BALLOON CATHETER WITH INTEGRATED STOP FEATURE FOR PRECISE STENT PLACEMENT, FOR OSTIAL, RENAL AND OTHER LOCATIONS
Systems and methods for delivering a medical device to a vessel within a mammalian body are provided. The medical device may have a tubular body with an interior and an exterior surface. A delivery device may include a balloon assembly having one or more balloons, with a proximal and portion with the medical device mounted thereon. When the balloon assembly is partially inflated the proximal portion has a larger diameter than the distal portion which may be inserted into the vessel. The proximal portion may have a sufficiently large diameter that prevents it from being inserted into the vessel and permits it to function as a stop. The balloon assembly may be further inflated to deploy the medical device within the vessel. The medical device diameter may expand and optionally contact the interior surface of the vessel when deployed. Alternatively, the invention may be configured to dilate tissue, without deploying a medical device.
This application claims priority from U.S. Provisional Patent Application No. 60/331,125, filed on Nov. 8, 2001, and titled Marker Catheter with Optional Rapid Exchange Capabilities, and U.S. Provisional Patent Application No. 60/347,291, filed on Jan. 14, 2002 and titled Slot for Directing a Wire along a Portion of a Tubular Vessel.
TECHNICAL FIELDThis invention relates to a rapid exchange catheter with multiple utilities for use inside mammalian tubular vessels or structures, and more particularly allows the catheter to be removed from around a guide wire by using a slot or channel to hold the guide wire.
BACKGROUNDDuring catheter-based procedures, the physician often visualizes the area being treated under fluoroscopy and visualizes the catheter and/or treatment area using radiopaque materials. One method of visualizing is to fabricate the catheter from a polymer that has been compounded with any of the radiopaque materials that are known in the art, such as barium sulfate, bismuth trioxide, bismuth subcarbonate, tantalum and/or other known combination of radiopaque additives. Another known method is to put one or more marker bands around the outer diameter of the catheter at various positions at the distal end of the catheter. The marker bands can be spaced at known distances along the length of the catheter such that a fluoroscopic procedure can be used to determine distances of, for example, a lesion. Contrast dyes also are used to visualize the treated area by injecting a contrast dye through the catheter while the fluoroscope is being operated. The physician then can see the vessel in which the catheter is positioned, as well as any lesion past which the contrast dye flows.
In the procedure, the physician may use a guiding device, such as a guide wire, to controllably reach the lesion or area to be treated. Once the guide wire is in position, the physician may need to pass one or more catheters, tubular devices, and/or medical devices along the guide wire to the lesion or treatment area. The physician may pull the catheter or tubular device back along the guide wire and finally off of the guide wire. A difficulty of this, however, is that the guide wire must be very long (i.e., longer than the catheter) in order to pull the catheter off the guide wire without needing to first or also pull the guide wire out of the patient. A known solution to this problem is the use of a rapid exchange configuration in which the distal end of the catheter has a pair of opening into a lumen and through which the guide wire may be passed by inserting the proximal end of the guide wire through the distal most opening and then passing the proximal end of the guide wire out of the proximal opening of the lumen. For example, such a configuration is described by Yock (U.S. Pat. No. 5,451,233), which is incorporated by reference herein in its entirety.
One common application of rapid exchange and marker catheters is during coronary angioplasty, which refers to the use of an inflatable balloon to increase the blood flow through a stenosis (i.e., a partially blocked section of a blood vessel feeding the heart). A typical coronary angioplasty consists of three steps. First, a physician inserts a guiding catheter into a patient's blood vessel, typically through the femoral artery at the top of the patient's leg. The guiding catheter is advanced toward the heart through the patient's blood vessel, stopping short of the coronary arteries, and is then fixed in place. Next, the physician inserts a guide wire into the guiding catheter until the distal end of the guide wire exits the guiding catheter and enters the coronary artery. The physician then positions the guide wire across the stenosis to be treated in the coronary artery, and the guide wire is fixed in place. Finally, the physician advances a balloon catheter along the guide wire until the balloon exits the guiding catheter and is positioned across the stenosis. The physician then inflates the balloon to treat the stenosis, deflates the balloon, and removes the balloon catheter without disturbing the placement of either the guide wire or the guiding catheter.
Physicians frequently need to exchange balloon catheters during a single coronary angioplasty procedure. For example, if a stenosis blocks most of the blood flow through a vessel, the physician may first need to use a small balloon to increase the size of the opening through the stenosis, and then use a larger balloon to further increase the opening. Another example of a catheter exchange is when a physician uses a first balloon catheter to open a lumen and a second catheter to deploy a stent.
SUMMARYIn one general aspect, a catheter is configured to be inserted into a vessel within a mammalian body. The catheter includes a tubular body, at least one channel extending along the tubular body; and a central lumen. The tubular body includes an exterior surface, a first end and a second end, and defines a length between the first end and the second end. The channel passes between a first opening and a second opening and includes a slot in the tubular body between the channel and the exterior surface of the tubular body such that a tubular member can be passed between the channel and the exterior surface. The slot extends from the first opening to the second opening and includes a pair of edges. The central lumen extends along the tubular body at least for a portion of the length of the tubular body.
Embodiments of the catheter may include one or more of the following features. For example, the catheter may further include a balloon extending around the tubular body proximal of the second end of the tubular body, at least a portion of the balloon being in contact with the exterior surface of the tubular body. The balloon may extend into the channel for at least a portion of the length of the channel. The balloon may further include a first surface extending from the channel and a second surface extending from the channel. Each of the first surface and the second surface may include a radially extending channel passing between the channel in the tubular body and an opening on an outer surface of the balloon. The catheter may further include a band encircling at least a portion of a circumference of the tubular body under the balloon.
The edges of the slot may overlap, be aligned and in contact along at least a portion of the length of the edges without being connected, or be aligned and spaced apart from one another.
The balloon may include at least two discrete diameters. The balloon may include a diameter that is tapered along a length of the balloon.
The catheter may further include a band encircling at least a portion of a circumference of the tubular body proximal of the second end of the tubular body. The channel may pass below the band.
In another general aspect, a catheter is configured to be inserted into a vessel within a mammalian body. The catheter includes a tubular body and at least one tube. The tubular body includes an exterior surface, a first end and a second end that define a length between the first end and the second end, and a central lumen extending along the tubular body at least for a portion of the length of the tubular body. The tube has an exterior surface and extends along the exterior surface of the tubular body at least for a portion of the length of the tubular body. The tube includes a first opening, a second opening, and a passage way passing between the first opening and the second opening.
