WO2016160905A1

WO2016160905A1 - Devices and methods for vascular interventions

Info

Publication number: WO2016160905A1
Application number: PCT/US2016/024871
Authority: WO
Inventors: James W. Vetter; Paul A. VETTER; Tomoaki Hinohara
Original assignee: Transmed7, Llc
Priority date: 2015-03-31
Filing date: 2016-03-30
Publication date: 2016-10-06

Abstract

A drug-eluting balloon or stent protective device may comprise structures and functionality for protecting coatings on balloon and stent devices, isolating coatings from exposure to fluids until the precise desired moment of release from within such a protective interior, the drug delivery device to permit expansion of the device with the resultant exposure and release of such coatings, as well as facilitating ease of precise placement of the protected devices and their coatings to the site of treatment, as well as providing pre-dilating of narrowed vascular segments prior to definitive procedures such as final balloon angioplasty, stenting, drug delivery, repositioning and/or recovery of interventional elements in the event an operator wishes to change the procedural sequence.

Description

DEVICES AND METHODS FOR VASCULAR INTERVENTIONS

BACKGROUND

[0001] Embodiments relate to medical devices and methods. More particularly, embodiments relate to improving vascular interventions including balloon angioplasty and stenting devices and procedures.

SUMMARY

[0002] Embodiments are drawn to medical devices and methods that are used for widening the capabilities of balloon angioplasty and stenting procedures including delivery of pharmacologic agents. Embodiments may comprise structures and functionality for protecting coatings on balloon and stent devices, isolating coatings from exposure to fluids until the desired moment of exposure and release of such coatings, facilitating ease of precise placement of the protected devices and their coatings, pre-dilating narrowed vascular segments prior to definitive procedures such as final balloon angioplasty, stenting, drug delivery, repositioning and/or recovery of interventional elements in the event an operator wishes to change the procedural sequence for example. Embodiments may be portable, disposable or reusable and may be electrically, mechanically and fluid and/or air powered and operated.

BRIEF DESCRIPTION OF THE DRAWINGS

[0003] Fig. 1A is a side view illustrating aspects of a device according to one embodiment of a protective placement and delivery device.

[0004] Fig. lb is a side view of an apparatus to control various functions of a protective placement and delivery device, according to one embodiment.

[0005] Fig. 1C is a side view illustrating further aspects of a device according to one embodiment of a protective placement and delivery device.

[0006] Fig. ID is a side view illustrating still further aspects of a device according to one embodiment of a protective placement and delivery device. [0007] Fig. IE is a side view illustrating yet further aspects of a device according to one embodiment of a protective placement and delivery device.

[0008] Figs. 2A is a side view of a protective placement device according to one embodiment.

[0009] Fig. 2B is a side view of a protective placement device shown in a vascular segment, according to one embodiment.

[0010] Fig. 2C is a side view of a protective placement device shown in a vascular segment, according to one embodiment.

[0011] Fig. 2D is a side view of a protective placement device shown in a vascular segment, according to one embodiment.

[0012] Fig. 3A is a perspective view of a protective placement device, according to one embodiment.

[0013] Fig. 3B are perspective views of a protective placement device in various states of functionality, according to one embodiment.

[0014] Fig. 4 A is a perspective view of a protective placement device in a phase of action with a protected, folded dilating balloon partially exposed in the lower panel, according to one embodiment.

[0015] Fig. 4B is a perspective view of a protective placement device in another phase of action with a protected, folded dilating balloon partially exposed in the lower panel, according to one embodiment.

[0016] Fig. 5A is a perspective views of a protective placement device in a phase of action, with its protected angioplasty balloon seen partially exposed, according to one embodiment.

[0017] Fig. 5B is a perspective views of a protective placement device in another phase of action, with its protected angioplasty balloon seen partially exposed, according to one embodiment.

[0018] Fig. 6 is a perspective partial view of the distal end of a protective placement device according to one embodiment; [0019] Fig. 7 is a perspective partial view of the distal end of a protective placement device, according to another embodiment;

[0020] Fig. 8 is a perspective view of another embodiment of a protective placement device according to one embodiment;

[0021] Fig. 9A is a first cross-sectional view of protective placement device and its components according to one embodiment.

[0022] Fig. 9B is a second view of protective placement device and its components according to one embodiment.

[0023] Fig. 9C is a third view of protective placement device and its components according to one embodiment.

[0024] Fig. 9D is a fourth view of protective placement device and its components according to one embodiment.

[0025] Fig. 9E is a fifth view of protective placement device and its components according to one embodiment.

DETAILED DESCRIPTION

[0026] Reference will now be made in detail to the construction and operation of embodiments illustrated in the accompanying drawings. The following description is only exemplary of the embodiments described and shown herein. The embodiments, therefore, are not limited to these implementations, but may be realized by other implementations.

