Medical balloon having barbs for endovascular use and related forming methods

Abstract

A medical apparatus is for performing an endovascular medical procedure. The medical apparatus includes one or more barbs (30,32), which may be rigid, projecting radially outwardly relative to an outer surface of the inflatable balloon (12), such as for assisting in cracking a lesion, drug delivery, anchoring the balloon in place, or engaging and positioning an implant in a vessel. The barb(s) may be provided on an outer layer of the balloon, which may comprise a sleeve (40) into which the inflatable balloon may be inserted. The sleeve may include one or more openings (O), which may be at least partially covered by a portion of the sleeve that when deployed forms the barb. The balloon may also be adapted for delivering an agent, such as a pharmaceutical composition for enhancing the treatment, including through the one or more openings in the sleeve. Related forming methods are also disclosed.

Description

MEDICAL BALLOON HAVING BARBS FOR ENDOVASCULAR USE AND RELATED FORMING METHODSBACKGROUND

[0001] A wide array of inflatable medical balloons exist for achieving a variety of endovascular treatments depending on a patient's needs. One particularly popular use of such a medical balloon is in connection with performing percutaneous transluminal angioplasty (PTA). This procedure may be done in order to restore patentcy to an occluded blood vessel.

[0002] In addition to use in connection with PTA, such balloons are also sometimes provided with external wires, rods, or like structures to achieve targeted cracking of calcium deposits. This procedure is sometimes performed in connection with drug delivery to a corresponding site in the course of a vascular intervention to enhance the treatment or outcome. For certain endovascular procedures, anchoring of an inflated balloon in a vessel may also be desirable. Such balloons may also be used in connection with the introduction of an implant, such as a stent or graft, to a particular location in vessel.

[0003] Past approaches to providing medical balloons for cracking deposits, drug delivery, endovascular anchoring, implant delivery, or other types of interventional procedures often present limitations. Primarily, medical balloons designed for such uses suffer from being unduly complex in construction, resulting in considerable manufacturing time and expense. Aside from this flaw in efficiency, known medical balloons cannot be readily used or adapted for use to selectively perform some or all of these types of procedures without further modification, which further reduces efficiency by requiring a variety of different types of balloons to provide the desired treatment effect.

[0004] Accordingly, a need exists for an apparatus in the nature of a medical balloon for endovascular use that addresses or overcomes these limitations. The medical balloon would include one or more rigid barbs along an outer surface. On inflation of the balloon, these rigid barbs may be selectively used for scoring or cracking calcium deposits, facilitating delivery of treatment agents to endovascular treatment locations, and / or anchoring the balloon in a vessel, such as to regulate flow therein. Such a balloon may also be useful in selectively positioning implants, such as stents or grafts, at different locations within a vessel. Any or all of thesefunctions would be achievable by making such a multi-purpose balloon using existing or known materials and manufacturing techniques, which would reduce the time and expense of manufacture, and thus enhance efficiency in terms of the delivery of medical treatment, providing a significant overall benefit to societal good in terms of health outcomes.SUMMARY

[0005] An object of the disclosure is to provide a medical balloon for endovascular use that includes one or more rigid barbs along an outer surface. On inflation of the balloon, these rigid barbs may be selectively used for scoring or cracking calcium deposits, facilitating delivery of treatment agents to endovascular treatment locations, and / or anchoring the balloon in a vessel, such as to regulate flow therein. Such a balloon is also useful in selectively positioning implants, such as stents or grafts, at different locations within a vessel.

[0006] According to a first aspect of this disclosure, an apparatus for performing an endovascular medical procedure is provided. The apparatus comprises an inflatable balloon having an outer surface including one or more rigid barbs. The one or more rigid barbs project radially outwardly relative to the outer surface of the inflatable balloon.

[0007] In one embodiment, the one or more rigid barbs are associated with a sleeve at least partially overlying the inflatable balloon. The inflatable balloon may be compliant and the sleeve may be non-compliant. The one or more rigid barbs may be associated with an opening in a wall of the sleeve, and inflatable balloon may be adapted to deliver an agent through the opening. The one or more rigid barbs may be connected to the sleeve by a hinge.

[0008] In other embodiments, the one or more rigid barbs comprise a plurality of rigid barbs. These rigid barbs may comprise at least one first barb having a first blade edge having a first degree of sharpness, and at least one second barb having a second blade edge having a second degree of sharpness. Additionally or alternatively, the plurality of rigid barbs may comprise a first barb pointing in a first direction, and a second barb pointing in a second direction opposite the first direction. The first direction may be a proximal direction and the second direction may be a distal direction. An implant attached to the plurality of barbs. A front face of the one or more barbs may extend at an acute angle relative to a longitudinal axis.