Embodiments of the catheter may include one or more of the following features. For example, the catheter may further include a balloon extending around the tube and the tubular body proximal of the second end of the tubular body, at least a portion of the balloon being in contact with the exterior surface of the tubular body and the exterior surface of the t tube. The tube may include a channel that includes a slot opening into the passage way such that a tubular member can be passed between the channel and the exterior surface of the tube. The slot extends from the first opening to the second opening and includes a pair of edges.
The catheter may further include a band encircling at least a portion of a circumference of the tube proximal of the second opening of the tube.
The balloon may extend into the channel for at least a portion of the length of the channel. The balloon may further include a first surface extending from the channel and a second surface extending from the channel. Each of the first surface and the second surface may include a radially extending channel passing between the channel in the tube and an opening on an outer surface of the balloon. The catheter may further include a band encircling at least a portion of a circumference of the tube under the balloon.
The edges of the slot may overlap, be aligned and in contact along at least a portion of the length of the edges without being connected, or be aligned and spaced apart from one another.
The balloon may include at least two discrete diameters. The balloon may include a diameter that is tapered along a length of the balloon.
In another general aspect, a catheter is configured to be inserted into a vessel within a mammalian body and track a guide wire. The catheter includes a tubular body and at least one coiled member extending from the tubular body. The tubular body has an exterior surface, a first end and a second end, a length defined between the first end and the second end, and a central lumen extending along the tubular body at least for a portion of the length of the tubular body. The coiled member extends from the second end of the tubular body and includes one or more extension members and one or more loop members configured to receive a guide wire and defining an inner diameter of each loop. The loop members are connected to the extension members and define a first opening and a second opening.
Embodiments of the catheter may include one or more of the following features. For example, the catheter may further include a balloon extending around the tubular body proximal of the second end of the tubular body and being in contact with the exterior surface of the tubular body. The loop member may have a closed circumference. The closed circumference may be openable. The loop member may have an open circumference.
In another general aspect, a guide wire can be removed from a catheter. The method of removing a guide wire from a catheter includes providing a catheter that includes a tubular body, at least one channel extending along the tubular body, and a central lumen. The tubular body includes an exterior surface, a first end and a second end, and defines a length between the first end and the second end. The channel extends along the tubular body at least for a portion of the length of the tubular body. The channel passes between a first opening and a second opening and has a slot in the tubular body between the channel and the exterior surface of the tubular body. The slot extends from the first opening to the second opening and includes a pair of edges. The central lumen extends along the tubular body at least for a portion of the length of the tubular body. The method also includes inserting a guide wire into the channel, advancing the catheter along the guide wire, and removing the guide wire from the channel. Removing the guide wire includes passing the guide wire from the channel to the exterior surface of the tubular body through the slot in the tubular body. Embodiments of the method may include one or more of the features described above.
In another general aspect, a guide wire can be removed from a catheter. The method of removing a guide wire from a catheter includes providing a catheter that includes a tubular body and a tube. The tubular body includes an exterior surface, a first end and a second end, a length defined between the first end and the second end, and a central lumen extending along the tubular body at least for a portion of the length of the tubular body. The tube includes an exterior surface and extends along the exterior surface of tubular body at least for a portion of the length of the tubular body. The tube includes a first opening, a second opening, and a passage way passing between the first opening and the second opening. The method also includes inserting a guide wire into passage way in the tube through either of the first opening and the second opening in the tube, advancing the catheter along the guide wire through the tube; and removing the guide wire from the passage way. Removing the guide wire includes withdrawing the guide wire from the passage way through either of the first opening and the second opening in the tube. Embodiments of the method may include one or more of the features described above.
In another general aspect, a guide wire can be removed from a catheter. The method of removing a guide wire from a catheter includes providing a catheter that includes a tubular body and at least one coiled member. The a tubular body includes an exterior surface, a first end and a second end, a length defined between the first end and the second end, and a central lumen extending along the tubular body at least for a portion of the length of the tubular body. The coiled member extends from the second end of the tubular body and includes one or more extension members and one or more loop members configured to receive a guide wire and define an inner diameter of each loop. The loop members are connected to the extension members and define a first opening and a second opening. The method also includes inserting a guide wire into the loop member through either of the first opening or the second opening, advancing the catheter along the guide wire through the loop member, and removing the guide wire from the loop member. Removing the guide wire includes withdrawing the guide wire from the loop member through either of the first opening or the second opening. Embodiments of the method may include one or more of the features described above.
The catheters, marker attachment, band, and/or coil devices and techniques described herein can advantageously enable the physician to more accurately determine the length and diameter of a lesion. In this manner, the physician can properly size a subsequent step, secondary operation, or therapy, such as the placement and inflation of a balloon and/or stent to open and maintain the patency of a vessel. The catheters, marker attachment, band, and/or coil devices and techniques can advantageously facilitate rapid exchange over a guide wire, reduce or eliminate the need for a long guide wire, provide improved visualization of the device and/or lesion, and provide accurate measurement of, for example, the length and diameter of a lesion, such as in a coronary artery. In particular, they allow a physician to remove a catheter from around a guide wire. The catheters, marker attachment, band, and/or coil devices and techniques can advantageously provide accurate sizing of a secondary therapeutic device, such as a stent or balloon, to the lesion, is easy to use, provides rapid exchange between guide and diagnostic catheters, between diagnostic and therapeutic catheters or device, and between therapeutic devices of different sizes. The marker attachment, band, and/or coil devices and techniques can advantageously be fabricated as a separate stand-alone device that can be attached to commercially available catheters and devices at the time of use or during manufacture of the catheter. Thus, the physician can decide at the time of a procedure to take a measurement and mount a marker attachment, band, or coil to, for example, an inexpensive off-the-shelf diagnostic, guide, infusion, or angioplasty catheter or device and take the measurement.
The rapid exchange catheter designs herein advantageously do not require an internal guide wire lumen, can allow complete removal of a catheter from around the side of a guide wire, can provide vessel access through an inflated balloon for several purposes including lesion sample access and retrieval, and can provide non-complete circumferential inflated balloon geometry. Non-complete circumferential geometry can advantageously provide alignment of the balloon void area with a calcified lesion so that the remainder of the vessel cross section can be safely dilated. This avoids putting excessive force on the hardened lesion, which in turn puts focused pressure on the wall of the artery at that site. A nonconcentric stent also may be loaded onto such a device to avoid a hardened lesion, while still supporting or reinforcing the remainder of the cross section of the vessel.