[0027] Vascular balloon angioplasty and stenting procedures have evolved rapidly in response to the favorable effects of such minimally invasive procedures as well as to overcome limitations that persist despite the rapid progress. One of the most important evolutions has been the addition of pharmacologic agents to both balloon angioplasty devices as well as implantable stents, both permanent and bio-absorbable varieties. These agents' main use has been to limit the formation of intimal hyperplasia following the initially successful procedures, which if left unchecked may often re-narrow the treated vessel in the general area of the original stenosis and intervention. Several medical device manufacturers have successfully introduced drug-eluting balloons and stents that have agents applied onto the surface of such devices and these formulations have been refined to provide rapid absorption into cells in the vascular walls where they have been shown to be effective in limiting restenosis due to exaggerated intimal hyperplasia. Among the significant limitations of the combination drug/device is that the coated balloons, for example, must be rapidly placed at the site of the narrowing in the vessel according to the instructions for use accompanying the devices, thus limiting manipulation once in contact with body fluids to typically 3 minutes or less. This limitation creates obvious anxiety among interventionists and requires a well-prepared site, generally including pre-dilation of the narrowing to make sure that the drug-eluting device can easily be positioned at the site within the time allowed. If the device placement is delayed beyond the recommended time frame, it has also been shown that the favorable effects of the pharmacologic agents are significantly diminished resulting in suboptimal treatment that results in a significantly higher chance of re-narrowing at the site and the need for re-treatment at a later date. Another significant problem is that the coating containing the pharmacologic agents are subject to being rubbed off if the device is handled roughly before and during introduction into the delivery catheters as well as while the devices are advanced through guiding catheters and to the site of vascular stenosis, including during fine-tuning placement at the site. The present embodiments relate to devices that according to embodiments isolate the active surfaces of the various treatment devices from exposure to bodily fluids as well as protecting the drug coating from removal or displacement by abrasion or absorption before and during placement at the site to prevent the pharmacologic agents from being accidentally rubbed off. Embodiments also have the capability of combining the functions of protection with site preparation such as pre- dilatation and marking of the proper extent of the treatment segment. Embodiments are also able to facilitate passage of the pharmacologically active devices with surface treatments of their own, such as hydrophilic coatings and other low-friction coatings and materials such as ePTFE among others. These materials and their coatings may be incompatible with the pharmacology of the active drug, its carriers and affixers if applied directly to the drug delivery device but they may be easily applied to the exposed surface(s) of the protective delivery devices of embodiments and methods described herein.

[0028] Reference will now be made in detail to the construction and operation of embodiments illustrated in the accompanying drawings. Fig. 1A shows a protective delivery and placement device 10 according to embodiments, within which is a drug delivery device 11. The drug delivery device 11 may be a coated balloon or a coated stent for example. The protective device may surround the protected drug delivery device 11 to prevent any leakage of fluids into the interior of protective device 10 and in the embodiment shown in Fig. 1A, the fenestrations 16 would in that case be of such small dimension (laser perforations of 5 micrometers or less for example) such as to not allow the passage of red blood cells into the interior, or these can also represent potential fenestrations 16 in a material such as ePTFE, which in undilated state may remain a fluid barrier unless expanded. Furthermore, the expansion of such potential fenestrations 16 may be unresponsive (remain fluid-tight) to stresses applied in one direction (for example, longitudinal stress in the axial direction with regard to the device 10) but may respond to stresses in another direction such as radial expansion. This is a characteristic that is a known property of such materials, which can be constructed to comprise this functionality, according to embodiments. These potential separation geometries may be constructed to be large enough to release distal edges from constraining locations under marker band 22 for example. Lumen 13 is a tubular element that provides a lumen for inflating and deflating the drug delivery device. Lumen 15 is a central tubular element that provides a channel for carrying a guiding element such as for example, a guide wire. Lumen 14 is a tubular element connected to the protective placement device 10, for the purposes of providing access to the internal volume of protective placement device 10.

[0029] In Fig. IB is shown a multi-lumen hemostatic valve 20 that is capable of separately enabling access to various coaxial lumens for a protective device 10, such a lumen indicated as 14 that connects to the protective placement device, as well as a central lumen 15 that may carry a guiding element such as a guide wire 12, and a third coaxial lumen 13 providing a lumen for inflating/deflating the drug delivery device 11. The guide wire 12 or other guiding element 12 may be controlled by a device 21, which in this case is represented by a simple manual torque-controlling device 21. Inflation of protective device 10 to expand its fenestrations for the purpose of enabling drug delivery there through or for creating stress concentrations that will enable the material to separate and yield the structural constraining integrity of device 10, to allow the exposure of fluids to the surfaces of drug delivery device 11 as well as escape of drug delivery device 11 from within protective device 10, may be provided by an injection of contrast agent for example, and this contrast agent may be carbon dioxide, or other radio-dense contrast for example. The carbon dioxide may be provided by attaching a canister of medical grade carbon dioxide pressurized in a small cylinder 18 of the gas and may be controlled by a valve 51 in the carrying apparatus 52. At the point where the drug delivery device 11 is in position and the protective device 10 is no longer needed, it may be withdrawn proximally to remove it as a barrier between drug delivery device 11 and the vascular wall to which the drug(s) is/are being delivered. It should be mentioned at this stage that the chemistry of attaching an active drug or drugs to a physical structure such as a balloon angioplasty/drug delivery device is complicated by the need to deliver the drug quickly to the vascular wall by allowing it to detach itself from the drug delivery device, since during delivery there is generally blockage of downstream flow in the vessel being treated and the time of blockage/delivery must therefore be limited to as small a time as possible while ensuring complete delivery of all of the drug needed for the desired effects. At the same time however the drug must not be released prematurely by abrasion, fluids washing the drug away (particularly fluids that may be similarly lipophilic compared with the vascular walls to which the drug is meant to be attracted) or other reasons for loss of drug(s) prior to apposition of the balloon surfaces against the vascular wall to elute the active drug(s).