[0009] According to another aspect of the disclosure, an apparatus for performing an endovascular medical procedure is provided. The apparatus comprises an inflatable balloon. A sleeve is positioned at least partially over the balloon. The sleeve includes an outer surface having one or more barbs.

[0010] In one embodiment, the inflatable balloon comprises a compliant inflatable balloon. The sleeve includes at least one opening for receiving a portion of the compliant inflatable balloon. The at least one opening is associated with a first barb of the one or more barbs, the first barb being movable from a retracted position at least partially covering the at least one opening and a deployed position spaced from the at least one opening as the result of engagement with the portion of the compliant inflatable balloon. The compliant inflatable balloon may be adapted to deliver an agent via the at least one opening in the sleeve, which may comprise a rigid material.

[0011] According to a further aspect of the disclosure, an apparatus for performing an endovascular medical procedure is provided. The apparatus comprises an at least partially compliant inflatable balloon. A sleeve is positioned at least partially over the at least partially compliant inflatable balloon. The sleeve includes an opening for receiving a portion of the at least partially compliant inflatable balloon when inflated.

[0012] In one embodiment, the opening is associated with a portion of the sleeve adapted for moving from a retracted position at least partially covering the opening and a deployed position as the result of engagement with the portion of the compliant balloon. The portion of the sleeve may comprise a barb, and a plurality of portions comprising barbs may be provided, each capable of actuation by way of the compliant balloon.

[0013] Still a further aspect of this disclosure pertains to an apparatus for performing an endovascular medical procedure. The apparatus includes a catheter shaft having a proximal end portion and a distal end portion. An inflatable balloon is arranged over the distal end portion. The inflatable balloon includes an outer surface having one or more barbs having a height greater near the proximal end portion that the distal end portion of the catheter shaft. In one embodiment, the one or more barbs extend toward the proximal end portion of the catheter shaft at an acute angle relative to the outer surface of the inflatable balloon.

[0014] A further aspect of this disclosure pertains to an apparatus for performing an endovascular medical procedure. The apparatus includes an inflatable balloon having an outer surface including one or more barbs projecting radially outwardly relative to the outer surface of the inflatable balloon. An implant is provided for at least partially overlying the inflatable balloon.

[0015] In one embodiment, the one or more barbs are rigid. The implant may comprise a stent or a graft. The one or more barbs may be associated with a sleeve at least partially overlying the inflatable balloon. The one or more barbs may be associated with an opening in a wall of the sleeve, in which case the inflatable balloon may be adapted to deliver an agent, such as a drug or pharmaceutical to enhance the treatment effect, through the opening.

[0016] Furthermore, this disclosure pertains to a method for forming a medical apparatus. The method comprises providing a sleeve including one or more barbs. The method further comprises providing an inflatable balloon at least partially within the sleeve.

[0017] In one embodiment, the method includes the step of attaching the inflatable balloon to the sleeve. The method may include the step of inflating the inflatable balloon within the sleeve to actuate one or more portions thereof to form the one or more barbs. Still further, the method may include the step of forming one or more openings in a wall of the sleeve, and / or providing the inflatable balloon with an agent for delivery through the one or more openings. In one example, the method further includes the step of inflating the balloon once positioned at least partially within the sleeve to cause one or more portions of the sleeve to project radially outwardly therefrom and form the one or more barbs.

[0018] Another aspect of this disclosure pertains to a method for forming a medical apparatus. The method comprises providing an inflatable balloon including one or more barbs, and providing an implant over the inflatable balloon in engagement with the one or more barbs.

[0019] The method may for example also include the steps of providing a sleeve including one or more barbs, and providing an inflatable balloon at least partially within the sleeve. Still further, the method may involve inflating the inflatable balloon to cause the engagement of the implant with the one or more barbs, deflating the inflatable balloon to disengage the implant from the one or more barbs, and withdrawing the inflatable balloon from the sleeve. The method may also include the step of providing the inflatable balloon with an agent for delivery through one or more openings in the sleeve on inflation therein.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The above and further advantages of the disclosure may be better understood by referring to the following description in conjunction with the accompanying drawings in which:

[0021] FIG. 1 is a perspective view of a medical apparatus including a balloon for endovascular use according to one aspect of the disclosure.

[0022] FIG. 2 is a cross-sectional view taken along line 2-2 of FIG. 1.

[0023] FIG. 3 is a perspective view of a catheter including the exemplary balloon of FIG.1.

[0024] FIG. 4 is an alternative embodiment of the catheter.

[0025] FIG. 5 is a partially cutaway, enlarged side view of a barbed medical balloon for a catheter according to one aspect of the disclosure.

