall of the cap 420 and a pointed tip 422, as shown in the enlarged portion of

[0104] As shown in Figure 8C The vessel delivery system 400 has been withdrawn from the vessel, leaving behind the cap 420. In this particular embodiment, the intimal flap has been repaired because the cap 420 acts to secure the tissue layer 464 to the tissue layer 462.

[0105] The cap 420 also can be used to deliver a therapeutic agent to the vessel wall. The cap 420 can be permanent or bioabsorbable. The cap 420 can be textured or barbed to lock into the tissue. For example, the cap 420 itself can include barbs that help anchor the sheath in place. The cap 420 can be polymeric or metallic. The cap 420 can include a swellable portion. For example, the tip of the cap 420 can be coated with a hydrogel that swells when it absorbs moisture. The swollen tip can help anchor the cap 420 in place.

[0106] ​Base 410 is similar to bases 10, 40, 100, 200, 310, and bases 10, 40, 100, 200, 310 can be combined with elements and features relative to system 400 by modifying or replacing base 410 with any of the features or elements described with respect to bases 10, 40, 100, 200, 310.

[0107] Example 6

[0108] Figures 9A-9D A medical device 500 suitable for endoluminal delivery is shown. Medical device 500 includes a diameter-adjustable tubular base 510 having a base 560 defining rotatable lateral struts 512 with raised (convex) edges 515 and circumferential struts 514 mounted on an elongated member 540. Raised edges 515 are adapted to remove thrombus from a vessel, as described with respect to Figure 10A -10C.

[0109] Base 510 defines a tubular major surface 509 including circumferential struts 514 and rotatable lateral struts 512. Base 510 is configured such that when base 510 is elongated in the circumferential direction by inflation of balloon 550, lateral struts 512 rotate relative to circumferential struts 514 and bend out of the plane of major surface 509 such that raised edges 515 extend radially outward.

[0110] Medical device 500 can be part of a vessel delivery system adapted for endovascular delivery via elongated member 540 to a target site within a patient vessel. The vessel delivery system can also include an inflatable balloon and / or a delivery device (not shown). Such a vessel delivery system and variations thereof are the same as or similar to those described with respect to vessel delivery system 300, except that there are no protrusions from lateral struts 512. For example, once at the target treatment site, the balloon can be inflated remotely, and lateral struts 512 will rotate into place during deployment, as previously described, for example, with respect to delivery system 300.

[0111] Base 510 is similar to bases 10, 40, 100, 200, 310, 410, and bases 10, 40, 100, 200, 310, 410 can be combined with elements and features relative to medical device 500 by modifying or replacing base 510 with any of the features or elements described with respect to bases 10, 40, 100, 200, 310, 410.

[0112] Figures 10A to 10CRemoval of a thrombus 565 from a vessel 562 of a patient using a medical device 500 is shown. The thrombus 565 is a vascular occlusion that can substantially prevent blood flow through the vessel 562. As shown, the medical device 500 can be used to scrape and clear the thrombus 565. First, the medical device 500 is delivered to the target treatment site, i.e., the location of the thrombus 565 in the vessel 562 Figure 10A ). Then, the distal end of the medical device 500, including the base 510, is pushed into the thrombus 565 Figure 10B ). Next, the base 510 is inflated, e.g., with a balloon (not shown) to rotate the lateral struts 512 and expose the raised edges 515. The exposed raised edges 515 are then used to scrape (shave) and clear the thrombus 565 Figure 10C ) by rotating the base 510 and / or moving the base longitudinally within the vessel 562 (e.g., via teleoperation of the elongate member 540). The raised edges 515 of the lateral struts 512 can act as a spoon to remove the thrombus 565 from the wall of the vessel 562. A bag or other filter (not shown) can be used to capture free thrombus particles released downstream within the vessel 562. The same or similar techniques can be used to remove plaque from within the vessel 562.

[0113] Example 7

[0114] In some embodiments, and with reference to Figure 7B , the tubular base 310 can be adapted for intravascular delivery to a target site within a patient's vessel.

[0115] The tubular base 310 can be deployed from a balloon (not shown) until the protrusions 316 reach and pierce the blood vessel. In this embodiment, the protrusions 316 will be configured to have a texture or barbs to enable them to engage and grip tissue, such as those shown in Figure 4B , Figure 4C , Figure 4D and Figure 4G . Once the balloon is deflated, the barbed protrusions 316 will pull the blood vessel or host tissue with them. In this case, the tubular base 310 can remain in the blood vessel and act to reduce the diameter of the blood vessel.