The catheter designs also may advantageously allow multiple guide wires to be used with the device for several purposes, including guiding a second catheter to a branched, or bifurcated section of an artery. Additional advantageous features include perfusion without the requirement of an internal catheter lumen as well as being compatible with devices such as those used for embolic protection. The designs also advantageously provide a device that can be produced as a separate component that can be used with other commercially available catheters, e.g., converting an Over-the-Wire (OTW) catheter to a Rapid Exchange (RX) catheter. The catheter designs can utilize a standard 0.014″ guide wire as well as a hollow tipped-guide wire for tissue and lesion sampling and retrieval.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
Like reference symbols in the various drawings indicate like elements.
DETAILED DESCRIPTIONThe marker attachment 120 extends from the mounting lumen 110 from the distal end of the marker catheter 100 (
The coils 130 also are open such that a physician can easily place the marker attachment 120 over, and remove from, a guide wire 135 without having to slide the catheter 100 all the way to the proximal end of the guide wire 135 or slide the catheter from the proximal end of the guide wire. The distal-most coil 140 can be open (
Referring to
Of course, the coils 130 all can be of the same outer and inner diameter with an inner diameter that is slightly larger than the outer diameter of the guide wire, and the marker attachment material being made of a thin diameter metal or polymer wire or tube. In this manner, the marker attachment has a minimized profile, optionally less than the outer diameter of the catheter to which it is attached.
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Other configurations and embodiments of the marker attachment 120 are illustrated in
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One end of the extension 145 can be mounted on the outer surface of the tube 150, the inner diameter of the tube, or to the wall surface formed between the inner and outer diameters. Of course, the extension 145 and the tube 150 can be formed as a single piece, for example by casting, machining, or other material removing operation, such as etching or electron discharge machining. The extension 145 and/or tube 150 also can be fabricated from a radiopaque polymer that has been loaded with a radiopaque additive or material.
Various configurations of the radiopaque tube 150 and the coils 130 described above are possible. For example, the marker attachment can be formed with a single coil 130 and a pair of radiopaque tubes 150 (
If the extension 145 and the tube 150 are formed from a non-radiopaque material, such as a polymer without radiopaque additives, radiopaque gauge or marker bands 155 can be placed along the length of the extension 145 at known distances so that they can be visualized under fluoroscopy (
The marker attachment using a radiopaque tube, as well as the other marker attachments described herein, can be used on any tubular device. In the cardiovascular field, the marker attachments can be used, for example, on guide catheters, diagnostic catheters, infusion catheters, etc. As illustrated in
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In general, the catheter 400 has a non-concentric balloon cross-sectional profile, with the slotted channel 415 (including and being formed to include a guide wire channel 417 and a guide wire slot 418) located on the outside of the main shaft 410, at the longitudinal balloon seam, or generally in the area where the balloon is in contact with the outer surface of catheter shaft 410, even when the balloon is inflated. The guide wire slot or groove 415 can have an internal, concave profile. The open groove or slot 415 is smaller than the diameter of the guide wire, allowing the wire to move freely within the channel, but without coming out of the slot or groove unless it is pulled out by the physician. The wall of the slot 415 can be somewhat flexible so that the guide wire can be easily inserted through and removed from the channel 415 to easy exchange of the catheter over the guide wire.
Moreover, in a modification of the catheter 400, a conventional marker band can be optionally placed around the slot 415 at its distal most end to provide a highly visible radiopaque indicator and give a sense assurance that the guide wire is less likely to come out of the slot unless the physician slidably removes the guide wire through the marker. Of course, the marker band is optional in this configuration and the catheter 400 will be extremely functional and usable for easy and rapid exchange of guide wires without the marker band. In another modification, the guide wire channel or slot (415, 417, and 418) may be positioned along a detented longitudinal area of the balloon 420.
The guide wire 425 also may be inserted into the proximal end of the guide wire slot 418, or, through the top opening of the slot or grove, and then snapped or positioned into place. In this manner, the concave geometry and size of the interior of the groove or slot prevents the guide wire from falling out.
The catheter 400 is formed using conventional techniques as are known in the art of catheter fabrication. For example, the shaft can be fabricated by pressure extrusion or tubing extrusion such that the tube has a cross-sectional profile of the inflation lumen 425 and the channel 415. The proximal end of the channel 415 then is removed such that only the distal end of the catheter has the channel 415. The inflation lumen 425 then is closed to have a taper (
Of course, the catheter can be formed by extruding a single lumen tube having the cross-sectional profile of
As illustrated in
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In other embodiments of the rapid exchange catheter, a guide wire lumen can be formed inside the catheter tubing wall rather than as a separate lumen. The guide wire lumen can be, for example, 0.5 cm long or less, and pass under a distal-most marker band. Where the catheter includes the guide wire being compressed between the balloon tubing and the vessel wall, longitudinal grooves, detents, valleys, cross-sectional voids, or other similar configurations in the balloon that would allow the wire to lay in a channel or groove-like region, and not be forced into the vessel wall under the pressures of balloon inflation. Additionally, the guide wire lumen can be formed separately as a separate piece that then is bonded under the balloon, and may or may not optionally continue or extend to the tip of the catheter. Finally, the catheter may be formed from multi-lumen tubing with one or more lumens removed at specific areas along the catheter length.
The catheter shafts described above can be formed from any biocompatible medical grade polymer, such as nylon, polyethylene, Pebax®, polyimide, polyamide, polyester, polypropylene or any other combination of these or other suitable materials. The shaft can be reinforced to provide, for example, increased pushability, with a polymer or polymers, metals, metal alloys (such as nitinol, stainless steel, Elgiloy®, inconel, 17-7 PH™), or any combination of these or other suitable materials. Reinforcing shaft components can include a mandrel, a hypotube, or any other article that can be used inside the shaft, outside the shaft, or be used as the catheter shaft itself, or other configuration. The reinforcing shaft components can be movable, removable, or fixed. The reinforcement can be along the entire length, or a partial length at selected locations, and can be used to improve catheter trackability, pushability, and provide a strain relief transition between bonded catheter segments. Other shaft reinforcing components include wire or tube (shaped to be round, flat, or any other geometry); multiple tubing layer(s), with or without a tie or bonding layer; a mandrel; a hypotube; by irradiation; by using a variable wall thickness; and/or any combination of these or other suitable component(s). The balloon material can be compliant or non-compliant. Examples of compliant balloon materials include but are not limited to polyethylene; polyurethane; Tecoflex®; or any combination of these or other suitable materials. Examples of non-compliant balloon materials include nylon; polyester (PET—polyethylene terephthalate, or other); Pebax®; polyimide; polyamide; or any combination of these or other suitable materials.