[0030] Fig. 1C shows a protective device 10 with asymmetric potential fenestrations 16 that may remain axially aligned when the device is deflated or only partially deflated. Again, these potential spaces may represent selectively weaker areas that may release the drug delivery device 11 from within the protective placement device 10 and these release elements may act as fracture lines when the protective placement device 10 is placed under radial stress to permit emergence of drug delivery device 11 distally or it may remain in position in the treatment site and the outer protective device 10 may be withdrawn away from the treatment area. Fig. ID shows a device with a closed tulip petal configuration with selectively scored, overlapped, rolled or otherwise made susceptible to separation, release components 17, which upon application of pressurized contrast media to protective device 10 may separate or otherwise assume a non- overlapped configuration to release drug delivery device 11 out the distal end of protective placement device 10 for example, for its intended usage. Marker band 22 is included as part of drug delivery device 11 and may additionally function to tuck distal edges of protective placement device 10 between it and drug delivery device 11, thus sealing the distal hoop edge of protective placement device 10 to prevent fluids or air passage to the inner volume of protective placement device 10 and external surface of drug delivery device 11. Fig IE shows an open tulip petal type pattern of wide-open configuration at the distal end of protective device 10.

[0031] Figs. 2A, 2B, 2C and 2D show, in several panels, an additional embodiment where protective device 10 is contiguous with drug delivery device 11 by invagination of 11 within the confines of the portion of device that is not drug coated, but may be, as indicated earlier, coated with substances that may help shield surface(s) 11 from coming in contact with fluids until such time as activation and elution is desired. Those substances may comprise coatings that may act as a barrier between the active drug surface(s) of drug delivery device 11 and such fluids. The inflation of the combined protective device 10 and its active component 11 causes the device to both expand and revert to its natural shape exposing the drug surface(s) to the vascular wall while at the same time firmly opposing it with pressure delivered by a suitable inflation device attached to the inflation lumen of the device 10/11.

[0032] According to embodiments, devices 10/11 may be invaginated distal to proximal as shown in Fig. 2C or proximal to distal as shown in Fig. 2D.

[0033] Fig. 2 B shows an optional capability of pre-dilation of a stenotic segment

23 in a vessel 24. In this case, an additional rigid tubular element (not shown) between the inner invaginated surface of protective portion 10 and the outer surface of active drug delivery portion 11 may be utilized to prevent unnecessary trauma to the drug-containing surface of portion 11.

[0034] Figs. 3A and 3B show, in two panels, another embodiment comprising an outer protective balloon device 10 that is wrapped completely around drug-eluting device 11. The folded edges 31 of protective device 10 are rolled and sealed with adhesive or heat sealed such that until protective (in this case, enveloping balloon) device 10 is inflated these edges isolate drug delivery device 11 from fluids and abrasion. Fig. 3A shows protective device 10 completely encapsulating the active surfaces of drug delivery device 11 and also shows the nose section of drug delivery device 11 protruding out distally from within the enveloping protective balloon device 10. Fig. 3B shows the state of the two devices 10 and 11 once protective balloon device 10 is partially or fully inflated to fully release drug delivery device 11 from within protective positioning and optionally pre-dilating device 10. The folded drug delivery balloon 11 is now ready to be inflated to compress its walls against the vascular intima to deliver the active drug(s) to the vessel walls.

[0035] Figs. 4A and 4B show, in two panels, an additional configuration of a protective device 10. In Fig. 4A is shown an example of a releasable mouth, held closed by heat tacking its folded, overlapping leading edges or by using a biocompatible adhesive, or, according to embodiments, utilizing additional edge geometries that may seal the edge until inflation stress may be applied to the inner volume of protective device 10 to release these edges to create a wide open distal end through which the drug delivery device 11 may emerge, which may be realized by retracting proximally protective device 10 to fully expose drug delivery device 11 to the treatment site. This may be accomplished by retracting outer lumen 14 while keeping inner lumens 13/15 in place.

