Patent Grant
7993350
The present invention relates generally to apparatus and methods for delivering instruments and/or agents during a medical procedure, and, more particularly, to apparatus and methods for delivering pacing leads or other devices, and/or for navigating and/or cannulating the coronary sinus, coronary vein branches, and/or other branches within a patient's vasculature.
Minimally invasive procedures have been implemented in a variety of medical settings, e.g., for vascular interventions, such as angioplasty, stenting, embolic protection, electrical heart stimulation, heart mapping and visualization, and the like. These procedures generally rely on accurately navigating and placing instruments within a patient's vasculature.
There are many risks involved with advancing instruments through a patient's vasculature. For example, a catheter or other instrument may dissect or otherwise damage a wall of a vessel or other body lumen, for example, as the instrument passes through narrow passages and/or tortuous anatomy, e.g., involving sharp bends. Such instruments also risk dislodging embolic material or even perforating body lumens.
In addition, it is often desirable to access body structures with precision such that an instrument or agent may be delivered precisely to a target location, e.g., where the instrument or agent may have diagnostic or therapeutic efficacy.
It is also often desirable to access very small vessels or other body lumens deep within a body, e.g., within a patient's heart, for example, to place a ventricular pacing lead within a coronary vein. However, instrument(s) used to access the vessels, e.g., a guide sheath, lead, and the like, may have a relatively large cross-section and/or may have relatively blunt and/or stiff distal tips, making it difficult to advance such instruments as deeply as desired into such small vessels. In some cases, it is desirable to access smaller side branches, e.g., off of the coronary veins, which may require bending and/or tracking an instrument through tortuous vasculature without causing kinks or torsion load problems.
Accordingly, apparatus, systems, and methods for delivering instruments and/or agents into blood vessels or other body lumens and/or for otherwise accessing vessels or other body lumens would be useful.
The present invention is directed generally to apparatus and methods for accessing body lumens and/or for delivering instruments and/or agents into body lumens during a medical procedure. More particularly, the present invention is directed to apparatus and methods for delivering pacing leads or other devices, and/or for navigating and/or cannulating the coronary sinus, coronary vein branches, and/or other branches within a patient's vasculature.
In accordance with one embodiment, an apparatus is provided for accessing a body lumen that includes a catheter or other tubular member and a stylet. In one embodiment, the catheter may include a proximal tubular member, a distal end sized for insertion into a body lumen, and at least one lumen extending between the proximal and distal ends. An elongate member, e.g., a relatively rigid backbone, may extend distally from the proximal tubular member. Optionally, the elongate member may vary in stiffness over its length, e.g., a distal tip of the elongate member may be relatively flexible, while a proximal portion of the elongate member may be less flexible. An expandable sheath may extend along at least a portion of the elongate member, the sheath being expandable from a contracted condition to minimize a profile of the sheath, e.g., to allow insertion along with the elongate member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen.
The stylet may be slidable distally and/or proximally along the elongate member and/or may be rotatable relative to the elongate member. For example, the elongate member may include one or more lumens, e.g., extending from the proximal portion to the distal tip, and the stylet may be slidable within one of the lumens. For example, the stylet may be insertable into and/or removable from the elongate member, e.g., insertable into and/or removable entirely from the proximal tubular member. Alternatively, the stylet may be substantially permanently coupled and/or integrated with the apparatus, e.g., to a handle on the proximal end of the proximal tubular member, and an actuator may be provided for advancing and/or withdrawing the stylet, e.g., into and/or from the distal tip of the elongate member.
In one embodiment, the rigidity of the stylet may be substantially greater than a distal tip of the elongate member such that the distal tip complies at least partially with a shape of the stylet when the stylet is advanced and/or positioned within the distal tip. For example, the stylet may have a predetermined shape set into the stylet before use, or the stylet may be malleable such that the stylet may be shaped by a user, e.g., to a desired curvature and/or angle that may facilitate navigation and/or cannulation of a target body lumen. Optionally, the distal tip of the elongate member may be pre-shaped to a predetermined curvature and/or angle, non-shaped, or “floppy,” e.g., to facilitate accessing a target body lumen.
Alternatively or in addition, the distal tip may be tapered and/or may include one or more different materials with varying stiffness profiles. For example, advancement and/or retraction of a shaped stylet may form varying curvatures and/or deflections for navigation through a patient's vasculature, other body lumens, and/or body cavities, e.g., based upon varying stiffness profiles along a length of the distal tip.
In a first embodiment, the stylet may have a distal shape-set tip and a substantially flexible distal tip may be provided on the elongate member that conforms substantially to the angle of deflection of the stylet tip. In another embodiment, the elongate member may include a shape-set distal tip and the stylet may include a shape-set tip such advancement of the stylet changes the shape of the distal tip and withdrawal of the stylet may bias the distal tip back towards its initial shape-set. Optionally, the stylet may be integrated with a handle of the tubular member to facilitate advancing and/or advancing the stylet while performing a medical procedure. In a further embodiment, the stylet may be removable and/or rotatable relative to the elongate member. For example, the shape-set distal tip of the elongate member may be advanced within a body lumen with the shape-set stylet in one orientation, and the stylet may be rotated, advanced, retracted, and/or otherwise moved relative to the distal tip such that each of the shape-set combinations may produce different profiles that may be shaped and/or steerable to facilitate tracking and/or navigation within a body cavity or lumen.
For example, such shapes may be optimized for cannulating tributaries within a patient's coronary venous system, such as mid-cardiac, posterior, lateral, antero-lateral, or other suitable targets for placing pacing leads. Additionally, shapes may be selected that facilitate direct delivery of leads to the right atrial, right ventricular, or other chambers of the heart.
