This document pertains generally, but not by way of limitation, to medical devices including balloons.
Medical devices including balloons, such as catheters (e.g., therapeutic, guide, delivery catheters or the like) are used in a variety of medical procedures for instance vascular and body cavity procedures (e.g., gastrointestinal). The balloon is provided in an initial deflated configuration. In some examples the balloon is delivered on its own catheter through a delivery catheter. The balloon is deployed from an end of the delivery catheter and inflated, for instance with saline, a gas or the like.
In some examples, a balloon is inflated within a vessel or body cavity to open the vessel or cavity, for instance as part of a therapeutic procedure where a portion of the anatomy is stenosed and balloon inflation opens the stenosis.
In other examples, a balloon includes one or more coatings such as medicament coatings configured to provide a therapeutic benefit to the patient. Inflation of the balloon in one example provides intimate contact between the balloon and tissue, such as a vessel wall. The drug coating is applied, absorbed or the like from the balloon surface by the tissue according to the intimate contact.
In other examples, a balloon is inflated within a vessel or body cavity to occlude the vessel or cavity, for instance as part of a therapeutic procedure where isolation of a portion of the anatomy is specified. Optionally, the balloon is constructed with compliant materials configured to closely contact the vessel or cavity tissues and provide a reliable seal between the balloon and the tissues.
The present inventors have recognized, among other things, that a problem to be solved can include minimizing the profile of a balloon upon deflation to facilitate retraction of the balloon into a delivery catheter or sheath (e.g., for removal from a patient). When a balloon system (balloon and a balloon catheter) is navigated through a patient to a treatment location, the balloon is provided in an initial deflated configuration (e.g., initial packaged configuration) with the balloon pleated and folded around the shaft of the balloon catheter. Once the balloon is positioned at the treatment site, the balloon is inflated (e.g., with saline, a gas or the like) to an unfolded, expanded configuration (e.g., an inflated configuration) to conduct a procedure including, but not limited to, the application of a medicament, expansion based treatments such as angioplasty or the like. At the conclusion of a procedure the balloon is deflated, retracted into the delivery catheter, and then removed from the patient through the delivery catheter.
During deflation the balloon flattens in an unrestrained fashion, and in at least some examples assumes a flat (e.g., pancake) configuration extending laterally from the balloon catheter. The flat configured deflated balloon is different from the initial packaged (folded) configuration and in some examples has a maximal width or maximal cross-sectional profile greater than an inner diameter of the delivery catheter. Consequently, upon retraction of the deflated balloon into the delivery catheter the balloon scrapes along the surfaces of the delivery catheter (e.g., the edges of the opening). Scraping in some examples abrades the balloon or dislodges coatings present on the balloon, and releases particulate material (e.g., debris). The dislodged debris remains in the vasculature, body cavity or the like after removal of the balloon and in some examples increases the risk of therapeutic complications, such as vascular stenosis or emboli formation.
The present subject matter provides a solution to this problem, such as by providing a balloon system including one or more deflation guides configured to predispose (guide) the deflating balloon away from a configuration with a profile that exceeds the inner diameter of the guiding delivery catheter. For instance, in one example, the one or more deflation guides guide the deflating balloon toward a folded deflated configuration by way of initiating pleats in the balloon (e.g., folds, ridges and grooves or the like). In an example, a folded perimeter of the balloon (when fully deflated) corresponds to the folded profile of the balloon. The folds (preceded by pleats that guide folding) minimize the folded profile of the deflated balloon and facilitate the retraction of the deflated balloon through the distal mouth of the delivery catheter while minimizing scraping and abrading of the balloon. The deflation guides bias the deflating balloon by initiating a pleated guiding configuration, and the pleated guiding configuration guides further deflation of the balloon to the folded deflated configuration. The folded deflated configuration in examples is not identical to the initial packaged configuration (e.g., as made and packaged). The folded deflated configuration includes pleats and folds provided according to post inflation pleating. Optionally, the folds in the folded deflated configuration in other examples are similar to or identical to folds in the initial packaged configuration.
In one example the deflation guides bias the balloon during a portion of deflation of the balloon, for instance at the initiation of deflation. In another example, after the initial bias (e.g., guidance) provided by the deflation guides during initial deflation the deflation guides become passive and thereby apply minimal force to the balloon (e.g., less or none). Accordingly, the one or more deflation guides in an example, provide a tuned force to the balloon that biases the balloon toward pleating (an initial push or pull) while minimizing the application of force to the balloon after a portion of the deflation. Conversely, the one or more deflation guides minimally interact with the inflation of the balloon to the fully deployed configuration (e.g., not at all or with a greatly decreased force relative to initial deflation) thereby ensuring the balloon fully inflates to the desired inflated configuration (e.g., a shape specified for treatment).
The one or more deflation guides include unitary or multi-component deflation guides. In one example, the one or more deflation guides include one or more deflation struts arranged around the balloon. The one or more deflation struts are optionally constructed with an elastomer (e.g., compliant and having a greater elasticity relative to the balloon). Optionally, the deflation struts are coupled at one or more locations along the balloon (e.g., discontinuously, continuously or the like). In another option, the deflation struts are coupled with (e.g., affixed, laid and thereby at least partially movable, or the like) the balloon.
In another example, the one or more deflation guides includes an elastomer shell applied to either of the inner or exterior portion of the balloon (or between layers of the balloon). The elastomer shell is optionally constructed with an elastomer having a greater elasticity and compliance relative to the balloon.
In still another example, the one or more deflation guides include telescoping shafts. For instance, the balloon catheter comprises an exterior shaft coupled (e.g., bonded, engaged with, crimped or the like) with a proximal end portion of the balloon, and an interior shaft coupled with a distal end portion of the balloon. The interior shaft is telescopically received in the exterior shaft, and during deflation the interior shaft is moved distally relative to the exterior shaft (or the exterior shaft is moved proximally) to bias the balloon to pleat and thereby guide folding of the balloon. Optionally, one of the shafts is rotated relative to the other shaft (independently or with longitudinal movement) to bias the balloon to pleat (e.g., helically).
In another option, the one or more deflation guides are provided with another component of the balloon system, such as the delivery catheter. In one example, the delivery catheter includes a braid (e.g., a helical coil, braid or the like) as the one or more deflation guides with a distal portion of the braid coupled near a distal mouth of the delivery catheter. Rotation of the braid relative to the remainder of the delivery catheter (or conversely, rotation of the catheter relative to the braid) causes the braid to expand (e.g., in an unwinding direction) and correspondingly expands the distal mouth of the delivery catheter. The expanded distal mouth readily receives the deflated balloon in a flat configuration or in a folded deflated configuration (e.g., initiated with another example of the one or more deflation guides).
This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. The detailed description is included to provide further information about the present patent application.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
Referring first to
As shown in
Referring now to
With the balloon 102 in the flat deflated configuration shown in
As further shown in
Referring again to
As described herein, in at least some examples, the one or more deflation guides include, but are not limited to, features such as struts, shells, telescoping shafts or the like configured to initiate pleating (e.g., creasing, beginning of folds or the like) of one or more portions of the balloon to thereby facilitate continued deflation (and folding) of the balloon into a folded deflated configuration for reception within the delivery catheter 110 without engagement against the distal mouth 114. Accordingly, large deflated profiles such as the flat deflated configuration 102 shown in
The balloon 204 is in the inflated configuration, for instance, with inflation fluid provided through the inflation lumen 310 to the balloon 204. The balloon 204 is, in one example, constructed with, but not limited to, noncompliant materials including, but not limited to, polyamides (nylon), polyether-block-amide (PEBAX®, VESTAMID® E), polyurethane or the like. Noncompliant balloons are used in some examples to apply a force to a vessel wall, plaques or the like to dilate the vessel and thereby increase blood flow. In another example, the balloon 204 is constructed with a compliant material, for instance, an elastomer or the like and configured to assume a configuration corresponding to the configuration of a cavity, vessel or the like (e.g., the balloon 204 stretches or deforms). For instance, in one example, the balloon 204 is inflated into the inflated configuration and because of the compliant material of the example balloon material the balloon deforms or stretches into a configuration corresponding to the vasculature (e.g., veins, arteries or the like), cavity or the like of the subject. Compliant balloons are used in other example to occlude a vessel or passage, for instance for a therapeutic procedure downstream from the balloon.