[0036] Figs. 5A and 5B show, according to one embodiment and method, an additional configuration and mechanism(s) that may be utilized to initially protect and then release inner drug delivery device 11 once properly in position in the desired area of disease in the vascular space. Lips 17 are either heat-tacked, held by adhesives or otherwise constrained with an additional overlapping geometry, any of which, or any combination of which may be released by increasing inner pressure with the volume of protective device 10. Additional helper elements 53 may act to increase the degree of opening of the mouth of protective device 10 by fully opening the lips 17 of the device 10 to permit atraumatic exit of drug delivery device 11. Fig. 5A shows protective device 10 with its lips sealed, and if these are to open simultaneously they may be rolled such that inflation rolls the lips off of the areas of attachment as a whole. Augmenting helper springs 53 may be of particular use to fully open the mouth of protective device 10 in this case, as illustrated in Fig. 5B. Also not shown is another configuration whereby the "jaw" and its lips 17 are simply expandable by multiple small serially located along the lips 17, expansions of a material such as ePTFE to effect an open mouth position, large enough to enable passage of inner drug delivery device 11 distally out the end of protective placement device 10, such that it may then be expanded radially to appose against the vessel wall to be treated with luminal expansion and drug delivery.

[0037] Fig. 6 shows extended lip sections 17 that are tacked to each other on their inner surfaces such that they can withstand abrasion and yet are easily rolled off of each other based on a change in the geometric angle of the lip edges once under the influence of the shape change resulting from inflation of the inner volume of protective device 10 that lifts the lips' edges away from each other. For example, a double hook shape (not shown) of the opposing lips would be stable when in the contracted, non-inflated configuration but these may be unhooked once a more rounded attitude of the walls is assumed during full or partial inflation. The geometries thus cycled between may permit simultaneous release of all lip edges to permit atraumatic exposure of drug carrying device 11 and its non-restricted emergence from within protective positioning device 10.

[0038] Fig. 7 shows an additional mechanism according to embodiments where lips

17 of protective delivery positioning device 10 comprise tubules, which when deflated are attached to their opposite number by geometry, heat sealing or other adhesive means. Once these tubules 35/17 are inflated, they assume a tubular shape releasing them from one wall of the jaws of the distal end of protective device 10 causing the mouth of device 10 to open widely, enabling exposure and escape of drug delivery device 11. An inflation device such as a simple syringe 36 may be attached and may be filled with contrast liquid or readily absorbable gas contrast media (carbon dioxide for example).

[0039] Fig. 8 shows another embodiment of a protective positioning device 10 where a strip of material 41 functions to seal the edges of device 10 by geometry of the strip 41, heat sealing or other adhesive means. This functional sealing strip 41 is activated to unzip or unseal the edges of protective device 10 by tensioning the attached portion 42 which extends all the way proximally such that it can be physically tugged in order to release the edges of protective device 10 to enable exposure and emergence of drug delivery device 11. The end 42 may also simply be held while twisting tube/lumen 14 to shorten the distance and strip off zip-strip 41.

[0040] Fig. 9A is a cross-section detail view of several components of a release assembly 17 including a solid core 61 surrounded by a release expandable tubular component 62, which is connected to and in continuity with, access lumen 14. Expanding geometry-releasing tubular component 66 is one element of a simultaneous edge release assembly 17 and for this function is attached to mating edges of outer pod 69 of a protective placement device 10. The opposing mating edges of outer pod 69 terminate in a folded or tubular capture component 31. Capture component 31 may be a split tube that is attached to outer pod 69 or it may be a simple rolled edge of outer pod 69, or still further may capture expanding tubular release actuator 66 by intermittent or continuous adhesive, heat sealing or with a simple tucked-in band for example.

[0041] Fig. 9B shows a partial cross-section view of marker band 22' s proximal edge constraining expandable release tube edge 62, which encircles the distal area of and is attached to pod component 69 of protective placement device 10. [0042] Fig. 9C shows a protective placement device 10 with its outer pod covering labeled 10/69. The closed mating edges are labeled 31 and 62 corresponding to their illustrations in cross-section in Fig. 9A. The distal securing function may be assumed by dual function marker band 22, which may have a slightly concave inner band configuration proximally where expandable, geometry- shifting tubular component may be located thereunder, which upon expansion would then release from constraint by marker band 22, to complete the pod-opening action simultaneous with the longitudinal opening of the pod-edges along one or more longitudinal lines of protective placement device 10 to delicately release drug delivery device 11 from within. Lumen 13, which is used to inflate and deflate drug delivery device 11 may be separate from or coaxial with protective placement device 10' s access lumen 14.

[0043] Fig. 9D shows partially opened pod edges with separation of expandable edge 62 from constraining edge 31 partially exposing elements (wire lumen 15 for example) of the drug delivery device 11 to view. At this point marker band 22 of drug delivery device 11 has yet to release distal encircling edges 62 of protective placement device 10 from under itself.