In yet another embodiment, a catheter with a shape-set stylet may achieve various deflections and/or geometries from advancing and/or retracting the stylet for further accessing a coronary side-branch or tributary. For example, as the stylet's position is adjusted, the catheter may exhibit varying curvatures to facilitate navigation through vessels and side-branches. In one embodiment, the stylet may be held substantially stationary while the catheter is advanced, e.g., over the stylet, to facilitate positioning within a targeted side branch or other body lumen. If the distal tip is shaped, a side branch having an acute take-off angle may be easily cannulated using a combination of a shape-set distal tip and a shape-set stylet.
In accordance with another embodiment of the invention, an apparatus is provided for accessing a body lumen that includes a tubular proximal portion, and an expandable distal portion. In one embodiment, the proximal portion may include a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending between the proximal and distal ends. The distal portion may include an elongate pushable and/or stiffening member or “backbone” extending from the distal end of the tubular member, and an expandable sheath that is expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the elongate member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen.
through the sheath. A stylet or other member may be a movable relative to the stiffening member for modifying a stiffness and/or changing a shape of the stiffening member.
In accordance with another embodiment, a method is provided for accessing a body lumen using an apparatus including a tubular proximal portion and an expandable distal portion having a size smaller than the proximal portion. The distal portion is advanced into a patient's body, e.g., vasculature, with an expandable sheath thereon in a contracted condition. The proximal portion has sufficient length such that a distal end of the proximal portion may reach a first location within the patient's body, e.g., including relatively large body lumens, passages, or chambers, such as the vena cava, right atrium, and/or coronary sinus. With the proximal portion reaching the first location, the distal portion may extend into relatively smaller body lumens, such as the coronary veins, to a target location that is to be accessed. A stylet or other member may be advanced relative to the distal portion for changing a shape of the distal portion to access a side branch extending from the first location. For example, the distal portion may have a first shape for accessing the first location, and the stylet may change the first shape to a second shape for accessing the side branch. Optionally, after accessing the side branch, the distal portion may be advanced over the stylet into the side branch.
The expandable sheath may be expanded, thereby providing a substantially continuous lumen through the proximal and distal portions to the target location. In one embodiment, a cardiac pacing lead may be advanced through the proximal portion and the expandable sheath to deliver the lead to the target location. Because such a lead may be floppy, the proximal portion may guide the lead through the relatively large body lumens, passages, or chambers, while the expandable sheath may guide the lead through relatively small and/or tortuous body lumens to the target location. Once the lead is delivered to the target location, the apparatus may be removed.
In accordance with another embodiment, a thin walled flexible sleeve is provided that includes a main lumen and an elongate steering element attached to the sleeve, the steering element including a secondary lumen for receiving a pull wire or similar element. The main lumen may be sized for delivery of a lead, guidewire, or similar device. The steering element may be pushed, pulled, and/or otherwise manipulated for deflecting a portion of the sleeve, e.g., a tip of the sleeve at a distal-most point of attachment of the steering element. The steering element may be attached to the sleeve at one or more locations, e.g., using a friction fit, bonding, mechanical fasteners, or similar mechanisms for attachment at the tip of the sleeve.
Optionally, the steering element may be removable from and/or adjustable relative to the sleeve. For example, a constricting mechanism may be provided that holds the steering element in place when the mechanism is activated and/or before the mechanism is removed. Alternatively, the sleeve may include an extra lumen that may be pressurized or otherwise inflated to grip or hold onto the steering element by friction during delivering. To remove or disable the steering element, the extra lumen may be evacuated, thereby removing the pressure-activated friction holding the steering element.
In yet another embodiment, an apparatus is provided that includes a thin walled flexible sleeve, including a first or major lumen, e.g., sized to accept a lead, guidewire, or similar device, a steering element, and a stiffening element. The stiffening element may be disposed within a second or minor lumen, e.g., within the sleeve or steering element. The stiffening element may be fixed or slidable, e.g., to allow for variable steering. In one embodiment, the steering element and stiffening element may be adjacent to each other on the sleeve. Alternatively, the steering and stiffening elements may be placed separately such that they are apart. Furthermore, there may be one or more stiffening elements and/or steering elements.
Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
The drawings illustrate exemplary embodiments of the invention, in which:
Turning to the drawings,
Generally, the apparatus 8 includes a tubular proximal portion 10 and an expandable distal portion 18. The tubular proximal portion 10 is an elongate tubular member, e.g., a catheter, sheath, and the like, including a proximal end 12, a distal end 14 sized for insertion into a body lumen, and a lumen 16 extending between the proximal and distal ends 12, 14. Optionally, the tubular proximal portion 10 may include one or more additional lumens (not shown), e.g., for receiving a guide wire, inflation media, and/or for perfusion, as described further below. Such additional lumens may be disposed concentrically around one another or in a side-by-side arrangement.
The wall of the tubular portion 10 may be sufficiently thick such that the diameter (or other peripheral dimension) of the tubular portion 10 remains substantially fixed during use of the apparatus 8. The wall of the tubular portion 10 may be rigid or flexible, although self-supporting such that the tubular portion 10 does not collapse on itself. The tubular portion 10 may be sufficiently flexible to allow the tubular portion 10 to bend or otherwise be advanced through a patient's vasculature, while minimizing the risk of kinking or buckling.
The tubular portion 10 may be formed from uniform or variable flexibility material along its length between the proximal and distal ends 12, 14, as desired. For example, it may be desirable for the proximal end 12 to be substantially rigid or semi-rigid, e.g., to facilitate pushing the apparatus 8, while the distal end 14 may be semi-rigid or substantially flexible to accommodate advancement through bends within a patient's vasculature.
