Medical devices including balloon modules

Abstract

The present invention relates to a medical device (10) for use within the human body, comprising a catheter tube (12) having a distal end and a proximal end, an inflation passage (30) defined within the catheter tube and having an outlet (32), at least one balloon module (38) having a first end (40) and a second end (42) engaging the catheter tube to surround the outlet, the at least one balloon module (38) having an outer wall (50), a closed perimeter (44), and an inner wall (52) disposed between the first end (40) and the second end (42) to define an inflation enclosure (55), and an inflation passage (56) defined within the inner wall. and a cavity (53) defined by an inlet, the balloon component being expandable from a deflated state to an inflated state by flow of inflation fluid into the inflation enclosure through the inlet, the balloon having at least one bonding zone (54) within which the inner wall is directly bonded to the outer wall, and in the inflated state, the outer wall and at least a portion of the inner wall move radially outward relative to a longitudinal axis of the catheter to cause an enlargement of the cavity and space the closed periphery radially from the longitudinal axis of the catheter.

Description

[Technical field]

[0001] The present invention relates to a medical device for use within the human body, such as, for example, a balloon catheter, introducer sheath or implant, that includes a hollow balloon component or module that is actuable between an inflated and a non-inflated state, and that maintains the inflated or deflated state via an inflation lumen, providing a configuration that can be used for many medical applications. [Background technology]

[0002] Medical balloon components are incorporated into many different types of medical devices to treat a variety of medical conditions, and these balloon components take a variety of shapes and configurations.

[0003] Hereinafter, the terms "component" and "module" are used interchangeably to refer to an individually inflatable balloon unit.

[0004] A typical balloon catheter includes a balloon component that, when inflated, expands to perform useful functions within the human body via percutaneous access. The balloon catheter includes a balloon component that can be manipulated or actuated by fluid injection between a non-inflated or deflated state having a relatively small diameter (so that it can be easily inserted into the human body through an introducer sheath, for example, in the groin) and an inflated or deployed state having a larger diameter. The balloon component performs its function by reaching a fully inflated or deployed state. For example, the balloon component can apply a radially outward force to an inner portion of a compressed / crimped metal stent or implant to expand the implant to its deployed state. Examples of these more typical balloon catheters include PTA (percutaneous transluminal angioplasty) balloon catheters, Foley balloon catheters, and TAVI (transcatheter aortic valve implantation) balloon catheters.

[0005] The balloon component may also undergo a Pleat and Wrap process in which longitudinal pleats or folds are induced in the balloon component to minimize the cross profile of the balloon in the uninflated or deflated state, and then the balloon component is wrapped around the catheter shaft.

[0006] Balloon components may also be used in introducer sheaths / ports, such as Applied Medical's Kii Balloon Blunt Tip Access System, which utilizes balloon components to provide fixation to the body during laparoscopic procedures.

[0007] In many devices that include a balloon component or balloon component assembly, the balloon component is attached near or at the distal end of the catheter shaft. However, the balloon component may also be attached at any intermediate point along the shaft, as in the case of Applied Medical's Kii Access System. The catheter shaft typically operates for some length (usually 10 cm to 120 cm) and has an inflation port at or near the proximal end of the catheter shaft. This inflation port is in fluid communication with the balloon component. As will be appreciated by those familiar with devices in the minimally invasive medical device industry, the catheter shaft often includes a guidewire lumen and / or working channel.

[0008] The balloon component is inserted into the human body in an uninflated state. Its small diameter allows for a smaller incision or access route, providing obvious medical advantages. The balloon component is often connected to an inflation means (e.g., a syringe or autoinflator) via an inflation lumen that runs the entire length of the catheter. As the balloon component advances into position, the inflation means is actuated, increasing pressure in the inflation port, the inflation lumen, and the balloon component. This increase in pressure is used to perform a task. For a "compliant balloon" component, the task is to occlude a vessel or opening (e.g., a Foley catheter), and for a "non-compliant" component, the task is to deploy a stent or dilate a narrowed artery. An example of this application is a PTA catheter.

[0009] Many balloon catheters only remain in the body for a short period of time. PTA, PTCA (percutaneous transluminal coronary angioplasty), and TAVI balloon catheters are examples that typically remain in the body for a few minutes. Other balloon catheters, such as Foley catheters or intra-aortic balloon pump (IABP) catheters, can remain in the body for weeks or even months.

[0010] Balloon catheter designers and engineers often refer to balloon components as "compliant," "semi-compliant," or "non-compliant." These three groupings are intended to describe how the diameter changes as the balloon component is inflated with greater and greater pressures or as the balloon component is inflated with greater and greater volumes of inflation fluid (e.g., saline or air).

[0011] Compliant balloon components increase in diameter significantly when inflated. Compliant balloon components are generally made of relatively soft and elastic polymer or rubber materials with Shore durometer hardness ranging from 20A to 90A, such as silicone, latex, thermoplastic polyurethane (TPU), or thermoplastic elastomer (TPE). These elastic materials can stretch or distort significantly when more inflation fluid is added within the balloon component. Balloon components made of these relatively soft materials typically expand to assume a mostly round spherical or spheroidal shape when inflated to pressures above about 3 psi to 20 psi. Compliant balloons typically inflate at fairly low pressures, ranging from 3 psi to 20 psi. In fact, some materials used for this type of balloon component have ultimate elongation values ​​of about 500% (e.g., TPU) to about 1500% (e.g., TPE and latex). Thus, compliant balloons can grow in diameter without bursting, from about 3 mm in the uninflated state to about 20 mm in the inflated state, at relatively low inflation pressures. This feature may be useful in applications where occlusion or mechanical fixation by the balloon component is required, or where the balloon component requires contact with the target anatomy or device while being deployed with a relatively low force against the target anatomy or device, such as a urethral balloon catheter, e.g., a Foley catheter.

[0012] Non-compliant balloon components, on the other hand, do not increase in diameter significantly when inflated to greater pressures. The strong, relatively stiff materials from which these balloon components are manufactured do not stretch or distort significantly when more inflation fluid is added within the balloon component. As a result, as more fluid is added, the pressure within the balloon component increases significantly, but the balloon does not increase in diameter as much. This may be useful for applications such as expansion of target anatomies or devices where a relatively large force (and pressure) is required to achieve a specific target diameter, such as the deployment of balloon-expandable TAVI stented heart valves. Non-compliant balloon components are often made from relatively stiff, inelastic, high-strength (high ultimate tensile strength) polymeric materials, such as polyethylene terephthalate (PET) and nylon 12 (PA12), with Shore durometer hardness ranging from 70D to 90D. Balloon components made from these relatively stiff materials typically retain their shape and diameter when inflated to relatively large pressures ranging from 4 atm to 40 atm.

[0013] Semi-compliant balloon components are components that fall into a group that falls between the compliant and non-compliant groups. Semi-compliant balloon components will grow in diameter when inflated to greater pressures than non-compliant balloon components. Semi-compliant balloons typically hold pressures in the range of 1 atm to 20 atm. They may also be configured to grow at relatively greater pressures and therefore can be used to provide a "one size fits all" type of device that allows the clinician to choose the diameter to which they wish to inflate the balloon (usually within a fairly narrow range) using a diameter vs. pressure chart or table typically provided by the device manufacturer within the instructions for use.

[0014] A standard shaped balloon component (such as those used in PTA or PTCA procedures) can be described as having geometric characteristics that include a first neck or distal neck (a mostly tubular or hollow cylindrical section, also known as the "leg" or "tail") that transitions to a first cone or proximal cone section (a conical or semi-spherical region having a smaller diameter at the transition from the neck to the cone and a larger diameter at the transition from the cone to the mid-section), which tapers more widely to a mid-section or "working length" of the balloon (which typically has a generally cylindrical outer surface and is the region of the balloon component with the largest diameter when inflated). In the distal direction, the mid-section transitions to a second cone or distal cone section that tapers more narrowly to a second neck or distal neck that is mostly tubular like the first neck.