Radiopaque marker bands or marker attachments can be formed form gold, platinum/iridium, tantalum, or any combination of these or other suitable materials.
The proximal adapter, adapters, or hub can be configured as a Luer or other type fitting to enable connection to an inflation source and be fabricated from, for example, polycarbonate, polyurethane, polyester, or any combination of these or other suitable materials.
The catheter shaft can be fabricated by extrusion (e.g., single or multiple layer extrusion, tubing extrusion, pressure extrusion), casting, injection molding, dip coating, or any combination of these or other suitable methods or processes. The catheter shaft can be formed as multiple shaft pieces with tubing bonding, balloon to shaft bonding, and shaft to proximal adapter bonding. The bonding can include thermal (including RF-induction, forced heated air, laser, etc.), adhesive, ultrasonic welding, molding, or any combination of these or other suitable methods and processes.
To reinforce the shaft, the methods and materials usable include coils and coiling, braids and braiding, wraps and wrapping, or any combination of these or other suitable methods and materials. These reinforcements can be positioned or located inside, outside, within the shaft, in between, or any combination of these on the catheter.
The balloon fabrication process includes heat forming, cold forming, or any combination of these or other suitable methods and processes.
The catheter or the various parts of the catheter can be coated (static or active eluding) to be lubricious, anti-thrombogenic, therapeutic, or any combination of these or other suitable coating types, materials, and objectives. For example, the marker attachments and coils can be coated with a low durometer polymer to increase the softness of the attachment for less trauma during interaction with lesions.
Alternative applications for the rapid exchange feature include percutaneous transluminal angioplasty (“PTA”), stent and graft deployment catheters, therapeutic infusion, and any other catheter or medical device that utilizes a guide wire or guiding member.
The catheter size ranges for the catheters described above may include a catheter shaft having different proximal and distal diameters in the range of approximately 2 to 5 French, or greater. The balloon may have an inflated diameter that is between approximately 1.5 and 4.5 mm, or greater or less, and may be tapered. The length of the balloon may be approximately 10 to 40 mm, or greater or less. The guide wire may be approximately 0.014″ diameter, although larger and smaller guide wire diameters are envisioned depending upon the application.
Additional views and embodiments of rapid exchange and marker catheters are illustrated in
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The slot can be formed to start adjacent to the hub, adjacent to the inflatable balloon, or at any position in between. For example, if the slot starts adjacent to the hub, the pushability and the trackability of the catheter 800 may be perceived to be better. Then, to remove the catheter from the guide wire, the guide wire can be pulled out of the slot until it is just proximal to the balloon. If the slot 805 starts in the vicinity of the balloon, that portion of the channel 830 between the hub and the slot can have a mandril inserted within to improve pushability and rigidity, as necessary or desirable. The mandril can be movable, removable, or fixed.
The catheter 800 can be modified to have slot 840 with a narrow width or wider width. For example, the distance between the longitudinal edges 840 can be less than 0.005 inches. If the catheter 800 is made from a flexible polymer, the edges will nonetheless be flexible enough such that the guide wire 135 still can be received or removed through the slot. The slot also can be wider so that the distance between the edges 840 is slightly less than the diameter of the guide wire, for example, 0.005 inches less than the diameter of the guide wire. In this manner the guide wire will still be retained within the slot but will be even more easily received and removed through the slot.
The channel 835 can be formed to have any cross-sectional profile to the extent that a guide wire can be at least partially retained within the channel. Moreover, the cross-sectional area of the channel only needs to be large enough to receive at least a part of the guide wire.
Referring to
The protrusions 860 are flexible enough to allow the guide wire to be inserted and removed between them (aligned protrusions) or between the protrusion and the longitudinal edge 865 (offset protrusions). In this manner, the guide wire can be easily removed from the catheter in a rapid exchange procedure.
The slot 855 can be formed to start adjacent to the hub, adjacent to the inflatable balloon, or at any position in between. For example, if the slot starts adjacent to the hub, the pushability and the trackability of the catheter 850 may be perceived to be better. Then, to remove the catheter from the guide wire, the guide wire can be pulled out of the slot until it is just proximal to the balloon. If the slot 855 starts in the vicinity of the balloon, that portion of the channel 830 between the hub and the slot can have a mandril inserted within to improve pushability and rigidity, as necessary or desirable.
The catheter 850 can be modified to have slot 855 with a narrow width or wider width. For example, the distance between the longitudinal edges 865 and the protrusions 860 can be less than approximately 0.005 inches or more than approximately 0.005 inches. If the catheter 850 is made from a flexible polymer, the edges will nonetheless be flexible enough such that the guide wire 135 still can be received or removed through the slot. The slot also can be wider so that the distance between the edges 865 and protrusions 860 is slightly less than the diameter of the guide wire, for example, 0.005 inches less than the diameter of the guide wire. In this manner the guide wire will still be retained within the slot but will be even more easily received and removed through the slot.
The channel 835 can be formed to have any cross-sectional profile to the extent that a guide wire can be at least partially retained within the channel. Moreover, the cross-sectional area of the channel only needs to be large enough to receive at least a part of the guide wire.
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By having a short guide tube 905, the catheter 900 can be easily and rapidly removed and exchanged from the guide wire 135. Moreover, the guide tube 905 can be fabricated to have a slotted configuration, as described above with respect to
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The slotted guide tube 925 may extend distally from the balloon a short distance, all the way to the distal tip, or not at all. The tube 925 may extend proximally from the balloon 810 a short distance, all the way to a position adjacent to the hub, or a position in between. As such, because the guide wire can be removed from the channel 830 at any point along its length, the length of the guide tube can be any length and not adversely affect the ability of the physician to remove the guide wire. Thus, the length of the guide tube can be tailored to beneficially affect other characteristics of the catheter 920 as needed.
