BALLOON CATHETER VISUALIZATION SYSTEMS, METHODS, AND DEVICES HAVING PLEDGETS
A balloon catheter visualization system for repairing a heart valve in a patent includes one or more elongate shafts, each shaft defining at least one lumen and comprising a distal end portion and a proximal end portion. The system also includes a transparent balloon member coupled to the one or more elongate shafts and is in fluid communication with at least one lumen of the one or more elongate shafts. The system also includes an imaging element disposed within the balloon member and coupled to a distal end portion of the one or more elongate shafts, a fastener releasably coupled to a distal end portion of the one or more elongate shafts, and a connector coupled to a distal end portion of the one or more elongate shafts. The connector is adapted to fasten the fastener to tissue.
This application claims priority to U.S. Provisional Application Ser. No. 62/107,068, filed on Jan. 23, 2015, and U.S. Provisional Application Ser. No. 62/106,936, filed on Jan. 23, 2015, the entire contents of which are hereby incorporated by reference.
TECHNICAL FIELDThis invention relates to medical devices, such as, for example, balloon catheter visualization devices and systems as well as to related methods.
BACKGROUNDHeart function can be significantly impaired when a heart valve is not performing properly. Potential causes for heart valve malfunction include dilation of an annulus around the valve, ventricular dilation, and a prolapsed or misshapen valve leaflet. When the heart valve is unable to close properly, blood within a heart chamber can leak backwards through the valve, which is commonly referred to as regurgitation.
Valve regurgitation may be treated by replacing or repairing a diseased valve. Although open heart surgery is one method for treating the diseased valve, a less invasive methods of treatment would be more desirable for many patients. Minimally invasive procedures, however, are significantly limited by the lack of adequate visualization through blood within a patient's beating heart. Accordingly, there is a need for alternative devices, systems and methods for treating heart valve disease that provide adequate visualization for users during a minimally invasive procedure.
SUMMARYBalloon catheter visualization device devices, systems and methods provided herein include features that improve minimally invasive surgical techniques used during a heart valve repair procedure such as, but not limited to, a procedure that can bicuspidize a tricuspid valve. While devices, systems and methods provided herein are described in the context of a tricuspid valve repair, other types of minimally invasive surgical procedures can be contemplated. For example, the systems and methods provided herein may also be advantageously applied to tissue repair procedures in the other areas of the heart, peripheral vasculature and other locations within the body.
In some aspects, a balloon catheter visualization system for repairing a heart valve in a patent provided herein can include one or more elongate shafts, a transparent balloon member, an imaging element, a fastener, and a connector. Each shaft can define at least one lumen and can include a distal end portion. The transparent balloon member can be coupled to the one or more elongate shafts and be in fluid communication with at least one lumen of the one or more elongate shafts. The imaging element can be disposed within the balloon member and coupled to a distal end portion of the one or more elongate shafts. The fastener can be releasably coupled to a distal end portion of the one or more elongate shafts. The connector can be coupled to a distal end portion of the one or more elongate shafts. The connector can be adapted to fasten the fastener to tissue.
In some cases, at least a portion of the balloon member defines a plurality of perforations. In some cases, the plurality of perforation are adapted to allow inflation media to flow from within an interior cavity of the balloon member to an exterior surface of the balloon member. In some cases, the imaging element is a camera. In some cases, the imaging element is an ultrasound probe. In some cases, a fiber optics light source disposed within an interior cavity of the balloon member and coupled to the distal end portion of the one or more elongate shafts. In some cases, the fastener is one of a suture, staple, hook, tack, clamp and clip. In some cases, the fastener and connector are adapted to penetrate tissue.
In some aspects, a balloon catheter visualization device for repairing a heart valve in a patent provided herein includes an elongate shaft, a transparent balloon member, an imaging element, a fastener, and a connector. The elongate shaft can define a plurality of lumens and include a distal end portion. The transparent balloon member can be coupled to the distal end portion. The balloon can have a wall defining an interior cavity and being in fluid communication with at least one of the plurality of lumens. The balloon member can include a material adapted to resist the propagation of tears. In some cases, the balloon member can include a first layer comprising thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer. The imaging element can be disposed within the interior cavity and coupled to the distal end portion. The fastener can be releasably coupled to the distal end portion. The connector can be at least partially disposed within the interior cavity and coupled to the distal end portion. The connector can be adapted to fasten the fastener to tissue.
In some cases, at least a portion of the balloon member defines a plurality of perforations such that inflation media is allowed to flow through the wall to an exterior surface of the balloon member. In some cases, the connector can include one or more needles adapted to penetrate tissue. In some cases, the balloon member comprises a material configured to resist the propagation of tears from one or more apertures created by the connector passing through the wall.