[0015] The first and second necks are typically portions of a balloon component that attach to one or more catheter shafts.

[0016] The conical balloon component is shaped similarly to the standard balloon shape described above, but does not have a middle section or "working length."

[0017] A spherical balloon component can be described as having two hemispherical cone sections connected to one another. Thus, for conical and spherical balloons, the cone portion can be described as the working length of the balloon since it is the only portion of the balloon that is not bonded or secured to the catheter shaft.

[0018] A spheroidal balloon component is similar to a spherical balloon component, but has a cylindrical working length or middle section disposed between hemispherical cones. In other words, a spheroidal balloon component is similar to a standard shaped balloon component, but with a round cone or a hemispherical cone.

[0019] For example, a compliant balloon component can undergo a large change in shape between its uninflated and inflated state: for example, a compliant balloon can assume a standard shape when partially inflated (to pressures as low as 0.1 psi to 0.5 psi) and then grow and change to a spherical shape when fully inflated.

[0020] Dilatation balloon components are often used to dilate or widen targets such as blocked or narrowed blood vessels or crimped metal stented implants. In some cases, the force required to dilate the target can be significant, necessitating a high-pressure resistant, non-compliant balloon component.

[0021] Dilatation balloons are often made from relatively stiff, inelastic, strong (high ultimate tensile strength) polymeric materials such as those described above as "non-compliant" or "semi-compliant." Balloons made from these stiffer materials are able to retain their shape when inflated to relatively high pressures, typically in the range of 6 atm to 30 atm, and are therefore better suited for dilatation applications that typically require moderate to large radially outward forces from the balloon components.

[0022] Occlusion balloons are used to block or occlude blood vessels or openings in the human body. Occlusion balloons are often generally spherical or prolate spheroid in shape. The "cones" of these types of balloons may be shaped to assume a conical shape when inflated to very little pressure, e.g., 0.3 psi. However, due to the soft and pliable nature of the materials used for occlusion balloons, they usually lose their shape and become "round" when inflated to greater pressures (e.g., 5 psi to 20 psi). Prolate spheroid balloons are shaped similarly to standard balloons, but have rounded, hemispherical "cones" at both ends of their working length. Spherical balloons usually lack a cylindrical center section, with each cone transitioning directly into the other cone.

[0023] Occlusion balloons are often made from relatively soft, elastic polymeric or rubber materials, as detailed in the compliant balloon description above. Balloons made from these relatively soft materials typically grow to assume a mostly round or spherical or spheroidal shape when inflated to pressures in excess of about 5 psi to 20 psi. Stated differently, occlusion balloons typically do not retain their shape definition during inflation, but rather expand toward a rounder version of their original shape.

[0024] Other, more exotic balloon catheters exist with balloon components of somewhat unusual shapes or configurations: for example, a valvuloplasty balloon component (used to dilate or radially expand a heart valve) may have an hourglass shape (where the working portion of the balloon contains a central "waist" area of ​​smaller diameter) that allows the balloon to fit more snugly within the target anatomy (in this example, the heart valve).

[0025] Cryoablation balloon catheters may be fitted with two balloon components, with the inner balloon located radially inward from the outer balloon, or in other words, the inner balloon located within the outer balloon. The Arctic Front system is an example of a balloon catheter that includes two balloons as described herein.

[0026] Some devices include balloon components with everted or everted regions. The Cook cervical dilation balloon is one example of this. By everting one end of the balloon component (e.g., the distal neck), a preferred shape of the balloon assembly or balloon module can be achieved, which can improve the functionality of the medical device.

[0027] In practice, the proximal neck of a standard shaped balloon component may be larger in diameter than the distal neck to allow the proximal balloon neck to be coupled to an outer catheter shaft and the distal balloon neck to be coupled to a smaller diameter inner catheter shaft. The annular space between the inner and outer shafts is often used as an inflation lumen for inflating the balloon component.

[0028] Those familiar with the art of balloon catheter design and manufacture will appreciate that, in other examples, the balloon component of a balloon catheter may have proximal and distal necks having the same or similar diameters and may be attached to a multi-lumen catheter shaft that can accommodate proximal and distal necks having similar diameters. One of the lumens in the multi-lumen shaft is used as an inflation lumen for the balloon component. The inflation lumen is often exposed by one or more "skives" or cuts or holes at a location between the proximal and distal necks of the balloon component such that an inner portion of the balloon component is in fluid communication with the inflation lumen, which is in fluid communication with the inflation port.

[0029] Potential uses for conical or spherical balloon components providing a hollow funnel have been discussed in the prior art, namely for occlusion of blood vessels and openings within the body and / or for retrieval of devices or waste materials or emboli from within the body.

[0030] As is known in the prior art, a hollow balloon component having a shape similar to a funnel can be achieved by inverting or everting one end of a standard shaped balloon component (including a neck and a cone, and possibly a portion of the working length). In reality, this prior art is at best limited and at worst fundamentally flawed.

[0031] In practice (as known to those who have constructed compliant eversion or eversion balloons), compliant or thin-walled occlusion balloons such as those described above collapse inwardly around their distal ends.

[0032] The prior art includes funnel-shaped balloons having at least one everted / everted neck region, as described in US Pat. No. 5,399,363 (Gore). This document describes a method and apparatus for removing emboli during angioplasty, stenting, or surgical procedures. The apparatus comprises a catheter having a uniform thickness, funnel-shaped occlusion balloon disposed at the distal end of the catheter. The occlusion balloon is fused to the distal end to provide a substantially seamless flow transition into the working lumen of the catheter. Additionally, the distal edge of the occlusion balloon is configured to be in close proximity to the inner wall of the blood vessel to promote blood flow into the catheter and efficiently remove emboli.

[0033] The problem with the Gore device is that when the balloon is inflated, the distal taper rounds off. Because the balloon is a flexible (or thin-walled) balloon, it is highly unlikely that it will become cone-shaped upon inflation. This unavoidable "rounding up" represents a deviation from the intended design, which is a conical distal taper that allows for a funnel shape that allows for easier retraction of the device or embolus.

[0034] Less commonly, some balloon catheters utilize multiple balloon components assembled in parallel to allow the device to perfuse through the vessel while the balloon is inflated internally. Examples of these include the Bard True Flow balloon catheter used to pre-dilatate the aortic valve prior to implantation of a TAVI valve, the Gore Tri-Lobe balloon catheter used to "remodel" or "post-dilatate" self-expanding stent grafts in the thoracic abdominal aorta, and more recently, the Disa Medinotec Trachealator airway dilation balloon used to dilate the trachea. All of these devices are designed such that when inflated, the balloon module or balloon assembly expands radially outward, dilating the target anatomy or target device by exerting a radially outward force from the inside (similar to a standard expansion type balloon), but at the same time still allowing fluid or blood to flow through at least a partially hollow section of the inflated balloon module or balloon assembly, thus permitting perfusion during use.

[0035] There are two significant drawbacks to having a device with multiple balloon components assembled in parallel. Because the structure being expanded by the balloon components, either the associated device being deployed or part of the patient's anatomy, is often roughly cylindrical, a device with multiple parallel balloons will contact that cylinder along several discrete lines or contact areas that may be undesirable. For example, if three balloons are positioned in parallel (as in the case of the Gore Tri-Lobe balloon catheter), the target implant may be forced into a rounded triangular shape (when viewed in cross section) rather than a more circular shape as may be desired. Furthermore, the individual balloon components that make up a multi-balloon module are typically fairly expensive parts. For example, in a standard PTA balloon catheter device, the cost of the balloon component may be higher than the other parts combined (including the catheter shaft, inflation luer / port). Thus, designs that rely on the use of multiple components typically have significantly higher part costs that may be commercially undesirable.

