US20120179097A1 - Methods and apparatus for an adjustable stiffness catheter - Google Patents

Abstract

Apparatus and methods for an endovascular catheter that can be inserted within tortuous body anatomies and then selectively stiffened and fixed in place. In a particular embodiment, this stiffness is reversible. The stiffness or a comparable mechanical characteristic of the catheter assembly may be adjusted to a relatively low value during insertion (so that it easily navigates a guide wire or the like), and then subsequently adjusted to a relatively high value in situ to keep the catheter assembly substantially fixed in place (i.e., during delivery of an interventional device).

Description

CROSS-REFERENCE TO A RELATED APPLICATION
• This application claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/430,303 filed on Jan. 6, 2011, the content of which is incorporated herein in its entirety.
TECHNICAL FIELD
• Embodiments of the subject matter described herein generally relate to catheter systems, and more particularly relate to catheters of the type used in the context of tortuous anatomic features.
BACKGROUND
• Catheters are useful in performing a wide range of medical procedures, such as diagnostic heart catheterization, percutaneous transluminal coronary angioplasty, and various endocardial mapping and ablation procedures. It is often difficult, however, to selectively catheterize certain vessels of the human body due to the tortuous paths that the vessels follow.FIG. 1, for example, is a conceptual diagram useful in depicting the humanaortic arch100. As shown, theascending aorta110 rises from its origin at the aortic valve (not shown). The rightcommon carotid104 and the right subclavian103 branch off of thebrachiocephalic artery102. The leftcommon carotid105 and the leftsubclavian artery106 branch and rise from the aorta just before it turns and descends to the descendingaorta120. Dashedline170 depicts a typical catheter placement that might be desirable in this context.
• Normal aortic arches such as that shown inFIG. 1 rarely require intervention. Instead, interventionalists most often find themselves viewing and navigating diseased and abnormal aortic pathology, such as that shown inFIGS. 2A-2D, which depict assorted variant conditions of the human aortic arch (201-204). It is clear that navigation from the descendingaorta120, up over the arch, and then back to gain access to the rightbrachiocepalic artery102 can be extremely difficult in such cases, particularly when the arteries are partially occluded with easily displaced and dislodged build-ups of plaque.
• As a result, catheterization procedures often require multiple catheter exchanges—i.e., successively exchanging catheters with different sizes and/or stiffness to “build a rail” through which subsequent catheters can be inserted, eventually resulting in a wire and guide stiff enough to allow delivery of the intended interventional device (e.g., a stent, stent-graft, or the like).
• Flexibility is therefore desirable in a catheter to allow it to track over a relatively flexible guidewire without causing the guidewire to pull out. That is, the “navigatibility” of the catheter is important. At the same time, the stiffness or rigidity of the same catheter is desirable to allow the guiding catheter to be robust enough to allow a relatively stiff device (such as a stent) to be tracked through the guiding catheter without causing the guiding catheter to lose position (i.e., becoming “dislodged”). If dislodgement occurs, the entire procedure of guide wire and guide catheter exchanges must be performed again from the beginning.
• Often, an optimal balance is sought, such that the distal end of the catheter is flexible, and the proximal end is stiff to enable tracking. However, in order to move the stiff part of a catheter in place, the flexible section typically needs to be buried deep within the anatomy to get “purchase” and to hold position. In many instances, the anatomy does not allow for deep purchase. Accordingly, there is a need for catheter designs and methods that overcome these and other shortcomings of the prior art.
SUMMARY OF THE INVENTION
• The present invention generally relates to a catheter assembly having an adjustable stiffness during, for example, endovascular procedures within the human body. That is, the stiffness or a comparable mechanical characteristic of the catheter assembly may be adjusted to a relatively low value during insertion (so that it easily navigates a guide wire or the like), and then subsequently adjusted to a relatively high value in situ to keep the catheter assembly substantially fixed in place (i.e., during delivery of an interventional device).
BRIEF DESCRIPTION OF THE DRAWINGS
• A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures.
• FIG. 1 is a conceptual diagram depicting a human aortic arch useful in describing the present invention;
• FIGS. 2(a)-(d) depict various common aortic pathologies;