The tubular portion 10 may be formed from a variety of materials, such as PTFE, FEP, PFA, PE, Polyamides (Nylon), Polyimide, Pebax, Urethane, and the like. Optionally, the tubular portion 10 may include one or more braids or coils, e.g., embedded within the wall, to provide reinforcement for the tubular portion. In exemplary embodiments, the tubular portion 10 may have a diameter between about half and five millimeters (0.5-5 mm), a wall thickness between about 0.02 and one millimeters (0.02-1.0 mm) (cross-sectional configurations, i.e. multi-lumen cross-sections, and the like may cause wall thicknesses to vary), and a length between about ten and one hundred ten centimeters (10-110 cm), or between about forty and seventy centimeters (40-70 cm). For example, if a subclavian approach is to be used, the proximal portion 10 may have a length of about thirty centimeters (30 cm) or less, while if a femoral approach is to be used, the proximal portion 10 may have a length of about one hundred ten centimeters (110 cm) or more. In one embodiment, the tubular portion 10 may have a length sufficient to reach the vena cava, the right atrium, or the coronary sinus of a patient's heart from a percutaneous entry location, such as a subclavian vein, as described further below.
With continued reference to
The stiffening member 20 may be a solid or hollow guidewire, catheter, thread or other filament (e.g., a monofilament), and/or other solid or hollow elongate member. The stiffening member 20 may be sufficiently flexible to facilitate advancement through tortuous anatomy without causing dissection or perforation, yet may have sufficient column strength and/or torque-ability to be “pushable,” i.e., such that the stiffening member 20 may be advanced through a body lumen by pushing the proximal end 12 of the tubular portion 10 without substantial risk of kinking and/or buckling. In addition, the stiffening member 20 may also provide sufficient support to facilitate introducing secondary devices, such as a cardiac lead, through the distal portion 18. Cardiac leads or other floppy devices may be difficult to deliver, because of their ability to “prolapse” or double over on themselves in large lumens, like atria, rather than advance to a desired proper location.
In addition, the stiffening member 20 may have sufficient length to be advanced from a first location where the proximal portion 12 terminates, e.g., within the right atrium or coronary sinus of a heart, and a site to be accessed and/or treated, e.g., a coronary vein, as described further below. In exemplary embodiments where the stiffening member 20 is attached to the distal end 14 of the proximal portion 10, the stiffening member 20 may be between about ten and fifty centimeters (10-50 cm), or may be not more than about thirty centimeters (30 cm), not more than about ten centimeters (10 cm), or not more than about seven centimeters (7 cm). Alternatively, the stiffening member 20 may extend proximally the entire length of the proximal portion 10, e.g., within or along the proximal portion 10, and therefore may have additional length corresponding to the length of the proximal portion 10.
As shown in
Optionally, as shown in
Alternatively, as shown in
Optionally, the stiffening member 20 may include one or more lumens 26 extending between the proximal and distal ends 22, 24. For example, in the embodiment of
As shown in
Optionally, as best seen in
In addition or alternatively, the stiffening member 20 may include one or more outlet ports 29 on the distal end 24, e.g., distal to the balloon 27, as shown in
The stiffening member 20 may be formed from a variety of materials and using various methods. For example, the stiffening member 20 may be formed from plastic, glass, metal, or composites of such materials using known methods, such as extrusion and the like, thereby providing a desired combination of flexibility and column strength. In exemplary embodiments, the stiffening member 20 may be formed from one or more of polyimide, polyamide (nylon)), Ultem, PEEK, Nitinol, and optionally, may include braid and/or coil reinforcing polymers, similar to other components described herein.
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In addition or alternatively, as shown in
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With additional reference to
The sheath 30 may be expandable from a contracted condition (not shown) to an enlarged condition, as shown in
Optionally, the sheath 30 may be secured in the contracted condition, e.g., using a constraint (not shown), such as a sheath, tether, or releasable adhesive or bonding material at one or more locations or continuously along the sheath 30. Alternatively, the sheath 30 may simply maintain the contracted condition until an external force, e.g., fluid or an instrument, are delivered therein to expand the sheath 30 towards the enlarged condition. Exemplary apparatus and methods for placing and/or maintaining the sheath 30 in the contracted condition are disclosed in application Ser. No. 10/423,321, incorporated by reference above. In the enlarged condition, the sheath 30 may unfold, untwist, unwrap, or otherwise expand to at least partially define the lumen 36, e.g., for receiving a fluid (e.g., a medicament, anti-thrombotic agent, and the like) and/or one or more instruments therethrough (not shown).
Because the sheath 30 is relatively thin-walled, the distal portion 18 may attain a relatively low profile when the sheath 30 is in the contracted condition compared to the proximal portion 10. For example, with the sheath 30 in the contracted condition, the distal portion 18 may have a maximum diameter between about 0.1 and about ten millimeters (0.1-10 mm), or between about 0.2 and about three millimeters (0.2-3 mm). Conversely, a relatively large lumen 36 may be provided when the sheath 30 is expanded to the enlarged condition, e.g., having a diameter or other maximum cross-section between about 0.3 and about one hundred millimeters (0.3-100 mm), or preferably between about 0.3 and about twenty millimeters (0.3-20 mm).
The sheath 30 may be formed from relatively thin, flexible material, as compared to the stiffening member 20 and/or tubular proximal portion 10. Thus, the sheath 30 may be “flimsy,” i.e., may have little or no rigidity such that the sheath 30 provides little resistance to expansion and/or contraction, and/or may conform substantially to anatomy within which it is deployed. As used herein, “flimsy” means that the material of the sheath 30 is not biased to assume any particular configuration or shape, and therefore, the sheath 30 may adopt whatever shape and/or configuration that is imposed upon it, e.g., by being folded or otherwise compressed, by being subjected to external or internal pressure or force, and the like. To achieve this, the sheath 30 may have a relatively thin wall thickness, e.g., between about 0.001-1.25 millimeters, or between about 0.005-0.06 millimeter.
