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

Methods and apparatus for an adjustable stiffness catheter Download PDF

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Publication number
US20120179097A1
US20120179097A1 US13/326,093 US201113326093A US2012179097A1 US 20120179097 A1 US20120179097 A1 US 20120179097A1 US 201113326093 A US201113326093 A US 201113326093A US 2012179097 A1 US2012179097 A1 US 2012179097A1
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United States
Prior art keywords
tubular body
state
catheter apparatus
value
catheter
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Abandoned
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US13/326,093
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English (en)
Inventor
Edward H. Cully
Jeffrey B. Duncan
Benjamin M. Trapp
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WL Gore and Associates Inc
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WL Gore and Associates Inc
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Priority to US13/326,093 priority Critical patent/US20120179097A1/en
Priority to BR112013016319A priority patent/BR112013016319A2/pt
Priority to AU2011353629A priority patent/AU2011353629B2/en
Priority to EP23165255.3A priority patent/EP4218883B1/en
Priority to CN201180064326.5A priority patent/CN103313749B/zh
Priority to CA2822355A priority patent/CA2822355A1/en
Priority to EP11804888.3A priority patent/EP2661302B1/en
Priority to JP2013548413A priority patent/JP6050251B2/ja
Priority to PCT/US2011/065515 priority patent/WO2012094135A2/en
Priority to RU2013136529/14A priority patent/RU2013136529A/ru
Priority to ES11804888T priority patent/ES2952411T3/es
Assigned to GORE ENTERPRISE HOLDINGS, INC. reassignment GORE ENTERPRISE HOLDINGS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: TRAPP, BENJAMIN M., DUNCAN, JEFFREY B., CULLY, EDWARD H.
Assigned to W. L. GORE & ASSOCIATES, INC. reassignment W. L. GORE & ASSOCIATES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GORE ENTERPRISE HOLDINGS, INC.
Publication of US20120179097A1 publication Critical patent/US20120179097A1/en
Priority to US14/294,008 priority patent/US9889273B2/en
Priority to US16/790,551 priority patent/USRE49557E1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0025—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter having a collapsible lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • A61M2025/0064—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body which become stiffer or softer when heated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0051—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility

Definitions

  • 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.
  • FIG. 1 is a conceptual diagram useful in depicting the human aortic arch 100 .
  • the ascending aorta 110 rises from its origin at the aortic valve (not shown).
  • the right common carotid 104 and the right subclavian 103 branch off of the brachiocephalic artery 102 .
  • FIGS. 2A-2D depict assorted variant conditions of the human aortic arch ( 201 - 204 ). It is clear that navigation from the descending aorta 120 , up over the arch, and then back to gain access to the right brachiocepalic artery 102 can be extremely difficult in such cases, particularly when the arteries are partially occluded with easily displaced and dislodged build-ups of plaque.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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 ) and 11 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.
  • FIG. 19 depicts a qualitative graph showing the value of a stiffness metric in accordance with one embodiment.
  • 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.
  • Catheter 300 extends from a distal end 308 (generally, the end configured to be inserted first within an anatomical feature) and a proximal end 310 opposite distal end 308 .
  • a controller 320 communicatively coupled to catheter body 304 and/or lumen 301 will also typically be provided for controlling the operation of catheter 300 , as discussed in further detail below.
  • An activation means (not illustrated in FIG. 3 ) is provided for causing body 304 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 into body 304 , lumen 301 , controller 320 , or a combination thereof.
  • controller 320 is one component of the activation means.
  • body 304 can be selectably placed in at least two states.
  • body 304 has a relatively low stiffness and/or has other mechanical properties selected such that catheter 300 can easily be inserted (e.g., via manual axial force applied at proximal end 310 ) over a guide wire or the like without substantially disturbing the placement of that guide wire.
  • body 304 has a relatively high stiffness and/or other has mechanical properties selected such that catheter 300 remains substantially in place within the anatomical feature during subsequent operations, including the removal of any guide wire used during insertion.
  • body 304 while in the first state, body 304 has a stiffness metric that is equal to or less than a predetermined “navigatibility threshold,” and while in the second state, body 304 has a stiffness metric that is greater than or equal to a predetermined “rigidity threshold.”
  • a predetermined “navigatibility threshold” a predetermined “navigatibility threshold”
  • body 304 has a stiffness metric that is greater than or equal to a predetermined “rigidity threshold.”