• FIG. 3 is a conceptual cross-sectional diagram depicting a catheter apparatus in accordance with one embodiment;
• FIGS. 4 and 5 are qualitative graphs showing the value of a stiffness metric as a function of length for catheters in accordance with various embodiments;
• FIG. 6 depicts a three-point bend test used for measuring a stiffness metric;
• FIGS. 7(a)-(c) depicts an alternate test used for measuring a stiffness metric;
• FIGS. 8(a)-(b) depicts a catheter apparatus in accordance with one embodiment;
• FIG. 9 depicts a catheter apparatus in accordance with one embodiment;
• FIGS. 10(a)-(b) and11 depict a catheter apparatus in accordance with one embodiment;
• FIGS. 12-13 depict a catheter apparatus in accordance with one embodiment;
• FIGS. 14-15 depict a catheter apparatus in accordance with one embodiment;
• FIGS. 16-17 depict a catheter apparatus in accordance with one embodiment;
• FIGS. 18(a)-(c) depicts lumen configurations in accordance with various embodiments; and
• FIG. 19 depicts a qualitative graph showing the value of a stiffness metric in accordance with one embodiment.
DETAILED DESCRIPTIONOverview
• Referring to the longitudinal cross-section shown inFIG. 3, a catheter apparatus (or simply “catheter”)300 in accordance with one embodiment generally includes a generally tubular body (or simply “body”)304 having a delivery lumen (or simply “lumen”)301 defined therein.Catheter300 extends from a distal end308 (generally, the end configured to be inserted first within an anatomical feature) and aproximal end310 oppositedistal end308. Acontroller320 communicatively coupled tocatheter body304 and/orlumen301 will also typically be provided for controlling the operation ofcatheter300, as discussed in further detail below.
• An activation means (not illustrated inFIG. 3) is provided for causingbody304 to enter two or more states, which may be discrete states or states that vary continuously, or a combination thereof. The activation means will generally include a variety of mechanical, pneumatic, hydraulic, electrical, thermal, chemical, and or other components as described in connection with the various embodiments presented below, and may be incorporated intobody304,lumen301,controller320, or a combination thereof. In various embodiments,controller320 is one component of the activation means.
• In general,body304 can be selectably placed in at least two states. In the first state,body304 has a relatively low stiffness and/or has other mechanical properties selected such thatcatheter300 can easily be inserted (e.g., via manual axial force applied at proximal end310) over a guide wire or the like without substantially disturbing the placement of that guide wire. A variety of conventional, commercially available guide wires are known in the art, and need not be discussed in detail herein. In the second state,body304 has a relatively high stiffness and/or other has mechanical properties selected such thatcatheter300 remains substantially in place within the anatomical feature during subsequent operations, including the removal of any guide wire used during insertion. Stated another way, while in the first state,body304 has a stiffness metric that is equal to or less than a predetermined “navigatibility threshold,” and while in the second state,body304 has a stiffness metric that is greater than or equal to a predetermined “rigidity threshold.” This is illustrated inFIG. 19, which qualitatively depicts two states (1902 and1904) and their corresponding stiffness threshold values (i.e., navigatibility threshold and rigidity threshold, respectively).
• The term “stiffness metric” as used herein refers to a dimensionless or dimensional parameter that may be defined in various ways, as described in further detail below. However, regardless of the nature of the stiffness metric, the navigatibility threshold and rigidity threshold define the primary modes of operation ofcatheter300. In this regard, note that “stiffness metric” is often used herein to refer to an actual stiffness metric value.
Stiffness Metric and Thresholds
• FIG. 4 presents a qualitative graphical representation of a stiffness metric (S) as a function of distance alongcatheter300 from its proximal end to its distal end.FIG. 4 corresponds to the case where the stiffness metric is substantially uniform along its length, but as will be seen below, the invention is not so limited.Dashed line412 indicates the navigatibility threshold, anddashed line410 represents the rigidity threshold for a given stiffness metric. While in the first state (during insertion)catheter300 has astiffness metric402 that is equal to or less thannavigatibility threshold412. Similarly, while in the second state,catheter300 has a stiffness metric410 that is greater than or equal torigidity threshold410.
• In one embodiment, the stiffness metric corresponds to the flexural modulus ofcatheter300—i.e., the ratio of stress to strain during bending, as is known in the art. This value may be determined empirically, for example, using a three-point bend test as shown inFIG. 6, wherein catheter300 (or a portion of catheter300) is placed on a pair ofsupports602 and604 that are a known distance apart, and a downward (radial)force608 is applied tocatheter300 via athird structure606 that is situated betweensupports602 and604.