[0116] This technique can be used to standardize the ostium of the left atrial appendage, restore the function of venous valves, create a landing zone for abdominal aneurysm stent grafts located just below the renal arteries, and / or completely occlude a blood vessel (total blockage). In some such embodiments, the tubular base 310 can be used as a "reverse" stent. In some such embodiments, the tubular base 310 can be formed from a shape memory alloy that is heat set to a collapsed diameter shape. In such embodiments, the protrusions 316 can be heat set outward or heat set to rotate outward with the rotatable lateral struts 312 during expansion of the tubular base 310 from the collapsed diameter to the expanded diameter.

[0117] In some such embodiments, the protrusions 316 are constrained by the delivery catheter device, and then the tubular base 310 is deployed from the distal end of the delivery catheter device.

[0118] In the same or different embodiments, the tubular base 310 can be mounted on a balloon to facilitate radial expansion of the tubular base 310 and / or penetration of the protrusions 316 into patient tissue or graft material. Inflation of the balloon will drive the barbs into the tissue or graft material. Deflation of the balloon will allow the tubular base 310 to pull the orifice closed.

[0119] At the entrance of the left atrial appendage, the sheath will be pulled back, thereby deploying the protrusions 316 that serve as anchors. Inflation of the balloon will drive the barbs into the tissue. Deflation of the balloon will allow the stent to pull the orifice closed, the tubular base 310 to pull the orifice closed. In this way, the stent is configured to radially collapse to pull tissue surfaces captured by the plurality of protrusions together.

[0120] Although described with respect to techniques that cause occlusion of the patient’s left atrial appendage, the techniques can be radially applied to pull other tissues together. For example, the tubular base 310 can be deployed to cause occlusion of a blood vessel, to cause occlusion of a tubular conduit or organ, to facilitate closure of a wall defect, to facilitate closure of a local wound, to facilitate closure of an internal wound, or to facilitate occlusion of an orifice or space within the patient.

[0121] In the same or different embodiments, the medical device including the tubular base 310 can also include a collar (sleeve) configured to substantially cover the central lumen of the tubular base 310. Optionally, such a collar can then be slid over the tubular base 310, thereby completely closing the orifice. Tabs opposite the protrusions 316 can be used to capture the collar. If further fixation is desired, a septal defect closure device such as Gore Helex or Eclipse can be deployed through the central lumen of the tubular base 310.

[0122] The tubular base 310 can be combined with other techniques for occluding the patient’s left atrial appendage, for example, as described in U.S. Patent No. 9,186,152, entitled “Left Atrial Appendage Occlusion Device,” which is incorporated herein by reference for all purposes.

[0123] Embodiment 8

[0124] A medical system can include a medical device having a tubular base corresponding to one of the bases 10, 40, 100, 200, 310, 410, or 510 and a delivery device configured to deliver the medical device within a vessel of a patient, with the medical device in a collapsed configuration. The delivery device is operable to deploy the tubular base within the vessel. The deployment of the medical device includes stretching the tubular base to an expanded configuration such that the lateral struts are configured to rotate relative to the longitudinal struts. The tubular base is configured to engage an inner wall of the vessel.

[00115] In some such embodiments, the deployment of the medical device includes stretching the tubular base to an expanded configuration such that the lateral struts and the protrusions are configured to rotate relative to the longitudinal struts. The protrusions can be configured to penetrate the inner wall of the vessel.

[0125] In the same or different embodiments, the tubular base forms at least a portion of a stent. For example, the protrusions can be used as tissue engagement members of a stent or stent graft, as described in U.S. Patent No. 9,333,101, entitled “Medical device fixation anchor,” which is incorporated herein by reference for all purposes.

[0126] In some such embodiments in which the tubular base forms at least a portion of a stent, the medical device can further include a tubular graft layered with the base to form a stent graft.

[0127] Embodiment 9 (valve implementation)

[0128] A medical system can include a medical device having a tubular base corresponding to one of the bases 10, 40, 100, 200, 310, 410, or 510 and a delivery device configured to deliver the medical device within a vessel of a patient, with the medical device in a collapsed configuration. The delivery device is operable to deploy the tubular base within the vessel. The deployment of the medical device includes stretching the tubular base to an expanded configuration such that the lateral struts are configured to rotate relative to the longitudinal struts.