The sheath 30 may be constructed of one or more materials that may be fabricated to a relatively thin, flexible configuration, e.g., polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), fluorinated ethylenepropylene (FEP), polyethylene teraphathalate (PET), urethane, olefins, polyethylene (PE), silicone, latex, isoprene, chronoprene; and the like. The sheath 30 may be formed from lubricious material and/or may be coated, e.g., with silicone or other coating, e.g., for facilitating inserting one or more instruments (not shown) through the lumen 36.
In some embodiments, it may be desirable that the internal surface of the sheath 30 be lubricious to allow for smooth passage of an instrument, such as an electrical pacing lead (not shown), therethrough. This may be accomplished by forming the sheath 30 out of a lubricious material such as, a hydrophobic fluoropolymer. Alternatively, the sheath 30 may be formed from material that has been surface-treated and/or coated with a hydrophilic coating material. If it is particularly difficult to treat or coat the interior surface of the sheath 30, the treatment or coating material may be applied to the exterior surface of the sheath 30. The sheath 30 may then be inverted or “everted,” for example, by pulling one end of the sheath 30 through the sheath lumen to place the exterior treated/coated surface on the interior of the sheath 30 (i.e., turn the sheath 30 inside-out).
The sheath 30 may be formed from thin-walled polymeric tubing or a thin polymeric film. With respect to tube-based structures, the tubing may be extruded (or co-extruded if multiple lumens are used as is described in more detail below) to a thin wall. Alternatively, one or more post-processing steps, such as blow molding, stretching, or drawing tube through a heated die may be used to form the thin walled sheath 30. In still another embodiment, a thin film may be produced and rolled into a tubular configuration. In this embodiment, the thin film may be surface-treated and/or coated before being rolled into the tubular configuration.
With respect to thin film-based structures, a seam may be formed along all or a portion of the length of the sheath 30. The seam may be formed from any number of methods, for example, chemical bonding with adhesives, heat sealing, ultrasonic welding, laser welding, or mechanical bonding using stitching or the like.
As described above, in one embodiment, the sheath 30 may be formed from a lubricious fluoropolymer. For example, a thin-walled sheath 30 may be formed by rolling a cast thin film formed from PTFE having a layer of FEP formed thereon into a tubular structure. The FEP may then be sealed (for example, by heat sealing) to form the final tubular structure. The PTFE layer is preferably disposed on the interior surface of the sheath 30 since PTFE is more lubricious than FEP.
In still another alternative embodiment, the sheath 30 may be formed from ePTFE manufactured into a thin-walled tube (or multiple tubes) or thin film. Additional lumens may also be formed within the sheath 30. For example, these additional lumens may be used to house the backbone (i.e., elongate stiffening member 20) or used to inject contrast for imaging and/or perfusing blood or other fluids. As one example, additional lumens may be formed by joining un-sintered PTFE or ePTFE tube structures, which may then be heat-sealed along their lengths, followed by a sintering process.
In one embodiment, the sheath 30 is formed from substantially inelastic material, i.e., such that a primary contribution to the sheath 30 expanding and contracting is unfolding or folding the material of the sheath 30. Alternatively, the sheath 30 may be formed from an elastic material such that a secondary contribution to the sheath 30 expanding and contracting is an elasticity of the material of the sheath 30, i.e., such that a circumference or other peripheral dimension of the sheath 30 may increase as the sheath 30 expands towards the enlarged condition.
The sheath 30 may be substantially nonporous. Alternatively, the sheath 30 may be porous, for example, substantially continuously along its length or at one or more locations, e.g., to allow fluid delivered into the lumen 36 to pass through the wall of the sheath 30 in a desired manner, e.g., to deliver fluid to a wall of a vessel (not shown) through which the sheath 30 extends. In a further alternative, the sheath 30 may include one or more discrete openings (not shown) at one or more locations along its length.
In addition or alternatively, the sheath 30 may include a thin mesh, e.g. a perforated urethane film and the like. In a further alternative, the lubricity of the sheath 30 may be enhanced by providing a lubricious coating, lining, ribbing, and the like (not shown), and/or applying a lubricant, e.g., to the interior surface and/or outer surface of the sheath 30. The sheath 30 may include a single layer or multiple layers of such materials, such that a desired flexibility and lubricity is achieved. Thus, the sheath 30 may easily expand and/or line a body lumen to reduce friction and/or accommodate instruments being advanced through the body lumen, as explained further below.
Optionally, the sheath 30 may include one or more reinforcing elements (not shown). For example, a wire, thread, filament, and the like, formed from plastic, glass, metal, or composites of such materials, may be attached to an outer surface, an inner surface, and/or embedded in a wall of the sheath 30. In addition or alternatively, the sheath 30 may include relatively thickened regions that may be formed directly from the wall material. The reinforcing element(s) may extend circumferentially and/or helically around the sheath 30, and/or may extend axially along the sheath 30, depending upon the reinforcement desired. The reinforcement element(s) may also bias the sheath 30 to assume a desired shape or configuration when expanded towards the enlarged condition.
With particular reference to
Turning to
The expandable distal portion 18″ may include a stiffening member 20″ and an expandable sheath 30,″ similar to the previous embodiments. The stiffening member 20″ may include a proximal end 22″ attached to the distal end 14″ of the tubular portion 18,″ e.g., aligned with one of the grooves 17″ such that a lumen 26″ within the stiffening member 20″ communicates with the groove 17.″ A catheter, other tubular body, or cover (not shown) may be snapped into the groove 17″ or otherwise attached to the tubular portion 10″ to provide a lumen communicating with the stiffening member 20.″
The tubular body or cover may extend at least partially towards the proximal end of the tubular portion 10,″ e.g., to provide a lumen for receiving a guidewire or other element therethrough. For example, the tubular body may extend entirely to the proximal end of the tubular portion 10″ or to an intermediate location, e.g., to provide a rapid exchange lumen.