[0026] FIG. 6 is a partially cutaway perspective view of the balloon of FIG. 5.

[0027] FIG. 7 is a perspective view of one embodiment of a barbed sleeve for use in connection with a balloon.

[0028] FIG. 8 is a plan view of another embodiment of the sleeve for use in connection with a balloon.

[0029] FIG. 9 is a side view of the sleeve of FIG. 8 and an inflatable balloon for insertion therein.

[0030] FIG. 10 is a side view of the sleeve of FIG. 8 with the inflatable balloon inserted therein.

[0031] FIG. 11 is a partially cutaway, enlarged side view of a barbed medical balloon for a catheter according to another aspect of the disclosure.

[0032] FIG. 12 is partially cutaway, enlarged side view of a barbed medical balloon for a catheter according to yet another aspect of the disclosure.

[0033] FIG. 13 illustrates a possible use of a barbed balloon anchored in a vessel.

[0034] FIGS. 14 and 15 illustrate another possible use of a barbed balloon in repositioning an implant within a vessel.

[0035] The dimensions of some of the elements in the drawings may be exaggerated relative to other elements for clarity or several physical components may be included in one or element. Further, sometimes reference numerals may be repeated among the drawings toindicate corresponding or analogous elements. Moreover, some of the items depicted in the drawings may be combined into a single function.DETAILED DESCRIPTION

[0036] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the disclosure in relation to various inventions. The disclosed embodiments may be practiced without these specific details. In other instances, well- known methods, procedures, components, or structures may not have been described in detail so as not to obscure the present invention.

[0037] The principles and operation of the apparatus and methods of the disclosure may be better understood with reference to the drawings and accompanying descriptions. The invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

[0038] Certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. The description provided below and in regard to the figures applies to all embodiments unless noted otherwise, and features common to each embodiment are similarly shown and numbered to the greatest extent possible to lend clarity, but should not be considered limiting in any respect.

[0039] Referring now to FIGS. 1, 2, and 3, provided is a catheter 10 having a distal portion 11 with an inflatable balloon 12 mounted on or connected to a distal end of a catheter shaft 14. The balloon 12 when inflated includes an intermediate or "barrel" section 16 forming a working surface W, and end sections 18, 20. In one embodiment, these end sections 18, 20 reduce in diameter or taper in opposite directions to join the intermediate section 16 with the catheter shaft 14 (and thus sections 18, 20 are generally termed cones or cone sections). The balloon 12 is sealed at balloon ends (proximal end 15a and distal end 15b) on the cone sections 18, 20 to allow for inflation of the balloon 12 via one or more inflationlumens 17 extending within catheter shaft 14 and communicating with the interior compartment of the balloon 12.

[0040] As noted above, and as can be further understood with combined reference to FIGS. 2 and 3, the catheter shaft 14 may include an elongated tube 24. This elongated tube 24 passes longitudinally through the entire catheter 10 including the interior of the balloon 12 and thus forms a lumen 23 that may serve to direct a guidewire 26 through the entire catheter 10 for facilitating endovascular placement. The cone section 20 at the distal end 15b of the balloon 12 may be fixed to this tube 24 adjacent the tip P of the catheter 10. The balloon 12 at the opposite or proximal end 15a end is connected to the catheter shaft 14, which may be coaxial with the tube 24.

[0041] As illustrated in FIGS. 1 and 3, this guidewire 26 when present may extend through the proximal end of the catheter 10 via a first introductory port 25 of a connector 27 into the lumen 23 to achieve an "over the wire" (OTW) arrangement. Alternatively, as shown in FIG. 4, a "rapid exchange" (RX) configuration may be used, in which the guidewire 26 may exit a lateral opening 14a closer to the distal end, or else may be fed through a passage associated with the tip P distally of the balloon 12 ("short" RX; not shown). A second inflation port 29 may also be associated with the connector 27 of catheter 10 for introducing a fluid (e.g., saline, a contrast agent, or both) into the interior compartment of the balloon 12 via the inflation lumen 17.

[0042] According to a first aspect of the disclosure, and with reference to FIGS. 5 and 6, the inflatable balloon 12 for associating with the catheter 10, such as constructed according to FIGS. 1, 3, or otherwise. An outer surface 12a of the balloon 12 may comprise one or more oblique, sharp projections, termed barbs 30 for purposes of this disclosure. In particular, these barb(s) 30 may project generally radially outwardly at an angle relative to the outer surface 12a of the intermediate or barrel section 16 of the balloon 12, but are omitted from the end sections 18, 20, or cones (as such typically provide no treatment effect). In the illustrated version, plural barbs 30 are shown as being aligned in a series of generally parallel rows extending both longitudinally and circumferentially, thus forming a matrix, but this type of arrangement is entirely optional.