As will be further described herein and as shown in
The deflation guides 304 are configured to predispose the balloon 204 to deflate into a configuration different from the flat deflated configuration of the balloon 102 shown, for instance, in
Referring now to
Referring now to
Accordingly, with the one or more deflation guides 304 described herein, the balloon system 200 including the deflation guides is configured to guide (e.g., predispose, bias, shape, preferentially dispose) deflation of the balloon 204 into a folded deflated configuration. In one example, the deflation guides 304 bias the balloon 204 at least at the initiation of deflation to assume the pleated guiding configuration. For example, the deflation guides 304 provided at localized positions around the balloon 204 predispose the balloon or bias the balloon to initiate pleating at locations corresponding to the one or more deflation guides 304. After initiating of pleating to form the pleats 316 shown in
As further shown in
In one example, the one or more deflation struts 410 include elastomer deflation struts configured to stretch with inflation of the balloon 404. In one example, the plurality of deflation struts 410 are coupled with a balloon exterior 416 as shown in
As previously described, the deflation struts 410 (e.g., deflation guides as described herein) optionally include one or more elastomer materials. In one example, the deflation struts 410 are constructed with, but not limited to, elastic Nylon, rubber, elastic polyurethane, silicone or the like. With elastomer deflation struts 410 inflation of the balloon 404, for instance from an initial packaged configuration (previously described herein) to the inflated configuration, stretches the deflation struts 410 and accordingly applies a compressive force to the balloon 404. In one example, as the balloon 404 is deflated, (e.g., at the initiation of deflation) the elastomer deflation struts 410 in the stretched configuration pleat the balloon 404 (see
In one example, where the deflation struts 410 include an elastomer the deflation struts 410 are slidably coupled along the balloon 404. For instance, as shown in
Referring now to
Referring now to
In the example shown in
In one example, the deflation shell 510 is coupled with one or both of the interior or exterior of the balloon 504. For instance, in one example the deflation shell 510 is provided along the balloon interior 512 as shown in
Referring again to
In another example, the deflation shell 510 like the previously described deflation struts is constructed with an elastomer material, for instance, one or more of the materials previously described herein such as elastic Nylon, silicone, elastic polyurethane, rubber or the like. The deflation shell 510 is configured to stretch with inflation of the balloon 504. For instance, inflation of the balloon 504 (e.g., constructed with one or more of a noncompliant or compliant material) stretches the deflation shell 510. Stretching of the deflation shell 510 and the tension in the shell applies compressive force to the balloon 504 and facilitates the initiation of pleating. In one example, the deflation shell 510 is provided continuously around the perimeter of the balloon 504 and accordingly applies a continuous compressive force inwardly toward the balloon catheter 502 within the balloon 504. In another example, the deflation shell 510 is provided discontinuously, for instance, at one or more radial locations around the perimeter of the balloon 504. In such an example, the deflation shell 510 applies localized inward directed compressive force to the balloon 504, for instance in an arrangement similar to the directional arrows shown in
Referring now to
Referring first to
When deflation is desired, the telescoping shaft 610 is moved, for instance, into a second orientation, for instance shown in
In one example, where the balloon distal end 608 is moved distally relative to the balloon proximal end 606, the pleats generated in the balloon 604 are aligned, for instance, with the telescoping shaft 610 and the balloon catheter 602 (e.g., parallel in one example). In another example, the balloon assembly 600 is moved from the inflated configuration shown in
As described herein, the telescoping shaft 610 is another example of a deflation guide associated with the balloon 604 of the balloon assembly 600. The telescoping shaft 610 is optionally used in combination with one or more of the other examples of deflation guides provided herein including, but not limited to, deflation struts, deflation shells or the like.
As further shown in
In one example, the expansion mechanism 712 extends proximally from the deformable distal mouth 710 to a proximal end portion 718 of the delivery catheter 708. In another example, the proximal mechanism portion 714 is coupled (e.g., by way of a butt weld, adhesive, bonding or the like) with an expansion catheter 720 provided within the delivery catheter 708. The expansion catheter 720 provides an operative interface between the expansion mechanism 712 and an operator (e.g., physician, clinician or the like) proximate the proximal end portion 718 of the delivery catheter 708.
The expansion mechanism 712 is movable relative to the delivery catheter 708 for instance, in one or more of longitudinal, rotational directions or the like. The distal mechanism portion 716 (in contrast to the remainder of the mechanism) is anchored to the deformable distal mouth 710. Accordingly, and as described further herein, with rotation or translation of the expansion mechanism 712, the mechanism 712 expands and correspondingly expands the deformable distal mouth 710 from a resting configuration (
The balloon system 700 is shown in the expanded configuration in
In one example, the deformable distal mouth 710 is expanded, for instance, with a profile greater than a relaxed or deflated profile of the balloon 706. In another example, the deformable distal mouth 710 is provided in expanded configuration having a profile sufficiently large to receive the balloon 706 in a substantially inflated configuration (e.g., fully or partially deflated), and sliding movement of the balloon 706 into the delivery catheter 708 further contracts the balloon 706 and facilitates the continued withdrawal of the balloon 706 into the delivery catheter 708 for eventual retraction of the balloon system 700 from the subject.
As further shown in
In one example, rotation of the expansion catheter 720 for instance in an unwinding direction of the expansion mechanism 712 correspondingly opens the expansion mechanism 712 and thereby also enlarges the deformable distal mouth 710 from the resting configuration to the expanded configuration. In another example, longitudinal movement of the expansion catheter 720 for instance in a distal direction (e.g., toward the distal mechanism portion 716) biases the expansion mechanism 712 in an outward manner because of the anchoring of the distal mechanism portion 716 to the deformable distal mouth 710.
After reception of the balloon 706 within the delivery catheter 708 in one example, one or more of the expansion mechanism 712 and the optional expansion catheter 720 are moved to reconfigure the deformable distal mouth 710 into the resting configuration shown, for instance, in
At 802, the method 800 includes deploying a balloon assembly such as the balloon assembly 201 (shown in
At 806, the method 800 includes deflating the balloon 204 from the inflated configuration (shown in
At 808, the method 800 further includes retracting the deflated balloon 204 in the folded deflated configuration (shown in
Several options for the method 800 follow. In one example inflating the balloon 204 includes stretching the one or more deflation guides 304, for instance elastomer or compliant deflation guides 304 or the like from a relaxed configuration to a stretched configuration. In another example, stretching the one or more deflation guides 304 from the relaxed configuration to the stretched configuration includes stretching the one or more deflation guides proximate to when the balloon assumes the inflated profile. For instance, in one example, the deflation guides are coupled with the balloon 204 in an example and configured for slidable movement over at least a portion of the balloon 204. Accordingly with inflation of the balloon, the deflation guides are in one example dimensioned and configured to slide over the balloon 204 and stretch upon full inflation (when the guides are taut, and just before full inflation) of the balloon 204 into the inflated configuration. Accordingly, in one example the compressive force supplied by the deflation guides 304 is minimized relative to the inflated balloon 204 to accordingly facilitate the full deployment of the balloon into the desired inflated shape (e.g., without escalating inflation pressure).