[0044] Fig. 9E shows the completed stage of release of all edges 17 of pod 69 of protective positioning device 10 so that drug delivery device 11 is now also fully released from within protective positioning device 10, which may now be withdrawn proximally in a vessel such that drug delivery device 11 may be in complete apposition against the wall of a vessel in the region of desired drug delivery treatment. Access to the distal vessel is maintained at all times with a guide wire 12 or equivalent device, located within lumen 15 of drug delivery device 11 for example.

[0045] While there are several methods and embodiments shown with which to protect, position, deliver and dispense a drug delivery device 11, it is to be understood, however, that the foregoing mechanisms and any embodiments referred to herein are exemplary in nature only. Those of skill in this art will recognize that other dimensions and/or configurations may be implemented, depending upon the application, and that the elements of the device could be of any length or dimension, all of which are considered within the scope of this disclosure. Furthermore, any discussion of dimensions or ranges of dimensions or physical or dynamic aspects such as attachment methods or ranges of motion or time factors outlined herein are exemplary in nature only and should not be considered to be limiting. [0046] The entire device may be configured to be disposable or may be configured to be reusable in whole or in part. Embodiments of the present device may be electrically powered, heated to release adhesives or otherwise activate configurations, and the power source may include one or more batteries and/or external power sources through a simple electrical coupling to connect to an external power supply conveniently placed, for example, in the handle or proximal end of the present biopsy device. The entire device may also be internally or externally manually powered, mechanically powered or be powered by means such as compressed air, gas such as carbon dioxide or pressurized fluid such as contrast agents suitable for vascular use. Powering the device entirely mechanically may be advantageous in areas in which the electric grid is absent, unavailable, or unreliable.

[0047] One embodiment is a method of carrying out the functions of protection, positioning, exposure and release of a drug delivery vascular device, by utilizing mechanisms of remote release of sealing edges, or otherwise allowing remote exposure and deliverance of a drug- eluting or otherwise drug delivering device once in position in the desired location using devices described herein, according to embodiments.

[0048] Another embodiment is another method of carrying out the function of enhanced delivery including coatings not otherwise applicable to the drug-coated surfaces of a drug-eluting balloon device by isolating the protective positioning device surface from the drug delivery device surface, whose characteristics may otherwise be mutually incompatible, according to device embodiments described herein.

[0049] One embodiment is a vascular device, comprising a protective outer physical barrier to prevent exposure to the drug/carrier complex of substances or forces that may result in premature delivery or loss of active drug from a drug delivery device, that is remotely activated to permit non-traumatic egress of a drug delivery device from within the protective device, or otherwise removing said barrier such that drug delivery device may then deliver its full dose of drug(s) at the treatment site.

[0050] A method, according to one embodiment, comprises isolating a drug delivery device from fluids, abrasion and contaminants until the drug delivery device is properly positioned in the desired treatment area which, therefore, allows unlimited time to properly place the device while permitting the control of the release of the active drug(s) to the optimum time. [0051] One embodiment comprises edge actuating devices that may open all edges together of a protective positioning device that are needed for non-disruptive release of an enclosed drug delivery device.

[0052] Another embodiment is a method of sealing a drug delivery device in a protected space until such device is properly positioned at the desired treatment site, and then non- disruptively releasing the drug delivery device from within the protected space for the purposes of eluting the drug at the desired time and to the desired treatment area.

[0053] According to one embodiment, a device may comprise a drug-eluting device configured for placement in a biological conduit and eluting a drug into the biological conduit upon contact with the biological conduit; and a protective device configured to encapsulate the drug-eluting device, the protective device comprising an outer physical barrier that, in a first selectable configuration within the biological conduit, prevents the drug-eluting device from contacting, and eluting the drug into, the biological conduit and that, in a second selectable configuration within the biological conduit, enables the drug-eluting device to come into contact with the biological conduit and elute the drug into the biological conduit.