In some aspects, a balloon catheter visualization system for repairing a heart valve in a patent provided herein can include a first shaft, a transparent balloon member, an imaging element, a second shaft, and a fastener. The first shaft can have a tubular, elongate body defining a lumen. The transparent balloon member can be attached to a distal end portion of the first shaft. The balloon can define an interior cavity in fluid communication with the lumen. The imaging element can be disposed within the interior cavity and coupled to a distal end portion of the first shaft. The second shaft can have a tubular, elongate body with a lumen. The fastener can be releasably coupled a connector disposed at least partially within the lumen of the second shaft. The connector can be adapted to fasten the fastener to tissue.
In some cases, the balloon member can be a donut-shaped balloon with a thru lumen configured to receive the second shaft. In some cases, at least a portion of the balloon member can define a plurality of perforations. In some cases, the plurality of perforation can be adapted to allow inflation media to flow from within the interior cavity to an exterior surface of the balloon member.
In some aspects, a method for repairing a heart valve in a patent provided herein includes advancing a balloon catheter visualization system into an atrium of a heart to attach a fastener to the valve annulus using a connector. The system can include one or more elongate shafts. Each shaft can define at least one lumen and include a distal end portion and a proximal end portion. The system can include a transparent balloon member coupled to the one or more elongate shafts and being in fluid communication with at least one lumen of the one or more elongate shafts. The system can include an imaging element disposed within the balloon member and coupled to a distal end portion of the one or more elongate shafts. The fastener can be releasably coupled to a distal end portion of the one or more elongate shafts. The connector can be coupled to a distal end portion of the one or more elongate shafts. The connector can be adapted to fasten the fastener to tissue. The balloon member can be advanced to a location proximate to a valve annulus, the balloon member deployed, the one or more elongate shafts positioned to visualize a target area of the valve annulus, the connector positioned at a proper location in the target area; the fastener attached to the valve annulus using the connector, and the fastener released from the connector.
The details of one or more embodiments of balloon catheter visualization devices, systems, and methods provided herein are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
Balloon catheter visualization device, systems and methods provided herein include features that improve minimally invasive surgical techniques used during a heart valve repair procedure such as, but not limited to, procedures that visualize one or more heart valve leaflets. In some cases, systems, devices, and methods provided herein can suture one or more heart valve leaflets. Exemplary procedures include those that bicuspidizes a tricuspid valve, edge to edge stitching techniques (or Alfieri stitches), mitral valve stitches, closures of paravalvular leaks, percutaneous paravalvular leak closure, and/or percutaneous closure of prevalvular leaks. The term “suture” is used herein to refer to any fastening of anatomical structures, which can be made with any suitable fastener including suturing thread, clips, staples, hooks, tacks, clamps, etc.
Balloon catheter visualization device, systems, and methods provided herein can allow for balloon catheter visualization of a target location, which can provide anatomy and pathology identification as well as device placement visual feedback to the physician user during a minimally invasive method. Balloon catheter visualization devices, systems, and methods provided herein can include an elongate, compliant balloon having a transparent wall. In some cases, the transparent wall can include portions arranged to be sutured to an anatomical location through the transparent wall and to separate from the remainder of the balloon catheter. In some case, the balloon can include pores to allow for the balloon to “weep” to provide a visually clear area surrounding the balloon. In some cases, the balloon wall (e.g., a transparent balloon wall) can have a structure that limits the propagation of tears. In some cases, as discussed below, the balloon all can include polymeric fibers within a matrix of a second material.
In some cases, balloon catheter visualization device, systems, and methods provided herein include pledgets retained at an external end of the balloon catheter visualization device. The pledgets can be adapted to be sutured to an anatomical location, separate from the balloon catheter, and remain with a resulting suture. As used herein, the term “pledget” will refer to a piece of material that is intended be sutured to an anatomical location. In some cases, the wall of the balloon can include portions arranged to be sutured to an anatomical location through the transparent wall and to separate from the remainder of the balloon catheter to become a pledget. In some cases, balloon catheter visualization devices, systems, and methods provided herein can include one or more pledgets held by the balloon catheter visualization devices and systems provided herein and positioned inside and/or outside the balloon such that the pledget(s) can be secured to an anatomical location using one or more fasteners. In some cases, balloon catheter visualization devices, systems, and methods provided herein can include cooperating pledgets that are arranged to clamp around an anatomical structure have one or more fasteners passed there through.