[0043] In addition to projecting outwardly from the outer surface 12a to a height H in a radial direction, the individual barb(s) 30 may comprise a body extending a predetermineddistance L in the circumferential direction C. The body of the barb 30 may include a contoured or curved front face 32, which is shown being concave and facing in the proximal direction P, and a contoured or curved rear face 34, which is shown being convex and facing in the distal direction D. This arrangement facilitates passing the balloon 12 though a tubular structure, such as a sheath or introducer, for entering the vasculature. However, the orientation of the barbs 30 may be reversed from what is shown, such that the rear face 34 is faces proximally, which may facilitate withdrawal using a sheath or the like. Furthermore, combinations of different orientations of barbs 30 may be provided, as outlined further in the following description. Additionally, the barbs 30 could also be concave or convex as a result of facing in a different direction (e.g., the circumferential direction C).

[0044] The barb(s) 30 may also be adapted to cut into or penetrate tissue, and in the illustrated example include a blade edge 36. This blade edge 36 may be sharpened for cutting as a result of thinning at the point where the curved front and rear faces 32, 34 meet. As is the case with blades in general, this edge 36 may thus define a radius of curvature, which may for example range from about 0.0001 pm, or 0.1 nm, to about 0.01 pm, or 10 nm, but different values may be used depending on the particular materials used or requirements of a desired procedure.

[0045] This blade edge 36 may also include an apex 38, which is the point where it reaches the greatest height in the radial direction, or may instead comprise an apical region. This may be useful for anchoring the balloon within a vessel in an anti-slip manner, as well as for creating puncture(s) for delivery of a treatment agent, such as to a stenosis. Plural barbs 30 may also have different degrees of sharpness (e.g., a different radius of curvature forming the blade edge 36 on different barbs to provide first and second different degrees of sharpness for different barbs). This differential sharpness may be useful to vary the treatment effect created or achieve other desired outcomes (such as for selectively anchoring the balloon 12 in the vasculature depending on the location or relative diameter of the vessel, which may is typically somewhat variable). Alternatively or additionally, the barbs 30 may have different lengths or heights, which may be useful to control the amount of anchoring or penetrating force provided as a result of the expansion of the balloon 12 (which may also be used to control these forces).

[0046] It is contemplated that the barb(s) 30 may be formed directly in the outer surface of the balloon 12, such as by blow molding (see, e.g., U.S. Patent App. Pub. No. 20230014677,the disclosure of which is incorporated herein by reference) or otherwise modifying an outer balloon layer (e.g., by cutting, which could be done by nicking this layer with a sharp blade (e.g., a razor blade) associated with a rotating fixture). Individual barb(s) 30 or the entire sleeve 40 could also be formed of a suitable rigid material (e.g., PEEK) and attached to the outer surface 12a of the balloon 12, which may be more flexible, as outlined further in the following description. This may be done using suitable means of attachment, such as by welding, bonding, adhesive, a mechanical connection (e.g., threading) or the like, for securing the barb(s) 30 or sleeve 40 including them to the outer surface 12a of the balloon 12.

[0047] Alternatively or additionally, the barb(s) 30 may be formed directly in or on a sleeve 40 adapted to receive an inflatable balloon 12, and thus forming an outer layer thereof in an assembled configuration. Thus, as shown in FIG. 7, the sleeve 40 may comprise a hollow cylinder having an inner diameter greater than the outer diameter of the balloon 12 to facilitate insertion during assembly. This sleeve 40 may have a length that corresponds to the length of the working surface W of the balloon 12 (but may also be shorter in length). In any case, this sleeve 40 may be attached to the balloon 12 using suitable means of attachment, such as by welding, bonding, adhesive, a mechanical connection, including as a friction or press fit, or the like.

[0048] As indicated in FIGS. 8, 9, and 10, the barb(s) 30 may be formed from one or more cutout portions 40a of a wall of the sleeve 40. These portion(s) 40a may be U-shaped in plan view as shown in FIG. 8, but could take other shapes (e.g., C-shaped or generally polygonal). Regardless of shape, the cutout portion(s) 40a form a hinge 42 as a result of remaining at least partially connected to the sleeve 40 along an uncut portion thereof. The cutout portion(s) 40a may also comprise the full thickness of the material forming the sleeve 40, or may be a lesser thickness (which may enhance flexibility), and may be formed by cutting (such as using a laser) with or without also forming a blade edge.