[0129] The base of the device includes protrusions operable to penetrate at least one of tissue of a patient and a graft material of the implantable medical device, such graft material of the heart valve device as part of a valve implant procedure in a valve.

[0130] Embodiment 10

[0131] A medical system can include a medical device having a base corresponding to one of the bases 10, 40, 100, 200, 310, 410, or 510 and a delivery device configured to deliver the medical device within a restricted orifice of a patient. The base is a flat sheet that is crimped (rolled up) within the delivery device. The delivery device is operable to deploy the base within the restricted orifice such that the flat sheet is at least partially uncrimped within the restricted orifice.

[0132] Deployment of the medical device can include stretching the base to an expanded configuration such that the lateral struts are configured to rotate relative to the longitudinal struts.

[0133] In some such embodiments, the medical device is configured for use as a hernia patch, with the protrusions configured to contact or penetrate tissue of a patient after deployment of the base from a delivery device. In such embodiments, the protrusions can be configured to contact or penetrate tissue of a patient at an opening in tissue adjacent to a hernia formation. For example, the base can be used as a hernia patch as described in U.S. Patent Application Publication No. 2012 / 0065649, entitled “Surgical Mesh,” which is incorporated herein by reference for all purposes.

[0134] Some representative embodiments of the present disclosure can be characterized according to the following clauses.

[0135] Clause 1 : A medical device comprising: a base defining a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending in a first direction, the plurality of first struts being interconnected with a plurality of second struts, the plurality of second struts extending in a second direction, the second direction being non-parallel to the first direction along the major surface, wherein a width of the second struts, measured along the major surface, is greater than a thickness of the second struts, measured perpendicular to the major surface, such that when the base is stretched in the first direction, a middle section of the second struts rotates relative to the first struts and the middle section of the second struts bends out of the plane of the major surface.

[0136] Clause 2: The medical device of Clause 1, wherein the first direction is perpendicular to the second direction.

[0137] Clause 3: The medical device of Clause 1 or Clause 2, wherein the plurality of second struts extend at an angle relative to a transverse direction, defining a serpentine portion having peaks and valleys, the plurality of first struts being interconnected with the plurality of second struts adjacent to apices of the peaks and valleys.

[0138] Clause 4: The medical device of Clause 3, wherein the serpentine portion comprises a V-shaped portion including the peaks and valleys.

[0139] Clause 5: The medical device of Clause 3, wherein the serpentine portion comprises a U-shaped portion including the peaks and valleys.

[0140] Clause 6: The medical device of any of Clauses 1-5, wherein the plurality of first struts have a curved shape operable to allow expansion of the first struts in the first direction prior to rotation of the middle section of the second struts as the base is stretched in a direction perpendicular to the first direction.

[0141] Clause 7: The medical device of any of clauses 1-6, wherein the base comprises one or more of a metal, a plastic, a superelastic metal, and a shape memory material.

[0142] Clause 8: The medical device of any of clauses 1-7, wherein the base comprises nitinol, the nitinol operable to self-expand to elongate the base in a direction perpendicular to the first direction or to self-contract to retract the base in a direction perpendicular to the first direction.

[0143] Clause 9: The medical device of any of clauses 1-8, wherein stretching the base in a direction perpendicular to the first direction causes plastic deformation of the base.

[0144] Clause 10: The medical device of any of clauses 1-8, wherein stretching the base in a direction perpendicular to the first direction causes elastic deformation of the base.

[0145] Clause 11 : The medical device of any of clauses 1-10, wherein the base is flat.

[0146] Clause 12: The medical device of any of clauses 1-10, wherein the base is a tubular base.

[0147] Clause 13: The medical device of clause 12, wherein the tubular base is radially self-expandable.

[0148] Clause 14: The medical device of clause 12, wherein the tubular base is radially balloon-expandable.

[0149] Clause 15: The medical device of clause 14, wherein the tubular base is radially self-expandable from a collapsed diameter to an intermediate diameter, wherein the tubular base is radially balloon-expandable from the intermediate diameter to an expanded diameter, and wherein the intermediate section of the second strut rotates relative to the first strut between the collapsed diameter and the expanded diameter.

[0150] Clause 16: The medical device of clause 15, wherein the intermediate section of the second strut rotates relative to the first strut between the intermediate diameter and the expanded diameter, and wherein the intermediate section of the second strut does not rotate significantly relative to the first strut between the collapsed diameter and the intermediate diameter.