In yet another example, initiating pleating of the balloon 204 includes transitioning the one or more deflation guides 304 from the stretched configuration to the relaxed configuration. For instance, as the balloon 204 begins to deflate in one example, the stretched deflation guides 304 apply compressive force according to tension in the stretched guides and then relax and arrest further application of the compressive force. Accordingly, in one example, the balloon 204 is provided in a pleated guiding configuration (e.g., with pleats 316) with operation of the deflation guides 304, and further deflation of the balloon 204 (by the withdrawal of inflation fluid) completes deflation of the balloon 204 into the folded deflated configuration. The deflation guides 304, having initiated pleating, guide the folding of the balloon 204 into the folded deflated configuration including the fold 318 shown in
The method 800 includes in another example, distributed and local application of compressive forces to the balloon 204 to initiate pleating of the balloon 204. For instance, initiating pleating of the balloon 204 includes applying a compressive force at one or more locations on the balloon 204 with the one or more deflation guides 304. In another example, applying the compressive force at one or more locations on the balloon 204 includes applying the compressive force continuously around the balloon with one or more deflation guides, for instance the deflation shells, a plurality of deflation struts arranged around the balloon or the like described herein. In another example, applying the compressive force at one or more locations includes applying the compressive force at discrete locations around the balloon, for instance, with one or more deflation guides 304 such as the one or more deflation struts described herein distributed (spaced) around the balloon 204.
As further described herein, in one example, the deflation guides include a telescoping shaft 610 received within an exterior shaft, such as the balloon catheter 602 of the balloon assembly or systems as described herein. The telescoping shaft 610 (shown in
In another example, the method 800 includes expanding the distal mouth, for instance the deformable distal mouth 710 show, in
In one example, expanding the distal mouth 710 includes one or more of rotating or translating a portion of the expansion mechanism 712 relative to a delivery catheter 708. For instance, expanding the deformable distal mouth 712 includes one or more of rotating or translating a portion of the expansion mechanism 712 including but not limited to, a braid (e.g., a wire or filar that is helically wound, coiled, a clockwise and counterclockwise extending braid or the like) relative to a catheter such as the delivery catheter 708 shown in
In another example, and as previously described herein, the proximal mechanism portion 714 is provided at the proximal end portion of the delivery catheter 718. In still another example, the proximal mechanism portion is coupled with an expansion catheter 720. The expansion mechanism 712 extending from the proximal mechanism portion 714 to the deformable distal mouth 710 is translated or rotated itself or with the expansion catheter 720 to transition the deformable distal mouth 710 from the resting configuration shown in
In examples of the subject matter disclosed herein, any portion of the balloon system (e.g., the balloon, balloon catheter or the like)includes a coating, such as a hydrophilic lubricious coating. For example, hydrophilic polymeric base coatings are applied to portions of the balloon system to impart lubricity and decrease friction. In other embodiments, a portion (a part or the entirety) of an insertion tool or article, or any portions of catheters of the disclosure are associated with a low friction article, such as a Teflon sleeve. In some embodiments, all or a portion of the inner diameter of the catheter (e.g., the balloon catheter, delivery catheter or the like) is coated with a hydrophilic coating, lined with a lubricious low friction sleeve (e.g. PTFE and PTFE liners) or the like. In some embodiments, all or a portion of the outer surface of the balloon catheter is coated with a hydrophilic coating, lined with a lubricious low friction sleeve or the like. Other materials for providing a lubricious low friction coating include, but are not limited to, a silicone oil, perfluorinated oils and waxes, optionally with covalent bonding, to decrease friction. These examples of low friction and hydrophilic coatings assist in increasing lubricity and decreasing the loss of bioactive agents (e.g., coatings) and the generation of particulate.
One class of hydrophilic polymers useful as polymeric materials for hydrophilic base coat formation includes synthetic hydrophilic polymers. Synthetic hydrophilic polymers that are biostable (i.e., that show no appreciable degradation in vivo) are prepared from a suitable monomer including, but not limited to, acrylic monomers, vinyl monomers, ether monomers, or combinations of any one or more of these types of monomers. Acrylic monomers include, but are not limited to, methacrylate, methyl methacrylate, hydroxyethyl methacrylate, hydroxyethyl acrylate, methacrylic acid, acrylic acid, glycerol acrylate, glycerol methacrylate, acrylamide, methacrylamide, dimethylacrylamide (DMA), and one or more of derivatives or mixtures of any of these. Vinyl monomers include, but are not limited to, vinyl acetate, vinylpyrrolidone, vinyl alcohol, and derivatives of any of these. Ether monomers include, but are not limited to, ethylene oxide, propylene oxide, butylene oxide, and derivatives of any of these. Examples of polymers formed from these monomers include, but are not limited to, poly(acrylamide), poly(methacrylamide), poly(vinylpyrrolidone), poly(acrylic acid), poly(ethylene glycol), poly(vinyl alcohol), and poly(HEMA). Examples of hydrophilic copolymers include, but are not limited to, methyl vinyl ether/maleic anhydride copolymers and vinyl pyrrolidone/(meth)acrylamide copolymers. Further, mixtures of one or more or homopolymers or copolymers are used in some examples for hydrophilic base coats.
Examples of some acrylamide-based polymers, such as poly(N,Ndimethylacrylamide-co-aminopropylmethacrylamide) and poly(acrylamide-co-N,Ndimethylaminopropylmethacrylamide) are described in example 2 of U.S. Pat. No. 7,807,750 (Taton et al.), the disclosure of which is incorporated herein by reference.
Other hydrophilic polymers used with the subject matter of this disclosure include derivatives of acrylamide polymers with photoreactive groups. One such representative hydrophilic polymer is the copolymerization of N-[3-(4-benzoylbenzamido)propyl] methacrylamide (Formula I) with N-(3-aminopropyl)methacrylamide (Formula II) to produce the polymer poly(N-3-aminopropyl)methacrylamide-co-N-[3-(4-benzoylbenzamido)propyl]methacrylamide (Formula III). The preparation of the polymer is disclosed in Example 1 of US Patent Publication 2007/0032882 (to Lodhi, et al.), the full content of which is incorporated herein by reference.
In some embodiments, the hydrophilic polymer includes a vinyl pyrrolidone polymer, or a vinyl pyrrolidone/(meth)acrylamide copolymer such as poly(vinylpyrrolidone-co-methacrylamide). If a PVP copolymer is used, in some examples it includes a copolymer of vinylpyrrolidone and a monomer selected from the group of acrylamide monomers. Exemplary acrylamide monomers include (meth)acrylamide and (meth)acrylamide derivatives, such as alkyl (meth)acrylamide, as exemplified by dimethylacrylamide, and aminoalkyl (meth)acrylamide, as exemplified by aminopropylmethacrylamide and dimethylaminopropylmethacrylamide. For example, poly(vinylpyrrolidone-co-N,N-dimethylaminopropylmethacrylamide) is described in example 2 of U.S. Pat. No. 7,807,750 (Taton et al.).
In one embodiment, the polymers and copolymers as described are derivatized with one or more photoactivatable group(s). Exemplary photoreactive groups that can be pendent from biostable hydrophilic polymer include aryl ketones, such as acetophenone, benzophenone, anthraquinone, anthrone, quinone, and anthrone-like heterocycles. Aryl ketones herein can specifically include diaryl ketones. Polymers herein can provide a hydrophilic polymer having a pendent activatable photogroup that can be applied to the expandable and collapsible structure, and can then treated with actinic radiation sufficient to activate the photogroups and cause covalent bonding to a target, such as the material of the expandable and collapsible structure. Use of photo-hydrophilic polymers can be used to provide a durable coating of a flexible hydrogel matrix, with the hydrophilic polymeric materials covalently bonded to the material of the expandable and collapsible structure.