The slotted guide tube 925 may be formed as a separated extruded tube that then is firmly attached to a separated extruded catheter shaft 930 (
Referring to
The slot 955 may extend distally from the balloon a short distance, all the way to the distal tip, or not at all. The slot 955 may extend proximally from the balloon 810 a short distance, all the way to a position adjacent to the hub, or a position in between. As such, because the guide wire can be removed from the channel 830 at any point along its length, the length of the slot can be any length and not adversely affect the ability of the physician to remove the guide wire. Thus, the length of the slot 955 relative to the remainder of the channel 830 can be tailored to beneficially affect other characteristics of the catheter 950 as needed by, for example, placing a mandril in the remainder of the channel 830.
The slot 955 may be formed in a separately extruded tube, perforated or weakened, and then firmly attached to the catheter. In another implementation, the catheter is extruded as a dual lumen catheter and then the perforation or weakening is performed.
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Although the catheters described above are illustrated to have only a single chamber balloon, a multiple chamber balloon (i.e., two balloon chambers, three balloon chamber, four balloon chambers, or more) also can be used. As illustrated in
The interior balloon walls are formed by overlapping two layers of the balloon material. The four-compartment balloon 1000 is constructed by using a clip 1075 with four prongs 1080 that are used to draw or press portions of an inflated balloon against the outside surface of catheter 1070 as shown in
The balloon may have a tapered geometry and/or two different diameters. One advantage of a tapered and/or multiple diameter balloon is that a larger section can function as a guide, reference, or stop when deploying a stent in the ostium to treat ostial lesions. Because of its size, it is unlikely that the larger diameter can be inserted into the coronary artery to allow accurate stent placement. A major complication that can occur when stenting the ostium is that of a section of the stent being deployed partially outside of the ostium and partially in the aorta. In this manner, the balloon can be partially inflated such that the larger diameter proximal section of the balloon is inflated and when pressed up against the coronary artery, the inflated balloon prevents that portion of the balloon from entering the coronary artery. Referring to
The balloon 1000 and rapid exchange catheters described above can be used in balloon angioplasty, stent deployment and other procedures. For example, the inflatable balloon catheter 1000 having four dilatation compartments 1005, 1010, 1020, and 1025 can be inserted in a vessel until it reaches the obstructed area. Radiopaque markers can be placed on the catheter shaft under the balloon 1000 to assist the physician in positioning the balloon adjacent an obstruction. The multiple compartments of the balloon are then inflated to contact the obstruction.
The balloon catheter also may additionally be used in stent deployment. A plastically expandable stent 1085 that substantially surrounds the balloon 1000 of a catheter, in any of the embodiments describe above, may have the four dilatation compartments 1005, 1010, 1020, and 1025. Once the balloon 1000 and the stent are located at the appropriate location within the vessel and adjacent an obstruction 1090, the balloon compartments are inflated to deform the stent into contact with the obstruction. The physician is able to control stent deployment by adjusting the inflation of the balloon dilatation compartments as necessary. Greater inflation may be required for dilatation compartments 1015 and 1020 than compartments 1005 and 1010. Thus, compartments 1015 and 1020 can be monitored so that over inflation (that could cause vessel damage) in the obstructed area 1090 would be avoided. Furthermore, by viewing the pressure between the artery wall and balloon with regard to the balloon inflation pressure, the physician can determine that the stent 1085 is fully deployed.
For multi-balloon versions of the catheter, the individual balloons may be tailored or designed for specific purposes. For example, the balloon intended to open an occlusion, may be different than the balloon that is intended to deploy a stent or a balloon with therapeutic infusion features. Examples of different version are found in Houser (U.S. Pat. No. 5,865,801), which is incorporated herein in its entirety by reference.
Referring to
The peelable configuration has been described with reference to a catheter. However, this configuration also can be applied to a method and design of other medical products, such as a vascular introducer, sheath, or deployment device for deploying a medical device. The wire can be configured as a string, wire, multi-filament wire, polymer cord, polymer strand, multiple polymer strands, or any similar element.
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The catheter 1300 of
In general, the catheters described above have a proximal adapter that can be configured as, for example, a single Luer fitting for a single chamber or compartment balloon inflation, or multiple fittings for multiple balloon chamber, compartment, or segment inflation. The multiple balloon chamber or segment inflation can be individual and/or simultaneous. The multiple balloon chambers or segments may or may not be in fluid communication with each other.
The proximal shaft can be bonded together with the distal shaft using a Teflon coated mandrel that is inserted into the inflation lumen and heated to join both tubing sections together. FEP or PTFE tubing can be placed on the outside of the tubing to maintain the OD size during the joining process and then removed. The proximal shaft also can include a moveable/replaceable reinforcing or shaping member, as described above. The member may or may not continue through the distal section of the catheter and may be inserted into a dedicated lumen, or may use the inflation/deflation lumen during insertion. The distal shaft also may include the same or a different moveable/ replaceable reinforcing member as described above. The member may be inserted into a dedicated lumen, or the inflation/deflation lumen during insertion and removed for the inflation.
The guide wire can be contained as described above along the entire catheter length; in the distal section only; in the proximal section only; through, over, or parallel to the balloon; in the distal tip only; on top of the tip; inside the tip; inside the tip in between or under a marker band; and/or with an eyelet or coil configuration. The containment of the guide wire can also serve as a perfusion lumen and can be a channel having incomplete circumferential coverage with interior geometry matching the radius of the guide wire; a channel with one or more guide wire “hold downs” (i.e., partial coverage in a manner that is similar to catheter packaging trays); a limited length lumen or channel that is under and through the balloon but on top of catheter shaft; constrained in between balloon segments or detent(s), on top of the balloon, or on top of the catheter shaft; and/or on top of, or through the distal tip (i.e., at a position forward of the balloon).
The balloon can be a single chamber balloon with non circumferential geometry (i.e., incomplete circle, cross section void) in which the non circumferential geometry section is partial of the balloon height (i.e., above the shaft) or in contact and bonded together with the top of the shaft. When a grooved balloon is used with incomplete circumferential cross section geometry, the seam where the ends of the balloon come together may be longitudinal, or other, such as spiral, and can have interlocking end geometries (“S” or other profile).