[0151] Clause 17: The medical device of any of clauses 1-16, further comprising a therapeutic coating covering at least a portion of the base, wherein the rotation of the intermediate section caused by stretching the base in a direction perpendicular to the first direction ruptures the therapeutic coating to facilitate delivery of the therapeutic coating to patient tissue adjacent the therapeutic coating.

[0152] Clause 18: The medical device of any of clauses 1-17, further comprising a plurality of protrusions extending from the intermediate sections of the plurality of second struts, wherein the plurality of protrusions rotate with the intermediate sections of the plurality of second struts to protrude outward relative to the plurality of first struts when the base is stretched in a direction perpendicular to the first direction.

[0153] Clause 19: The medical device of clause 18, further comprising a cap on a distal end of each of the plurality of protrusions, the caps configured to remain within the patient tissue after the distal end is inserted and removed from the patient tissue.

[0154] Clause 20: The medical device of clause 18, wherein the plurality of protrusions each extend within the base parallel to the first struts.

[0155] Clause 21 : The medical device of any of clauses 18-20, wherein the plurality of protrusions extend from opposite respective sides of the plurality of second struts, such that the plurality of protrusions rotate with the intermediate sections of the plurality of second struts to protrude in opposite respective directions relative to the plurality of first struts when the base is stretched in a direction perpendicular to the first direction.

[0156] Clause 22: The medical device of any of clauses 18-21, wherein the plurality of protrusions define anchors, each anchor comprising a pointed tip.

[0157] Clause 23: The medical device of clause 22, wherein the anchors are operable to penetrate at least one of a tissue of the patient and a graft material of the implantable medical device.

[0158] Clause 24: The medical device of clause 22 or clause 23, wherein the anchors each comprise a base portion, a tip portion distal to the base portion, and a body portion between the base portion and the tip portion, wherein the base portion is integral with one of the intermediate sections of the plurality of second struts.

[0159] Clause 25: The medical device of clause 24, wherein the anchors are operable to penetrate a tissue of a blood vessel, and wherein the tip portion is operable to prevent being pulled out once penetrated into the tissue.

[0160] Clause 26: The medical device of clause 24 or clause 25, wherein the tip portion is in a form selected from the group consisting of pointed, arrowed, single-sided arrowed, barbed, textured, rectangular, square, oval, circular, diamond, triangular, elliptical, polygonal, U-shaped, and star-shaped.

[0161] Clause 27: The medical device of any of clauses 22-26, wherein the anchors are operable to perform one or more of: anchoring into tissue, delivering a drug to tissue, stimulating tissue, concealing tissue, exposing tissue, securing tissue together, and securing tissue to the medical device.

[0162] Clause 28: The medical device of any of clauses 22-27, wherein the anchors each comprise a removable distal section.

[0163] Clause 29: The medical device of clause 28, wherein the removable distal section comprises one or more of: a barbed sleeve, an erodible portion, an absorbable portion, a fractured distal portion, a sticky distal portion, a barbed fractured distal tip, a therapeutic compound, and a biological moiety.

[0164] Clause 30: The medical device of any of clauses 18-21, wherein the plurality of protrusions are microneedles comprising a lumen in fluid communication with the manifold and the fluid reservoir, and wherein the microneedles are operable to deliver a therapeutic fluid or collect a sample via the lumens and the manifold.

[0165] Clause 31: The medical device of clause 30, wherein at least some of the first struts and the second struts are tubular structures and have a lumen, and are in fluid communication with the microneedles and the fluid reservoir.

[0166] Clause 32: The medical device of clause 30 or clause 31, wherein the fluid reservoir is located proximate a proximal end of a delivery device adapted to facilitate delivery of the medical device.

[0167] Clause 33: The medical device of clause 30 or clause 31, wherein the fluid reservoir is located proximate a proximal end of the medical device.

[0168] Clause 34: The medical device of any of clauses 18-33, further comprising a therapeutic coating covering the plurality of protrusions, wherein rotation of the plurality of protrusions resulting from stretching the base in a direction perpendicular to the first direction causes the therapeutic coating to break to facilitate delivery of the therapeutic coating to patient tissue adjacent the therapeutic coating.

[0169] Clause 35: The medical device of any of clauses 18-34, wherein the base is a tubular base, wherein the tubular base defines a lumen having a longitudinal axis, wherein the plurality of protrusions remain coincident with the base when the base is radially unstretched, and wherein the plurality of protrusions extend radially outward when radially stretching the base causes the second struts to rotate relative to the first struts.