A hydrophilic polymer having pendent photoreactive groups can be used to prepare the flexible hydrogel coating. Methods of preparing hydrophilic polymers having photoreactive groups are known in the art. For example, methods for the preparation of photo-PVP are described in U.S. Pat. No. 5,414,075 (to Swan et al), the disclosure of which is incorporated herein by reference. Hydrophilic photo-polyacrylamide polymers such as poly(acrylamide-co-N-(3-(4-benzoylbenzamido)propyl) methacylamide), “Photo PA”, and derivatives thereof can be used to form hydrophilic base coats in exemplary embodiments of the present disclosure. Methods for the preparation of photo-polyacrylamide are described in U.S. Pat. No. 6,007,833 (to Chudzik et al.), the disclosure of which is incorporated herein by reference.
Other embodiments of hydrophilic base coats include derivatives of photo-polyacrylamide polymers incorporating additional reactive moieties. Some exemplary reactive moieties include N-oxysuccinimide and glycidyl methacrylate. Representative photo-polyacrylamide derivatives incorporating additional reactive moieties include poly(acrylamide-co-maleic-6-aminocaproic acid-N-oxysuccinimide-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide) and poly(acrylamide-co-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-glycidylmethacrylate. Additional photo-polyacrylamide polymers incorporating reactive moieties are described in U.S. Pat. No. 6,465,178 (to Chappa, et al.), U.S. Pat. No. 6,762,019 (to Swan, et al.) and U.S. Pat. No. 7,309,593 (to Ofstead, et al.), the disclosures of which are herein incorporated by reference.
Other embodiments of exemplary hydrophilic base coats that include derivatives of photo-polyacrylamide polymers incorporating additional reactive moieties can be found in U.S. Pat. No. 6,514,734 (to Clapper, et al.), the disclosure of which is incorporated herein by reference in its entirety.
In yet other embodiments, the hydrophilic base coat can include derivatives of photo-polyacrylamide polymers incorporating charged moieties. Charged moieties include both positively and negatively charged species. Exemplary charged species include, but are not limited to, sulfonates, phosphates and quaternary amine derivatives. Some examples include the negatively charged species N-acetylated poly(acrylamide-co-sodium-2-acrylamido-2-methylpropanesulfonate-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-methoxy poly(ethylene glycol) monomethacrylate. Other negatively charged species that can be incorporated into the hydrophilic base coat are described in U.S. Pat. No. 4,973,493 (to Guire et al.), the disclosure of which is incorporated herein by reference in its entirety. Positively charged species can include poly(acrylamide-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide) -co-(3-(methacryloylamino)propyl)trimethylammonium chloride. Other positively charged species that can be incorporated into the hydrophilic base coat are described in U.S. Pat. No. 5,858,653 (to Duran et al.), the disclosure of which is incorporated herein by reference in its entirety.
In another embodiment, the polymers and copolymers as described are derivatized with one or more polymerizable group(s). Polymers with pendent polymerizable groups are commonly referred to as macromers. The polymerizable group(s) can be present at the terminal portions (ends) of the polymeric strand or can be present along the length of the polymer. In one embodiment polymerizable groups are located randomly along the length of the polymer.
Exemplary hydrophilic polymer coatings can be prepared using polymer grafting techniques. Polymer grafting techniques can include applying a nonpolymeric grafting agent and monomers to a substrate surface then causing polymerization of the monomers on the substrate surface upon appropriate activation (for example, but not limited to, UV radiation) of the grafting agent. Grafting methods producing hydrophilic polymeric surfaces are exemplified in U.S. Pat. Nos. 7,348,055; 7,736,689 and 8,039,524 (all to Chappa et al.) the full disclosures of which are incorporated herein by reference.
Optionally, the coating can include a crosslinking agent. A crosslinking agent can promote the association of polymers in the coating, or the bonding of polymers to the coated surface. The choice of a particular crosslinking agent can depend on the ingredients of the coating composition.
Suitable crosslinking agents can include two or more activatable groups, which can react with the polymers in the composition. Suitable activatable groups can include photoreactive groups as described herein, like aryl ketones, such as acetophenone, benzophenone, anthraquinone, anthrone, quinone, and anthrone-like heterocycles. A crosslinking agent including a photoreactive group can be referred to as a photo-crosslinker or photoactivatable crosslinking agent. The photoactivatable crosslinking agent can be ionic, and can have good solubility in an aqueous composition. Thus, in some embodiments, at least one ionic photoactivatable crosslinking agent can be used to form the coating. The ionic crosslinking agent can include an acidic group or salt thereof, such as selected from sulfonic acids, carboxylic acids, phosphonic acids, salts thereof, and the like. Exemplary counter ions include alkali, alkaline earths metals, ammonium, protonated amines, and the like.
Exemplary ionic photoactivatable crosslinking agents include 4,5-bis(4-benzoylphenylmethyleneoxy) benzene-1,3-disulfonic acid or salt; 2,5-bis(4-benzoylphenylmethyleneoxy)benzene-1,4-disulfonic acid or salt; 2,5-bis(4-benzoylmethyleneoxy)benzene-1-sulfonic acid or salt; N,N-bis[2-(4-benzoylbenzyloxy)ethyl]-2-aminoethanesulfonic acid or salt, and the like. See U.S. Pat. No. 6,077,698 (Swan et al.), U.S. Pat. No. 6,278,018 (Swan), U.S. Pat. No. 6,603,040 (Swan) and U.S. Pat. No. 7,138,541 (Swan) the disclosures of which are incorporated herein by reference.
Other exemplary ionic photoactivatable crosslinking agents include ethylenebis(4-benzoylbenzyldimethylammonium) dibromide and hexamethylenebis(4-benzoylbenzyldimethylammonium) dibromide and the like. See U.S. Pat. No. 5,714,360 (Swan et al.) the disclosures of which are incorporated herein by reference.
In yet other embodiments, restrained multifunctional reagents with photoactivable crosslinking groups can be used. In some examples these restrained multifunctional reagents include tetrakis (4-benzoylbenzyl ether) of pentaerthyritol and the tetrakis (4-benzoylbenzoate ester) of pentaerthyritol. See U.S. Pat. No. 5,414,075 (Swan et al.) and U.S. Pat. No. 5,637,460 (Swan et al.) the disclosures of which are incorporated herein by reference.
Additional crosslinking agents can include those having formula Photo1-LG-Photo2, wherein Photo1 and Photo2 independently represent at least one photoreactive group and LG represents a linking group comprising at least one silicon or at least one phosphorus atom, wherein the degradable linking agent comprises a covalent linkage between at least one photoreactive group and the linking group, wherein the covalent linkage between at least one photoreactive group and the linking group is interrupted by at least one heteroatom. See U.S. Pat. No. 8,889,760 (Kurdyumov, et al.), the disclosure of which is incorporated herein by reference. Further crosslinking agents can include those having a core molecule with one or more charged groups and one or more photoreactive groups covalently attached to the core molecule by one or more degradable linkers. See U.S. Publ. Pat. App. No. 2011/0144373 (Swan, et al.), the disclosure of which is incorporated herein by reference.
In some embodiments, the first and/or second crosslinking agent can have a molecular weight of less than about 1500 kDa. In some embodiments the crosslinking agent can have a molecular weight of less than about 1200, 1100, 1000, 900, 800, 700, 600, 500, or 400.
In some embodiments, at least one of the first and second crosslinking agents comprising a linking agent having formula Photo1-LG-Photo2, wherein Photo1 and Photo2, independently represent at least one photoreactive group and LG represents a linking group comprising at least one silicon or at least one phosphorus atom, there is a covalent linkage between at least one photoreactive group and the linking group, wherein the covalent linkage between at least one photoreactive group and the linking group is interrupted by at least one heteroatom.