[0049] As shown in FIG. 9 in particular, the cutout(s) 40a for forming the barb(s) 30 may normally lie in common plane with the outer surface of the sleeve 40. When moved radially outwardly as a result of being actuated or deployed, the barb(s) 30 may assume an angular orientation relative to surface of the sleeve 40 in view of the associated hinge 42 and create openings O therein. This angular orientation may form an acute angle a relative to a longitudinalaxis X of the sleeve 40, which angle may be broadly within the range of about 1 degree to about 90 degrees or, more specifically, less than about 45 degrees.

[0050] In one example, the sleeve 40 is more rigid, or less compliant (including non- compliant, which means the sleeve expands in diameter by less than 5% when an outwardly directed radial force is applied to the interior thereof) than the inflatable balloon 12 inserted into it. In contrast, the inflatable balloon 12 for combination with the sleeve 40 may be compliant, which includes "ultra-compliant" (meaning expansion in diameter by greater than 15% when inflated to its rated pressure), or "semi-compliant" (meaning expansion in diameter by about 5% to 15% when inflated to its rated pressure). This differential rigidity or compliance may be achieved using different materials to form the sleeve 40 and balloon 12. For example, the sleeve 40 may comprise rigid materials, such as one or more polymers, metals, or combinations thereof, while the balloon 12 may comprise flexible or elastic materials in the latter case, which are typically polymers as outlined further in the following description.

[0051] Accordingly, as indicated in the progressive views of FIGS. 9 and 10, such a balloon 12 may be inserted at least partially into the sleeve 40 in a deflated or folded state (12') and inflated or expanded. As a result of the compliance, inflated balloon portions 12" may press radially outwardly against the cutouts 40A therein to deploy them (possibly simultaneously or nearly so) and form the barb(s) 30. As can be appreciated, the degree of deployment may depend on the ability of the portions of the balloon 12 to pass into or through the respective opening O and press against the corresponding material of the cutout portion 40a of the sleeve 40 to form the barb(s) 30, or the relative flexibility of the materials used. Deflation of the inner balloon 12 results in relaxation or retraction of the barb(s) 30, which may reassume the home or planar orientation in view of the flexible memory of the material used (which may comprise a polymer, metal, or combination thereof). As can be appreciated, this allows for selective actuation or deployment of the barb(s) 30, with full control by a clinician by controlling the inflation state of the associated balloon 12 when positioned at least partially in the sleeve 40.

[0052] In a particular example, the balloon 12 may be provided with an agent, such as one for therapeutic purposes (e.g., a pharmaceutical or drug, for example, but also potentially a filler, adhesive or similar compound for inter- or intra-vascular use). This agent may be provided along the outer surface 12a thereof, providing within an interior compartment of the balloon 12,and / or adapted on inflation to disperse or release the agent, such as by weeping (see, e.g., U.S. Patent App. Pub. No. 20210154372, the disclosure of which is incorporated herein by reference). The agent may be integral with the balloon 12 as a result of manufacture, or may be introduced to the balloon with an inflation fluid and designed to permeate through a surface thereof, such as the outer surface 12a.

[0053] Accordingly, in addition to deploying the barb(s) 30, the balloon 12 on inflation may thus result in a release of the treatment agent upon inflation. When combined with the potential penetration of an endovascular surface with the barb(s) 30 (which may result from simply being deployed and / or moving the balloon 12 to and fro), delivery of the treatment agent is enhanced, along with a potential improvement in the treatment effect achieved as a result. When the sleeve 40 of FIGS. 8, 9, or 10 is present, the strategic location of the openings O and relative degree of actuation of the cutout portions (s) 40a to form barb(s) 30 resulting from selective inflation of the balloon 12 may also facilitate targeted delivery of the agent. Such delivery in a controlled manner may be especially useful to achieve a particular or desired outcome for a given endovascular medical procedure.

[0054] Turning to FIG. 11, an illustration is provided of a catheter 100 including a balloon 102 having one or more first barbs 104 oriented in a first direction, such as proximally, and one or more second barbs 106 oriented in a second direction, such as distally. While the alternating orientation is shown as being the same among barbs 104, 106 in common rows, it should be appreciated that individual rows (circumferential, longitudinal, or both) may also have barbs 104, 106 that alternate in orientation, as shown in FIG. 12.

[0055] FIG. 13 illustrates one possible use of a catheter 10 with an inflatable balloon 12 including barb(s) 30 connected to a shaft 14. Specifically, the balloon 12 may be inflated to cause the barb(s) 30 to engage an inner wall of a vessel V, such as a blood vessel in the vasculature. This engagement may retain the balloon 12 in position in the vessel V, and thus create an indwelling arrangement (such as for IVC / SVS occlusion, for example). Deflation of the balloon 12 may then disengage the barb(s) 30 for repositioning or removal of the balloon 12 from the vessel V.