The balloon also can be a multi-chamber or compartment balloon as described in Houser, U.S. Pat. No. 5,865,801, which is incorporated herein by reference in its entirety. When multiple grooved balloons are used (i.e., with an incomplete circumferential cross section geometry), the seam where the ends of the balloon come together may be longitudinal, or other, and can have interlocking end geometries (“S” or other profile).
The balloon inflation can be accomplished in a number of ways. For example, the non-circumferential geometry balloon may have circumferential interior vessel contact when inflated. Inflation of the balloon in a confined space will cause the radial ends of the balloon to come together, in particular when the balloon is made, partially or completely, from a compliant material, such as the materials described in Houser, U.S. Pat. No. 5,865,801.
The balloon is bonded to the catheter shaft by using a variety of methods, as described above, and includes the use of adhesives, solvents, heat, a combination of these, or other any other suitable method as known to those in the art.
The bonding of the balloon to the catheter shaft may further be configured in the traditional method, namely, the balloon shoulders being bonded to the catheter shaft. The balloon also may be bonded to the top with the balloon wall bonded inside the guide wire channel (maintaining channel geometry). The outside of the top of balloon may be bonded to the bottom of the shaft, with the balloon shoulders being modified (i.e., sections removed so that there are not two layers of balloon material where the shoulders are bonded to the shaft). The balloon also may have a hole that is positioned and secured to align with the inflation/deflation port on the catheter shaft. The longitudinal edges of the balloon may be designed to expand and come in contact closest to the shaft initially, but with increasing internal balloon pressure, the contact of the balloon edges continues in an outward direction from the shaft to the outer surface of the balloon.
The balloon may be a single or dual longitudinally spaced balloons that are inflatable independently, or simultaneously. The balloon geometry may be different between balloons and non concentric, non circumferential balloon geometries may be used. The balloon may have openings to bond onto the shaft at the proximal and distal ends. The balloon also may also have a longitudinal edge, seam, opening, or cross-sectional void, to allow longitudinal bonding of the balloon directly to the catheter shaft, and also to create a void for the guide wire channel. The balloon strength may be increased by exposing the balloon material to radiation which causes cross-linking of the polymer chain.
The balloon also can be processed to impart a smaller cross section “memory” profile, after the balloon (and or balloon chambers or segments) has been inflated, deflated, and is ready to be withdrawn from the body (causing the balloon “wings” to be closer to the catheter shaft after deflation making it less likely to dislodge emboli or cause other deleterious effects during withdrawal of the catheter from the body). The process may include irradiation to cross-link, or heating to anneal, the balloon material while in a constrained configuration. Certain balloon materials and or compound additives, such as, for example, ProRad, may be used to impart this characteristic.
The balloon also may be designed to have sections that expand at different rates and/or lengths during inflation. This characteristic may be realized by several methods, such as by thinning the balloon wall in the areas to allow for more expansion, and/or a special extrusion with different materials at different areas around the circumference of the balloon tubing (e.g., extruding more elastic material in the areas that are desired to expand more). This method also may produce a balloon with asymmetric inflation utility.
The balloon also may have a reduced diameter profile in the area just under the stent, such as the sides, to reduce the crossing profile as well as to “nest” the ends of the stent, which reduces the potential for the stent end to abrade the inside of the vessel during stent advancement in the vessel.
A coil or other mandrel may be inserted into the inflation lumen during the inserting into the vascular system, to provide additional pushability. The coil or other mandrel may or may not be removed prior to inflating the balloon.
The distal tip may be heat formed to taper to seal the inflation/deflation lumen and provide a tapered transition between the guide wire and tip of catheter
The catheter can be used in stent deployment, drug delivery, therapeutic infusion, and/or other diagnostic, therapeutic, preventative procedures or any combination of these or other suitable procedure. For example, the catheter can be used for therapeutic infusion by including ports or “weeping” through on the balloon, recessed region in the balloon for pooling of therapeutics for prolonged exposure, as described in greater detail in Houser (U.S. Pat. No. 5,865,801). The catheter also can be configured to have an infusion port in between a pair of lumens. The infusion port may be in fluid communication with the proximal end of the catheter using a Luer fitting or other suitable fitting. The infusion port also can be implemented using a separate, full catheter length lumen.
The catheter also can be configured to include one or more lumens and port(s) that exit the catheter wall, are located proximal to and/or distal to the balloon, or in the case of multiple balloons, in-between multiple balloons. This feature may be used for therapeutic or diagnostic fluid suction and/or infusion, or may used for other purposes, such as to insert a device or other object.
The balloon may be formed as described, for example, in Anderson (U.S. Pat. No. 6,007,517), which is incorporated herein by reference in its entirety. The balloon may be formed with flow channels for perfusion or guide wire passages passing through it. The channels or passages can be formed by molding and/or extrusion techniques. In one method, a modified modeling process, prior to the molding process, both the proximal and distal ends of the balloon are affixed to the catheter shaft. The balloon has excess material about the sites where one or more channels are to be formed. The excess material corresponds to the surface(s) on the interior to the balloon and therefore will be sufficient to permit formation of inner channels or passages. If the channel or passage material should be thicker than typical, the manufacturer can use thicker material in this region where excess material is desired. This can be accomplished in several ways. In one aspect, prior to bonding to the shaft, the balloon material is extended with thickened walls in the regions where a channel is to be formed. The quantities of excess balloon material and proper thickness can be determined in a given case by routine experimentation. Upon molding, the thicker regions form the channels. Alternatively, one can layer standard longitudinal sections of balloon material in those regions where thickening is required using bonding techniques and then mold the balloon. The bonded layer not only thickens the regions needed to form the channels but functions as a scaffold. Conventional adhesives also can be used to bond the extruded balloon to the shaft. The layers also can be conventionally heat-sealed. The channel walls also can includes materials other than balloon materials that are adjoined to the balloon to form the channels. In addition, the channel walls can be treated to increase strength.
During manufacturing, one or more cylindrical members may be placed within a balloon mold in the position of the one or more desired channel(s). The members may be pre-mounted to the mold. When the balloon is inflated within the mold, the excess balloon material envelopes the cylindrical members. During or after the molding process, the contiguous balloon material is conventionally heat sealed to form the channel(s) or is otherwise sealed using, for example, adhesives. For example, once the balloon molding is completed, the mold is separated, the cylindrical members used to support the flow channels during molding are removed, and the initially excess balloon material is bonded together using the techniques describe above to complete its circumference. That excess material will have formed channel(s) and includes the outermost portion of the channels. It is also possible to use one or more movable cylindrical members that are moved toward each other during the molding process to facilitate achievement of the channels.