In some embodiments, at least one of the first and second crosslinking agents comprising a linking agent having a formula selected from:
(a)
wherein R1, R2, R8 and R9 are any substitution; R3, R4, R6 and R7 are alkyl, aryl, or a combination thereof; R5 is any substitution; and each X, independently, is O, N, Se, S, or alkyl, or a combination thereof;
(b)
wherein R1 and R5 are any substitution; R2 and R4 can be any substitution, except OH; R3 can be alkyl, aryl, or a combination thereof; and X, independently, are O, N, Se, S, alkylene, or a combination thereof;
(c)
wherein R1, R2, R4 and R5 are any substitution; R3 is any substitution; R6 and R7 are alkyl, aryl, or a combination thereof; and each X can independently be O, N, Se, S, alkylene, or a combination thereof; and
(d)
In a particular embodiment, the crosslinking agent can be bis(4-benzoylphenyl) phosphate.
In some embodiments, the photoactivatable crosslinking agent can be ionic, and can have good solubility in an aqueous composition, such as the first and/or second coating composition. Thus, in some embodiments, at least one ionic photoactivatable crosslinking agent is used to form the coating. In some cases, an ionic photoactivatable crosslinking agent can crosslink the polymers within the second coating layer which can also improve the durability of the coating.
Any suitable ionic photoactivatable crosslinking agent can be used. In some embodiments, the ionic photoactivatable crosslinking agent is a compound of formula I: X1-Y—X2 where Y is a radical containing at least one acidic group, basic group, or a salt of an acidic group or basic group. X1 and X2 are each independently a radical containing a latent photoreactive group. The photoreactive groups can be the same as those described herein. Spacers can also be part of X1 or X2 along with the latent photoreactive group. In some embodiments, the latent photoreactive group includes an aryl ketone or a quinone.
The radical Y in formula I provides the desired water solubility for the ionic photoactivatable crosslinking agent. The water solubility (at room temperature and optimal pH) is at least about 0.05 mg/ml. In some embodiments, the solubility is about 0.1 to about 10 mg/ml or about 1 to about 5 mg/ml.
In some embodiments of formula I, Y is a radical containing at least one acidic group or salt thereof. Such a photoactivatable crosslinking agent can be anionic depending upon the pH of the coating composition. Suitable acidic groups include, for example, sulfonic acids, carboxylic acids, phosphonic acids, and the like. Suitable salts of such groups include, for example, sulfonate, carboxylate, and phosphate salts. In some embodiments, the ionic crosslinking agent includes a sulfonic acid or sulfonate group. Suitable counter ions include alkali, alkaline earths metals, ammonium, protonated amines, and the like.
For example, a compound of formula I can have a radical Y that contains a sulfonic acid or sulfonate group; X1 and X2 can contain photoreactive groups such as aryl ketones. Such compounds include 4,5-bis(4-benzoylphenylmethyleneoxy) benzene-1,3-disulfonic acid or salt; 2,5-bis(4-benzoylphenylmethyleneoxy)benzene-1,4-disulfonic acid or salt; 2,5-bis(4-benzoylmethyleneoxy)benzene-1-sulfonic acid or salt; N,N-bis[2-(4-benzoylbenzyloxy)ethyl]-2-aminoethanesulfonic acid or salt, and the like. See U.S. Pat. No. 6,278,018 (to Swan). The counter ion of the salt can be, for example, ammonium or an alkali metal such as sodium, potassium, or lithium.
In other embodiments of formula I, Y can be a radical that contains a basic group or a salt thereof. Such Y radicals can include, for example, an ammonium, a phosphonium, or a sulfonium group. The group can be neutral or positively charged, depending upon the pH of the coating composition. In some embodiments, the radical Y includes an ammonium group. Suitable counter ions include, for example, carboxylates, halides, sulfate, and phosphate. For example, compounds of formula I can have a Y radical that contains an ammonium group; X1 and X2 can contain photoreactive groups that include aryl ketones. Such photoactivatable crosslinking agents include ethylenebis(4-benzoylbenzyldimethylammonium) salt; hexamethylenebis (4-benzoylbenzyldimethylammonium) salt; 1,4-bis(4-benzoylbenzyl)-1,4-dimethylpiperazinediium) salt, bis(4-benzoylbenzyl) hexamethylenetetraminediium salt, bis[2-(4-benzoylbenzyldimethylammonio) ethyl]-4-benzoylbenzylmethylammonium salt; 4,4-bis(4-benzoylbenzyl) morpholinium salt; ethylenebis[(2-(4-benzoylbenzyldimethylammonio)ethyl)-4-benzoylbenzylmethylammonium] salt; and 1,1,4,4-tetrakis(4-benzoylbenzyl) piperzinediium salt. See U.S. Pat. No. 5,714,360 (to Swan et al.). The counter ion is typically a carboxylate ion or a halide. On one embodiment, the halide is bromide.
In other embodiments, the ionic photoactivatable crosslinking agent can be a compound having the formula:
wherein X1 includes a first photoreactive group; X2 includes a second photoreactive group; Y includes a core molecule; Z includes at least one charged group; D1 includes a first degradable linker; and D2 includes a second degradable linker. Additional exemplary degradable ionic photoactivatable crosslinking agents are described in US Patent Application Publication US 2011/0144373 (Swan et al., “Water Soluble Degradable Crosslinker”), the disclosure of which is incorporated herein by reference.
In some aspects a non-ionic photoactivatable crosslinking agent can be used. In one embodiment, the non-ionic photoactivatable crosslinking agent has the formula XR1R2R3R4, where X is a chemical backbone, and R1, R2, R3, and R4 are radicals that include a latent photoreactive group. Exemplary non-ionic crosslinking agents are described, for example, in U.S. Pat. Nos. 5,414,075 and 5,637,460 (Swan et al., “Restrained Multifunctional Reagent for Surface Modification”). Chemically, the first and second photoreactive groups, and respective spacers, can be the same or different.
In other embodiments, the non-ionic photoactivatable crosslinking agent can be represented by the formula:
PG2-LE2-X-LE1-PG1
wherein PG1 and PG2 include, independently, one or more photoreactive groups, for example, an aryl ketone photoreactive group, including, but not limited to, aryl ketones such as acetophenone, benzophenone, anthraquinone, anthrone, anthrone-like heterocycles, their substituted derivatives or a combination thereof; LE1 and LE2 are, independently, linking elements, including, for example, segments that include urea, carbamate, or a combination thereof; and X represents a core molecule, which can be either polymeric or non-polymeric, including, but not limited to a hydrocarbon, including a hydrocarbon that is linear, branched, cyclic, or a combination thereof; aromatic, non-aromatic, or a combination thereof; monocyclic, polycyclic, carbocyclic, heterocyclic, or a combination thereof; benzene or a derivative thereof; or a combination thereof. Other non-ionic crosslinking agents are described, for example, in Publ. No. US 2012/0149934(to Kurdyumov, “Photocrosslinker”), the disclosure of which is incorporated herein by reference.
Further embodiments of non-ionic photoactivatable crosslinking agents can include, for example, those described in US Pat. Publication 2013/0143056 (Swan et al., “Photo-Vinyl Linking Agents”), the disclosure of which is incorporated herein by reference. Exemplary crosslinking agents can include non-ionic photoactivatable crosslinking agents having the general formula R1-X—R2, wherein R1 is a radical comprising a vinyl group, X is a radical comprising from about one to about twenty carbon atoms, and R2 is a radical comprising a photoreactive group.