[0056] FIGS. 14 and 15 progressively illustrate another possible use of an inflatable balloon 12 including barb(s) 30 in connection with repositioning an endovascular implant, suchas a graft G position in a vessel V. In particular, the balloon 12 may be associated with the implant, such as by positioning in the hollow interior thereof in the case of a graft G. The balloon 12 may then be inflated such that the barb(s) 30 engage with the implant, or in this case the interior surface of the graft G, to manufacture or form an assembly (including possibly in vivo). As a result of this engagement, the balloon 12 during use in the course of a medical procedure may be advanced or retracted via the associated shaft 14 to reposition the graft G to a desired location in the vessel V. Removal of the balloon 12 involves deflation to disengage the implant from the barb(s) 30, which operation may be repeated as necessary or desired to recreate the assembly.

[0057] In any embodiment, the balloon 12 may include a multi-layered balloon wall forming the interior for receiving the inflation fluid, including an outer, more rigid layer including the barb(s) 30 and an inner layer that is more flexible. As noted previously, the barb(s) 30 may also be provided on a sleeve 40 serving as or forming the outer layer of the balloon 12. This sleeve 40 may be rigid, such as by being formed of PEEK, a polyimide, or other polymer material having a Young's Modulus of greater than about 3 GPa (e.g, PEEK has a Young's Modulus of about 3.6 GPa).

[0058] In such case, the balloon 12 adapted to be inserted into the sleeve 40 to deploy the barb(s) 30 may be formed of a flexible or elastic polymer material (that is, one having a Young's Modulus of less than about 3 GPa) using conventional techniques, such as blow molding. Examples of materials for forming compliant balloons include latex and silicone, polyamides (Nylon 11 or Nylon 12), polyimide block co-polymers (Pebax), polyurethanes (Pellethane), polycarbonate-based thermoplastic polyurethanes (Carbothane).

[0059] Summarizing, this disclosure may relate to any of the following items in any combination:1. An apparatus for performing an endovascular medical procedure, comprising: an inflatable balloon having an outer surface including one or more rigid barbs projecting radially outwardly relative to the outer surface of the inflatable balloon.2. The apparatus of item 1, wherein one or more rigid barbs are associated with a sleeve at least partially overlying the inflatable balloon.3. The apparatus of item 2, wherein the inflatable balloon is compliant and the sleeve is non-compliant.4. The apparatus of item 2 or item 3, wherein the one or more rigid barbs are associated with an opening in a wall of the sleeve.5. The apparatus of item 4, wherein the inflatable balloon is adapted to deliver an agent through the opening.6. The apparatus of any of items 2-5, wherein the one or more rigid barbs are connected to the sleeve by a hinge.7. The apparatus of any of items 1-6, wherein the one or more rigid barbs comprise a plurality of rigid barbs.8. The apparatus of item 7, wherein the plurality of rigid barbs comprise at least one first barb having a first blade edge having a first degree of sharpness.9. The apparatus of item 8, wherein the plurality of rigid barbs comprise at least one second barb having a second blade edge having a second degree of sharpness.10. The apparatus of any of item 7-9, wherein the plurality of rigid barbs comprise a first barb pointing in a first direction, and a second barb pointing in a second direction opposite the first direction.11. The apparatus of item 10, wherein the first direction is a proximal direction and the second direction is a distal direction.12. The apparatus of any of items 1-11, further including an implant attached to the plurality of barbs.13. The apparatus of any of items 1-12, wherein a front face of the one or more barbs extends at an acute angle relative to a longitudinal axis.14. An apparatus for performing an endovascular medical procedure, comprising: an inflatable balloon; and a sleeve positioned at least partially over the balloon, the sleeve including an outer surface having one or more barbs.15. The apparatus of item 14, wherein the inflatable balloon comprises a compliant inflatable balloon.16. The apparatus of item 14 or item 15, wherein the sleeve includes at least one opening for receiving a portion of the compliant inflatable balloon.17. The apparatus of item 16, wherein the at least one opening is associated with a first barb of the one or more barbs, the first barb being movable from a retracted position at least partially covering the at least one opening and a deployed position spaced from the at least one opening as the result of engagement with the portion of the compliant inflatable balloon.18. The apparatus of item 16 or item 17, wherein the compliant inflatable balloon is adapted to deliver an agent via the at least one opening in the sleeve.19. The apparatus of item any of items 14-18, wherein the sleeve comprises a rigid material.20. An apparatus for performing an endovascular medical procedure, comprising: an at least partially compliant inflatable balloon; and a sleeve positioned at least partially over the at least partially compliant inflatable balloon, the sleeve including an opening for receiving a portion of the at least partially compliant inflatable balloon when inflated.21. The apparatus of item 20, wherein the opening is associated with a portion of the sleeve adapted for moving from a retracted position at least partially covering the opening and a deployed position as the result of engagement with the portion of the compliant balloon.22. The apparatus of item 20 or item 21, wherein the portion of the sleeve comprises a barb.23. An apparatus for performing an endovascular medical procedure, comprising: a catheter shaft having a proximal end portion and a distal end portion; and an inflatable balloon arranged over the distal end portion, the inflatable balloon having an outer surface including one or more barbs having a height greater near the proximal end portion that the distal end portion of the catheter shaft.24. The apparatus of item 23, wherein the one or more barbs extend toward the proximal end portion of the catheter shaft at an acute angle relative to the outer surface of the inflatable balloon.25. An apparatus for performing an endovascular medical procedure, comprising:an inflatable balloon having an outer surface including one or more barbs projecting radially outwardly relative to the outer surface of the inflatable balloon; and an implant at least partially overlying the inflatable balloon.26. The apparatus of item 25, wherein the one or more barbs are rigid.27. The apparatus of item 25 or item 26, wherein the implant comprises a stent or a graft.28. The apparatus of any of items 25-27, wherein the one or more barbs are associated with a sleeve at least partially overlying the inflatable balloon.29. The apparatus of claim 28, wherein the one or more barbs are associated with an opening in a wall of the sleeve, and wherein the inflatable balloon is adapted to deliver an agent through the opening.30. A method for forming a medical apparatus, comprising: providing a sleeve including one or more barbs; and providing an inflatable balloon at least partially within the sleeve.31. The method of item 30, further including the step of attaching the inflatable balloon to the sleeve.32. The method of item 30 or item 31, further including the step of inflating the inflatable balloon within the sleeve to actuate one or more portions thereof to form the one or more barbs.33. The method of any of items 30-32, further including the step of forming one or more openings in a wall of the sleeve.34. The method of any of items 30-33, further including the step of providing the inflatable balloon with an agent for delivery through the one or more openings.35. The method of any of items 30-34, further including the step of inflating the balloon once positioned at least partially within the sleeve to cause one or more portions of the sleeve to project radially outwardly therefrom and form the one or more barbs.36. A method for forming a medical apparatus, comprising: providing an inflatable balloon including one or more barbs; and providing an implant over the inflatable balloon in engagement with the one or more barbs.37. The method of item 36, further including the steps of: providing a sleeve including one or more barbs; and providing an inflatable balloon at least partially within the sleeve.38. The method of item 36 or item 36, further including the steps of: inflating the inflatable balloon to cause the engagement of the implant with the one or more barbs; deflating the inflatable balloon to disengage the implant from the one or more barbs; and withdrawing the inflatable balloon from the sleeve.39. The method of item 38, further including the step of providing the inflatable balloon with an agent for delivery through one or more openings in the sleeve on inflation therein.