[0036] Other prior art shows spiral balloons wound into a circular tube to form a hollow perfusion balloon module. These hollow spiral perfusion balloons have been shown to have applications including balloon expansion applications such as valvuloplasty, stent deployment, and deployment of balloon-expandable TAVI valves, which are possible while maintaining perfusion thanks to the hollow central portion within the windings of the spiral. One drawback of some of these spiral balloons is that a separate frame or connector is usually required to create a structural bond between each winding of each spiral coil to prevent the coils from collapsing or collapsing when exposed to large resistance forces (e.g., non-deployed metal stents, etc.). These additional components add material and volume to the balloon module assembly. Furthermore, the additional structural components, such as frames, themselves may require a certain expansion force from the spiral balloon to expand the frame, which represents an inefficiency or loss of outward radial force available to perform useful actuation.

[0037] By placing one standard shaped balloon component inside another and including an inner support member located radially inward of both balloons, a hollow balloon component is achieved that allows for perfusion while the balloon is inflated. Such an invention is described in US Pat. No. 5,399,633. [Prior art documents] [Patent documents]

[0038] [Patent Document 1] Canadian Patent Application Publication No. 2492020 [Patent Document 2] US Patent Publication No. 20200179116 Summary of the Invention [Problem to be solved by the invention]

[0039] The present invention provides a medical device, such as a balloon catheter, introducer sheath, or implant, that includes a hollow balloon component and can be actuated between an inflated state and a non-inflated or deflated state by means of an inflation lumen contained within a catheter to which a balloon module is attached.

[0040] More specifically, the present invention provides a novel configuration of a balloon component having a body having in one embodiment at least one conical section, and in another embodiment having a conical section, a cylindrical working section, and a cavity spaced radially inward of the conical section, or the conical section and the cylindrical section.

[0041] In an inflated state, the body of the balloon module can assume an overall shape generally similar to either a standard shaped balloon component (as described in the Background section) having a first neck region that transitions into a first conical region, which transitions into a first working region, which transitions into a second conical region, which transitions into a second neck region, or a funnel shaped balloon component (as described in the Prior Art) having a first neck region that transitions into the first conical region, which optionally transitions into a working region.

[0042] The balloon module is configured to be mounted on, secured to, or coupled to the catheter.

[0043] The catheter may include an inflation lumen and / or a working passage or channel.

[0044] The body of the balloon component can be comprised of an outer layer or wall and an inner layer or wall defining an inflatable enclosure therebetween that is in fluid communication with the inflation lumen of the catheter to which the balloon module is attached.

[0045] The inflatable enclosure can be inflated by the entry of an inflation medium passing along the inflation lumen to move from an uninflated state to an inflated state.

[0046] Unlike the prior art, at least a portion of the inner wall may be directly bonded to at least a portion of the outer wall by any suitable method, such as, for example, thermal bonding or heat welding, to provide at least one bond zone.

[0047] The object of the invention is that upon expansion of the inflatable enclosure between the inner and outer walls, at least one bonding zone prevents or limits radially inward expansion of the inner wall, advantageously providing a cavity located radially inside the inner wall which remains open in the expanded state and is not affected by the ingress of the expanding or collapsing inner wall. [Means for solving the problem]

[0048] From a first aspect, the present invention provides a method for producing a semiconductor device comprising: a first neck section including an outer neck wall and an inner neck wall, each adapted to engage the catheter shaft and surround an outlet to the inflation passage of the catheter shaft; a first conical section comprising an outer conical wall as an extension of the outer neck wall and an inner conical wall as an extension of the inner neck wall; a closed periphery around which the outer conical wall and the inner conical wall are sealably connected; an expansion enclosure between the outer cone wall and the inner cone wall; At least a portion of the inner conical wall is directly bonded, by any suitable method, to at least a portion of the outer conical wall to provide a medical device including a balloon module providing at least one bonding zone.

[0049] The inner conical wall may be connected to the outer conical wall along a closed periphery such that the cavity is defined entirely within the conical region and is located radially inward from the inner conical wall.

[0050] Alternatively, the balloon module can include an actuation section with an outer actuation wall as an extension of the outer conical wall and an inner actuation wall as an extension of the inner conical wall.

[0051] The expansion enclosure in this alternative can be between the outer cone wall, the inner cone wall, the outer working wall, and the inner working wall.

[0052] The working section region can have a mostly cylindrical, spherical, or barrel-shaped exterior shape. The catheter can include a working passageway that can terminate near the transition from the inner neck wall to the inner cone wall. Alternatively, the working passageway can extend distally beyond the neck region. Alternatively, the working passageway can extend beyond the working region.

[0053] The outer working wall may be continuously connected to the inner working wall around the closed perimeter.

[0054] The working passage may terminate near the transition from the inner neck wall to the inner cone wall.

[0055] Alternatively, the balloon module can include an actuation section with an outer actuation wall as an extension of the outer conical wall and an inner actuation wall as an extension of the inner conical wall.

[0056] Further alternatively, the balloon module can include a second cone section extending from the actuating section and terminating in a second neck section. Because the outer actuating wall is continuously connected to the inner actuating wall around the closed periphery, the second cone section and the second neck section are not inflatable and can be constructed from a single wall.

[0057] Preferably, the working channel terminates distal to the second neck section.

[0058] The first conical section can include at least one opening configured to allow fluid flow or perfusion therethrough when the balloon module is inflated, or to allow other equipment, such as a guidewire, guide catheter, or delivery catheter, to pass therethrough.

[0059] The at least one opening may be sealed around a respective periphery by bonding the outer conical wall to the inner conical wall.

[0060] The balloon module can include a flexible mesh, filter, or fabric covering or extending across at least one opening, the at least one opening adapted to allow fluid, such as blood, to flow through the at least one opening while preventing larger particles, such as calcium debris from a TAVI procedure, from passing through the flexible filter.

[0061] Alternatively or additionally, the working section may include at least one opening as described above.

[0062] The second conical region can also include at least one window cutout adapted to allow fluid flow or perfusion therethrough or to allow other devices, such as, for example, a guidewire, guide catheter, or delivery catheter, to pass therethrough when the device is deployed and expanded.

[0063] At least one window cutout can be spanned by a flexible mesh, filter, or fabric configured to allow fluid, e.g., blood, to flow therethrough while preventing larger particles, e.g., calcium debris from a TAVI procedure, from passing through the flexible filter.

[0064] In one alternative, the non-distensible second conical section may be made entirely of a flexible mesh or filter adapted as described above.

[0065] The balloon module can be attached to the catheter with the first cone region located distal to the first neck region.

[0066] Alternatively, the balloon module can be attached to the catheter with the first cone region located proximal to the first neck region, ie, the balloon module can be attached inversely.

[0067] From a second aspect, the present invention provides a medical device for use in the human body, comprising: a catheter tube having a distal end and a proximal end; an inflation passage defined within the catheter tube and having an outlet; at least one balloon module having a first end and a second end that engage the catheter tube to surround the outlet, with an outer wall, a closed perimeter, and an inner wall disposed between the first end and the second end to define an inflation enclosure; a cavity defined in the inner wall; the balloon component is expandable from a deflated state to an inflated state by flowing an inflation fluid into the inflation enclosure through the inlet; the balloon has at least one bond zone where the inner wall is directly bonded to the outer wall; The medical device is provided such that, in an expanded state, the outer wall and at least a portion of the inner wall are radially spaced apart from the longitudinal axis of the catheter such that the outer wall and at least a portion of the inner wall move radially outward relative to the longitudinal axis of the catheter, causing an enlargement of the cavity and radially spacing the closed periphery away from the longitudinal axis of the catheter.