A single photoactivatable crosslinking agent or any combination of photoactivatable crosslinking agents can be used in forming the coating. In some embodiments, at least one nonionic crosslinking agent such as tetrakis(4-benzoylbenzyl ether) of pentaerythritol can be used with at least one ionic crosslinking agent. For example, at least one non-ionic photoactivatable crosslinking agent can be used with at least one cationic photoactivatable crosslinking agent such as an ethylenebis(4-benzoylbenzyldimethylammonium) salt or at least one anionic photoactivatable crosslinking agent such as 4,5-bis(4-benzoyl-phenylmethyleneoxy)benzene-1,3-disulfonic acid or salt. In another example, at least one nonionic crosslinking agent can be used with at least one cationic crosslinking agent and at least one anionic crosslinking agent. In yet another example, a least one cationic crosslinking agent can be used with at least one anionic crosslinking agent but without a non-ionic crosslinking agent. An exemplary crosslinking agent is disodium 4,5-bis[(4-benzoylbenzyl)oxy]-1,3-benzenedisulfonate (DBDS). This reagent can be prepared by combining 4,5-Dihydroxylbenzyl-1,3-disulfonate (CHBDS) with 4-bromomethylbenzophenone (BMBP) in THF and sodium hydroxide, then refluxing and cooling the mixture followed by purification and recrystallization (also as described in U.S. Pat. No. 5,714,360, incorporated herein by reference).
Further crosslinking agents can include the crosslinking agents described in U.S. Pat. No. 8,487,137 (to Guire et al.) and U.S. Pat. No. 7,772,393 (to Guire et al.) the content of all of which is herein incorporated by reference.
In some embodiments, crosslinking agents can include boron-containing linking agents including, but not limited to, the boron-containing linking agents disclosed in U.S. Pat. No. 9,410,044 (to Kurdyumov) the content of which is herein incorporated by reference. By way of example, linking agents can include borate, borazine, or boronate groups and coatings and devices that incorporate such linking agents, along with related methods. In an embodiment, the linking agent includes a compound having the structure (I):
wherein R1 is a radical comprising a photoreactive group; R2 is selected from OH and a radical comprising a photoreactive group, an alkyl group and an aryl group; and R3 is selected from OH and a radical comprising a photoreactive group. In some embodiments the bonds B—R1, B—R2 and B—R3 can be chosen independently to be interrupted by a heteroatom, such as O, N, S, or mixtures thereof.
Additional agents for use with embodiments herein can include stilbene-based reactive compounds including, but not limited to, those disclosed in U.S. Pat. No. 8,487,137, entitled “Stilbene-Based Reactive Compounds, Polymeric Matrices Formed Therefrom, and Articles Visualizable by Fluorescence” by Kurdyumov et al., the content of which is herein incorporated by reference.
Additional photoreactive agents, crosslinking agents, hydrophilic coatings, and associated reagents are disclosed in U.S. Pat. No. 8,513,320 (to Rooijmans et al.); 8,809,411 (to Rooijmans); and 2010/0198168 (to Rooijmans), the content of all of which is herein incorporated by reference.
Natural polymers can also be used to form the hydrophilic base coat. Natural polymers include polysaccharides, for example, polydextrans, carboxymethylcellulose, and hydroxymethylcellulose; glycosaminoglycans, for example, hyaluronic acid; polypeptides, for example, soluble proteins such as collagen, albumin, and avidin; and combinations of these natural polymers. Combinations of natural and synthetic polymers can also be used.
In some instances a tie layer can be used to form the hydrophilic base layer. In yet other instances the tie layer can be added to the hydrophilic base layer. The tie layer can act to increase the adhesion of the hydrophilic base layer to the substrate. In other embodiments, the tie layer can act to increase adhesion of the hydrophobic active agent to the hydrophilic base layer. Exemplary ties layers include, but are not limited to silane, butadiene, polyurethane and parylene. Silane tie layers are described in US Patent Publication 2012/0148852 (to Jelle, et al.), the content of which is herein incorporated by reference.
In exemplary embodiments, the hydrophilic base layer can include tannic acid, polydopamine or other catechol containing materials.
In some embodiments of the present disclosure medicaments (e.g., bioactive agents) can be coated on balloon catheters. Additionally, excipients can be coated on balloon catheters to provide improved in vivo transfer characteristics of medicaments. Materials and devices for delivery of medicaments are described in U.S. Pat. Publications 2015/0140107 and 2012-0296274 (both to Slager), the content of both of which are herein incorporated by reference.
Example 1 can include subject matter such as a balloon system comprising: a balloon catheter extending from a proximal end portion to a distal end portion, the balloon catheter includes an inflation lumen therein; and a balloon assembly coupled with the distal end portion of the balloon catheter, the balloon assembly includes: a balloon having distal and proximal balloon ends, the balloon includes inflated and folded deflated configurations, and one or more deflation guides coupled with the balloon, the one or more deflation guides are configured to bias the balloon toward the folded deflated configuration.
Example 2 can include, or can optionally be combined with the subject matter of Example 1, to optionally include wherein the one or more deflation guides includes a plurality of deflation guides coupled along the balloon.
Example 3 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 or 2 to optionally include wherein the one or more deflation guides are within the balloon.
Example 4 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1-3 to optionally include wherein the one or more deflation guides include at least one deflation strut extending between the proximal and distal balloon ends.
Example 5 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1-4 to optionally include wherein the at least one deflation strut includes a plurality of deflation struts coupled at distributed locations around the balloon.
Example 6 can include, or can optionally be combined with the subject matter of Examples 1-5 to optionally include wherein the at least one deflation strut includes a deflation strut cage coupled around the balloon.
Example 7 can include, or can optionally be combined with the subject matter of Examples 1-6 to optionally include wherein the one or more deflation guides include a deflation shell continuously coupled across the balloon.
Example 8 can include, or can optionally be combined with the subject matter of Examples 1-7 to optionally include wherein the deflation shell is continuously coupled across one or more of a balloon interior or exterior.
Example 9 can include, or can optionally be combined with the subject matter of Examples 1-8 to optionally include wherein the deflation shell is coupled between a balloon interior and a balloon exterior.
Example 10 can include, or can optionally be combined with the subject matter of Examples 1-9 to optionally include wherein the balloon has a first compliance, and the one or more deflation guides have a second compliance greater than the first compliance.
Example 11 can include, or can optionally be combined with the subject matter of Examples 1-10 to optionally include wherein the balloon is non-compliant and the one or more deflation guides include an elastomer having a greater compliance than the balloon.
Example 12 can include, or can optionally be combined with the subject matter of Examples 1-11 to optionally include wherein the one or more deflation guides are configured to provide a compressive force at one or more discrete locations around the balloon to bias the balloon toward the folded deflated configuration.
Example 13 can include, or can optionally be combined with the subject matter of Examples 1-12 to optionally include wherein the one or more deflation guides are configured to initiate a pleated guiding configuration in the balloon that guides folding of the balloon to the folded deflated configuration.
Example 14 can include, or can optionally be combined with the subject matter of Examples 1-13 to optionally include wherein the one or more deflation guides are configured to initiate the pleated guiding configuration immediately after the balloon begins deflation.
Example 15 can include, or can optionally be combined with the subject matter of Examples 1-14 to optionally include wherein the one or more deflation guides are configured to arrest bias of the balloon at the pleated guiding configuration of the balloon.
Example 16 can include, or can optionally be combined with the subject matter of Examples 1-15 to optionally include wherein the balloon catheter and the balloon assembly include the one or more deflation guides.
Example 17 can include, or can optionally be combined with the subject matter of Examples 1-16 to optionally include wherein the balloon catheter includes an exterior shaft and the one or more deformation guides include a telescoping interior shaft within the exterior shaft, the exterior shaft is coupled with the proximal balloon end, and the interior shaft is coupled with the distal balloon end, the interior shaft is slidable within the exterior shaft, and one or more of relative rotation or longitudinal relative movement of the interior shaft relative to the exterior shaft is configured to bias the balloon toward the folded deflated configuration.