[0170] Clause 36: The medical device of Clause 35, wherein the plurality of protrusions remain flat relative to the base when the base is stretched longitudinally and is not stretched radially.

[0171] Clause 37: The medical device of any of Clauses 18-34, wherein the base is a tubular base, wherein the tubular base defines an inner lumen having a longitudinal axis, wherein the plurality of protrusions remain coincident relative to the base when the base is not stretched longitudinally, and wherein the plurality of protrusions extend radially outward when stretching the base longitudinally causes the second struts to rotate relative to the first struts.

[0172] Clause 38: The medical device of Clause 37, wherein the plurality of protrusions remain flat relative to the base when the base is stretched radially and is not stretched longitudinally.

[0173] Clause 39: The medical device of any of Clauses 35-38, wherein the medical device is configured to collapse radially to draw tissue surfaces captured by the plurality of protrusions together.

[0174] Clause 40: The medical device of Clause 39, wherein the medical device further comprises a collar configured to substantially cover the inner lumen.

[0175] Clause 41: The medical device of any of Clauses 35-40, wherein the tubular base is radially self-expandable.

[0176] Clause 42: The medical device of Clause 41, wherein the tubular base is radially balloon-expandable.

[0177] Clause 43: The medical device of Clause 42, wherein the tubular base is radially self-expandable from a collapsed diameter to an intermediate diameter, wherein the tubular base is radially balloon-expandable from the intermediate diameter to an expanded diameter, and wherein between the collapsed diameter and the expanded diameter, the plurality of protrusions rotate with the intermediate sections of the second struts to protrude outward relative to the first struts.

[0178] Clause 44: The medical device of Clause 43, wherein between the intermediate diameter and the expanded diameter, the plurality of protrusions rotate with the intermediate sections of the second struts to protrude outward relative to the first struts, and wherein the plurality of protrusions remain flat relative to the base when the base is inflated from the collapsed diameter to the intermediate diameter.

[0179] Clause 45: The medical device of any of Clauses 12-17 and 35-44, wherein the tubular base forms at least a portion of a stent.

[0180] Clause 46: The medical device of Clause 45, further comprising a tubular graft layered with the base to form a stent-graft.

[0181] Clause 47: A medical system comprising: the medical device of any of clauses 1-46, and a delivery device configured to cause stretching of the base, wherein the deployment of the medical device comprises stretching the base such that the second struts rotate relative to the first struts.

[0182] Clause 48: A medical system comprising: the medical device of any of clauses 18-34, and a delivery device configured to deliver the medical device within a restricted orifice of a patient, wherein the base is a flat sheet that is crimped within the delivery device, wherein the delivery device is operable to deploy the base within the restricted orifice such that the flat sheet is at least partially uncrimped within the restricted orifice, and wherein the medical device is configured to function as a hernia patch, wherein the plurality of protrusions are configured to contact or penetrate tissue of the patient adjacent to an opening in the tissue at a hernia formation.

[0183] Clause 49: A medical system comprising: the medical device of any of clauses 12-17 and 35-46, and a delivery device configured to deliver the medical device within a vessel of a patient, wherein the medical device is in a collapsed configuration, wherein the delivery device is operable to deploy the tubular base within the vessel, and wherein the deployment of the medical device comprises stretching the tubular base to an expanded configuration such that the second struts rotate relative to the first struts.

[0184] Clause 50: The medical system of clause 49, wherein the elevated edges of the tubular base are configured to scrape and clear thrombus from within the vessel when the tubular base is deployed to the expanded configuration.

[0185] Clause 51: The medical system of clause 49, wherein the tubular base is configured to engage an inner wall of the vessel when the tubular base is deployed to the expanded configuration.

[0186] Clause 52: The medical system of clause 49, wherein the medical device is the medical device of any of clauses 35-46, and wherein the deployment of the medical device comprises stretching the tubular base to an expanded configuration such that the second struts and the plurality of protrusions rotate relative to the first struts.

[0187] Clause 53: The medical system of clause 52, wherein the plurality of protrusions are configured to penetrate the inner wall of the vessel.

[0188] Clause 54: A method of manufacturing the medical device of any of clauses 1-46, the method comprising: cutting a sheet of base material to form a base comprising a plurality of first struts and a plurality of second struts, wherein, in the cut sheet of base material, the plurality of first struts are interconnected with the plurality of second struts.