In addition, as best seen in
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Turning to
With particular reference to
Optionally, the inner member 60 may include a blade 68 adjacent the tubular section, e.g., partially embedded or otherwise attached to the outer surface of the tubular section. The blade 68 may provide a slitter for splitting or otherwise cutting the outer member 70, and/or one or more portions of the sheath 30 (or other apparatus coupled to the handle 50), as described further below.
Turning to
Returning to
An expandable sheath 30 (not shown in
As shown in
As described further below, when it is desired to remove the stiffening member 20 and expandable sheath 30, the outer member 70 may be withdrawn proximally relative to the inner member 60. This causes the blade 68 to contact the weakened or easily cut region 79 of the outer member 70, e.g., to cut through the outer member 70. As the outer member 70 is withdrawn further, the blade 68 may cut through the expandable sheath 30 (and/or the tubular proximal portion, if present), causing the expandable sheath 30 to split. Thus, the handle 50 may allow the expandable sheath 30 to be removed, while leaving the inner member 60 in place, e.g. with an instrument (not shown) maintained within the lumen 66 of the inner member 60 substantially stationary.
In alternative embodiments, other handles may be provided on the sheath apparatus 8 or any other sheath apparatus described elsewhere herein. In addition, the handle apparatus described herein may be useful for other applications, including introducer sheaths (not shown) for catheter-based procedures, and the like.
Turning to
Unlike the previous embodiment, the handle 50a includes a detachable slitter tool 68a that may be attached to the handle 50a, e.g., along the tubular section 60a. The slitter tool 68a may be attached by one or more tabs or other elements that may be broken, e.g., by bending the slitter 68a relative to the tubular section 60a. Once separated, the slitter 68a may be used to split or otherwise cut the tubular section 60a and/or the expandable sheath 30 similar to other embodiments described herein.
Turning to
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During use, a sheath apparatus, such as apparatus 8 shown in
Generally (with reference to
The sheath 30 may then be expanded to an enlarged condition, thereby defining a lumen 36 within the sheath 30. Thus, the apparatus 8 may provide a substantially continuous lumen, i.e., through the lumen 16 of the tubular proximal portion 10 and the lumen 36 of the sheath 30. The resulting lumen may extend continuously from the entry site through any intervening body passages to the target body lumen or site to provide a path from the entry site to the target body lumen or site.
A diagnostic and/or therapeutic procedure, such as the exemplary procedures described elsewhere herein, may be performed within the body lumen via the lumen defined by the apparatus 8. For example, one or more guidewires, catheters, leads, and the like may be advanced through the lumen provided by the apparatus 8. Upon completing the procedure(s), the apparatus 8 may be withdrawn from the body lumen, and entirely from the patient's body.
Turning to
For example, with the sheath 30 collapsed, the apparatus 8 may be introduced from a percutaneous entry site, e.g., a femoral vein or subclavian vein (not shown), and advanced through the patient's venous system into the vena cava 90, the right atrium 92 of the heart, and finally into the coronary sinus 94 to reach the target coronary vein 96. The apparatus 8 may be advanced over a guidewire (not shown), e.g., by placing the guidewire along the desired path to the coronary vein 96 using conventional methods. Exemplary apparatus and methods for accessing the coronary sinus 94 to deliver the apparatus 8 are disclosed in U.S. Pat. No. 6,959,290, issued Dec. 27, 2005, the entire disclosure of which is expressly incorporated herein by reference.
Because of the relatively low profile of the expandable distal portion 18 with the sheath 30 collapsed (which is substantially the size of the stiffening member 20), the apparatus 8 may be able to access smaller coronary veins or be advanced further into a target coronary vein than the tubular proximal portion 10 or conventional access sheaths.
Thus, the distal portion 18 with the sheath 30 collapsed may be advanced first from the percutaneous site into the right atrium 92 and coronary sinus 94. As the apparatus 8 is advanced further, the distal tip 28 of the distal portion 18 may be introduced into the target vein 96. As this occurs, the proximal portion 10 may pass through the vena cava 90 and into the right atrium 92, or even the coronary sinus 94, as shown. Because the proximal portion 10 may only pass through larger, less tortuous vessels, the larger profile may not impair advancement of the apparatus 8 to place the distal tip within the target vein 96.
If the distal portion 10 has a tapered distal end 14, the distal end 14 may also provide a transition to facilitate the tubular portion 10 following the smaller distal portion 18. In addition or alternatively, as shown in
Once the apparatus 8 is positioned with the expandable distal portion 18 in or near the target vein 96, fluoroscopy and/or other external imaging may be used to facilitate positioning the apparatus 8. Optionally, the apparatus 8 may include one or more radiopaque markers, e.g., on the distal end 24 of the stiffening member 20, the distal end 34 of the sheath 30, and/or the distal end 14 of the proximal tubular portion 10, to facilitate such imaging. In addition or alternatively, contrast may be introduced into the vein, e.g., via a fluid lumen in the stiffening member 20 of the apparatus 8 and/or through the lumen 34 of the sheath 30, to facilitate fluoroscopic imaging. Such imaging may be used to identify the location of the sheath 30 relative to nearby structures, e.g., to ensure that the apparatus 8 is advanced as close as possible to a target location. In the exemplary embodiment shown in
The expandable sheath 30 may then be expanded between the distal end 14 of the proximal tubular portion 10 and the target vein 96. A fluid, e.g., including saline and/or contrast, may be introduced into the sheath 30 to expand the sheath 30 towards its enlarged condition. Contrast delivered into the sheath 30 may also facilitate imaging the vein 96. In addition or alternatively, an instrument (not shown) may be advanced through the apparatus 8 to expand the sheath 30.