Example 18 can include, or can optionally be combined with the subject matter of Examples 1-17 to optionally include a delivery catheter, the balloon assembly and the balloon catheter are slidable within a delivery lumen of the delivery catheter, and the delivery catheter includes: a deformable distal mouth including a resting configuration and an expanded configuration, and an expansion mechanism coupled with the deformable distal mouth, the expansion mechanism is configured to transition the deformable distal mouth between the resting and expanded configurations.
Example 19 can include, or can optionally be combined with the subject matter of Examples 1-18 to optionally include wherein the expansion mechanism includes a braid having proximal and distal braid portions, the distal braid portion is anchored to the deformable distal mouth, and the braid transitions the deformable distal mouth with one or more of rotation or longitudinal translation of the braid relative to the delivery catheter.
Example 20 can include, or can optionally be combined with the subject matter of Examples 1-19 to optionally include a balloon system comprising: a balloon catheter extending from a proximal end portion to a distal end portion, the balloon catheter includes an inflation lumen therein; a balloon assembly coupled with the distal end portion of the balloon catheter, the balloon assembly includes: a balloon having distal and proximal balloon ends, the balloon includes inflated and folded deflated configurations, and one or more elastomer deflation struts coupled with the balloon between the distal and proximal balloon ends; and wherein the one or more elastomer deflation struts are configured to stretch in the inflated configuration of the balloon and to initiate pleating of the balloon with transition from the inflated configuration toward the folded deflated configuration according to the stretching of the one or more elastomer deflation struts.
Example 21 can include, or can optionally be combined with the subject matter of Examples 1-20 to optionally include wherein the one or more elastomer deflation struts are within the balloon.
Example 22 can include, or can optionally be combined with the subject matter of Examples 1-21 to optionally include wherein the one or more elastomer deflation struts are coupled along the balloon.
Example 23 can include, or can optionally be combined with the subject matter of Examples 1-22 to optionally include wherein at least a portion of each of the one or more elastomer deflation struts are slidably coupled along the balloon.
Example 24 can include, or can optionally be combined with the subject matter of Examples 1-23 to optionally include wherein at least a portion of each of the one or more elastomer deflation struts is anchored along the balloon.
Example 25 can include, or can optionally be combined with the subject matter of Examples 1-24 to optionally include wherein the one or more elastomer deflation struts are anchored to a midpoint of the balloon.
Example 26 can include, or can optionally be combined with the subject matter of Examples 1-25 to optionally include wherein the one or more elastomer deflation struts include a plurality of elastomer deflation struts coupled at distributed locations around the balloon.
Example 27 can include, or can optionally be combined with the subject matter of Examples 1-26 to optionally include wherein the plurality of elastomer deflation struts are arranged as a deflation cage around the balloon.
Example 28 can include, or can optionally be combined with the subject matter of Examples 1-27 to optionally include wherein the one or more elastomer deflation struts include at least one helical deflation strut extending around the balloon between the proximal and distal balloon ends.
Example 29 can include, or can optionally be combined with the subject matter of Examples 1-28 to optionally include wherein the one or more elastomer deflation struts include one or more deflation rings extending around the balloon.
Example 30 can include, or can optionally be combined with the subject matter of Examples 1-29 to optionally include wherein the balloon has a first compliance and the one or more elastomer deflation struts have a second compliance greater than the first compliance.
Example 31 can include, or can optionally be combined with the subject matter of Examples 1-30 to optionally include wherein the one or more elastomer deflation struts are configured to provide a compressive force at one or more discrete locations around the balloon according to the stretching of the one or more elastomer deflation struts.
Example 32 can include, or can optionally be combined with the subject matter of Examples 1-31 to optionally include wherein the one or more elastomer deflation struts include stretched and relaxed configurations: in the inflated configuration of the balloon the one or more elastomer deflation struts are in the stretched configuration, and in the folded deflated configuration the one or more elastomer deflation struts are in the relaxed configuration.
Example 33 can include, or can optionally be combined with the subject matter of Examples 1-32 to optionally include wherein the one or more elastomer deflation struts are configured to transition from the stretched configuration to the relaxed configuration at initiating of pleating.
Example 34 can include, or can optionally be combined with the subject matter of Examples 1-33 to optionally include wherein the one or more elastomer deflation struts are configured to guide deflation of the balloon toward the folded deflated configuration with initiating of pleating of the balloon.
Example 35 can include, or can optionally be combined with the subject matter of Examples 1-34 to optionally include wherein the one or more elastomer deflation struts are configured to arrest bias of the balloon at the initiating of pleating in the balloon with relaxation of the one or more elastomer deflation struts.
Example 36 can include, or can optionally be combined with the subject matter of Examples 1-35 to optionally include a balloon system comprising: a balloon catheter extending from a proximal end portion to a distal end portion, the balloon catheter includes an inflation lumen therein; a balloon assembly coupled with the distal end portion of the balloon catheter, the balloon assembly includes: a balloon having distal and proximal balloon ends, the balloon includes inflated and folded deflated configurations, and an elastomer deflation shell coupled along the balloon; and wherein the elastomer deflation shell is configured to stretch in the inflated configuration and to initiate pleating of the balloon with transition from the inflated configuration toward the folded deflated configuration according to the stretching of the elastomer deflation shell.
Example 37 can include, or can optionally be combined with the subject matter of Examples 1-36 to optionally include wherein elastomer deflation shell is continuously coupled across the balloon between the distal and proximal balloon ends.
Example 38 can include, or can optionally be combined with the subject matter of Examples 1-37 to optionally include wherein the elastomer deflation shell is continuously coupled across one or more of a balloon interior or exterior.
Example 39 can include, or can optionally be combined with the subject matter of Examples 1-38 to optionally include wherein the elastomer deflation shell is coupled between a balloon interior and a balloon exterior.
Example 40 can include, or can optionally be combined with the subject matter of Examples 1-39 to optionally include wherein the elastomer deflation shell includes a plurality of deflations struts extending between the distal and proximal balloon ends.
Example 41 can include, or can optionally be combined with the subject matter of Examples 1-40 to optionally include wherein the balloon and the elastomer deflation shell are a coextruded laminate.
Example 42 can include, or can optionally be combined with the subject matter of Examples 1-41 to optionally include wherein the balloon is non-compliant and the elastomer deflation shell is compliant.
Example 43 can include, or can optionally be combined with the subject matter of Examples 1-42 to optionally include wherein the elastomer deflation shell is configured to provide a compressive force around the balloon according to the stretching of the elastomer deflation shell.
Example 44 can include, or can optionally be combined with the subject matter of Examples 1-43 to optionally include wherein the elastomer deflation shell includes stretched and relaxed configurations: in the inflated configuration of the balloon the elastomer deflation shell is in the stretched configuration, and in the folded deflated configuration the elastomer deflation shell is in the relaxed configuration.
Example 45 can include, or can optionally be combined with the subject matter of Examples 1-44 to optionally include wherein the elastomer deflation shell is configured to transition from the stretched configuration to the relaxed configuration at initiating of pleating in the balloon.
Example 46 can include, or can optionally be combined with the subject matter of Examples 1-45 to optionally include wherein the elastomer deflation shell is configured to guide deflation of the balloon toward the folded deflated configuration with initiating of pleating of the balloon. Example 47 can include, or can optionally be combined with the subject matter of Examples 1-46 to optionally include wherein the elastomer deflation shell is configured to decrease bias of the balloon at the initiation of pleating in the balloon.