Balloon catheter visualization system 100 can include a pledget 126 located distal to fastening tool 124 such that a fastener delivered through the balloon is also delivered through pledget 126 to suture pledget 126 to an anatomical location. Pledget 126 can, in some cases, be a part of the balloon wall of balloon 108 adapted to tear away from the balloon wall. In some cases, pledget 126 is laminated to an outside surface of the balloon wall. In some cases, a balloon wall can include weakened tear lines such that pledget 126 tears away from balloon 108 to leave a pledget sized hole. In some cases, pledget 126 can be held within balloon 108. In some cases, pledget 126 can be held adjacent the exterior of balloon 108. These different options are explained in further detail below.
In
Manifold 122 generally connects an external fluid supply to one or more lumens of balloon catheter visualization system 100. Manifold 122 can include one or more ports 128 to facilitate a fluid connection to another medical device or a fluid source. For example, port 128 can supply saline solution into one or more lumens of tubular body 112. Manifold 122 may be coupled to tubular body 112 directly or indirectly. In some cases, a flexible tubing, sometimes referred to as a strain relief tubing, is coupled between manifold 122 and the tubular body 112 at the proximal end 116 to provide a longitudinal tapered transition between manifold 122 and tubular body 112. Flexible tubing can help to increase kink resistance of tubular body 112 at proximal end portion 114.
In
As shown in
Pledgets 126 can be sutured to an anatomical location and separated from balloon 108 after suturing to become pledgets. In some cases, pledgets 126 are laminated onto the wall of balloon 108 such that a resulting hole from the separation of the pledget is limited to the size of fasteners passed through the wall of balloon 108. In some cases, pledgets 126 can be defined by weakened sections or tear lines 196 of the balloon wall surrounding each pledget 126 such that detachment of each pledget 126 creates a pledget sized hole in balloon 108. In some cases, pledgets 126 can each be secured to anatomical locations prior to separation. In some cases, an inflation medium flow can be reduced or stopped prior to separation.
Balloon 108 of balloon catheter visualization system 100 can be a weeping balloon. Weeping balloon, in the context of the present disclosure, includes a balloon structure defining one or more perforations (also described as apertures or micropores, extending through a balloon wall). As such, weeping balloons can transfer inflation media through the balloon wall, from interior cavity to exterior surface of balloon 108. Transferring inflation media to exterior surface can provide a benefit of displacing blood from exterior surface of balloon 108 that would otherwise blur or obstruct visual imaging through balloon 108. In other words, inflation media transferred through the one or more perforations can help keep the exterior surface visually clear. If you just put a balloon against an anatomical surface, blood can be trapped on the balloon surface and thus obscures the view, but inflation media (e.g., saline) exiting the pores of a weeping balloon can wash away this blood on the balloon surface adjacent to the wall. In some cases, a weeping balloon used in a balloon catheter visualization system or device provided herein can have at least 3 punctured holes. In some cases, weeping balloons used in balloon catheter visualization systems or devices provided herein can have between 3 and 10,000 puncture holes, between 3 and 1,000 puncture holes, between 3 and 100 puncture holes, or between 3 and 10 puncture holes. In some cases, the number and dimensions of puncture holes in a weeping balloon used in a balloon catheter visualization system or device provided herein allows for an inflation media flow rate of between 1 and 50 ml/minute. In some cases, systems and methods provided herein control an inflation media flow rate to be between 3 ml/minute and 10 ml/minute. In some cases, a weeping balloon used in balloon catheter visualization systems and devices provided herein can have hundreds of holes that perfuse inflation media (e.g., saline) through the balloon and into the blood. In some cases, a weeping balloon used in a balloon catheter visualization system or device provided herein can have a greater pore density in portions of the balloon wall in the center of the field of view and a lower pore density around a periphery of the field of view.
In
Balloon catheter visualization system 200 can include a fastening tool 210 adapted to penetrate tissue, separate tissue, and/or deliver a fastener 212 through the pledget and tissue, to secure a suture to tissue and/or to attach two pieces of tissues together. As shown, fastener 212 is suturing thread. In some cases, fastening tool 210 can be in the form of, for example, a needle, knife, scalpel, cutter and combinations thereof. In some cases, staple, hook, tack, clamp, a clip, or other suturing devices can be used instead of or with suturing thread 212.