In another manufacturing method, the balloon and its one or more channels are extruded using conventional plastic extrusion technology. The one or more interior channels are achieved by extrusion of one or more cylinders or mandrils or wires having walls of a desired thickness within the larger cylinder that is the balloon. The inner channel may be extruded at the same time as the exterior balloon in a single process. The channel(s) also may be separately extruded and then added to the interior of the larger, exterior balloon at the time of assembly by sealing using, for example, adhesives or by heat sealing and cutting away the openings to the channels.
Referring to
The potential benefits of these balloon designs include the ability to position a non-balloon section or a reduced balloon section over a calcified lesion to reduce or eliminate direct pressure at that site, which is believed to be useful in preventing damage to the vessel. The dual balloon configuration (
Referring to
Referring also to
The hollow tipped guide wire or other suitable device is used to access, capture, and retrieve a sample of the lesion (including plaque or other type of occlusion) for better diagnosis and to choose the best mode of treatment. For example, the retrieved tissue, lesion, or plaque may be analyzed to determine its physical and chemical composition before the physician decides the most appropriate treatment method for that particular site. For therapeutic purposes, a special hollow guide wire or infusion device may be used to infuse a therapeutic material, such as a pharmacological or gene-therapy based agent at, in or near the plaque, occlusion or vessel wall. The infused or applied material may include materials that would bind, reinforce, seal or stabilize the occlusion to prevent or make the vulnerable plaque less likely to rupture. Examples of the general classes of these materials include an adhesive and/or a pharmacological material. The infused material may be a liquid that becomes a solid or gel upon placement and/or activation.
The guide wire 1600 can be used in the diagnosis and treatment of vulnerable plaque by obtaining a sample of plaque and identifying characteristics of vulnerable plaque: Some of the diagnostic methods include temperature measurement (by means of one or more of a thermocouple, thermistor, fluorescing means or other temperature sensing means), density measurement, oxygen content measurement, composition analysis, shape or size characteristics, location within the lesion, and/or physical strength.
In this implementation, a first guide wire 1630 may be used to direct the catheter to the desired location and a second guide wire 1600 may be the hollow guide wire for tissue or plaque access and retrieval. When the catheter is used to access and retrieve a lesion sample, the balloon 1560 may be inflated to a lower pressure than would be used for a therapeutic dilatation so that the lesion remains stable during the process of accessing and removing the sample. The balloon can remain inflated, if necessary, to keep it stable during the time required to analyze the sample to determine it composition and the best treatment for the particular lesion. For periods of extended balloon inflation, a perfusion feature (e.g., a perfusion lumen in or on catheter shaft or openings through the tubing wall placed proximal and distal to the balloon) may be included in the catheter design.
Referring to
The fold 1680 and radially extending channel 1670 can be formed by placing a cylindrical member, such as a pin 1690 (
Although only one cylindrical member or pin can be used in forming the radially extending channel, one or more cylindrical members or pins can placed within the balloon mold in the position of the one or more desired channels. When inflating the balloon within the mold, the balloon material envelopes the one or more cylindrical members to form one or more radially extending channels. The members may be pre-attached to the mold or may be a separate piece or pieces. These and other balloon forming methods known to those of skill in the art are disclosed in Houser (U.S. Pat. No. 5,865,801) and Anderson (U.S. Pat. No. 6,007,517), both of which are incorporated herein by reference.
Another version of the catheter design may be implemented without a balloon. This implementation may be used as a carrier for insertion of multiple guide wires, catheters, and/or other devices, such as leads, at various locations within the cardiovascular system, particularly the main and branching coronary arteries. Once the guide wires have been inserted into the desired vessels (e.g., main vessel and side branch) the guide wire carrier catheter is withdrawn. The proximal ends of the guide wires may be temporarily or permanently marked with the specific anatomic location of each guide wire. Therapeutic, diagnostic or other medical devices (including other catheters) may then be guided to the appropriate anatomic location by the previously inserted guide wires.
The catheters described herein optionally can be configured to provide electroporation during therapeutic infusion. In this mode, the catheters provide the ability to actively stimulate tissue to facilitate intracellular application of the therapeutic solutions. For example, a section of the balloon or catheter body may include a component or coating that can function as an electrode to deliver high voltage electrical pulses into adjacent tissue to cause electroporation of tissue within the desired region, for greater absorption of the therapeutic fluid into the tissue.
The catheters described herein also optionally can be configured to include a piezoelectric film on the balloon for inducement of cavitation (e.g., during therapeutic infusion), an ultrasonic transducer to provide for visualization, ultrasonic ablation, electroporation, and/or pressure sensing devices. The catheters also can optionally include heating capabilities without or without temperature sensing or control using direct resistive element or ohmic tissue methods to treat tissue, deliver or deploy a shape memory stent or other shape memory device. The heating capabilities can be provided using one or more heating means, such as a thin film heating element, a resistive wire or strip (e.g., for resistive element heating), a conductive wire or strip (e.g., for ohmic tissue heating), or an ultrasonic transducer. The heating means can be positioned on the catheter, on or inside the balloon, or as a separate device positioned within or adjacent to the catheter. Many of these features and capabilities are described in Houser (U.S. Pat. No. 5,865,801).
While several particular forms of the invention have been illustrated and described, it will be apparent that various modifications and combinations of the invention detailed in the text and drawings can be made without departing from the spirit and scope of the invention. For example, references to materials of construction, methods of construction, specific dimensions, shapes, utilities or applications are also not intended to be limiting in any manner and other materials and dimensions could be substituted and remain within the spirit and scope of the invention. Finally, it is contemplated that any single feature or any combination of optional features of the inventive variations described herein may be specifically excluded from the claimed invention and be so described as a negative invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
Claims
1-34. (canceled)
35. A method for delivering a medical device to a vessel within a mammalian body, said method comprising:
- providing the medical device, wherein the medical device has a tubular body having an exterior surface and an interior surface, and a first end and a second end that define a length between the first end and the second end;
- providing a balloon assembly comprising one or more balloons, wherein the balloon assembly has a distal portion and a proximal portion, and wherein the medical device is provided on the distal portion of the balloon assembly, thereby permitting the distal portion of the balloon assembly to contact the interior surface of the medical device;
- at least partially inflating the balloon assembly so that the proximal portion of the balloon assembly has a larger diameter than the distal portion of the balloon assembly with the medical device thereon;
- inserting the distal portion of the balloon assembly and the medical device into the vessel so that the proximal portion of the balloon assembly does not enter the vessel; and
- further inflating the balloon assembly so that the distal portion expands in diameter, thereby deploying the medical device within the vessel.