• In another embodiment, the stiffness metric corresponds to an empirical measurement that more closely models the actual operation ofcatheter300. For example,FIGS. 7(a)-(c) depict a “dislodgment” test that simulates the placement of acatheter300 placed at approximately a 90-degree angle (although this angle may vary depending upon the test). More particularly,stationary supports702,704, and706 are positioned in a predetermined geometric relation such that catheter300 (or a short segment cut from catheter300) must bend to fit betweensupports702 and704 while contactingsupport706. Additional supports (not illustrated) may also be used to assist in placingcatheter300.
• During the start of the test, aprobe702 is inserted within one end ofcatheter300 as shown (FIG. 7(a)).Probe702 might be configured to approximate the stiffness of a typical stent-graft or the like. Asprobe702 is further inserted into thelumen301 ofcatheter300, it makes contact with the inner surface of thelumen301 and causes end308 to move with respect to support702. Ultimately, whenprobe702 is inserted with a sufficient force,catheter300 will be released entirely from betweensupports702 and704 as shown. The force necessary to dislodgecatheter300 in this way then becomes the stiffness metric. The test is advantageously conducted at approximately 37° C. (body temperature). Further, the test may be initiated with an exemplary guide wire in place, thereby allowing the navigatibility threshold to be determined.
Stiffness Metric Variation
• WhileFIG. 4 depicts the stiffness metric as being invariant over the length ofcatheter300, the invention is not so limited.FIG. 5 presents a qualitative graphical representation of stiffness metric (S) as a function of distance alongcatheter300 from its proximal end to its distal end; however, in this embodiment,catheter300 includes two “zones” or segments, each having a corresponding stiffness metric while in the second state. That is, inzone520, the stiffness metric in the second state (504) is substantially the same as the stiffness metric in the first state (502) (i.e., is generally below the navigatibility threshold412). Withinzone522, the stiffness metric in the second state (504) is above therigidity threshold410.
• Catheter300 may include any number of such zones. Furthermore, the stiffness metric within each zone may be constant or vary continuously. In a particular embodiment, a first zone is adjacent to the distal end ofcatheter300, and a second zone is adjacent to the first zone, wherein the stiffness metric of the first zone is less than the stiffness metric of the second zone while in the second state.
• In an alternate embodiment,catheter300 has one stiffness metric value along a first curvature axis and another stiffness metric value along a second curvature axis that is orthogonal to the first curvature axis.
Catheter Body
• Catheter body304 may have any suitable structure, and be fabricated using any suitable combination of materials capable of achieving the selectable stiffness metric described above. For example, in one embodiment,catheter body304 includes a helical (spiral) channel formed within its exterior and/or its interior. The channel effectively weakensbody304 such that the stiffness metric in the first state is lower than it would be if thebody304 were perfectly tubular. In another embodiment,catheter body304 includes a plurality of ring-shaped channels formed circumferentially therein. In a particular embodiment, the plurality of ring-shaped channels are distributed irregularly along the tubular body. Such an embodiment allows the baseline stiffness metric to vary in a specified way along the length ofcatheter300.
• Catheter body304 may comprise a variety of materials. Typical materials used to construct catheters can comprise commonly known materials such as Amorphous Commodity Thermoplastics that include Polymethyl Methacrylate (PMMA or Acrylic), Polystyrene (PS), Acrylonitrile Butadiene Styrene (ABS), Polyvinyl Chloride (PVC), Modified Polyethylene Terephthalate Glycol (PETG), Cellulose Acetate Butyrate (CAB); Semi-Crystalline Commodity Plastics that include Polyethylene (PE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE or LLDPE), Polypropylene (PP), Polymethylpentene (PMP); Amorphous Engineering Thermoplastics that include Polycarbonate (PC), Polyphenylene Oxide (PPO), Modified Polyphenylene Oxide (Mod PPO), Polyphenelyne Ether (PPE), Modified Polyphenelyne Ether (Mod PPE), Polyurethane (PU), Thermoplastic Polyurethane (TPU); Semi-Crystalline Engineering Thermoplastics that include Polyamide (PA or Nylon), Polyoxymethylene (POM or Acetal), Polyethylene Terephthalate (PET, Thermoplastic Polyester), Polybutylene Terephthalate (PBT, Thermoplastic Polyester), Ultra High Molecular Weight Polyethylene (UHMW-PE); High Performance Thermoplastics that include Polyimide (PI, Imidized Plastic), Polyamide Imide (PAI, Imidized Plastic), Polybenzimidazole (PBI, Imidized Plastic); Amorphous High Performance Thermoplastics that include Polysulfone (PSU), Polyetherimide (PEI), Polyether Sulfone (PES), Polyaryl Sulfone (PAS); Semi-Crystalline High Performance Thermoplastics that include Polyphenylene Sulfide (PPS), Polyetheretherketone (PEEK); and Semi-Crystalline High Performance Thermoplastics, Fluoropolymers that include Fluorinated Ethylene Propylene (FEP), Ethylene Chlorotrifluroethylene (ECTFE), Ethylene, Ethylene Tetrafluoroethylene (ETFE), Polychlortrifluoroethylene (PCTFE), Polytetrafluoroethylene (PTFE), Expanded Polytetrafluoroethylene (ePTFE), Polyvinylidene Fluoride (PVDF), Perfluoroalkoxy (PFA). Other commonly known medical grade materials include elastomeric organosilicon polymers, polyether block amide or thermoplastic copolyether (PEBAX), Kevlar, and metals such as stainless steel and nickel/titanium (nitinol) alloys.
• The material or materials selected forcatheter body304 may depend upon, for example, the nature of the activation means used to effect a transition from the first state to the second state of operation.Catheter body304 may be manufactured, for example, using conventional extrusion methods or film-wrapping techniques as described in U.S. Pat. App. No. 2005/0059957, which is hereby incorporated by reference. Additional information regarding the manufacture of catheters may be found, for example, at U.S. Pat. No. 5,324,284, U.S. Pat. No. 3,485,234, and U.S. Pat. No. 3,585,707, all of which are hereby incorporated by reference.
Activation Means (Generally)
• Catheter300 includes activation means for causingbody304 to enter two or more states as detailed above. The activation means may make use of a variety of physical phenomenon and be composed of any number of components provided within and/or communicatively coupled tocatheter300, including for example,controller320 as illustrated inFIG. 1. The change of state may be accomplished, for example, via mechanical activation, electrical activation, pneumatic activation, chemical activation, and/or thermal activation. Typically, activation will occur subsequent to catheter placement—i.e., in situ. Various specific types of activation means will now be discussed below in conjunction the exemplary embodiments.
EMBODIMENT 1Thermal Activation
• In one embodiment, the activation means includes acontroller320 communicatively coupled tobody304 as well features withinbody304 that are together adapted to place the body in the second state by subjecting at least a portion of thecatheter300 to a reduction or change in temperature.
• Referring now toFIGS. 8 (a)-(b) in conjunction withFIG. 1, acatheter300 in accordance with one embodiment generally includes two auxiliary lumens orchannels802 and804 that are interconnected (e.g., fluidly coupled near a distal end) such that the coolant travels throughbody304. Thechannels804 and802 are separated, for example, by a membrane (such as an ePTFE membrane)806.
• After delivery of catheter300 (during which it is in the first state), acoolant805 such as liquid nitrogen is supplied to channel804 (e.g., via a coolant delivery system within controller320), where it travels parallel to lumen301 along the length of (or a portion of)body304. As the changes from liquid to gas atmembrane806, it coolsbody304 as well asmembrane806. The materials forcatheter body304 and/ormembrane806 are selected that their stiffness increases as the temperature is reduced. Exemplary materials include, for example, urethane and the like. Aschannel804 is significantly smaller thanchannel802,compressed gas803 is allowed to expand as it passes throughmembrane806 intochannel802.
• As a result of heat transfer from the coolant, the coolant (in the case of liquid nitrogen) changes to a gas phase and exits throughchannel802. In other embodiments, the coolant remains in liquid form during operation. Suitable coolants include, for example, chilled saline, liquid CO₂, liquid N₂, and the like. Other approved medical chilling methods may also be employed.
EMBODIMENT 2Axial Compression
• Referring now toFIGS. 16 and 17 in conjunction withFIG. 1, in one embodiment, the activation means includescontroller320 communicatively coupled to thebody304 and components withinbody304 that are adapted to placebody304 in the second state by subjecting it to an increase in axial compression.
• As shown inFIG. 16, one ormore tension lines1602 may be used to selectively apply a compressive force tobody304. Thetension lines1602 are attached at thedistal end308 ofcatheter300 and are slideably received by correspondingaccessory lumens1402 that pass through a series ofbody segments1605. Theaccessory lumens1402 are preferably sized to allow the free axial movement oftension lines1602. Depending upon the particular design,body segments1605 will typically be separated by a smallinterstitial gaps1607.