As shown in
A rectangular-shaped balloon 208, as shown in
Balloon 208 of balloon catheter visualization system 200 can be a weeping balloon. Weeping balloon, in the context of the present disclosure, includes a balloon structure defining one or more perforations (also described as apertures or micropores, extending through a balloon wall). As such, weeping balloons can transfer inflation media through a balloon wall, from interior cavity 214 to exterior surface of balloon 208. Transferring inflation media to exterior surface can provide a benefit of displacing blood from exterior surface of balloon 208 that would otherwise blur or obstruct visual imaging through balloon 208. In other words, inflation media transferred through the one or more perforations can help keep the exterior surface visually clear. If you just put a balloon against an anatomical surface, blood can be trapped on the balloon surface and thus obscures the view, but inflation media (e.g., saline) exiting the pores of a weeping balloon can wash away this blood on the balloon surface adjacent to the wall. In some cases, a weeping balloon used in a balloon catheter visualization system or device provided herein can have at least 3 punctured holes. In some cases, weeping balloons used in balloon catheter visualization systems or devices provided herein can have between 3 and 10,000 puncture holes, between 3 and 1,000 puncture holes, between 3 and 100 puncture holes, or between 3 and 10 puncture holes. In some cases, the number and dimensions of puncture holes in a weeping balloon used in a balloon catheter visualization system or device provided herein allows for an inflation media flow rate of between 1 and 50 ml/minute. In some cases, systems and methods provided herein control an inflation media flow rate to be between 3 ml/minute and 10 ml/minute. In some cases, a weeping balloon used in balloon catheter visualization systems and devices provided herein can have hundreds of holes that perfuse inflation media (e.g., saline) through the balloon and into the blood. In some cases, a weeping balloon used in a balloon catheter visualization system or device provided herein can have a greater pore density in portions of the balloon wall in the center of the field of view and a lower pore density around a periphery of the field of view.
As shown in
In some cases, inner pledget 322 can be positioned within balloon 308. In cases where an inner pledget 322 is positioned within balloon 308, inner pledget support 332 and inner pledget support shaft 333 can be positioned within balloon 308. In cases where an inner pledget 332 is positioned within balloon 308, balloon 308 can be torn or cut to be separated from inner pledget 332 after suturing. In some cases, balloon 308 can be torn or cut to be separated from the pledgets 322 and 324. In some cases, a portion of a balloon wall between pledgets 322 and 324 can rip along weakened tear lines to remain a part of the suture and an additional pledget structure. In some cases, balloon 308 can rip to be allow inner pledget 322 to be separated from balloon catheter visualization system 300.
Referring back to
Referring to
As shown in
Internal locking structures 428 within external apertures 425a and 425b can lock together distal anvils 411a and 411b of stylet fasteners 412a and 412b. Outer pledget 424 can include an internal plate 427. In some cases, pledget 424 can be formed by injection molding a polymeric material around plate 427. Plate 427 includes two plate apertures surrounded by locking structures 428, which can clasp and lock distal anvils 411a and 411b. Distal anvils 411a and 411b can be conical to push locking structures out as distal anvils 411a and 411b are pressed against locking structures 428 until a bottom edge of the conical tip passes a lower edge of locking structures 428, which results in locking structures 428 snapping against a shaft of stylet fasteners 412 a and 412b. A bottom edge of the conical tip thus acts as a mechanical stop that locks the distal anvil from be retracted out of outer pledget apertures 425a and 425b. After the pledgets 422 and 424 are secured together on opposite sides of tissue, wires 414a and 414b can be retracted from proximal anvils 413a and 413b.
Balloons used in the balloon catheter visualization systems of
Balloons can be constructed from various forms, e.g., a film, sheet or tube of transparent materials. Also, balloons 500, 520, 540, 560, 580, and 590 may be formed into a variety of different shapes.
Balloon 500, 520, 540, 560, 580, and 590 can be a compliant balloon that fills with an inflation media, which inflates balloon from a smaller deflated size to a larger inflated size thus allowing a larger device to be transferred through the catheter. Balloon 500, 520, 540, 560, 580, and 590 can be adapted to be filled with inflation media supplied through one or more lumens of a tubular body, e.g., tubular body 112 of
Balloon 500, 520, 540, 560, 580, and 590 as well as other medical device components, can be constructed of various materials that are optically transparent when exposed to inflation media, e.g., saline solution, and/or bodily fluids, e.g., blood. In some cases, balloon 500, 520, 540, 560, 580, and 590 can be constructed of various transparent materials that maintain transparency within the body over a desired duration. For example, suitable balloon materials can have anti-fouling properties, e.g., materials resistant to protein-binding and platelet adsorption, which maintain transparency over longer durations than materials that are do not have anti-fouling properties. The term “fouling” generally refers to a material that undesirably accumulates foulants, such as biomacromolecules, microorganisms, hydrocarbons, particles and colloids, from the surrounding environment. Anti-fouling properties, also referred to as a “stealth effect,” reduces intermolecular forces of interactions between foulants and the balloon material. In some cases, such as in implantable applications, balloon materials can have anti-thrombogenic properties to prevent the formation of clots in the body. In some cases, balloon 500, 520, 540, 560, 580, and 590 can include a hydrophilic material. Hydrophilic materials can allow the saline to preferentially be wet over allowing the air to contact the surface. In some cases, any air bubble which may occur in the balloon can be flushed out of the field of view or broken up
Balloon 500, 520, 540, 560, 580, and 590 may be constructed of various materials having physical, mechanical or functional properties that can improve device performance. Furthermore, these various materials can be incorporated at specific locations of the balloon where specific functional properties are desired. For example, balloon 500, 520, 540, 560, 580, and 590 can be constructed of various materials that are self-healing. Self-healing refers to a structural ability of a material, e.g., fiber-reinforced polymers, to repair mechanical damage. In another example, balloon 500, 520, 540, 560, 580, and 590 may be constructed of various materials having suitable mechanical properties, such as tensile strength, ductility and elastic modulus. In some cases, at least a portion of a balloon material can have a Shore A hardness of 90 or less to provide the balloon with suitable flexibility. In another example, balloon 500, 520, 540, 560, 580, and 590 can be constructed of various materials having suitable lubricity. Lubricity can help facilitate proper balloon placement within the anatomy and minimize blood vessel and tissue damage otherwise caused by balloon 208 or alternative medical devices.