36. The method of claim 35 wherein the medical device is a stent.
37. The method of claim 35 wherein the medical device is a graft.
38. The method of claim 35 wherein the balloon assembly comprises a single balloon, and wherein the proximal portion of the single balloon has a larger diameter than the distal portion of the single balloon.
39. The method of claim 35 wherein the balloon assembly comprises a plurality of balloons.
40. The method of claim 39 wherein the plurality of balloons are inflated together.
41. The method of claim 39 wherein the plurality of balloons are inflated separately.
42. The method of claim 35 wherein the medical device deployed within the vessel does not extend outside the vessel.
43. The method of claim 35 wherein the exterior surface of the medical device deployed within the vessel contacts the interior surface of the vessel.
44. The method of claim 35 wherein the larger diameter of the proximal portion of the balloon assembly tapers to a smaller diameter of the distal portion.
45. The method of claim 35 wherein the larger diameter of the proximal portion of the balloon assembly abruptly becomes the smaller diameter of the distal portion.
46. The method of claim 35 wherein the vessel is an artery.
47. A delivery device for delivering a medical device to a vessel within a mammalian body, said delivery device comprising:
- a balloon assembly comprising one or more balloons, wherein the balloon assembly has a distal portion and a proximal portion,
- wherein a medical device is provided on the distal portion of the balloon assembly, the medical device having a tubular body having an exterior surface and an interior surface, and a first end and a second end that define a length between the first end and the second end, thereby permitting the distal portion of the balloon assembly to contact the interior surface of the medical device, and
- wherein the balloon assembly is configured to have (i) an at least partially inflated state wherein the proximal portion of the balloon assembly has a larger diameter than the distal portion of the balloon assembly, thereby permitting the distal portion of the balloon assembly and the medical device to be inserted into the vessel and not permitting the proximal portion of the balloon assembly to enter the vessel, and (ii) a further inflated state wherein the distal portion is expanded in diameter, thereby deploying the medical device within the vessel.
48. The delivery device of claim 46 wherein the balloon assembly comprises a single balloon, wherein the proximal portion of the single balloon has a larger diameter than the distal portion of the single balloon.
49. The delivery device of claim 46 wherein the balloon assembly comprises a plurality of balloons.
50. The delivery device of claim 48 wherein interiors of the plurality of balloons are in fluid communication with one another.
51. The delivery device of claim 48 wherein interiors of the plurality of balloons are not in fluid communication with one another.
52. The delivery device of claim 46 wherein the medical device deployed within the vessel does not extend outside the vessel.
53. The delivery device of claim 46 wherein the larger diameter of the proximal portion of the balloon assembly tapers to a smaller diameter of the distal portion.
54. The delivery device of claim 46 wherein the larger diameter of the proximal portion of the balloon assembly abruptly becomes the smaller diameter of the distal portion.
55. The delivery device of claim 46 wherein the vessel is an artery.
56. A method for dilating tissue of a vessel within a mammalian body, said method comprising:
- providing a balloon assembly comprising one or more balloons, wherein the balloon assembly has a distal portion and a proximal portion;
- at least partially inflating the balloon assembly so that the proximal portion of the balloon assembly has a larger diameter than the distal portion of the balloon assembly;
- inserting the distal portion of the balloon assembly into the vessel so that the proximal portion of the balloon assembly does not enter the vessel; and
- further inflating the balloon assembly so that the distal portion expands in diameter, thereby contacting an interior surface of the vessel and dilating the tissue of the vessel.
57. The method of claim 56 wherein the balloon assembly comprises a single balloon, and wherein the proximal portion of the single balloon has a larger diameter than the distal portion of the single balloon.
58. The method of claim 56 wherein the balloon assembly comprises a plurality of balloons.
59. The method of claim 58 wherein the plurality of balloons are inflated together.
60. The method of claim 58 wherein the plurality of balloons are inflated separately.
61. The method of claim 56 wherein the larger diameter of the proximal portion of the balloon assembly tapers to a smaller diameter of the distal portion.
62. The method of claim 56 wherein the larger diameter of the proximal portion of the balloon assembly abruptly becomes the smaller diameter of the distal portion.
63. The method of claim 56 wherein the vessel is an artery.
64. A dilation device for dilating tissue of a vessel within a mammalian body, said dilation device comprising:
- a balloon assembly comprising one or more balloons, wherein the balloon assembly has a distal portion and a proximal portion,
- wherein the balloon assembly is configured to have (i) an at least partially inflated state wherein the proximal portion of the balloon assembly has a larger diameter than the distal portion of the balloon assembly, thereby permitting the distal portion of the balloon assembly to be inserted into the vessel and not permitting the proximal portion of the balloon assembly to enter the vessel, and (ii) a further inflated state wherein the distal portion is expanded in diameter, thereby contacting an interior surface of the vessel and dilating the tissue of the vessel.
65. The delivery device of claim 64 wherein the balloon assembly comprises a single balloon, wherein the proximal portion of the single balloon has a larger diameter than the distal portion of the single balloon.
66. The delivery device of claim 64 wherein the balloon assembly comprises a plurality of balloons.
67. The delivery device of claim 66 wherein interiors of the plurality of balloons are in fluid communication with one another.
68. The delivery device of claim 66 wherein interiors of the plurality of balloons are not in fluid communication with one another.
69. The delivery device of claim 64 wherein the larger diameter of the proximal portion of the balloon assembly tapers to a smaller diameter of the distal portion.
70. The delivery device of claim 64 wherein the larger diameter of the proximal portion of the balloon assembly abruptly becomes the smaller diameter of the distal portion.
71. The delivery device of claim 64 wherein the vessel is an artery.
Type: Application
Filed: Feb 2, 2012
Publication Date: Aug 2, 2012
Inventor: Russell A. Houser (Livermoor, CA)
Application Number: 13/365,165
International Classification: A61F 2/84 (20060101); A61M 29/02 (20060101);