An electrical pacing lead (not shown) and/or other instrument may then be advanced through the proximal tubular portion 10 and the sheath 30 (which may expand or further expand the sheath 30) until the lead is disposed within the vein 96 beyond the distal tip 28. Because cardiac leads are extremely flexible or floppy, the relative strength and/or rigidity of the proximal portion 10 may facilitate advancing the lead through larger vessels, where the lead may otherwise wander or bind up. As the lead enters the sheath 30, the sheath 30 may provide a lubricious interface between the lead and the surrounding vessel wall, which may facilitate advancing the lead deeper into the patient's vasculature.
Once the lead is delivered, the apparatus 8 may be removed. For example, as described above, a handle, such as handle 50 described above (not shown in
To remove the apparatus 8, the outer member 70 may be retracted proximally, thereby withdrawing the tubular proximal portion 10, as well as the distal portion 18 (i.e., the stiffening member 20 and sheath 30), proximally from the patient's body. As the sheath 30 is removed from the percutaneous site, the sheath 30 may be split, e.g., by a blade 78 or other slitter tool (not shown) on the inner member 60.
While the outer member 70, tubular proximal portion 10 and expandable distal portion 18 are removed, the inner member 60 may be maintained substantially stationary, thereby maintaining the end of the lead within the target vein 96. Once the tubular proximal portion 10 and sheath 30 are removed from the patient, the inner member 60 may also be removed, while maintaining the lead substantially stationary. Because the inner member 60 has a relatively short length, the inner member 60 may be removed more easily with reduced risk of displacement of the lead, thereby ensuring that the lead remains within the target vein 96.
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As shown in
As shown in
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Unlike the previous embodiments, the apparatus 208 includes a balloon or other expandable member 260 on a distal end 234 of the sheath 230. The stiffening member 220 or sheath 230 may include a lumen (not shown) that communicates with an interior of the balloon 260, for delivering inflation media into the balloon 260 from a proximal end (not shown) of the apparatus 208. Thus, the balloon 260 may be expanded or collapsed by delivering or evacuating fluid into and out of the balloon 260.
As best seen in
The apparatus 208 may be used for delivering a lead 100, similar to the previous embodiments. For example, as shown in
Thereafter, as shown in
Turning to FIGS. 17 and 18A-18C, a thin sleeve 106 is shown that may be delivered in conjunction with a lead 100, e.g., a cardiac pacing lead. As best seen in
Turning to
Generally, after a lead, such as lead 100, is implanted, the wall of the coronary sinus may fibrose or otherwise attach to the lead 100. Because the sleeve 106 is disposed around the lead 100, any tissue fibrosis may attach to the sleeve 106, rather than to the lead 100 itself. Thereafter, if it is desired to remove or move the lead 100 (e.g., as often becomes necessary over time as the heart remodels itself to CRT therapy), the lead 100 may be manipulated or even removed, while the sleeve 106 remains in place. Without the sleeve 106, if the lead 100 is removed or otherwise moved, there is a substantial risk that the wall of the coronary sinus may rupture or otherwise be damaged due to the tissue fibrosis, requiring acute treatment of the patient.
Optionally, as shown in
Such a balloon or constraint may be provided on the lead 100 or on an apparatus (not shown) used to deliver the lead 100, e.g., on an exterior of a proximal portion of any of the apparatus described herein. Alternatively, the thin sleeve 106 may be delivered independently, e.g., before the lead 100 is delivered through the coronary sinus 96.
In other alternatives, the lead may include a drug or other material embedded within or otherwise carried by the lead that may prevent or minimize tissue fibrosis to the lead. In addition or alternatively, the outer surface of the lead may be treated, e.g., by micro-texturing that may prevent surrounding tissue from binding to the lead.
Turning to
The flexible sheath 130 may be affixed or otherwise secured to the elongate stiffening member 120 using any number of configurations.
In an alternative embodiment, a secondary tube 121 may be inserted through the lumen 120(b) of the elongate stiffening member 120 such that the sheath 130 is sandwiched between the exterior of the secondary tube 121 and the internal surface 120(c) of the elongate stiffening member 120. A mechanical junction is formed between elongate stiffening member 120 and the flexible sheath 130. This structure is particularly advantageous for materials that are difficult to heat or chemically bond, such as fluoropolymers. For example, the elongate stiffening member 120 and secondary tube 121 may be constructed out of a polymer material that reflows with heat (e.g., ePTFE) or a material coated with flowable polymer material. A mechanical lock may be achieved between the elongate stiffening member 120 and secondary tube 121 upon the reflowing of polymer material through the pores of the ePTFE within the sheath 130.
After bonding the two opposing FEP-FEP surfaces 140(b), 142(b), the structure shown in
In thin-walled materials with a low “hoop” strength, the collapse of the sheath 130 occurs readily. The collapse of the sheath 130 (either on itself or around another structure such as an elongate stiffening member 120) may prevent blood loss and/or further reinforce the pressure differential that keeps the sheath material in the collapsed configuration.
Turning to
As shown in
In an exemplary embodiment, an apparatus 3304, including the sleeve 3301 and the steering element 3302 may be loaded over a standard device 3303 (such as a guidewire, pacing lead, catheter, and the like) immediately before or during a procedure to impart steerability to the device 3303. Alternatively, the apparatus 3304 may be loaded onto the device 3303 in advance, e.g., during manufacturing.
Turning to
In an alternative embodiment, the pull wire 3305 may be replaced with a shaped or shapeable stylet or wire, which may be inserted into the tubular structure 3308 to impart steerability. In a further alternative, the tubular structure 3308 may be omitted, and the pull wire 3305 may extend proximally along an outer surface of the sleeve 3301 from the fixed distal end 3305a. Optionally, in this alternative, one or more bands, receivers, or other elements (not shown) may be provided spaced apart along the sleeve 3301 to capture the pull wire 3305 and/or otherwise prevent the pull wire 3305 from twisting around the sleeve 3301 and/or separating from the sleeve 3301, while allowing the pull wire 3305 to be pulled from the proximal end of the sleeve 3301.