As shown in
Distal end portions 601 of system 600 include a stabilizing portion 608 that has an elongate shaft 622 coupled to the donut-shaped balloon 618. Stabilizing portion 608 can be used to stabilize balloon catheter visualization system 600 within a target area, e.g., such as right atrium, by expanding and anchoring balloon 618 within right atrium. More specifically, balloon 618 can be placed within right atrium and placed in contact with at least a portion of an atrial interior surface such that balloon catheter visualization system 600 moves synchronously with the heart. In some cases, stabilizing portion 608 can include an expandable stent (not shown) or other types of anchoring structures that stabilize the system 600 within right atrium.
As shown, stabilizing portion 608 can include elongate shaft 622 that partially extends into an interior cavity 624 of balloon 618. Elongate shaft 622 can have an angled distal end 626 that includes an integrated camera 628. In some cases, elongate shaft 622 can be straight or curved. In some cases, at least a portion of elongate shaft 622 can include a deflectable tip that can be adjusted to various angles. Elongate shaft 622 can include a lumen (not shown) adapted to receive electrical wiring and/or a camera 628.
In
In
As shown in
At operation 820, direct visualization catheter, e.g., a balloon or stent, is advanced to the target area and expanded at the target area to stabilize balloon catheter visualization system.
At operation 830, a desired surgical location at the target area can be verified by using direct visual or ultrasound imaging provided by balloon catheter visualization system. In some cases, a primary camera located in balloon or stent portion of catheter can be used to verify the surgical location. In some cases, balloon catheter visualization system includes a secondary visualization portion that can be used in conjunction with the primary camera to visually verify the surgical location. In such cases, primary camera may provide anterior visual images and the secondary visualization portion may provide posterior visual images.
At operation 840, a fastening portion of balloon catheter visualization system can be manipulated such that a fastener is positioned near or at the desired surgical location. In some cases, a distal end portion of balloon catheter visualization system can be deflected at a specific angle to position a fastener to a desired location. In some cases, a select portion of direct visual catheter, e.g., a fastening portion, is advanced to the desired location.
At operation 850, the tissue is pierced using either a portion of balloon catheter visualization system or the fastener. In some cases, a portion of balloon catheter visualization system, e.g., a needle, can be used to pierce tissue at the surgical location. In some cases, catheter can advance a fastener, such as a staple or clasp, such that the fastener pierces the tissue at the surgical location.
At operation 860, fastener is attached to tissue. In some cases, attaching the fastener to tissue can include securing a suture through tissue at the surgical location. In some cases, attaching fastener to tissue can include attaching a pledget, staple or clasp to tissue at the surgical location.
At operation 870, fastener is optionally released from balloon catheter visualization system. In some cases, fastener is released from the catheter using an actuator at a proximal end of balloon catheter visualization system. In some cases, fastener is released from the catheter by advancing a portion of the catheter, e.g., a pusher rod, to push the fastener away from a distal end of the catheter. In some cases, fastener is released from the catheter by retracting the catheter away from the surgical location. In some cases, a fastener, such as a suture, may not be released from the catheter until multiple surgical areas have been secured with the fasteners.
In
In
Balloon catheter visualization devices and systems provided herein may include a balloon constructed of one or more polymeric, transparent materials. In some cases, at least a portion of the balloon can be constructed of a polymeric fibrous matrix or a polymer film. In various cases, the balloon is constructed of a modified thermoset polymer (also described as a composite of polymeric fibers and polymers).
As shown in
Exemplary materials of various thermoset polymers 1008 include, but are not limited to, polyurethanes, silicones, phenolic polymers, amino polymers, epoxy polymers and combinations thereof.