  • FIG. 19 which qualitatively depicts two states ( 1902 and 1904 ) and their corresponding stiffness threshold values (i.e., navigatibility threshold and rigidity threshold, respectively).
  • stiffness metric 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 of catheter 300 . In this regard, note that “stiffness metric” is often used herein to refer to an actual stiffness metric value.
  • FIG. 4 presents a qualitative graphical representation of a stiffness metric (S) as a function of distance along catheter 300 from its proximal end to its distal end.
  • S stiffness metric
  • 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 line 412 indicates the navigatibility threshold
  • dashed line 410 represents the rigidity threshold for a given stiffness metric.
  • catheter 300 While in the first state (during insertion) catheter 300 has a stiffness metric 402 that is equal to or less than navigatibility threshold 412 .
  • catheter 300 has a stiffness metric 410 that is greater than or equal to rigidity threshold 410 .
  • the stiffness metric corresponds to the flexural modulus of catheter 300 —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 in FIG. 6 , wherein catheter 300 (or a portion of catheter 300 ) is placed on a pair of supports 602 and 604 that are a known distance apart, and a downward (radial) force 608 is applied to catheter 300 via a third structure 606 that is situated between supports 602 and 604 .
  • the stiffness metric corresponds to an empirical measurement that more closely models the actual operation of catheter 300 .
  • FIGS. 7( a )-( c ) depict a “dislodgment” test that simulates the placement of a catheter 300 placed at approximately a 90-degree angle (although this angle may vary depending upon the test). More particularly, stationary supports 702 , 704 , and 706 are positioned in a predetermined geometric relation such that catheter 300 (or a short segment cut from catheter 300 ) must bend to fit between supports 702 and 704 while contacting support 706 . Additional supports (not illustrated) may also be used to assist in placing catheter 300 .
  • a probe 702 is inserted within one end of catheter 300 as shown ( FIG. 7( a )).
  • Probe 702 might be configured to approximate the stiffness of a typical stent-graft or the like.
  • As probe 702 is further inserted into the lumen 301 of catheter 300 it makes contact with the inner surface of the lumen 301 and causes end 308 to move with respect to support 702 .
  • catheter 300 will be released entirely from between supports 702 and 704 as shown.
  • the force necessary to dislodge catheter 300 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.
  • FIG. 4 depicts the stiffness metric as being invariant over the length of catheter 300
  • the invention is not so limited.
  • FIG. 5 presents a qualitative graphical representation of stiffness metric (S) as a function of distance along catheter 300 from its proximal end to its distal end; however, in this embodiment, catheter 300 includes two “zones” or segments, each having a corresponding stiffness metric while in the second state. That is, in zone 520 , 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 threshold 412 ). Within zone 522 , the stiffness metric in the second state ( 504 ) is above the rigidity threshold 410 .
  • Catheter 300 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 of catheter 300 , 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.
  • catheter 300 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 304 may have any suitable structure, and be fabricated using any suitable combination of materials capable of achieving the selectable stiffness metric described above.
  • catheter body 304 includes a helical (spiral) channel formed within its exterior and/or its interior. The channel effectively weakens body 304 such that the stiffness metric in the first state is lower than it would be if the body 304 were perfectly tubular.
  • catheter body 304 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 of catheter 300 .
  • Catheter body 304 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), Ther
  • elastomeric organosilicon polymers include polyether block amide or thermoplastic copolyether (PEBAX), Kevlar, and metals such as stainless steel and nickel/titanium (nitinol) alloys.
  • PEBAX polyether block amide or thermoplastic copolyether
  • Kevlar thermoplastic copolyether
  • metals such as stainless steel and nickel/titanium (nitinol) alloys.
  • catheter body 304 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 body 304 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.
  • Catheter 300 includes activation means for causing body 304 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 to catheter 300 , including for example, controller 320 as illustrated in FIG. 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.
  • the activation means includes a controller 320 communicatively coupled to body 304 as well features within body 304 that are together adapted to place the body in the second state by subjecting at least a portion of the catheter 300 to a reduction or change in temperature.
  • a catheter 300 in accordance with one embodiment generally includes two auxiliary lumens or channels 802 and 804 that are interconnected (e.g., fluidly coupled near a distal end) such that the coolant travels through body 304 .
  • the channels 804 and 802 are separated, for example, by a membrane (such as an ePTFE membrane) 806 .