Turning to
The tubular structures 3307′ and 3308′ may be disposed adjacent to one another around the periphery of the sleeve 3301′ or aligned against one another such that one is disposed radially away from the sleeve 3301.′ Alternatively, the stiffening element 3306′ may be separated from the steering element 3302,′ e.g., located opposite to the steering element 3302′ or any other position on the sleeve 3301′ (not shown). In further alternatives, there may be more than one steering element or stiffening element (not shown). While the steering element, stiffening element, and sleeve are shown as discrete lumens, the lumens may be formed such that they are segregated out of at least one or more major lumens (not shown).
Turning to
A distal end of the pressurization lumen 3309″ is closed such that, when inflation media, e.g., saline or nitrogen, are introduced into the pressurization lumen 3309,″ the pressurization lumen 3309″ may expand inwardly to engage a device 303 received in the device lumen 3301a.″ Thus, an interference or friction fit may be created between the sleeve 3301″ and the device 3303, thereby securing the sleeve 3301″ to the device 3303. Subsequently, if it is desired to remove the sleeve 3301,″ the pressurization lumen 3309″ may be evacuated, allowing the sleeve 3301″ to be removed, e.g., pulled from the proximal end (not shown) of the device 3303.
Turning to
With continued reference to
Optionally, the distal tip 3428 of the stiffening member 3420 may be radiopaque, e.g., to enhance visibility of the distal tip 3428 under fluoroscopy. In addition or alternatively, the distal tip 3428 may be tapered and/or substantially flat, e.g., to facilitate trackability through a patient's anatomy. In a further option, the distal tip 3428 may be substantially flexible, e.g., to facilitate navigation and/or enhance atraumaticity. In yet another alternative, the distal tip 3428 may be substantially stiff, e.g., to enhance maintaining the distal tip 3428 in a desired position at a desired anatomical site.
Similar to the previous embodiments, the distal tip 3428 may be shaped and/or steerable to facilitate tracking or navigation within a body cavity or lumen. For example, as shown in
Alternatively, as shown in
Alternatively, or in addition to having a pre-shaped distal tip, the apparatus 3408 may have a steerable or deflectable distal tip (not shown). For example, the expandable sheath 3430 and/or stiffening member 3420 may include one or more steering elements, e.g., a pull wire, rotatable and/or translatable shaped stylet, or any other available means for steering or deflection. For example, similar to previous embodiments, a pull wire (not shown) may extend through a lumen or other tubular structure extending along the expandable sheath 3430. Alternatively, a pull wire (also not shown) may extend through a lumen in the stiffening member 3420. If the expandable sheath 3430 connects to a tubular member, e.g., a catheter or sheath (not shown), the pull wire may extend through a lumen in the tubular member to a proximal end of the apparatus. An actuator on a handle or other location on the proximal end may be coupled to the pull wire to actuate the pull wire, e.g., to cause the expandable sheath 3430 to curve or otherwise bend in a desired manner.
Optionally, the steering element may include one or more elements for providing variable steering, similar to those described elsewhere herein and/or in application Ser. No. 11/062,074, incorporated by reference above.
Turning to
The guidewire lumen 3901 may exit at the proximal end (not shown) of the apparatus 3508 or anywhere along the length of the apparatus 3508. For example, in a rapid-exchange configuration, the guidewire may exit through a proximal opening 3902 in the stiffening member 3520 disposed a predetermined distance from the distal opening 3901a.
The expandable sheath 3530 and its distal opening 3531 may be adapted, for example, by appropriate attachment, reinforcement, and/or lubricity (e.g., using a hydrophylic coating) to track into a dilated or undilated vessel puncture in conjunction with advancing the stiffening member 3520 into a vessel over a guidewire.
Turning to
The expandable distal portion 318 generally includes an elongate stiffening member, catheter, or “backbone” 320 and an expandable sheath 330. The stiffening member 320 includes a distal tip 328, which may terminate distal to, proximal to, or be approximately co-terminus with the expandable sheath 330. The distal tip 328 and/or other portions of the stiffening member 320 may be constructed of one or more polymeric materials, such as PEBAX, urethanes, polyethylenes, fluoro-polymers, polyesters, polyamides, polyimides, and the like. The expandable sheath 330 may be expandable from a contracted condition (not shown) to an expanded condition (e.g., as shown in
Similar to other embodiments described herein, the distal tip 328 may be shaped and/or steerable to facilitated tracking or navigation within a body cavity or lumen. For example, the distal tip 328 may be substantially flexible, e.g., relatively flexible compared to the stylet 370 such that the stylet 370 may be used to change the shape or otherwise manipulate the distal tip 328, as described further elsewhere herein. In addition or alternatively, the distal tip 328 and/or a distal portion 329 of the stiffening member 320 may be shape-set, i.e., may be biased to a predetermined nonlinear shape. For example, similar to the embodiments shown in
The stylet 370 may be a substantially rigid, semi-rigid, or flexible elongate member that includes a proximal end 372, e.g., including a handle 373, a distal end 374 sized for insertion into the stiffening member 320, and a distal portion 376 including a nonlinear shape. As shown in
For example, in one embodiment, at least the distal portion 376 of the stylet 370 may be formed from malleable material, e.g., Nitinol, stainless steel, or other similar memory retaining materials, such that the stylet 370 may be manipulated into a desired shape and then remain biased to that shape. For example, at least the distal portion 376 of the stylet 370 may be bent, curved, or otherwise formed into a desired nonlinear shape while the stylet 370 is separate from the apparatus 308. The stylet 370 may then remember the shape while being advanced through the apparatus 308 and/or into the stiffening member 320, and/or while being delivered through a patient's vasculature and/or other tortuous anatomy, e.g., together with or separate from the apparatus 308. In addition or alternatively, the stylet 370 may include a pre-set shape, e.g., including one or more bends or other nonlinear shapes to which the stylet 370 is biased. The stylet 370 may be sufficiently flexible to allow the stylet 370 to conform to the shape of the apparatus 308 and/or surrounding anatomy, e.g., during delivery, but may be biased to the shape-set, e.g. upon being advanced into the distal tip 328 of the stiffening member 320 and/or otherwise deployed.