[0068] The at least one bond zone is capable of causing the inner wall to move radially outward with the outer wall upon expansion to expand the cavity.

[0069] The balloon component can expand in the deployment or insertion direction of the catheter (hereinafter, distal direction). In this alternative, the balloon component engages the catheter tube with a first end located proximal to a second end (hereinafter, a "forward expanding balloon").

[0070] The balloon component may expand in the catheter rearward (hereinafter proximally) direction, in which the balloon component engages the catheter tube with a first end distal to a second end (hereinafter referred to as a "rearward expanding balloon").

[0071] The closed perimeter may be a curved or bent edge or region that defines a boundary or transition between an outer wall and an inner wall (hereinafter referred to as an "edge"). The edge may describe a generally circumferential path. Alternatively, the edge may be jagged, wavy, sinusoidal, or crowned, or may have a mitered joint or wedge shape (e.g., resembling the sharp tip of a hypodermic needle).

[0072] The outlet can be located anywhere along the catheter tube, preferably at or towards the distal end.

[0073] The catheter tube can have at least one working passage or channel.

[0074] A guidewire can be threaded along or through the at least one working channel.

[0075] The catheter tube can include a conduit having at least one working passage defined therein.

[0076] A first end of the balloon component can engage the catheter tube and a second end can engage the conduit.

[0077] Alternatively, a first end of the balloon component can engage the conduit and a second end can engage the catheter tube.

[0078] The conduit may have an inlet located at or towards the distal end.

[0079] In applications requiring improved guidance or tracking along the vessel within which the catheter is deployed, the conduit can extend beyond the edge of the balloon component as an expanded section. The conduit can include an atraumatic tip and a radiopaque marker band.

[0080] The balloon module can include a plurality of tethers, each of the tethers extending between the edge and the expansion section.

[0081] The tethers may be equally circumferentially spaced from one another.

[0082] The multiple tethers can extend diagonally between the edge and the extension section. The multiple tethers can converge at a tubular neck adapted to be coupled to an outer surface of the extension section.

[0083] The medical device can include a flexible conical filter extending between the rim and the extension section and sealably connected to the rim or working portion and the extension section, the flexible filter or fabric or mesh configured to allow fluid, e.g., blood, to flow therethrough while preventing larger particles, e.g., calcium debris from a TAVI procedure, from passing through the flexible filter.

[0084] The balloon component may be configured with a conical portion between the first and second ends and an edge.

[0085] The at least one bonding zone may be a circumferentially continuous band.

[0086] At least one circumferentially continuous band may be adjacent the edge.

[0087] The at least one bond zone may be formed by direct sealing engagement of the inner wall with the outer wall using any suitable method.

[0088] Alternatively, the balloon component can have multiple bond zones.

[0089] Each bond zone can be elongated or circular. The elongated bond zones can be configured longitudinally, circumferentially, helically, or spirally. The elongated bond zones can be straight or V-, W-, or angle-shaped. A pair of elongated bond zones can cross or join to provide an X-shaped bond zone, or a zigzag bond zone, or an S-shaped bond zone, or a sinusoidal bond zone.

[0090] It is envisaged within the scope of the present invention that the bonding zone may take any shape including a combination of any one or more of the above mentioned shapes.

[0091] The balloon component can include a plurality of inflatable pockets defined between the bond zones.

[0092] At least one of the inflatable pockets may be a circumferentially continuous inflatable pocket adjacent an edge.

[0093] As an alternative to the balloon component being comprised solely of a conical portion, the balloon component may be configured to include a conical portion and a cylindrical portion between the conical portion and the edge.

[0094] The multiple bonding zones may be on the cylindrical portion (or working area or length), on the conical portion, or on both the cylindrical and conical portions.

[0095] In non-occlusive or perfusion embodiments, at least one of the bonding zones can include an opening that opens a hollow space or cavity to the outside of the outer wall to allow fluids, such as blood, or other devices, such as a guidewire or guide catheter, to pass through the conical or cylindrical or working portion of the balloon.

[0096] In non-occlusive embodiments, one or more of the outer and inner walls may be coated with a drug-containing layer.

[0097] Preferably, the multiple bond zones may include openings, which may extend through the bond zones on the conical portion, the cylindrical portion, or the conical portion and the cylindrical portion.

[0098] The opening or openings can be sealably covered with a flexible filter or woven mesh configured to allow fluid, e.g., blood, to flow therethrough while preventing larger particles, e.g., calcium debris from a TAVI procedure, from passing through the flexible filter.

[0099] The outer wall and the inner wall may be made of a first material and a second material, respectively.

[0100] The first material can be a softer, more elastic material than the second material to aid in forming a seal against the blood vessel within which the catheter is deployed while maintaining the shape of the cavity.

[0101] Alternatively or additionally, the second material may be harder than the first material to limit inward expansion of the inner wall.

[0102] Further alternatively, the first material may have a greater or lesser coefficient of friction than the second material.

[0103] If the first material has a higher coefficient of friction and the second material is more lubricious, it can allow the catheter to be secured within the blood vessel while facilitating movement of the body or device within the lumen.

[0104] The present invention relates to a catheter tube having a distal end and a proximal end, an inflation passage defined within the catheter tube, and a balloon capsule on the catheter tube including a forward dilatation balloon and a rearward dilatation balloon, respectively, as described above; The forward and rearward dilatation balloons also extend to the balloon capsule catheter, engaging each other along their respective edges.

[0105] The generally distal portion of the catheter, preferably the distal portion of the outer tube, may be steerable by means of pull wires and handles attached at or near the hub, or by other methods commonly used for steerable catheters.

[0106] The catheter may include an outer sheath adapted to slide over the balloon module when the balloon is in a deflated state, which aids in inserting the balloon into the body and through narrow vasculature on the way to the target treatment site.

[0107] The invention will now be further described, by way of example, with reference to the accompanying drawings in which: [Brief description of the drawings]

[0108] [Figure 1A] 1A-1D are schematic diagrams illustrating various embodiments of a medical device comprising one or more balloon modules. [Figure 1B] 1A-1D are schematic diagrams illustrating various embodiments of a medical device comprising one or more balloon modules. [Figure 1C] 1A-1D are schematic diagrams illustrating various embodiments of a medical device comprising one or more balloon modules. [Figure 1D] 1A-1D are schematic diagrams illustrating various embodiments of a medical device comprising one or more balloon modules. [Figure 1E] 1A-1D are schematic diagrams illustrating various embodiments of a medical device comprising one or more balloon modules. [Figure 1F] 1A-1D are schematic diagrams illustrating various embodiments of a medical device comprising one or more balloon modules. [Diagram 2] FIG. 1 is an elevational view of a medical device according to a first embodiment showing a single balloon module in a conical or funnel-shaped configuration. [Diagram 3] 3 is the medical device of FIG. 2 shown in isometric longitudinal section. [Figure 3A] 2 illustrates a schematic diagram of a bonding area or neck of a balloon module of the medical device of FIG. 1. [Figure 4] FIG. 13 is a longitudinal cross-sectional isometric view of a medical device according to a second embodiment of the present invention showing a single balloon module in a conical configuration. [Diagram 5] FIG. 5 is an elevational view of the medical device of FIG. 4. [Figure 6]FIG. 13 is a longitudinal cross-sectional isometric view of a medical device according to a third embodiment of the present invention showing a single balloon module with a conical portion and a cylindrical working length portion. [Figure 7] FIG. 7 is a longitudinal sectional elevation view of the medical device of FIG. 6. [Figure 8] FIG. 13 is an isometric view from one end of a medical device according to a fourth embodiment of the present invention showing a single balloon module within a conical portion and a cylindrical portion. [Figure 9] FIG. 9 is an isometric view from the other end of the medical device of FIG. 8. [Figure 10] 13 illustrates an isometric view of a fifth single balloon embodiment of a medical device. [Figure 11] 13 illustrates an isometric view of a sixth single balloon embodiment of a medical device. [Figure 12] FIG. 13 is an isometric view of a medical device according to a seventh single balloon embodiment of the present invention. [Figure 13] FIG. 13 is an isometric view of a medical device according to an eighth, single balloon embodiment of the present invention. [Figure 14] FIG. 13 is an isometric view of a medical device according to a ninth single balloon embodiment of the present invention. [Figure 14A] FIG. 16 is an isometric view of a medical device according to a tenth single balloon embodiment of the present invention having multiple distal end tethers. [Figure 15] FIG. 15 is an isometric view of a medical device according to an eleventh single balloon embodiment of the present invention having multiple distal end tethers. [Figure 16] FIG. 15 is an isometric view of a medical device according to an eleventh embodiment of the present invention comprising a pair of balloon modules. [Figure 17] FIG. 23 is a longitudinal cross-sectional view of a medical device according to a twelfth single balloon rearward expansion embodiment. [Figure 18] FIG. 13 is a longitudinal cross-sectional view of a medical device according to a thirteenth single balloon embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0109] 1A-1E illustrate various embodiments and configurations of a medical device 10 according to the present invention.