• Thetension lines1602 are subjected to approximately zero tension (i.e., are generally “slack”) while navigating the anatomy during the first state; however, when stiffening of all or a portion ofcatheter300 is desired,tension lines1602 are pulled substantially simultaneously as depicted inFIG. 17. Gaps and the orientation betweenbody segments1605 may be optimized to reduce (and/or increase the repeatability of) the foreshortening that occurs when tension is applied. In one embodiment,tension wires1602 are attached to a floating gimbal mechanism incorporated intocontroller320. Once tension is applied, the compressive force tends to bind the catheter; thereby decreasing it's flexibility in that section. Reduction in the axial length may accompany the application of tension. That is, as illustrated, theinterstitial gaps1607 may be reduced.
• The tension lines may be made of any suitably strong and flexible material, such as polymeric or metallic filaments or ribbons. The force necessary to placecatheter300 in the second state may vary depending upon the length, material, and cross-section oftension lines1602, as well as the structural characteristics ofbody304.
• Any number oftension lines1602 andaccessory lumens1402 may be used.FIGS. 18(a)-(c) present a cross-sectional view of various designs forcatheter body304, including three equidistant accessory lumens1402 (FIG. 18(a)), two equidistant accessory lumens1402 (FIG. 18(b)), and four equidistant accessory lumens (FIG. 18(c)). In addition, equidistant accessory lumens may be distributed in any arbitrary fashion, and need not be symmetrical or equidistant as illustrated.
• In one embodiment, the column stiffness ofbody304 is modified to allow for tracking, then increased to deployment without foreshortening during stiffening.
EMBODIMENT 3Radial Compression
• In one embodiment, the activation means includescontroller320 communicatively coupled to thebody304 and adapted to place thebody304 in the second state by subjecting at least a portion of the tubular body to an increase in radial compression. For example,body304 may include two fluid impermeable layers defining a pressure-responsive chamber and at least one interstitial structure provided within the pressure-responsive chamber. The controller is configured to cause a change in internal pressure within the pressure-responsive chamber; and the interstitial structure is adapted to exhibit radial compression in response to the change in internal pressure.
• Referring now toFIG. 9, in the illustratedembodiment catheter300 includes anaccessory lumen902 extending fromchambers906 to ahub302.Hub302 in this embodiment is configured as a standard “Y” fitting, wherein negative pressure (i.e., a reduction from some baseline pressure) is applied be attaching a syringe toluer fitting910. When negative pressure is applied,chambers906 collapse and apply pressure to corresponding body segments904 (as illustrated inFIGS. 12 and 13). The pressure is preferably great enough to cause a change in stiffness metric of the affected portion ofcatheter300.
• In an alternate embodiment shown inFIGS. 10A and 10B, thebody304 comprises a layered structure1002 (i.e., an interstitial component) positioned between two or more layers of an air-impermeable chamber1004. To facilitate the use of negative pressure, thechamber1004 includes a flexible polymeric material configured to be non-permeable while in the bloodstream. The flexible polymeric comprise, for example, Polyethylene Terephthalate (PET), Polyurethane, Fluorinated Ethylene Propylene (FEP), Nylons or Flouropolymers, including Polytetrafluoroethylene (PTFE) or Expanded Polytetrafluoroethylene (ePTFE), or combinations thereof.
• At atmospheric pressure, bending causes the individual components oflayers1002 to slide across each other with minimum friction. When the individual layers are allowed to slide and act individually, the resulting stiffness metric is very low. Upon application of negative pressure, however, a normal (i.e., radial)force1008 is created withinstructure1002 by the collapse of theflexible polymeric material1004. This normal force is translated through the layers, increasing the layer-to-layer friction and limiting their ability to slide with respect to each other. As a result, the stiffness metric of the structure is increased. In an alternate embodiment, the pressure is increased in an adjacent pressure chamber, thereby causing that chamber to press the adjacent layered structure.
• Thelayered structure1002 of the present invention may be manufactured using a variety of processes, including, for example, tape wrapping, braiding, serving, coiling, and manual layup. Suitable materials include, include, fibers/yarns (Kelvar, nylon, glass, etc), wires (flat or round, stainless steel, nitinol, alloys, etc), and/or thin slits of film (Polyester, Nylon, Polyimide, Fluoropolymers including PTFE and ePTFE, etc.) In this embodiment, the change in stiffness metric is easily reversed by allowing the chamber pressure to increase (e.g., by relaxation of a syringe attached to luer fitting910), thereby decreasing the applied normal force.