Example 48 can include, or can optionally be combined with the subject matter of Examples 1-47 to optionally include a balloon system comprising: a balloon catheter extending from a proximal end portion to a distal end portion, the balloon catheter includes an inflation lumen therein; a balloon assembly coupled with the distal end portion of the balloon catheter, the balloon assembly includes a balloon having distal and proximal balloon ends; and a telescoping shaft slidably received in the balloon catheter, the telescoping shaft is coupled with the distal balloon end and the balloon catheter is coupled with the proximal balloon end, and the telescoping shaft is movable between inflation and pleat initiating configurations: in the inflation configuration the distal balloon end is at a first orientation relative to the proximal balloon end, and in the pleat initiating configuration the distal balloon end is at a second orientation relative to the proximal balloon end different from the first orientation, and the second orientation biases the balloon to pleat; and wherein the telescoping shaft transitions between the inflation and pleat initiating configurations according to one or more of longitudinal or rotational movement of the telescoping shaft relative to the balloon catheter.
Example 49 can include, or can optionally be combined with the subject matter of Examples 1-48 to optionally include wherein the first orientation includes the distal and proximal balloon ends at a first spacing, and the second orientation includes the distal and proximal balloon ends at a second spacing greater than the first spacing according to longitudinal movement of the telescoping shaft relative to the balloon catheter.
Example 50 can include, or can optionally be combined with the subject matter of Examples 1-49 to optionally include wherein pleats in the second orientation are aligned with the telescoping shaft between the proximal and distal balloon ends.
Example 51 can include, or can optionally be combined with the subject matter of Examples 1-50 to optionally include wherein the first orientation includes the distal and proximal balloon ends at a first angular orientation, and the second orientation includes the distal and proximal balloon ends relatively rotated to a second angular orientation different than the first angular orientation according to rotation of the telescoping shaft relative to the balloon catheter.
Example 52 can include, or can optionally be combined with the subject matter of Examples 1-51 to optionally include wherein pleats in the second orientation extend helically around the telescoping shaft between the proximal and distal balloon ends.
Example 53 can include, or can optionally be combined with the subject matter of Examples 1-52 to optionally include a balloon system comprising: a balloon catheter extending from a proximal end portion to a distal end portion, the balloon catheter includes an inflation lumen therein; a balloon coupled with the distal end portion of the balloon catheter, the balloon includes distal and proximal balloon ends, the balloon includes inflated and deflated configurations; and a delivery catheter, the balloon and the balloon catheter are slidable within a delivery lumen of the delivery catheter, and the delivery catheter includes: a deformable distal mouth including a resting configuration and an expanded configuration, and an expansion mechanism coupled with the deformable distal mouth, the expansion mechanism is configured to transition the deformable distal mouth between the resting and expanded configurations.
Example 54 can include, or can optionally be combined with the subject matter of Examples 1-53 to optionally include wherein the expansion mechanism includes a braid having proximal and distal braid portions, the distal braid portion is anchored to the deformable distal mouth, and the braid transitions the deformable distal mouth between the resting and expanded configurations with one or more of rotation or longitudinal translation of the braid relative to the delivery catheter.
Example 55 can include, or can optionally be combined with the subject matter of Examples 1-54 to optionally include wherein the braid extends from the deformable distal mouth to a proximal end portion of the delivery catheter.
Example 56 can include, or can optionally be combined with the subject matter of Examples 1-55 to optionally include wherein the proximal braid portion is anchored to an expansion catheter within the delivery catheter, and one or more of rotational or longitudinal translation of the expansion catheter and the braid relative to the delivery catheter transitions the deformable distal mouth between the resting and expanded configurations.
Example 57 can include, or can optionally be combined with the subject matter of Examples 1-56 to optionally include wherein the braid includes a braid, coiled wire, coiled filar or the like.
Example 58 can include, or can optionally be combined with the subject matter of Examples 1-57 to optionally include wherein the braid is slidably coupled relative to the delivery catheter between the distal and proximal braid portions.
Example 59 can include, or can optionally be combined with the subject matter of Examples 1-58 to optionally include one or more deflation guides coupled with the balloon, the one or more deflation guides are configured to bias the balloon toward the deflated configuration.
Example 60 can include, or can optionally be combined with the subject matter of Examples 1-59 to optionally include wherein the deflated configuration is a folded deflated configuration.
Example 61 can include, or can optionally be combined with the subject matter of Examples 1-60 to optionally include a method of using a balloon system comprising: deploying a balloon assembly from a distal mouth of a delivery catheter, the balloon assembly includes a balloon in an initial packaged configuration; inflating the balloon to an inflated configuration, the balloon having an inflated profile larger than a mouth profile of the distal mouth; deflating the balloon from the inflated configuration to a folded deflated configuration having a folded profile smaller than the mouth profile, deflating including: withdrawing an inflation fluid from the balloon, and initiating pleating of the balloon with one or more deflation guides coupled with one or more of the balloon or a balloon catheter; and retracting the deflated balloon in the folded deflated configuration with the folded profile through the distal mouth having the mouth profile.
Example 62 can include, or can optionally be combined with the subject matter of Examples 1-61 to optionally include wherein inflating the balloon includes stretching the one or more deflation guides from a relaxed configuration to a stretched configuration.
Example 63 can include, or can optionally be combined with the subject matter of Examples 1-62 to optionally include wherein stretching the one or more deflation guides from the relaxed configuration to the stretched configuration includes stretching the one or more deflation guides proximate to when the balloon assumes the inflated profile.
Example 64 can include, or can optionally be combined with the subject matter of Examples 1-63 to optionally include wherein initiating pleating of the balloon includes transitioning the one or more deflation guides from the stretched configuration to the relaxed configuration.
Example 65 can include, or can optionally be combined with the subject matter of Examples 1-64 to optionally include wherein deflating the balloon to the folded deflated configuration includes after initiating of pleating of the balloon: folding of the balloon according to the initiated pleating, and continued withdrawal of inflation fluid.
Example 66 can include, or can optionally be combined with the subject matter of Examples 1-65 to optionally include wherein initiating pleating of the balloon includes applying a compressive force at one or more locations on the balloon with the one or more deflation guides.
Example 67 can include, or can optionally be combined with the subject matter of Examples 1-66 to optionally include wherein applying the compressive force at one or more locations on the balloon including applying the compressive force continuously around the balloon with the one or more deflation guides.
Example 68 can include, or can optionally be combined with the subject matter of Examples 1-67 to optionally include wherein applying the compressive force at one or more locations on the balloon including applying the compressive force at discrete locations around the balloon with the one or more deflation guides.
Example 69 can include, or can optionally be combined with the subject matter of Examples 1-68 to optionally include wherein initiating pleating of the balloon with one or more deflation guides includes one or more of longitudinally or rotationally moving a telescoping shaft relative to a balloon catheter between inflation and pleated guiding configurations.
Example 70 can include, or can optionally be combined with the subject matter of Examples 1-69 to optionally include expanding the distal mouth of the delivery catheter with an expansion mechanism.
Example 71 can include, or can optionally be combined with the subject matter of Examples 1-70 to optionally include wherein expanding the distal mouth includes enlarging the distal mouth from the mouth profile to an enlarged mouth profile.
Example 72 can include, or can optionally be combined with the subject matter of Examples 1-71 to optionally include wherein expanding the distal mouth includes one or more of rotating or translating a portion of a braid relative to a delivery catheter and another portion of the braid anchored to the delivery catheter near the distal mouth.
Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the disclosure can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the disclosure should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application claims the benefit of priority of U.S. Patent Application Ser. No. 62/402,853, filed on Sep. 30, 2016, which is hereby incorporated by reference herein in its entirety.
Number | Date | Country | |
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62402853 | Sep 2016 | US |