During use, the apparatus 308 may be introduced into a patient's vasculature or other body lumens during a procedure, e.g., to deliver a pacing lead, similar to other embodiments. The stylet 370 may be separate from the apparatus 308 during introduction or may be preloaded within the apparatus 308 proximal to at least the distal tip 328. If preloaded, the proximal portion of the stiffening member 320, e.g., proximal to the distal tip 328, may be sufficiently rigid to resist substantially adopting the shape of the stylet 370 or being affected by the shape-set of the stylet 370. Alternatively, the stylet 370 may be disposed within the tubular member 310 during delivery.
Once the stiffening member 320 is disposed within a first location, e.g., a vessel within a patient's coronary venous system, the stylet 370 may be inserted into the distal tip 328, thereby biasing the distal tip 328 towards a desired nonlinear shape. For example, the distal tip 328 of the stiffening member 320 may be sufficiently flexible to comply with the curvature of the stylet 376, e.g., such that the distal tip 328 may be biased to the shape-set of the stylet 376. Alternatively, the distal tip 328 may have a first shape-set, and the stylet 370 may have a second shape-set such that insertion of the stylet 370 causes the distal tip 328 to adopt a third shape based upon the combined geometries of the first and second shape-sets and/or the relative rigidities of the stylet 370 and the distal tip 328. Optionally, the stylet 370 may be rotated and/or directable axially within or otherwise relative to the distal tip 328, e.g., to change the shape and/or orientation of the distal tip 328 within a patient's vasculature or other body lumen.
In an alternative embodiment, the stylet 370 may not be removable entirely from the apparatus 308. For example, the handle 350 may include an actuator (not shown) to which the stylet 370 is coupled such that the stylet 370 is integrated with the tubular member 310 and/or stiffening member 320. For example, the actuator may limit movement of the stylet 370 between a proximal position, e.g., where the stylet 370 is removed from the distal tip 328, and a distal position, e.g., where the stylet 370 is inserted into the distal tip 328. Thus, during delivery, the stylet 370 may be maintained in the proximal position, but may be advanced to the distal position when desired using the actuator. Optionally, the stylet 370 may be movable to multiple preset distal positions, e.g., where the stylet 370 is moved relative to the distal tip 328 to modify a shape of the distal tip 328, or may be movable freely between the proximal and distal positions.
Optionally, as shown in
Turning to
The apparatus 308 may be manipulated to direct the distal tip 328 with the stylet 370 therein into the branch 96. For example, with the stylet 370 within the distal tip 328, the distal tip 328 may become biased to adopting an acute bend, as shown in
Once the stylet 370 and distal tip 328 have been positioned in the branch 96, the apparatus 308 may be advanced further into the branch 96 over the stylet 370. For example, the position of the stylet 370 may be maintained, e.g., by placing tension on the stylet 370 and/or otherwise holding the stylet 370 substantially stationary, while advancing the apparatus 308 distally over the stylet 376, as shown in
Turning to
Optionally, additional curvatures and/or shapes may be achieved by rotating the shape-set stylet 370 relative to the distal tip 328, and/or by a combination of relative rotation and/or advancement/retraction between the shape-set stylet 370 and the stiffening member 320. In addition or alternatively, the distal tip 328 may have a shape memory and/or may be malleable such that the distal tip 328 becomes biased towards a shape created when the stylet 370 is advanced into the distal tip 328. Thereafter, as the stylet 370 is retracted, the angle of the distal tip 328 may be maintained, as created by the shape-set of the stylet 370, e.g., as shown in
Turning to
In addition and/or alternatively, a shape-set and/or varying stiffness distal tip in combination with a shape-set stylet may be combined to provide any desired degree of deflection and/or curvature in the embodiments described herein or in other catheter devices. For example, such shapes may be used for cannulating coronary vein tributaries within the coronary venous system, such as mid-cardiac, posterior, lateral, antero-lateral, or other suitable target locations, e.g., for placing pacing leads. Optionally, other alternative shapes may be selected that may facilitate direct delivery of leads to the right atrial, right ventricular, or other chambers of the heart.
Optionally, in addition to having a shape-set tip and/or stylet, the embodiments described herein may include other components, materials, and/or constructions, such as those described elsewhere herein. The steerable and/or shapeable features described herein may be included in other catheters or tubular devices, e.g., not including an expandable sheath, if desired. In addition or alternatively, the embodiments described herein may be formed using methods of construction for slitting and/or peeling, e.g., with ripcords and/or tabs, such as those disclosed in U.S. application Ser. No. 11/563,142, filed Nov. 24, 2006, the entire disclosure of which is expressly incorporated by reference herein.
Turning to
Turning to
Turning to
Referring to
Turning to
In
Referring to
It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.
While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims.
This application claims benefit of provisional application Ser. No. 60/798,915, filed May 9, 2006. This application is also a continuation-in-part of co-pending application Ser. No. 11/347,361, filed Feb. 3, 2006, which claims benefit of provisional applications Ser. No. 60/649,497, filed Feb. 3, 2005, and 60/752,763 filed Dec. 20, 2005, and is a continuation-in-part of co-pending application Ser. No. 10/958,034, filed Oct. 4, 2004 and Ser. No. 11/062,074 filed Feb. 17, 2005. The entire disclosures of these applications are expressly incorporated herein by reference.
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