[0110] The medical device 10 includes an elongated flexible catheter tube 12 extending between a proximal end 14 and a distal end 16. The tube is typically made from extruded polymer tubing such as PEBAX, polyurethane, nylon 12, or multi-layer or braided reinforced extrusions, and typically has a length of 100 mm to 1200 mm. The catheter has at least a Y-connector or hub 20 (including one or more luer fittings) at the proximal end. The hub 20 includes at least two ports: an actuation port or guidewire port 22 and an inflation port 24. The hub may house or include additional features or components such as a hemostasis valve (as is common in introducer sheaths), and a deairing port that allows other instruments to be inserted into or withdrawn through the working passage while minimizing leakage of blood or other bodily fluids and maintaining air ingress. The hub may also include an actuation mechanism for advancing and retracting a sheath configured to encase the balloon module when deflated. The hub may also include an actuation mechanism for a steerable catheter, which allows the distal end of the catheter tube 12 to be actuated from a straight state to a somewhat curled or curved state to aid in positioning the balloon module within the body.

[0111] The catheter tube comprises an outer tube 26 and a generally concentric inner tube 28. An inflation passage 30 (see Figures 3 and 4) is defined by the annular space between the outer and inner tubes. The inflation passage has an outlet 32 ​​at or near its distal end. The inflation passage provides fluid communication between the inflation port 24 and the outlet 32.

[0112] It should be noted that although a coaxial expansion configuration is shown in the figures, another method of expanding the balloon module is to use a multi-lumen extrusion, as is common practice and well known to those familiar with the art of balloon catheter design and manufacturing, and thus the coaxial configuration is not intended to be a limitation of the invention, nor is the location of the distal end of the outlet intended to be a limitation of the invention.

[0113] A working passage 34 is defined within the inner tube 28. The passage communicates the actuation port 22 on the proximal end 14 with a working passage opening 36. The working passage 34 can be used as a guidewire lumen. The working passage opening 36 can be configured to receive a proximal end of a guidewire, and the working passage can be configured to allow a guidewire to be routed proximally until the guidewire extends beyond the proximal end 14 and beyond the proximal end of the guidewire port 22. The working passage opening 36 can be configured to allow a second (smaller version) of the balloon module of the present invention to translate therethrough, such that the second balloon module can be slidably and rotationally actuated relative to the first balloon module.

[0114] As shown in Figures 1A, 1B, and 2, the device 10 has a single balloon module 38 at the distal end of the catheter tube 12. However, it is considered within the scope of the present invention that the balloon module may be located at any point between the proximal and distal ends (14, 16) of the catheter tube 12. In this regard, see Figure 1C. Additionally, the balloon module may be attached to the catheter shaft in a forward or reverse orientation.

[0115] Please refer to Figures 1A-1E to show that the position of the balloon module on the catheter tube, the orientation of the balloon module, the shape of the balloon module, and the number of balloon modules are not limiting of the present invention. In Figure 1D, two balloon modules are shown: a single balloon module 38.1 and a composite balloon module 38.2. In Figure 1C, a composite balloon module 38.3 comprising two single balloon modules is shown. In Figure 1D, the single balloon module 38.1 is a rearward-facing module. The rearward-facing balloon module 38.1 is disposed distal to the forward-facing balloon module 38.2, and the single balloon module 38.1 is a rearward-facing module. In Figure 1E, the first device 10.1 includes a first catheter tube 12.1 and a first composite balloon module 38.3, and the first device 10.1 terminates distally at a first passage opening 36.1. Projecting further distally from the first passage opening 36.1 is a second device 10.2 including a second catheter tube 12.2 (configured for slidable and rotatable movement in a proximal or distal direction within the first catheter tube 12.1), a second composite balloon module 38.4, and a second passage opening 36.2. Both the first device 10.1 and the second device 10.2 can include steerable catheters within their respective catheter tubes, for example using pull wires to actuate the respective catheter tubes and enable navigation of the devices through tortuous anatomy as is conventional in the field of percutaneous guide catheters and delivery systems.

[0116] As best shown in Figures 3, 3A, and 18, the balloon module has first and second ends (designated 40 and 42, respectively), a closed perimeter 44 (which in some embodiments is a bent edge and in other embodiments is a curved or rounded rim), an outer wall 50 between the first end and the perimeter, and an inner wall 52 between the perimeter and the second end. A lumen, hollow region, or cavity 53 is defined within the inner wall.

[0117] The balloon module 38 is sealably secured to the catheter at both the first end 40 and the second end 42, enclosing the outlet 32 ​​to the inflation passage 30. In the embodiment, the first end is circumferentially secured in a band to the outer surface 46 of the outer tube 26 (hereafter referred to as the "neck"), and the second end is circumferentially secured in a band to the outer surface 48 of the inner tube 28. In this way, the annular outlet is encased. The balloon module transitions from a conical shape to a tubular shape at both anchoring zones toward the proximal end 14, as shown in FIG. 3A. However, in FIG. 18, the inner tube extends significantly beyond the outer tube, and the anchoring zones around the second end extend toward the distal end 16.

[0118] Configuring the balloon module as shown in FIG. 18 can facilitate ease of manufacturing by eliminating the need to invert second end 42 and evert first end 40 prior to assembly onto the catheter, avoiding tasks that can pose significant challenges, particularly if the balloon module is made of a relatively stiff material such as, for example, PET or Nylon 12.

[0119] The balloon module can be inflated from a deflated state to an inflated state by introducing an inflation medium or fluid, such as saline (or saline plus a contrast agent such as barium sulfate, which can be mixed with the saline to allow visualization of the balloon module under x-ray or fluoroscopy), water, air, nitrogen, or carbon dioxide, into the inflation port 24, which flows along the inflation passageway 30 and out the outlet 32 ​​into the interior of the balloon module (inflation enclosure 55). As with a typical medical balloon, the deflated state will be significantly smaller in volume (or smaller in diameter) than the inflated state. Thus, the balloon module can be actuated to a deflated state, which is substantially smaller in diameter and has less displacement than when in the inflated state. This function is similar to a standard balloon component, and has the same advantage in that the medical device 10 can be inserted into the human body (usually via an introducer sheath or port) and maneuvered to a target location within the human body in a deflated state. Once the balloon module is in the target location, it can be inflated to perform useful work.