[0189] Clause 55: The method of clause 54, wherein the medical device is the medical device of any of clauses 18-46, and wherein cutting the sheet of base material to form the base further comprises forming a plurality of protrusions extending from the middle section of the second strut.

[0190] Clause 56: The method of clause 54 or clause 54, further comprising stretching the base in a direction perpendicular to the first direction to rotate the second strut relative to the first strut and to bend the middle section of the second strut in a plane parallel to the width of the second strut as the base elongates in the direction perpendicular to the first direction.

[0191] The application of the present application has been described generally and with respect to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes can be made to the embodiments without departing from the scope of the disclosure. Therefore, it is intended that the embodiments cover any and all modifications and variations of the application that fall within the scope of the appended claims and their equivalents.

Claims

1. A medical device for treating or delivering a treatment to a target site, comprising: a substrate defining a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along the major surface and in a first direction, the plurality of first struts being interconnected with a plurality of second struts extending along the major surface and in a second direction non-parallel to the first direction, each of the second struts including an intermediate section having a plurality of protrusions extending therefrom, wherein the intermediate section and the plurality of protrusions of each of the second struts are operable to rotate relative to the first struts when the substrate is stretched in the second direction and the intermediate section and the plurality of protrusions of each of the second struts are bent out of the plane of the major surface when the substrate is stretched in the first direction, the plurality of protrusions including microneedles having lumens operable to be in fluid communication with a manifold and a fluid reservoir.

2. The medical device of claim 1, wherein, at least some of the first struts and the second struts are tubular structures and have lumens in fluid communication with the microneedles and the fluid reservoir.

3. The medical device of claim 1 or 2, wherein, the fluid reservoir is located proximate a proximal end of a delivery device, the proximal end of the delivery device being adapted to facilitate delivery of the medical device.

4. The medical device of claim 1 or 2, wherein, the fluid reservoir is located proximate a proximal end of the medical device.

5. The medical device of claims 1 or 2, wherein, a therapeutic coating covering the plurality of protrusions, wherein rotation of the plurality of protrusions from stretching of the substrate in a direction perpendicular to the first direction is operable to cause the therapeutic coating to break.

6. The medical device of claims 1 or 2, wherein, the substrate is a tubular substrate, wherein the tubular substrate defines a lumen having a longitudinal axis, wherein the plurality of protrusions remain coincident relative to the substrate when the substrate is not stretched radially, and wherein the plurality of protrusions extend radially outward when radial stretching of the substrate causes rotation of the second struts relative to the first struts.

7. The medical device as claimed in claim 6, characterized in that, the plurality of protrusions remain flat relative to the substrate when the substrate is stretched longitudinally and not stretched radially.

8. The medical device of claims 1 or 2, wherein, the substrate is a tubular substrate, wherein the tubular substrate defines a lumen having a longitudinal axis, wherein the plurality of protrusions remain coincident relative to the substrate when the substrate is not stretched longitudinally, and wherein the plurality of protrusions extend radially outward when longitudinal stretching of the substrate causes rotation of the second struts relative to the first struts.

9. The medical device of claim 8, wherein, the plurality of protrusions remain flat relative to the substrate when the substrate is stretched radially and not stretched longitudinally.

10. The medical device of claim 6, wherein, the medical device is configured to be radially collapsed to draw each tissue surface captured by the plurality of protrusions together.

11. The medical device of claim 10, wherein, the medical device further includes a collar configured to cover the lumen.

12. The medical device of claim 6, wherein, the tubular substrate is radially self-expandable.

13. The medical device of claim 12, wherein, the tubular substrate is radially balloon-expandable.

14. The medical device of claim 13, wherein, the tubular substrate is radially self-expandable from a collapsed diameter to an intermediate diameter, wherein the tubular substrate is radially balloon-expandable from the intermediate diameter to an expanded diameter, and wherein the plurality of protrusions rotate with the intermediate sections of the plurality of second struts to protrude outward relative to the plurality of first struts between the collapsed diameter and the expanded diameter.

15. The medical device of claim 14, wherein the at least one of the plurality of electrodes is configured to deliver a defibrillation shock to the heart of the patient. The plurality of protrusions rotate with the intermediate sections of the plurality of second struts to protrude outward relative to the plurality of first struts between the intermediate diameter and the expanded diameter, and wherein the plurality of protrusions remain flat relative to the base as the base expands from the collapsed diameter to the intermediate diameter.