The plurality of polymeric fibers 1010 of
Polymeric fibers can be constructed of biocompatible materials including various thermoplastic materials. In particular, fibers may be formed of thermoplastic materials suitable for electrospinning, force spinning or melt-blowing processes. Electrospinning is a process that uses electrical charge to create fibers from a liquid while force spinning is a process that uses centrifugal force to create fibers. Melt-blowing is a process in which a molten thermoplastic resin is extruded through a die and then stretched and cooled with high-velocity air to form long, fine fibers. In some cases, fibers can be constructed of various polymers that exhibit hydrophilic or hydrophobic characteristics. In some cases, fibers can be raw e-spun fibers, such as those shown in
Suitable polymers for fibers can be formed from fluoropolymers including, but not limited to, for example, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF) (e.g. Kynar™ and Solef™), poly(vinylidene fluoride-co-hexafluoropropene) (PVDF-HFP), cyclic fluoropolyethers such as Cytop™, perfluoroalkoxy alkane resins (PFA), poly(pentafluorostyrene), poly(2,2,3,3,4,4,4-heptafluorobutyl methacrylate), fluoroethylene-alkyl vinyl ether (FEVE; Lumiflon™), poly[4,5 difluoro 2,2 bis(trifluoromethyl)-1,3-dioxole-co-tetrafluoroethylene, and combinations thereof. Other suitable polymers for forming fibers are urethane-based polymers that include, but are not limited to, for example, polyurethanes, polyurethane elastomers (e.g. Pellethane), polyether-based polyurethanes (e.g. Tecothane), polycarbonate-based polyurethanes (e.g. Bionate and/or Chronoflex) and combinations thereof. Other examples of suitable polymer materials for fibers can include, but are not limited to, polycarbonate, polyether, polyester, polyamide, nylon 6, nylon 12, nylon 66, nylon 10, nylon 11, polyetherimide and combinations thereof. In some embodiments, fibers are formed from block polymers such as, for example, a poly(styrene-b-isobutylene-b-styrene) (SIBS) tri-block polymer and/or a polyisobutylene polyurethane (PIB-PUR).
Polymeric fibers can have diameters in the range of about 40 nanometers (nm) to 10,000 nm, for example. The fiber diameter size can include a range of about 100 nm to 3,000 nm. In some examples, suitable fiber diameter sizes can include ranges of about 40 nm to 2,000 nm, about 100 nm to 1,500 nm or about 100 nm to 1,000 nm, for example. In still further examples, fibers 412 can have average fiber diameters ranging between about 900 nm to 10,000 nanometers or between about 800 nm to 10,000. In some cases, fibers 912 are nanofibers having diameters less than 1,000 nm. For example, nanofiber diameters can range from about 100 nm to 800 nm, or be any value there between. In some examples, nanofiber diameters can range from 100 nm to 400 nm.
Outer layer 1004 of
Various suitable hydrogels include, but are not limited to, olefin based polymers such as a polyethylene glycol (PEG) or a PEG derivative, for example, PEG-dimethacrylate, UV-curable PEG, PEG diacrylate, polyethylene glycol-neopentyl glycol diacrylate methyl acrylate (PEG-NPDGA), PEG-Bioslide™, chitosan-PEG, thiol-PEG, maleimide-PEG, amino-PEG, azide-PEG, and carboxyl-PEG. Examples of other suitable hydrogels include, but are not limited to, polyvinylpyrrolidone (PVP), polyvinyl acetate (PVA), glycosaminoglycans (e.g. heparin), poly[N-(2-hydroxypropyl) methacrylamide] (PHPMA), poly(vinyl pyrrolidone), polyethylene/oligoethylene, polyHEMA, polytetraglyme, hyaluronic acid, chitosan and any derivatives thereof.
In some cases, at least a portion of the hydrogel is embedded with a plurality of polymeric fibers 1010. In some cases, the hydrogel can covalently bond to individual fibers that make up the plurality of polymeric fibers 1010. In some cases, the hydrogel can bond to individual fibers by chemical association bonding, such as hydrogen bonding and/or intermolecular hydrophobic associations. In some cases, the hydrogel can mechanically engage with at least a portion of the plurality of polymeric fibers 1010 by interpenetrating space between individual fibers protruding from a surface of an adjacent layer. For example, as shown in
In some cases, selection portions of the different layers shown in
At operation 1212, a curable thermoset material, e.g. polydimethylsiloxane (PDMS), in liquid form is injected into the mold. Thermoset material at least partially penetrates the plurality of nanofibers.
At operation 1213, thermoset material is cured to form a pre-formed balloon.
At operation 1214, pre-formed balloon is removed from balloon mold and an exterior surface of the pre-formed balloon is treated with a crosslinkable, hydrophilizing agent, such as PEG-dimethacrylate, described herein. Following the treatment, the hydrophilized balloon may continue on to other manufacturing operations to build a balloon catheter visualization device or an alternative medical device.