[0060] As used herein, the following terms have the following meanings: "A", "an", and "the" as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, "a compartment" refers to one or more than one compartment. "About," "substantially," or "approximately," as used herein referring to a measurable value, such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of + / - 20% or less, including + / -10% or less, + / - %> or less, + / -!%> or less, and + / -0.1% or less of and from the specified value, in so far such variations are appropriate to perform in the disclosed invention. However, it is to be understood that the value to which such modifiers refer is itself also specifically disclosed. Comprise", "comprising", and "comprises" and "comprised of" as used herein are synonymous with "include", "including", "includes" or "contain", "containing", "contains" and are inclusive or open-ended terms that specifies the presence of what follows e.g. component and do not exclude or preclude the presence of additional, non-recited components, features, element, members, steps, known in the art or disclosed therein.

[0061] Although the invention has been described in conjunction with specific embodiments, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it embraces all such alternatives, modifications, and variations that fall within the spirit and scope of the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure.

Claims

IN THE CLAIMS1. An apparatus for performing an endovascular medical procedure, comprising: an inflatable balloon having an outer surface including one or more rigid barbs projecting radially outwardly relative to the outer surface of the inflatable balloon.

2. The apparatus of claim 1, wherein one or more rigid barbs are associated with a sleeve at least partially overlying the inflatable balloon.

3. The apparatus of claim 2, wherein the inflatable balloon is compliant and the sleeve is non-compliant.

4. The apparatus of claim 3, wherein the one or more rigid barbs are associated with an opening in a wall of the sleeve.

5. The apparatus of claim 4, wherein the inflatable balloon is adapted to deliver an agent through the opening.

6. The apparatus of claim 2, wherein the one or more rigid barbs are connected to the sleeve by a hinge.

7. The apparatus of claim 1, wherein the one or more rigid barbs comprise a plurality of rigid barbs.

8. The apparatus of claim 7, wherein the plurality of rigid barbs comprise at least one first barb having a first blade edge having a first degree of sharpness.