[0054] According to one embodiment, the outer physical barrier may comprise a plurality of fenestrations through the outer physical barrier. At least some of the plurality of fenestrations may be configured to be fluid tight when the outer physical barrier may be unstressed and configured to enable fluids to pass therethrough when the outer physical barrier may be subjected to stress. At least a portion of the outer physical barrier (a distal portion thereof, for example) may be configured to be selectable movable to selectable expose at least a portion of the drug-eluting device to the biological conduit. The outer physical barrier may comprise a first portion that may be sealed against a second portion in the first selectable configuration and unsealed from the second portion in the second selectable configuration. The first portion may be heat sealed or sealed with an adhesive against the second portion, among other possibilities. The outer physical barrier may be configured to respond to a proximally-directed force by transitioning from the first selectable configuration in which the drug-eluting device is encapsulated within and isolated from the biological conduit to the second selectable configuration in which the drug- eluting device comes into contact with the biological conduit. [0055] The outer physical barrier may comprise a plurality of petals that may be tucked into a distal band in the first selectable configuration and that may become untucked and free of the distal band in the second selectable configuration. The outer physical barrier may comprise a longitudinal slit defined by folded edges that are sealed in the first selectable configuration and that may become unsealed in the second selectable configuration. At least one distal portion of the outer physical barrier may be folded back on itself and sealed in the first selectable configuration and unsealed and unfolded in the second selectable configuration. The outer physical barrier may comprise a distally-disposed mouth that may be closed and sealed in the first selectable configuration and that may become unsealed and open in the second selectable configuration. The outer physical barrier may comprise one or more lip portions that may be closed and sealed in the first selectable configuration and that may become unsealed and open in the second selectable configuration. The lip(s) may comprise inflatable tubules. A sealing strip may be provided, sealed against the outer physical barrier and configured to keep the drug-eluting device encapsulated within the protective device in the first selectable configuration and configured to become unsealed from the outer physical barrier and bring the drug-eluting device into contact with the biological conduit in the second selectable configuration.

[0056] According to one embodiment, expansion of the drug-eluting device causes the outer physical barrier to transition from the first selectable configuration to the second selectable configuration. In another embodiment, expansion (e.g., inflation) of the protective device causes the outer physical barrier to transition from the first selectable configuration to the second selectable configuration.

[0057] The biological conduit may be created (by the physician, for example) within biological tissue. The drug-eluting device may be or comprise a stent. The drug-eluting device may be or comprise an inflatable balloon.

[0058] One embodiment is method, comprising providing an assembly may comprise a drug-eluting device configured for placement in biological tissue and eluting a drug into the biological tissue upon contact with the biological tissue, and a protective device configured to releasably encapsulate the drug-eluting device, the protective device may comprise an outer physical barrier; inserting the assembly into the biological tissue in a first selectable configuration that prevents the drug-eluting device from contacting and eluting the drug into the biological tissue; and when the inserted assembly has reached a target location within the biological tissue at which the drug may be to be eluted, acting upon at least one of the drug-eluting device and the assembly to cause the assembly to assume a second selectable configuration, in which the drug- eluting device comes into contact with and elutes the drug into the biological tissue.

[0059] Providing may be carried out with the outer physical barrier comprising a plurality of fenestrations through the outer physical barrier. At least some of the plurality of fenestrations may be configured to be fluid tight when the outer physical barrier is unstressed and acting upon may comprise subjecting the outer physical barrier to stress to deform at least some of the plurality of fenestrations to enable fluids to pass through the deformed fenestrations.

[0060] In one embodiment, acting upon selectably moves at least a portion of the outer physical barrier (a distal portion thereof, for example) to selectably expose at least a portion of the drug-eluting device to the biological tissue. The outer physical barrier may comprise a first portion sealed against a second portion in the first selectable configuration and acting upon may cause the first portion to become unsealed from the second portion in the second selectable configuration. The first portion may be, for example, heat sealed and/or adhesively sealed against the second portion. Acting upon may comprise subjecting the outer physical barrier to a proximally-directed force to cause a transition from the first selectable configuration in which the drug-eluting device is encapsulated within and isolated from the biological conduit to the second selectable configuration in which the drug-eluting device comes into contact with the biological tissue. The outer physical barrier may comprise a plurality of petals that may be tucked into a distal band in the first selectable configuration and acting upon may comprise causing at least some of the plurality of petals to become untucked and free of the distal band in the second selectable configuration. The outer physical barrier may comprise a longitudinal slit defined by folded edges sealed in the first selectable configuration and acting upon may cause the folded edges to become unsealed in the second selectable configuration. A distal portion of the outer physical barrier may be folded back on itself and sealed in the first selectable configuration and acting upon may cause the at least one distal portion to become unsealed and unfolded in the second selectable configuration. The outer physical barrier may comprise a distally-disposed mouth that may be closed and sealed in the first selectable configuration and acting upon may cause the distally- disposed mouth to become unsealed and open in the second selectable configuration. The outer physical barrier may comprise at least one lip portion that may be closed and sealed in the first selectable configuration and acting upon may cause causes the lip portion(s) to become unsealed and open in the second selectable configuration. The lip(s) may comprise inflatable tubules. A sealing strip may be provided, sealed against the outer physical barrier and configured to keep the drug-eluting device encapsulated within the protective device in the first selectable configuration. Acting upon, in this embodiment, may cause the sealing strip to become unsealed from the outer physical barrier and bring the drug-eluting device into contact with the biological tissue in the second selectable configuration.

[0061] In one embodiment, acting upon may comprise expanding the drug-eluting device to cause the outer physical barrier to transition from the first selectable configuration to the second selectable configuration. The drug-eluting device may comprise, for example, a stent and/or an inflatable balloon (e.g., an angioplasty balloon). Other drug-eluting or delivering devices may be accommodated as well.