[0120] However, a unique configuration of the medical device 10 of the present invention is that the outer wall 50 of the balloon module 38 is bonded to the inner wall 52 within at least one bonding zone 54. As a first example, in the first embodiment shown in Figures 2 and 3, in which the balloon has a conical shape, the at least one bonding zone is a circumferentially continuous band 54.1 adjacent the closed perimeter 44.

[0121] The balloon module 38 can be made from a polymer such as polyurethane, nylon 12, PEBAX, PET (polyethylene terephthalate), or THV (e.g., a polymer containing tetrafluoroethylene, hexafluoropropylene, and vinylidene fluoride). The polymer can also include fiber reinforcement to improve impact or burst resistance at higher inflation pressures. The balloon module can be made using compliant or semi-compliant medical balloon materials such as polyurethane, Pebax, or thermoplastic elastomers (TPE), or non-compliant medical balloon materials such as PET (polyethylene terephthalate) or nylon 12. The balloon module can also be made using one material for the outer wall 50 and another material for the inner wall 52.

[0122] The balloon module 38 may be manufactured using balloon components or elements made using a blow molding process, a dip casting or dip molding process, or an injection molding process. Bonding of the outer wall 50 to the inner wall 52 may be accomplished using heat bonding, thermal bonding, ultrasonic welding, adhesives, rivets, staples, clips, hoops, weaves or threads, or any combination of the foregoing.

[0123] Upon inflation, moving from a contracted state to an inflated state, the balloon assumes an inflated shape that creates a measurable outward radial force on the wall of the body cavity or vessel in which the balloon catheter is deployed, while maintaining a hollow region or cavity within the inner wall 52.

[0124] By fastening, joining, or bonding the outer wall 50 to the inner wall 52, the inner wall is largely prevented from stretching, wrinkling, buckling, or folding inward (preventing blockage of the lumen, hollow area, or cavity 53). When connected in this manner, the outer wall 50 generates a radially outward force upon inflation of the balloon module, thereby pulling the inner wall 52 radially outward. When the balloon is inflated, the net outward radial force is approximately equal to the inflation pressure multiplied by the area of ​​the outer wall ("outward area") minus the area of ​​the inner wall ("inward area"). Because balloon components are typically configured to provide a greater outward area than the inward area, the net force generated by the present invention when inflated with positive pressure is a radially outward force. This radial outward force may be useful to form a seal against the inner diameter of a blood vessel and / or to open or expand a blood vessel or a stented implant, such as a stent or balloon-expandable TAVI valve or stent graft, for treating an aneurysm via a percutaneous minimally invasive procedure.

[0125] The medical device 10 of the present invention may be used in many medical treatment applications, such as, for example, as a retrieval device for filtering or capturing or retrieving or removing calcific deposits or debris from the body, such as in a cerebral protection system; for retrieving other medical devices, such as, for example, a balloon catheter; as an expansion perfusion balloon for providing an outward radial force to a blood vessel (such as in a valvuloplasty procedure) or an implant (such as in a balloon-expandable TAVI procedure) within the body while maintaining perfusion when in an inflated state; or as a drug delivery device in which the outer wall of the balloon module 38 is coated with a drug and upon inflation of the balloon module, this wall contacts a target anatomical structure, such as a blood vessel, to deliver a drug to the target anatomical structure while maintaining perfusion when inflated.

[0126] The working passage 34 can be used to introduce irrigation or pressurized or contrast fluids, or as a working channel or conduit through which other equipment can be passed, such as, for example, a guidewire or an intravascular snare system (designed to retrieve and manipulate foreign objects within a body cavity) or another balloon catheter, to name a few.

[0127] Returning to the first embodiment 10A shown in Figures 2 and 3, here the outer wall 50 is continuously and sealably connected to the inner wall 52 in a continuous circumferential band 54.1 behind which is located an inflatable region 56. The balloon of this embodiment can be manufactured by inverting or everting one neck of a conical medical balloon (as described in the Background) to form the first end 40 or second end 42 of the balloon module.

[0128] Providing a circumferential band 54.1 on the balloon module has the advantage that it is not necessary to invert and evert portions of the balloon components used to make the balloon module to provide the outer and inner walls. Both walls can be blow molded or made separately as balloon components and then cut circumferentially at or near the working area and assembled in the orientation shown in Figures 2, 3, 4, 9, 11, 12, 14, 15, 16, and 17, and then the outer and inner walls (50 and 52, respectively) can be connected or bonded together along band 54.1.

[0129] It is beneficial to manufacture the balloon module 38 in this manner because it is not easy, and in some cases impossible, to invert or evert the balloon if it is made of harder materials such as Pebax, Nylon 12, and PET. Additionally, this manufacturing method allows for the use of different materials for the outer and inner walls, with advantages discussed below.

[0130] Fabricating the balloon 38 in this manner allows for the introduction of stiffer and stronger materials, which is beneficial for high pressure balloon applications, such as when a large outward radial force is required to open a stenosed vessel, deploy a stent, post-expand a stent, or deploy or post-expand a stented heart valve. Additionally, this method of fabrication allows each wall (50, 52) to be formed from a separate material, for example the outer membrane can be made from Pebax 72D material while the inner membrane can be made from a softer, more elastic Pebax 63D material. The advantage here is that each surface can be optimized to promote improved function. For example, the inner wall 51 can be made from a lubricious material such as THV to allow foreign objects (such as previously deployed medical devices) to be easily pulled inward, while the outer wall 50 can be made from a material with a higher coefficient of friction such as polyurethane to promote fixation within the vessel.

[0131] Alternatively, the inner wall 52 can be made of a stronger, stiffer material (such as Nylon 12 or Pebax 72D) that is less likely to collapse inward under inflation pressure, while the outer wall 50 can be made of a softer, more elastic material (such as polyurethane or Pebax 35D with a Shore hardness of 70A-80A) that is better suited to expanding outward under pressure like a standard compliant balloon component. This allows the outer wall to stretch without compromising the internal hollow shape of the lumen 53, forming a more comprehensive seal with the target vessel or device or implant expanding therein.

[0132] In a second embodiment 10B shown in Figure 4, the balloon has multiple bond zones, including a circumferential band 54.1 with its attendant advantages described above, and a series of substantially longitudinally aligned elongated bond lines (54.2, 54.3, ... 54.N) radiating from the passage opening 36 to the band 54.1.

[0133] This pattern does not limit the present invention. Similarly, the bonding zone can be oriented circumferentially, spirally, or helically, and each zone can exhibit a linear, V-shaped, W-shaped, X-shaped, or mountain-shaped, S-shaped, zigzag-shaped, or circular shape, or any combination thereof.

[0134] The third embodiment 10C shown in FIG. 5 is similar to the foregoing embodiments, but differs in that it does not have a circumferential band seal 54.1. Here, the region of the closed peripheral portion 44 is not bonded, and in this embodiment, an inflatable pocket 56.1 that is completely continuous in the circumferential direction is formed. This feature promotes the sealing of the catheter 10C with the blood vessel in which it is deployed or promotes the application of an outward radial expansion force to the blood vessel or implant.

[0135] In addition to the inflatable pocket 56.1, there are a plurality of inflatable pockets (each denoted as 56.2, 56.3, 56.N) between the longitudinally aligned bonding zones (54) that enable fluid communication between the outlet 312 and the inflatable pocket 56.1.

[0136] The fourth embodiment 10D is shown in FIGS. 6 and 7. Different from the foregoing embodiments, this embodiment is not conical. The balloon emerging from the neck 40 has a first conical portion 58 and a cylindrical portion 60, and the cylindrical portion 60 defines an operating length or operating region. The cylindrical portion terminates at the closed peripheral portion 44. This embodiment is shown with a cylindrical portion having a length similar to the diameter of the same cylindrical portion. However, it may be advantageous for the length of the cylindrical portion to be significantly greater than the diameter of the cylindrical portion. If the operating length (the length of the cylindrical portion) is the value "L" and the outer diameter of the cylindrical portion during inflation is the value "D" (the outer diameter of the inflated balloon module), the long balloon module can be configured such that D < L < 300D. This may be advantageous for retrieving long devices such as long balloon catheters, for example.