• In an alternate embodiment depicted inFIG. 11, multiplediscrete air chambers1102 are distributed along the length ofcatheter300 and can be toggled independently.Chambers1102 may be composed of differentiated layered structures, such as layers of slit,thin film1104. The distal air chambers may be controlled independently throughlumen1109, while the proximal air chamber is controlled throughlumen1108. This allows the operator to control the segments independently to varying degrees of stiffness change. Thelumens1108 and1109 may be constructed in a variety of conventional ways, including evacuation through the annular space of the chamber, or individual lumens of tubing such as polyimide that either have an open end in communication with the hub, or holes through the sidewall allowing for unobstructed evacuation.
EMBODIMENT 4Torsional Activation
• In one embodiment, the activation means includes a controller rotatably coupled to at least two body segments (i.e., portions of body304), whereincontroller320 is configured to apply a relative rotational force between the body segments to cause the tubular body to enter the second state. In one embodiment, two body segments includes an outer layer, an inner layer, and a torsionally-responsive structure provided therebetween. In one embodiment, for example, the torsionally-responsive structure comprises a substantially cylindrical braided structure.
EMBODIMENT 5Solidifying Material/Membrane
• In one embodiment,body304 includes at least one inner chamber, a selectably solidifiable material provided within the inner chamber; and a controller fluidly coupled to the at least one inner chamber. The solidifiable material is adapted to substantially solidify in response to, for example, UV radiation, the introduction of a catalyst within the inner chamber, a temperature change, the introduction of water (in the case of hydrophilic particles), acoustic energy (in the case of an acoustically-active polymer), or an electrical current or field (in the case of an electroactive polymer).
• FIGS. 14 and 15 depict an exemplary embodiment incorporating a selectably solidifiable material to effect transition to the second state. As shown inFIG. 14,body304 is at least partially filled with a medium1404 (for example, within individual chambers as illustrated) that together can alter the stiffness metric ofcatheter300. In this embodiment, the medium1404 is injected throughaccessory lumens1402.Medium1404 may be a substance that hardens relatively quickly, such as a silicone or polyurethane. If medium1404 requires a catalyst to activate, that catalyst may already reside within the walls of thebody304 or within the material ofcatheter300 itself.
• In one embodiment, medium1404 is a slurry of particles suspended in solution as depicted inFIG. 15. In this case, the walls of body304 (or membranes provided therein) may be selectively permeable so to allow a carrier liquid to escape (e.g., the chamber and/or catheter body walls) while confining the particles themselves. Once these particles build up and “pack” into the chamber they cause an increased stiffness metric in that section. A variety of suitable particle materials and sizes can be used. In one embodiment, the particle possesses neutral buoyancy in the selected carrier liquid. A hydrophilic particle is advantageous in that it swells during hydration, causing additional binding and increased catheter stiffness.
EMBODIMENT 6Memory Metal
• In one embodiment, the activation means includes at least one metallic structure having shape-memory properties provided withinbody304 and communicatively coupled to a power source (e.g. a voltage and/or current source located within controller320). In one embodiment, the shape-memory metallic structure comprises a Ni/Ti alloy (nitinol).
CONCLUSION
• What has been described are methods and apparatus for an endovascular catheter that can be inserted within tortuous body anatomies and then selectively stiffened and fixed in place. In a particular embodiment, this stiffness is reversible. In this regard, the foregoing detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Thus, although several exemplary embodiments have been presented in the foregoing description, it should be appreciated that a vast number of alternate but equivalent variations exist, and the examples presented herein are not intended to limit the scope, applicability, or configuration of the invention in any way. To the contrary, various changes may be made in the function and arrangement of the various features described herein without departing from the scope of the claims and their legal equivalents.
• Techniques and technologies may be described herein in terms of functional and/or logical block components, and with reference to symbolic representations of operations, processing tasks, and functions that may be performed by various computing components or devices.
• While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.