[0062] It is to be understood that the above descriptions are but exemplary methodologies and that one or more of the steps described above may be omitted, while other steps may be added thereto to any of these embodiments, depending on the target site within the body. Other operator method embodiments and device embodiments are supported as well. The order of some of the steps may additionally be changed, according to the desired procedure.

[0063] The present device may be formed of or comprise one or more biocompatible materials such as, for example, stainless steel or other biocompatible alloys, and may be made of, comprise or be coated with polymers, such as polyimide, and/or biopolymer materials and other biologic materials as needed to optimize function(s). Some of the components may be purposely surface-treated differentially with respect to adjacent components, as detailed, including hydrophilic and hydrophobic coatings. Various biocompatible adhesives may also be used at locations needed for proper functioning. The materials used in the present device may also be carefully selected from a ferro-magnetic standpoint, such that the present biopsy device maintains compatibility with MRI equipment.

[0064] The power source may comprise an external commercially available gas and fluid moving device to provide inflation and vacuum as well as movements of various components of embodiments. The source of movements may also be manually powered and transmitted or may include in embodiments electrical and thermal energies. Power for actions, according to various embodiments, may comprise a transformer approved for medical device use and plugged into a provided socket in the present biopsy device, or may comprise an enclosed battery of any suitable and commercially available power source. The battery may be of the one-time use disposable (and optionally recyclable) variety, or may be of the rechargeable variety. Additionally, other power sources, for example, mechanical linkages or compressed air motors, compressed gas chambers such as portable carbon dioxide canisters or compressed gas containers such as aerosol delivery vessels such as may be commercially available to power air guns and medical devices may also be used.

[0065] While certain embodiments of the disclosure have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. Indeed, the novel methods, devices and systems described herein may be embodied in a variety of other forms and other applications. All such other applications making use of the principles disclosed herein for this device and that could be envisioned by one skilled in the art are therefore considered to be within the scope of this disclosure. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure. For example, those skilled in the art will appreciate that in various embodiments, the actual physical and logical structures and dimensions thereof may differ from those shown in the figures. Depending on the embodiment, certain steps described in the example above may be removed, others may be added. Also, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Although the present disclosure provides certain preferred embodiments and applications, other embodiments that are apparent to those of ordinary skill in the art, including embodiments which do not provide all of the features and advantages set forth herein, are also within the scope of this disclosure. Accordingly, the scope of the present disclosure is intended to be defined only by reference to the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A device, comprising: a drug-eluting device configured for placement in a biological conduit and eluting a drug into the biological conduit upon contact with the biological conduit; and a protective device configured to encapsulate the drug-eluting device, the protective device comprising an outer physical barrier that, in a first selectable configuration within the biological conduit, prevents the drug-eluting device from contacting, and eluting the drug into, the biological conduit and that, in a second selectable configuration within the biological conduit, enables the drug-eluting device to come into contact with the biological conduit and elute the drug into the biological conduit.

2. The device of claim 1, wherein the outer physical barrier comprises a plurality of fenestrations through the outer physical barrier.

3. The device of claim 2, wherein at least some of the plurality of fenestrations are configured to be fluid tight when the outer physical barrier is unstressed and configured to enable fluids to pass therethrough when the outer physical barrier is subjected to stress.

4. The device of claim 1, wherein at least a portion of the outer physical barrier is configured to be selectable movable to selectable expose at least a portion of the drug-eluting device to the biological conduit.

5. The device of claim 4, wherein the at least a portion comprises a distal portion of the outer physical barrier.

6. The device of claim 1, wherein the outer physical barrier comprises a first portion that is sealed against a second portion in the first selectable configuration and unsealed from the second portion in the second selectable configuration.

7. The device of claim 6, wherein the first portion is one of heat sealed and sealed with an adhesive against the second portion.

8. The device of claim 1, wherein the outer physical barrier is configured to respond to a proximally-directed force by transitioning from the first selectable configuration in which the drug-eluting device is encapsulated within and isolated from the biological conduit to the second selectable configuration in which the drug-eluting device comes into contact with the biological conduit.

9. The device of claim 1, wherein the outer physical barrier comprises a plurality of petals that are tucked into a distal band in the first selectable configuration and that become untucked and free of the distal band in the second selectable configuration.

10. The device of claim 1, wherein the outer physical barrier comprises a longitudinal slit defined by folded edges that are sealed in the first selectable configuration and that become unsealed in the second selectable configuration.

11. The device of claim 1, wherein at least one distal portion of the outer physical barrier is folded back on itself and sealed in the first selectable configuration and wherein the at least one distal portion becomes unsealed and unfolded in the second selectable configuration.

12. The device of claim 1, wherein the outer physical barrier comprises a distally- disposed mouth that is closed and sealed in the first selectable configuration and that becomes unsealed and open in the second selectable configuration.