At operation 1220, a plurality of polymeric nanofibers are formed onto partially cured thermoset material using an electrospinning process or alternative process, such as force spinning. Because thermoset material is not fully cured, at least a portion of plurality of polymeric nanofibers penetrates into thermoset material such that nanofibers are exposed at an exterior surface of balloon. In some cases, the electrospinning process and/or the force spinning process can arrange the delivery of fibers to create weakened tear lines in a resulting balloon.
At operation 1230, thermoset material is cured to form an inner layer of a pre-formed balloon. Thermoset material may be cured as described herein.
At operation 1240, pre-formed balloon is optionally removed from balloon mold and, at operation 1250, per-formed balloon is inverted such that at least a portion of plurality of polymeric nanofibers are exposed along an exterior surface of balloon. In some cases, operation step 1250 may not be necessary if during operation, at least a portion of the plurality of polymeric nanofibers penetrates into thermoset material such that fibers would be exposed at exterior surface of a non-inverted balloon
At operation 1260, exterior surface of the pre-formed balloon is treated with a crosslinkable, hydrophilizing agent, e.g., PEG-dimethacrylate, described herein.
Following the treatment, a hydrophilized balloon may continue on to other manufacturing operations, if applicable.
At operation 1320, a plurality of polymeric nanofibers are formed on a shaped mandrel using an electrospinning process or a force spinning process. The plurality of polymeric nanofibers are formed onto thermoset material such that at portion of the nanofibers penetrates into thermoset material and another portion of the nanofibers remains exposed at an exterior surface of the balloon. In some cases, the electrospinning process and/or the force spinning process can arrange the delivery of fibers to create weakened tear lines in a resulting balloon.
At operation 1330, thermoset material is fully cured to form an inner layer of a pre-formed balloon. Thermoset material may be cured as described herein.
At operation 1340, the pre-formed balloon is treated with a crosslinkable, hydrophilizing agent, such as PEG-dimethacrylate, described herein. A hydrophilized balloon may be removed from the mandrel at any time after thermoset material has been cured. Hydrophilized balloon may be subject to subsequent manufacturing operations to build a balloon catheter visualization device or an alternative medical device.
At operation 1420, the balloon catheter visualization system, is advanced to the target area and a portion thereof expanded at the target area to stabilize the balloon catheter visualization system. In some cases, a balloon or stent is expanded to stabilize the balloon catheter visualization system.
At operation 1430, a desired surgical location at the target area can be verified by using direct visual or ultrasound imaging provided by the balloon catheter visualization system. In some cases, a primary camera located in balloon or stent portion of catheter can be used to verify the surgical location. In some cases, the balloon catheter visualization system includes a secondary visualization portion that can be used in conjunction with the primary camera to visually verify the surgical location. In such cases, primary camera may provide anterior visual images and the secondary visualization portion may provide posterior visual images.
At operation 1440, the balloon catheter visualization system can be manipulated such that a pledget or pledget section of a balloon is positioned near or at the desired surgical location. In some cases, a distal end portion of balloon catheter visualization device can be deflected at a specific angle to position one or more pledgets in a desired location. In some cases, a select portion of direct visual catheter is advanced to the desired location.
At operation 1450, the tissue is pierced using a fastening tool. In some cases, a portion of the balloon catheter visualization system, e.g., a needle, can be used to pierce tissue at the surgical location. In some cases, the balloon catheter visualization system can advance a fastener, such as a staple or clasp, such that the fastener pierces the tissue at the surgical location and a pledget section of a balloon. In some cases, the advancement of the fastener can interlock the fastener with a pledget.
At operation 1460, fastener is attached to tissue and the pledget or pledget section of a balloon. In some cases, attaching the fastener to tissue can include securing a suture through tissue at the surgical location and through a hole in a pledget. In some cases, attaching fastener to tissue can include attaching a pledget, staple or clasp to tissue at the surgical location through a pledget section of a balloon wall.
At operation 1470, the fastener and pledget are released from the balloon catheter visualization system. In some cases, a pledget section of a balloon wall is torn away from the balloon by retracting the balloon. In some cases, the pledget is released from the catheter using an actuator at a proximal end of the balloon catheter visualization system. In some cases, fastener is released from the catheter using an actuator at a proximal end of the balloon catheter visualization system. In some cases, pledget and/or fastener is released from the catheter by advancing a portion of the catheter, e.g., a pusher rod, to push the fastener away from a distal end of the catheter. In some cases, pledgets and/or fastener, such as a suture thread, may not be released from the catheter until multiple surgical areas have been secured with the fasteners and pledgets.