[0137] In this embodiment, the balloon is constructed with a circumferential series of inflatable pockets 56.1 and a plurality of longitudinally aligned bond zones (54.2-54.N) formed on a cylindrical portion 60.

[0138] 8 and 9 show a fifth embodiment 10E of the invention, where the bond zones 54.N diverge and rise along and arc around the conical portion 58 of the balloon, and the bond zones 54.1, 54.2, 54.3, and 54.4 extend circumferentially but discontinuously around the cylindrical portion 60. The discontinuity means that the pockets 56 are interconnected or in fluid communication with each other, and therefore can be pressurized. Because the pockets 56 are circumferential, they form an inflatable arched structure, which provides a structurally superior configuration capable of exerting a greater radially outward force suitable for expansion applications.

[0139] Within the cone portion's bonding zone, notches or openings 62 are formed. These window cutouts serve two important functions: they allow the balloon to be inflated without occluding the vessel in which it is inflated (which can be used to dilate a sensed vessel or valve (valvuloplasty) or to deploy a stent, stented heart valve, or stent graft for treating aneurysms without occluding blood flow), and they remove material from the balloon module, reducing the total amount of material required, thereby improving the balloon's ability to fit into smaller spaces when deflated, which can be advantageous when inserted through a guide catheter, sheath, port, or working channel of another device, such as an endoscope.

[0140] Moreover, this particular non-occlusive embodiment (see Figs. 8, 9, 14, and 15) can be used as a drug delivery mechanism. At least the outer wall 50 of the balloon 38 can be coated with a drug-containing layer (not shown) for localized application of the drug to a target delivery site by the blood vessel within which the catheter 10 is deployed. For example, catheters 10E, 10J, and 10K with openings allow for blood perfusion, thus allowing these embodiments to be used for drug delivery over relatively long periods of time. If the fully inflated balloon module 38 of these catheters remains deployed within the vessel for 1 minute to 24 hours, depending on the particular drug indication, there is little risk of blood flow obstruction. And, with the drug-containing layer on at least the outer wall, which is in contact with the vessel wall, the drug can be delivered to and through the vessel wall in a location-specific and efficient manner while maintaining perfusion. Fig. 10 shows embodiment 10F. Here, the connected region begins at or near the bottom of the conical region and extends longitudinally, terminating just short of the distal end of the balloon module. This results in one or more longitudinal inflatable pockets and a circumferential inflatable pocket at the distal end. This embodiment configuration allows fluid to more easily enter and exit the balloon module. It also improves "deflation" of the balloon module, a common practice for balloon devices or balloon catheters that must be inflated within the blood circulation system. Proper de-airing means that the balloon module does not accidentally break or burst, allowing air to enter. Air pockets or bubbles can cause serious complications within the bloodstream.

[0141] Instead of the circumferential inflatable pocket 56.1, this arrangement may be replaced with a circumferential band 54.1, depending on the application.

[0142] FIG. 11 illustrates embodiment 10G, where the bond zones (54.2, 54.3, and 54.4) begin at or near the bottom of the cone region and extend in a spiral fashion, terminating at the closed perimeter 44 of the balloon module. There is also a full circumferential bond zone 54.1 at the distal end of the balloon module. This results in one or more spiral inflatable pockets (56.1, 56.2, ..., 56.N). The configuration of this embodiment, as in embodiment 10D, allows for easy fluid passage into and out of the balloon module, while more closely approximating the structurally superior arched inflatable pocket 56, thus providing a compromise or hybrid solution.

[0143] Embodiment 10H is shown in Figure 12, where the bonding zones are circular in shape, starting at or near the bottom of the conical region or where the neck meets the cone, and terminating just short of the closed perimeter 44 of the balloon module. This balloon module has a single circumferential bonding zone (band) 54.1 adjacent the closed perimeter 44. These circular bonding zones can include windows or notches 62 to provide perfusion. These windows can be located on the conical region or on the working length (cylinder) region or on both regions.

[0144] Embodiment 10I is shown in FIG. 13. This embodiment is similar to the previous embodiment in that the bond zone is circular in shape, beginning at or near the bottom of the cone-shaped region or where the neck 40 meets the cone, and terminating just short of the round closed perimeter 44 that forms part of the inflatable pocket 56.1. This embodiment includes a bond 63 that runs the entire length of the balloon module. This bond can have a zigzag shape or a spiral wrapping pattern around the balloon module. The bond 62 is a feature of the manufacturing process used to make this balloon module, where a single sheet of polymeric material is first folded to form the inner and outer layers or walls, and then rolled up around the longitudinal axis and edges of the sealed sheet along the bond 63 to provide the balloon module.

[0145] Another embodiment 10J is shown in FIG. 14. In this embodiment, the closed perimeter 44 is sealed, but unlike the previous embodiment, the seal is not a circumferential band, but rather a circumferential crown shape. The joints in this embodiment can be chevron-shaped, or S-shaped, or zigzag-shaped, or partially circumferential crown-shaped to allow the joints to bend and thereby stretch circumferentially as the balloon module expands. This allows the outer diameter of the balloon module to increase as it expands. This feature provides for the production of a more "compliant" (see Background Art definition) balloon module. The window cutouts on the cone in this embodiment have a diamond shape, which can be advantageous during insertion or removal of the balloon module in a deflated state. This is because the diamond shape avoids an unsupported periphery that may be difficult to pass through narrow passages, such as an introducer sheath.

[0146] FIG. 14A shows a balloon module similar to FIG. 14, but depicted to include an inner tube 28 that extends in both directions beyond the closed perimeter 44. The inner tube has a marker band 67 disposed thereon to define the working portion 102 or working length of the balloon module under x-ray or fluoroscopy. Attached to the closed perimeter are a number of tethers 65 that are configured to include diamond-shaped notches or openings 62 in the second conical region 103 and in a portion of the working region 102, also known as the cylindrical portion 60. The tethers converge at a neck in a second neck region 104 (depicted distally in this view) that is coupled to the inner tube 28. This helps to center the distal end of the balloon module relative to the inner tube 28 or a guidewire located therein. The tethers also help to improve insertion of the balloon module through an introduction port. The diamond shaped cutout, together with the crown shaped closed perimeter and tether, avoids large, unsupported perimeter edges that may cause difficulties during insertion or removal of the device from the body.

[0147] FIG. 14A shows a balloon module similar to FIG. 14, but depicted to show the inner tube 28 extending in both directions beyond the closed perimeter 44. The inner tube has a marker band 67 located thereon to define the working portion 102 or working length of the balloon module under x-ray or fluoroscopy. A number of tethers 65 are connected to the closed perimeter and are configured to include diamond shaped notches or openings in the second conical region 103 and in a portion of the working region 102 (sometimes known as the cylindrical portion 60). The tethers converge at a second neck region 104 (depicted distally in this view) that is coupled to the inner tube 28. This helps to center the distal end of the balloon module relative to the inner tube 28 or a guidewire disposed therein. The tethers also help to improve insertion of the balloon module through an introduction port. The diamond-shaped cutout 62, together with the crown-shaped closed perimeter and tether, avoids a large, unsupported perimeter that may cause difficulties during insertion or removal of the device from the body.