Claims (43)

1. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein; and

activation means for selectably causing the tubular body to enter a first state and a second state;

wherein, in the first state, the tubular body has a first value of a stiffness metric that is below a predetermined navigatibility threshold; and

wherein, in the second state, the tubular body has a second value of the stiffness metric that is above a predetermined rigidity threshold value.

2. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein; and

activation means for selectably causing the tubular body to enter a first state and a second state;

wherein, in the first state, the tubular body has a first value of a stiffness metric;

wherein, in the second state, the tubular body has a second value of the stiffness metric that is greater than the first value; and

wherein the activation means includes a controller communicatively coupled to the tubular body and adapted to place the tubular body in the second state by subjecting at least a portion of the catheter apparatus to a reduction or change in temperature.

3. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein; and

activation means for selectably causing the tubular body to enter a first state and a second state;

wherein, in the first state, the tubular body has a first value of a stiffness metric;

wherein, in the second state, the tubular body has a second value of the stiffness metric that is greater than the first value; and

wherein the activation means includes a controller communicatively coupled to the tubular body and adapted to place the tubular body in the second state by subjecting at least a portion of the tubular body to an increase in axial compression.

4. The catheter apparatus ofclaim 3, wherein the tubular body comprises a plurality of axial segments responsive to the increase in axial compression.

5. The catheter apparatus ofclaim 4, wherein the controller includes at least one linkage component mechanically coupled to at least one of the plurality of axial segments and extending to the proximal end of the tubular body.

6. The catheter apparatus ofclaim 5, wherein the tubular body includes an auxiliary lumen provided therein, and wherein the at least one linkage component includes at least one wire component extending through the auxiliary lumen.

7. The catheter apparatus ofclaim 6, wherein the tubular body includes at least two auxiliary lumens distributed symmetrically within the tubular body.

8. The catheter apparatus ofclaim 7, wherein the at least one wire includes two or more wires, and the controller includes a gimble component coupled to the two or more wires, the gimble component configured to apply substantially equal tension on the two or more wires.

9. The catheter apparatus ofclaim 8, wherein the two or more wires includes four three wires.

10. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein; and

activation means for selectably causing the tubular body to enter a first state and a second state;

wherein, in the first state, the tubular body has a first value of a stiffness metric;

wherein, in the second state, the tubular body has a second value of the stiffness metric that is greater than the first value; and

wherein the activation means includes a controller communicatively coupled to the tubular body and adapted to place the tubular body in the second state by subjecting at least a portion of the tubular body to an increase in radial compression.

11. The catheter apparatus ofclaim 10, wherein:

the tubular body includes at least two fluid impermeable layers defining a pressure-responsive chamber;

the tubular body includes at least one interstitial structure provided within the pressure-responsive chamber;

the controller is configured to cause a change in internal pressure within the pressure-responsive chamber; and

the at least one interstitial structure is adapted to exhibit radial compression in response to the change in internal pressure.

12. The catheter apparatus ofclaim 11, wherein the at least one interstitial structure includes a plurality of laminar members configured to be substantially slideable with respect to each other during the first state, and be substantially non-slideable with respect to each other during the second state.

13. The catheter apparatus ofclaim 12, wherein the plurality of laminar members comprise a braid or a helically wrapped structure.

14. The catheter apparatus ofclaim 10,

wherein the tubular body includes an outer layer, an inner layer, and one or more interstitial structures provided therebetween; and

wherein the controller includes at least one linkage component mechanically coupled to at least one of the interstitial structures and configured to cause the at least on linkage component to expand and contract radially.

15. The catheter apparatus ofclaim 12, wherein the at least one interstitial component comprises a substantially cylindrical braided structure.

16. The catheter apparatus ofclaim 12, wherein the at least one interstial component comprises a helically-wrapped structure.

17. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein; and

activation means for selectably causing the tubular body to enter a first state and a second state;

wherein, in the first state, the tubular body has a first value of a stiffness metric;

wherein, in the second state, the tubular body has a second value of the stiffness metric that is greater than the first value; and

wherein the tubular body includes at least two body segments, the activation means includes a controller rotatably coupled to the at least two body segments, and the controller is configured to apply a relative rotational force between the at least two body segments to cause the tubular body to enter the second state.

18. The catheter apparatus ofclaim 17, wherein the at least two body segments includes an outer layer, an inner layer, and a torsionally-responsive structure provided therebetween.