9. The apparatus of claim 8, wherein the plurality of rigid barbs comprise at least one second barb having a second blade edge having a second degree of sharpness.

10. The apparatus of claim 7, wherein the plurality of rigid barbs comprise a first barb pointing in a first direction, and a second barb pointing in a second direction opposite the first direction.

11. The apparatus of claim 10, wherein the first direction is a proximal direction and the second direction is a distal direction.

12. The apparatus of claim 7, further including an implant attached to the plurality of barbs.

13. The apparatus of claim 1, wherein a front face of the one or more barbs extends at an acute angle relative to a longitudinal axis.

14. An apparatus for performing an endovascular medical procedure, comprising: an inflatable balloon; and a sleeve positioned at least partially over the balloon, the sleeve including an outer surface having one or more barbs.

15. The apparatus of claim 14, wherein the inflatable balloon comprises a compliant inflatable balloon.

16. The apparatus of claim 15, wherein the sleeve includes at least one opening for receiving a portion of the compliant inflatable balloon.

17. The apparatus of claim 16, wherein the at least one opening is associated with a first barb of the one or more barbs, the first barb being movable from a retracted position at least partially covering the at least one opening and a deployed position spaced from the at least one opening as the result of engagement with the portion of the compliant inflatable balloon.

18. The apparatus of claim 16, wherein the compliant inflatable balloon is adapted to deliver an agent via the at least one opening in the sleeve.

19. The apparatus of claim 14, wherein the sleeve comprises a rigid material.

20. An apparatus for performing an endovascular medical procedure, comprising: an at least partially compliant inflatable balloon; and a sleeve positioned at least partially over the at least partially compliant inflatable balloon, the sleeve including an opening for receiving a portion of the at least partially compliant inflatable balloon when inflated.

21. The apparatus of claim 20, wherein the opening is associated with a portion of the sleeve adapted for moving from a retracted position at least partially covering the opening and a deployed position as the result of engagement with the portion of the compliant balloon.

22. The apparatus of claim 21, wherein the portion of the sleeve comprises a barb.

23. An apparatus for performing an endovascular medical procedure, comprising: a catheter shaft having a proximal end portion and a distal end portion; and an inflatable balloon arranged over the distal end portion, the inflatable balloon having an outer surface including one or more barbs having a height greater near the proximal end portion that the distal end portion of the catheter shaft.

24. The apparatus of claim 23, wherein the one or more barbs extend toward the proximal end portion of the catheter shaft at an acute angle relative to the outer surface of the inflatable balloon.

25. An apparatus for performing an endovascular medical procedure, comprising: an inflatable balloon having an outer surface including one or more barbs projecting radially outwardly relative to the outer surface of the inflatable balloon; and an implant at least partially overlying the inflatable balloon.

26. The apparatus of claim 25, wherein the one or more barbs are rigid.

27. The apparatus of claim 25, wherein the implant comprises a stent or a graft.

28. The apparatus of claim 25, wherein the one or more barbs are associated with a sleeve at least partially overlying the inflatable balloon.

29. The apparatus of claim 28, wherein the one or more barbs are associated with an opening in a wall of the sleeve, and wherein the inflatable balloon is adapted to deliver an agent through the opening.

30. A method for forming a medical apparatus, comprising: providing a sleeve including one or more barbs; and providing an inflatable balloon at least partially within the sleeve.

31. The method of claim 30, further including the step of attaching the inflatable balloon to the sleeve.

32. The method of claim 30, further including the step of inflating the inflatable balloon within the sleeve to actuate one or more portions thereof to form the one or more barbs.

33. The method of claim 30, further including the step of forming one or more openings in a wall of the sleeve.

34. The method of claim 30, further including the step of providing the inflatable balloon with an agent for delivery through the one or more openings.

35. The method of claim 30, further including the step of inflating the balloon once positioned at least partially within the sleeve to cause one or more portions of the sleeve to project radially outwardly therefrom and form the one or more barbs.

36. A method for forming a medical apparatus, comprising: providing an inflatable balloon including one or more barbs; and providing an implant over the inflatable balloon in engagement with the one or more barbs.

37. The method of claim 36, further including the steps of: providing a sleeve including one or more barbs; and providing an inflatable balloon at least partially within the sleeve.

38. The method of claim 36, further including the steps of: inflating the inflatable balloon to cause the engagement of the implant with the one or more barbs; deflating the inflatable balloon to disengage the implant from the one or more barbs; and withdrawing the inflatable balloon from the sleeve.

39. The method of claim 38, further including the step of providing the inflatable balloon with an agent for delivery through one or more openings in the sleeve on inflation therein.

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