[0148] FIG. 14B shows a balloon module similar to FIG. 14A, but including a distal cone region 103 and a distal neck region 104, which are formed from the same piece 68 made of flexible mesh or filter or fabric, shown with small perforations 69 (enlarged for visualization and may not actually be visible to the naked eye). This cone-shaped filter 68 is bonded to the closed perimeter or edge of the balloon module and also to the outer surface of the inner tube 28. This cone-shaped flexible filter can be configured to allow fluid (e.g., blood, etc.) to flow therethrough, while preventing larger particles (e.g., calcium particles from a TAVI procedure, etc.) from passing through the flexible filter. This additional feature allows the balloon module to be positioned such that bodily fluids, such as blood, can freely flow into the hollow space or cavity 53 through the window cutouts or openings located in the first cone region 101. Once in the hollow space or cavity, it is forced by upstream pressure through the filter. Thus, particles that are too large to pass through the filter remain trapped in the hollow space or cavity within the balloon module. Once the treatment is complete, the balloon module returns to its deflated state and is collected along with the filtered particulates. FIG. 14C is a side view of the same embodiment shown in FIG. 14B, but for purposes of illustrating the general areas of the invention. This embodiment includes a first neck region 100, a first cone region 101, an actuation region 102, a second cone region 103, and a second neck region 104. All embodiments include regions 100 and 101, but only some embodiments include regions 102, 103, 104.

[0149] FIG. 15 shows a balloon module similar to that shown in FIGS. 8 and 9, but this embodiment 10K is configured such that the working channel opening 36 is located distal to the closed perimeter 44. This allows for radiopaque marker bands 67 to be placed, connected, or bonded to the inner tube 28. These marker bands can be aligned with the proximal and distal ends of the cylindrical portion 60 (also known as the working region 102) of the balloon module. This allows for proper placement of the balloon module by x-ray or fluoroscopy prior to inflation of the balloon module, as is common with many balloon catheters. This embodiment can further include a number of tension elements or tethers 65 (which can also take the form of a second cone with a window cutout for perfusion, as shown in FIG. 14A), both of which would help to stabilize and center the distal end of the working region 102 or cylindrical region 60 relative to the inner tube 28 and thus the guidewire extending through the inner tube. Additionally, these tethers or second cones may also help make the balloon module more robust during insertion into and retrieval from the introducer sheath, as they prevent the cylindrical portion of the balloon module from collapsing or folding.

[0150] In another embodiment 10L shown in Figure 16, two balloon modules (designated 10.1 and 10.2, respectively) of the type embodied in embodiment 10E are configured to form a non-occlusive dilatation balloon catheter. Specifically, the two balloon modules are bonded or connected to each other at their respective closed perimeters 44 (see the inset in Figure 16 showing this).

[0151] This embodiment can be configured so that both balloon modules can be inflated simultaneously from the same pressure source (as shown) or can be inflated separately in a two-stage inflation protocol. This can be accomplished by extending the inner tube 28 to the proximal end or hub 20 of the catheter, thereby creating a second inflation lumen or a second annular inflation space. This allows the annular lumen between the outer catheter shaft and the central catheter shaft to be independently pressurized, thereby inflating the proximal balloon module but not the distal balloon module. Particularly when deploying an implant, it can be beneficial for the balloon modules to be inflated from the proximal as well as distal side. This feature can aid in uniform deployment of the implant by expanding both the proximal and distal ends of the implant together when the balloons are inflated simultaneously from each end.

[0152] Like the non-inflatable tether 65 of embodiment 10K, the distal balloon module 10.2 of this embodiment functions as an inflatable tether to the proximal balloon module 10.1 in that it connects the closed perimeter 44 to the inner tube 28, and has the advantages described above in paragraph 0146.

[0153] A guidewire 66 can pass through the inner catheter shaft, pass through the tip and exit the distal end of the device. A radiopaque marker band 67 can be added to the central catheter shaft to allow for positioning of the device within the target site under x-ray image guidance.

[0154] In all of the above-described embodiments, all of the balloon modules 38 are shown to include forward expanding balloons, in that the direction of expansion of the balloon 38 from the ends (40, 42) to the edge or rim 44 is in the deployment or forward direction of the catheter. However, as shown in FIG. 17, one embodiment 10M includes a rearward expanding balloon module. In this embodiment, the extension direction of the balloon from the ends 40 and 42 to the closed perimeter 44 is in the retraction direction of the catheter. In this embodiment, an outer wall 50 is defined between the second end 42 and the closed perimeter 44, and an inner wall 52 is defined between the first end 40 and the closed perimeter. This embodiment is useful in situations where the anatomy is shaped to accept this configuration more easily than others. This embodiment can also be used to orient the balloon module in this reverse orientation to allow for easier insertion of the balloon module through a narrow passageway, such as an introducer sheath or working channel.

[0155] Potential applications of the medical device of the present invention include use in procedures such as cerebral protection, transcatheter aortic valve replacement, balloon valvuloplasty, and tracheal balloon dilatation, among others.

Claims

1. A medical device for use within the human body, comprising a catheter tube having a distal end and a proximal end, an inflation passage defined within the catheter tube and having an outlet, at least one balloon module having a first end and a second end engaging the catheter tube so as to surround the outlet, and having an outer wall, an inner wall, and an edge between the outer wall and the inner wall disposed therebetween to define an inflation enclosure, at least one bonding zone where the inner wall is directly bonded to the outer wall therein, a cavity defined within the inner wall, and wherein the balloon component is inflatable from a contracted state to an inflated state by inflation fluid flowing into the inflation enclosure through an inlet, in the medical device, wherein the edge is disposed radially spaced from the longitudinal axis of the catheter such that when the balloon component moves from the contracted state to the inflated state, the outer wall and at least a portion of the inner wall move radially outward relative to the longitudinal axis of the catheter to cause an expansion of the cavity.

2. The medical device according to claim 1, wherein the edge is a curved or bent edge or region defining a boundary or transition between the outer wall and the inner wall.

3. The medical device according to claim 2, wherein the edge follows a circumferential path.

4. The medical device according to claim 3, wherein the edge is chamfered, beveled, or inclined to form a butt joint.

5. The medical device according to claim 4, wherein the catheter tube has at least one working passage.

6. The medical device according to claim 5, wherein the catheter tube includes a conduit in which the at least one working passage is defined inside.

7. The medical device according to claim 6, wherein the first end engages with the catheter tube and the second end engages with the conduit.

8. The medical device according to claim 6, wherein the first end engages with the conduit and the second end engages with the catheter tube.

9. The medical device according to any one of claims 6 to 8, wherein the conduit has an inlet disposed at or toward a distal end.

10. The medical device according to any one of claims 6 to 8, wherein the conduit extends beyond an edge of the balloon component as an expansion section.

11. The medical device according to claim 10, wherein the balloon module includes a plurality of tethers, and each of the tethers extends between the edge and the expansion section.

12. The medical device according to claim 11, wherein the tethers are circumferentially equidistantly arranged from each other.

13. The medical device according to claim 12, wherein the tethers extend obliquely between the edge and the expansion section.

14. The medical device according to claim 13, wherein the tethers converge at a tubular neck adapted to be coupled to an outer surface of the expansion section.

15. The medical device according to claim 10, including a conical filter extending between the edge and the expansion section.

16. The medical device according to any one of claims 1 to 8, including a plurality of coupling zones.

17. The medical device according to claim 16, wherein each coupling zone is elongated or circular. **Claim 18** The medical device according to claim 16, wherein each coupling zone is configured in a longitudinal direction, a circumferential direction, a spiral, or a scroll shape. **Claim 19** The medical device according to claim 17, wherein the elongated coupling zone is straight or has a V-shaped, W-shaped, or mountain-shaped configuration. **Claim 20** The medical device according to claim 17, wherein a pair of elongated coupling zones intersect or join to provide an X-shaped coupling zone, or a zigzag coupling zone, or an S-shaped coupling zone, or a sine-wave coupling zone.

Images