16. The medical device of claim 6, wherein, The tubular base forms at least a portion of a stent.

17. The medical device of claim 16, wherein the at least one of the plurality of electrodes is configured to deliver a therapy to the patient. Also included is a tubular graft that is layered with the base to form a stent graft.

18. A medical system comprising: a medical device for treating or delivering a therapeutic to a target site as in any of claims 1-17; and a delivery device configured to cause the tubular base to stretch, wherein deployment of the medical device includes stretching the tubular base such that the second struts rotate relative to the first struts.

19. A medical system comprising: a medical device for treating or delivering a therapeutic to a target site as in any of claims 1-5; and a delivery device configured to deliver the medical device within a closed orifice of a patient, wherein the base is a flat sheet that is rolled up within the delivery device, wherein the delivery device is operable to deploy the base within the closed orifice such that the flat sheet is at least partially unrolled within the closed orifice, and wherein the medical device is configured to function as a hernia patch, wherein the plurality of protrusions are configured to contact or penetrate tissue of the patient adjacent to an opening in the tissue at which a hernia is formed.

20. A medical system comprising: a medical device for treating or delivering a therapeutic to a target site as in any of claims 6-17; and a delivery device configured to deliver the medical device within a vessel of a patient, wherein the medical device is in a collapsed configuration, wherein the delivery device is operable to deploy the tubular base within the vessel, and wherein deployment of the medical device includes stretching the tubular base to an expanded configuration such that the second struts rotate relative to the first struts.

21. The medical system of claim 20, wherein, The tubular base is deployed in the expanded configuration, the raised edges of the tubular base are operable to scrape and clear thrombus from within the vessel.

22. The medical system of claim 20, wherein, The tubular base is configured to engage an inner wall of the vessel when the tubular base is deployed in the expanded configuration.

23. The medical system of claim 20, wherein, The medical device is as in any of claims 6-17, and wherein deploying the medical device includes stretching the tubular base to the expanded configuration such that the second struts and the plurality of protrusions rotate relative to the first struts.

24. The medical system of claim 23, wherein, The plurality of protrusions are configured to penetrate the inner wall of the vessel.

25. A method of manufacturing a medical device for treating or delivering a therapeutic to a target site as in any of claims 1-17, the method comprising: cutting a sheet of base material to form the base including the plurality of first struts and the plurality of second struts, wherein, in the cut sheet of base material, the plurality of first struts are interconnected with the plurality of second struts.

26. The method of claim 25, wherein, cutting a sheet of base material to form the base further includes forming the plurality of protrusions extending from the intermediate section of the second struts.

27. The method of claim 25 or 26, wherein, Further included is stretching the base in a direction perpendicular to the first direction to rotate the second struts relative to the first struts and to bend the intermediate section of the second struts in a plane parallel to the width of the second struts as the base elongates in the direction perpendicular to the first direction.

28. A medical device for treating or delivering a therapeutic to a target site, comprising: a base defining a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along the major surface and in a first direction, the plurality of first struts being interconnected with a plurality of second struts, the plurality of second struts extending in a second direction that is non-parallel to the first direction, and the plurality of second struts including an intermediate section having a plurality of protrusions extending therefrom, wherein, when the base is stretched in the second direction, the intermediate section and the plurality of protrusions of each of the second struts are operable to rotate relative to the first struts, and when the base is stretched in the first direction, the intermediate section and the plurality of protrusions of each of the second struts bend out of the plane of the major surface, the plurality of protrusions including a plurality of caps configured to remain within a patient tissue after insertion and removal of distal ends of the protrusions into and out of the patient tissue.

29. The medical device as claimed in claim 28, characterized in that, the plurality of caps are positioned on distal tips of the plurality of protrusions.

30. The medical device of claim 28 or 29, wherein, the plurality of caps include a coating or releasable sheath.

31. The medical device of claim 28 or 29, wherein, the plurality of caps include barbed sleeves.

32. The medical device of claim 28 or 29, wherein, the plurality of caps are biodegradable.

33. The medical device of claims 28 or 29, wherein, the plurality of caps are polymeric or metallic.

34. The medical device of claim 28 or 29, wherein, the plurality of caps are coated with a hydrogel, the plurality of caps being operable to swell as the hydrogel absorbs moisture.

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