19. The catheter apparatus ofclaim 18, wherein the torsionally-responsive structure comprises a substantially cylindrical braided structure.

20. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein; and

activation means for selectably causing the tubular body to enter a first state and a second state;

wherein, in the first state, the tubular body has a first value of a stiffness metric;

wherein, in the second state, the tubular body has a second value of the stiffness metric that is greater than the first value; and

wherein the tubular body includes at least one inner chamber, a selectably solidifiable material provided within the inner chamber; and a controller fluidly coupled to the at least one inner chamber.

21. The catheter apparatus ofclaim 20, wherein the solidifiable material is adapted to substantially solidify in response to UV radiation.

22. The catheter apparatus ofclaim 20, wherein the solidifiable material is adapted to substantially solidify in response to introduction of a catalyst within the inner chamber.

23. The catheter apparatus ofclaim 20, wherein the solidifiable material is a polymer adapted to substantially solidify in response to a temperature change.

24. The catheter apparatus ofclaim 20, wherein the solidifiable material includes hydrophilic particles configured to expand when contacting water, and the controller is configured to introduce a volume of water into the inner chamber.

25. The catheter apparatus ofclaim 24, further including a perfusion lumen provided within the inner chamber, the perfusion lumen fluidly coupled to the controller.

26. The catheter apparatus ofclaim 20, wherein the solidifiable material is an acoustically-active polymer.

27. The catheter apparatus ofclaim 20, wherein the solidifiable material is an electroactive polymer (EAP).

28. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein;

activation means for selectably causing the tubular body to enter a first state and a second state; and

a controller adapted to selectably dispense an aqueous mixture;

wherein, in the first state, the tubular body has a first value of a stiffness metric;

wherein, in the second state, the tubular body has a second value of the stiffness metric that is greater than the first value;

wherein the tubular body includes a chamber fluidly coupled to the controller and at least partially bounded by a membrane; and

wherein the membrane is configured to be permeable to a liquid portion of the aqueous mixture and impermeable to a solid portion of the aqueous mixture.

29. The catheter apparatus ofclaim 28, wherein the aqueous mixture is a saline mixture.

30. A catheter apparatus comprising:

a tubular body having a distal end, a proximal end, and a lumen defined therein;

activation means for selectably causing the tubular body to enter a first state and a second state; and

a controller comprising a voltage source;

wherein, in the first state, the tubular body has a first value of a stiffness metric;

wherein, in the second state, the tubular body has a second value of the stiffness metric that is greater than the first value; and

wherein the activation means includes at least one shape-memory metallic structure provided within the tubular body and communicatively coupled to the voltage source.

31. The catheter apparatus ofclaim 30, wherein the shape-memory metallic structure comprises a Ni/Ti alloy.

32. The catheter apparatus ofclaim 30, wherein the stiffness metric is a measurement of the bending stiffness of the tubular body.

33. The catheter apparatus ofclaim 30, wherein the stiffness metric is a catheter pull-out metric.

34. The catheter apparatus ofclaim 30, wherein the tubular body has a plurality of zones, each zone having a corresponding stiffness metric while in the second state.

35. The catheter apparatus ofclaim 34, wherein, within a first zone, the stiffness metric of the tubular body varies continuously along its length while in the second state.

36. The catheter apparatus ofclaim 35, wherein a first zone is adjacent the distal end of the tubular body, and a second zone is adjacent the first zone, further wherein the corresponding stiffness metric of the first zone is less than the corresponding stiffness metric of the second zone while in the second state.

37. The catheter apparatus ofclaim 30, wherein, while in the second state, the tubular body has the second stiffness value along a first curvature axis and a third stiffness value along a second curvature axis that is orthogonal to the first curvature axis.

38. The catheter apparatus ofclaim 30, wherein the activation means is coupled to a controller provided at the proximal end of the tubular body.

39. The catheter apparatus ofclaim 30, wherein the activation means is communicatively coupled to a controller configured to be slideably inserted within the lumen.

40. The catheter apparatus ofclaim 30, wherein the activation means is coupled to a controller that is remote from the tubular body.

41. The catheter apparatus ofclaim 30, wherein the tubular body includes a helical channel formed therein.

42. The catheter apparatus ofclaim 30, wherein the tubular body includes a plurality of ring-shaped channels formed circumferentially therein.

43. The catheter apparatus ofclaim 42, wherein the plurality of ring-shaped channels are distributed irregularly along the tubular body.

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