Distal end portion 1504 of fastening tool 1500 includes a distal end 1514 and defines a distal opening 1516 adapted to receive and temporarily retain fastener 1508. As shown in
Proximal end portion 1506 can include a proximal end 1518 and defines a proximal opening 1520 adapted to receive fastener 1508. In
In
As shown in
As shown in
A number of embodiments of the balloon catheter visualization devices, systems, and methods have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the subject matter described herein. Accordingly, other embodiments are within the scope of the following claims.
Claims
1. A balloon catheter visualization system for repairing a heart valve in a patent, the system comprising:
- one or more elongate shafts, each shaft defining at least one lumen and comprising a distal end portion and a proximal end portion;
- a transparent balloon member coupled to the one or more elongate shafts and being in fluid communication with at least one lumen of the one or more elongate shafts;
- an imaging element disposed within the balloon member and coupled to a distal end portion of the one or more elongate shafts;
- a fastener releasably coupled to a distal end portion of the one or more elongate shafts; and
- a connector coupled to a distal end portion of the one or more elongate shafts, the connector adapted to fasten the fastener to tissue.
2. The system of claim 1, wherein at least a portion of the balloon member defines a plurality of perforations.
3. The system of claim 2, wherein the plurality of perforation are adapted to allow inflation media to flow from within an interior cavity of the balloon member to an exterior surface of the balloon member.
4. The system of claim 1, wherein the imaging element is one of a camera and an ultrasound probe.
5. The system of claim 1, further comprising a fiber optics light source disposed within an interior cavity of the balloon member and coupled to the distal end portion of the one or more elongate shafts.
6. The system of claim 1, wherein the fastener is one of a suture, staple, hook, tack, clamp and clip.
7. The system of claim 1, wherein one of the fastener and connector is adapted to penetrate tissue.
8. A balloon catheter visualization device for repairing a heart valve in a patent, the catheter comprising:
- an elongate shaft defining a plurality of lumens and comprising a distal end portion;
- a transparent balloon member coupled to the distal end portion, the balloon having a wall defining an interior cavity and being in fluid communication with at least one of the plurality of lumens, the balloon member comprising a first layer comprising thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer;
- an imaging element disposed within the interior cavity and coupled to the distal end portion;
- a fastener releasably coupled to the distal end portion; and
- a connector at least partially disposed within the interior cavity and coupled to the distal end portion, the connector adapted to fasten the fastener to tissue.
9. The catheter of claim 8, wherein at least a portion of the balloon member defines a plurality of perforations such that inflation media is allowed to flow through the wall to an exterior surface of the balloon member.
10. The catheter of claim 8, wherein the connector comprises one or more needles adapted to penetrate tissue.
11. The catheter of claim 8, wherein the balloon member comprises a first layer comprising thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer.
12. A balloon catheter visualization system for repairing a heart valve in a patent, the system comprising:
- a first shaft having a tubular, elongate body defining a lumen;
- a transparent balloon member attached to a distal end portion of the first shaft, the balloon comprising an interior cavity in fluid communication with the lumen;
- an imaging element disposed within the interior cavity and coupled to a distal end portion of the first shaft;
- a second shaft having a tubular, elongate body with a lumen; and
- a fastener releasably coupled a connector disposed at least partially within the lumen of the second shaft, the connector adapted to fasten the fastener to tissue.
13. The system of claim 12, wherein the balloon member is a donut-shaped balloon with a thru lumen configured to receive the second shaft.
14. The system of claim 12, wherein at least a portion of the balloon member defines a plurality of perforations.
15. The system of claim 14, wherein the plurality of perforation are adapted to allow inflation media to flow from within the interior cavity to an exterior surface of the balloon member.
16. The system of claim 12, further comprising an imaging element disposed.
17. The system of claim 16, wherein the imaging element is one of a camera and an ultrasound probe.
18. The system of claim 12, wherein the second shaft is adapted to translate independently of the first shaft in a proximal or a distal direction.
19. The system of claim 12, further comprising a third shaft having a tubular, elongate body and an additional imaging element disposed with an additional balloon member coupled to a distal end portion of the third shaft.
20. The system of claim 12, wherein the balloon member comprises a first layer comprising thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer.
Type: Application
Filed: Jan 22, 2016
Publication Date: Jul 28, 2016
Inventors: James P. Rohl (Prescott, WI), David R. Wulfman (Maple Grove, MN), Brian T. Berg (St. Paul, MN), Joseph Thomas Delaney (Minneapolis, MN), Brian J. Tischler (New Brighton, MN), Peter M. Pollak (Atlantic Beach, FL), Harold M. Burkhart (Rochester, MN), Joseph A. Dearani (Rochester, MN), Sorin V. Pislaru (Rochester, MN)
Application Number: 15/003,920