13. The device of claim 1, wherein the outer physical barrier comprises at least one lip portion that is closed and sealed in the first selectable configuration and that becomes unsealed and open in the second selectable configuration.

14. The device of claim 13, wherein the at least one lip comprises inflatable tubules.

15. The device of claim 1, further comprising a sealing strip, sealed against the outer physical barrier and configured to keep the drug-eluting device encapsulated within the protective device in the first selectable configuration and configured to become unsealed from the outer physical barrier and bring the drug-eluting device into contact with the biological conduit in the second selectable configuration.

16. The device of claim 1, wherein expansion of the drug-eluting device causes the outer physical barrier to transition from the first selectable configuration to the second selectable configuration.

17. The device of claim 1, wherein expansion of the protective device causes the outer physical barrier to transition from the first selectable configuration to the second selectable configuration.

18. The device of claim 1, wherein the biological conduit is created within biological tissue.

19. The device of claim 1, wherein the drug-eluting device comprises a stent.

20. The device of claim 1, wherein the drug-eluting device comprises an inflatable balloon.

21. A method, comprising: providing an assembly comprising a drug-eluting device configured for placement in biological tissue and eluting a drug into the biological tissue upon contact with the biological tissue, and a protective device configured to releasably encapsulate the drug-eluting device, the protective device comprising an outer physical barrier; inserting the assembly into the biological tissue in a first selectable configuration that prevents the drug-eluting device from contacting and eluting the drug into the biological tissue; and when the inserted assembly has reached a target location within the biological tissue at which the drug is to be eluted, acting upon at least one of the drug-eluting device and the assembly to cause the assembly to assume a second selectable configuration, in which the drug-eluting device comes into contact with and elutes the drug into the biological tissue.

22. The method of claim 21, wherein providing is carried out with the outer physical barrier comprising a plurality of fenestrations through the outer physical barrier.

23. The method of claim 21, wherein at least some of the plurality of fenestrations are configured to be fluid tight when the outer physical barrier is unstressed and wherein acting upon comprises subjecting the outer physical barrier to stress to deform at least some of the plurality of fenestrations to enable fluids to pass through the deformed fenestrations.

24. The method of claim 21, wherein acting upon selectably moves at least a portion of the outer physical barrier to selectably expose at least a portion of the drug-eluting device to the biological tissue.

25. The method of claim 24, wherein the at least a portion comprises a distal portion of the outer physical barrier.

26. The method of claim 21, wherein the outer physical barrier comprises a first portion that is sealed against a second portion in the first selectable configuration and wherein acting upon causes the first portion to become unsealed from the second portion in the second selectable configuration.

27. The method of claim 26, wherein the first portion is one of heat sealed and adhesively sealed against the second portion.

28. The method of claim 21, wherein acting upon comprises subjecting the outer physical barrier to a proximally-directed force to cause a transition from the first selectable configuration in which the drug-eluting device is encapsulated within and isolated from the biological tissue to the second selectable configuration in which the drug-eluting device comes into contact with the biological tissue.

29. The method of claim 21, wherein the outer physical barrier comprises a plurality of petals that are tucked into a distal band in the first selectable configuration and wherein acting upon causes at least some of the plurality of petals to become untucked and free of the distal band in the second selectable configuration.

30. The method of claim 21 , wherein the outer physical barrier comprises a longitudinal slit defined by folded edges that are sealed in the first selectable configuration and wherein acting upon causes the folded edges to become unsealed in the second selectable configuration.

31. The method of claim 21, wherein at least one distal portion of the outer physical barrier is folded back on itself and sealed in the first selectable configuration and wherein acting upon causes the at least one distal portion to become unsealed and unfolded in the second selectable configuration.

32. The method of claim 21, wherein the outer physical barrier comprises a distally- disposed mouth that is closed and sealed in the first selectable configuration and wherein acting upon causes the distally-disposed mouth to become unsealed and open in the second selectable configuration.

33. The method of claim 21, wherein the outer physical barrier comprises at least one lip portion that is closed and sealed in the first selectable configuration and wherein acting upon causes the at least one lip portion to become unsealed and open in the second selectable configuration.

34. The method of claim 33, wherein the at least one lip comprises inflatable tubules.

35. The method of claim 34, wherein acting upon comprises inflating the inflatable tubules.

36. The method of claim 21, further comprising a sealing strip, sealed against the outer physical barrier and configured to keep the drug-eluting device encapsulated within the protective device in the first selectable configuration and wherein acting upon causes the sealing strip to become unsealed from the outer physical barrier and bring the drug-eluting device into contact with the biological tissue in the second selectable configuration.

37. The method of claim 21 , wherein acting upon comprises expanding the drug-eluting device to cause the outer physical barrier to transition from the first selectable configuration to the second selectable configuration.

38. The method of claim 21, wherein the drug-eluting device comprises a stent.

39. The method of claim 21, wherein the drug-eluting device comprises an inflatable balloon.