  • a coolant 805 such as liquid nitrogen is supplied to channel 804 (e.g., via a coolant delivery system within controller 320 ), where it travels parallel to lumen 301 along the length of (or a portion of) body 304 .
  • a coolant 805 such as liquid nitrogen is supplied to channel 804 (e.g., via a coolant delivery system within controller 320 ), where it travels parallel to lumen 301 along the length of (or a portion of) body 304 .
  • the materials for catheter body 304 and/or membrane 806 are selected that their stiffness increases as the temperature is reduced. Exemplary materials include, for example, urethane and the like.
  • compressed gas 803 is allowed to expand as it passes through membrane 806 into channel 802 .
  • the coolant in the case of liquid nitrogen changes to a gas phase and exits through channel 802 .
  • the coolant remains in liquid form during operation.
  • Suitable coolants include, for example, chilled saline, liquid CO 2 , liquid N 2 , and the like. Other approved medical chilling methods may also be employed.
  • the activation means includes controller 320 communicatively coupled to the body 304 and components within body 304 that are adapted to place body 304 in the second state by subjecting it to an increase in axial compression.
  • one or more tension lines 1602 may be used to selectively apply a compressive force to body 304 .
  • the tension lines 1602 are attached at the distal end 308 of catheter 300 and are slideably received by corresponding accessory lumens 1402 that pass through a series of body segments 1605 .
  • the accessory lumens 1402 are preferably sized to allow the free axial movement of tension lines 1602 .
  • body segments 1605 will typically be separated by a small interstitial gaps 1607 .
  • the tension lines 1602 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 of catheter 300 is desired, tension lines 1602 are pulled substantially simultaneously as depicted in FIG. 17 . Gaps and the orientation between body segments 1605 may be optimized to reduce (and/or increase the repeatability of) the foreshortening that occurs when tension is applied.
  • tension wires 1602 are attached to a floating gimbal mechanism incorporated into controller 320 . 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, the interstitial gaps 1607 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 place catheter 300 in the second state may vary depending upon the length, material, and cross-section of tension lines 1602 , as well as the structural characteristics of body 304 .
  • FIGS. 18( a )-( c ) present a cross-sectional view of various designs for catheter body 304 , including three equidistant accessory lumens 1402 ( FIG. 18( a )), two equidistant accessory lumens 1402 ( FIG. 18( b )), and four equidistant accessory lumens ( FIG. 18( c )).
  • equidistant accessory lumens may be distributed in any arbitrary fashion, and need not be symmetrical or equidistant as illustrated.
  • the column stiffness of body 304 is modified to allow for tracking, then increased to deployment without foreshortening during stiffening.
  • the activation means includes controller 320 communicatively coupled to the body 304 and adapted to place the body 304 in the second state by subjecting at least a portion of the tubular body to an increase in radial compression.
  • body 304 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.
  • catheter 300 includes an accessory lumen 902 extending from chambers 906 to a hub 302 .
  • Hub 302 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 to luer fitting 910 .
  • negative pressure i.e., a reduction from some baseline pressure
  • chambers 906 collapse and apply pressure to corresponding body segments 904 (as illustrated in FIGS. 12 and 13 ).
  • the pressure is preferably great enough to cause a change in stiffness metric of the affected portion of catheter 300 .
  • the body 304 comprises a layered structure 1002 (i.e., an interstitial component) positioned between two or more layers of an air-impermeable chamber 1004 .
  • the chamber 1004 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.
  • bending causes the individual components of layers 1002 to slide across each other with minimum friction.
  • the resulting stiffness metric is very low.
  • a normal (i.e., radial) force 1008 is created within structure 1002 by the collapse of the flexible polymeric material 1004 .
  • 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.
  • the stiffness metric of the structure is increased.
  • the pressure is increased in an adjacent pressure chamber, thereby causing that chamber to press the adjacent layered structure.
  • the layered structure 1002 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.)
  • 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 fitting 910 ), thereby decreasing the applied normal force.
  • multiple discrete air chambers 1102 are distributed along the length of catheter 300 and can be toggled independently.
  • Chambers 1102 may be composed of differentiated layered structures, such as layers of slit, thin film 1104 .
  • the distal air chambers may be controlled independently through lumen 1109 , while the proximal air chamber is controlled through lumen 1108 . This allows the operator to control the segments independently to varying degrees of stiffness change.
  • the lumens 1108 and 1109 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.
  • the activation means includes a controller rotatably coupled to at least two body segments (i.e., portions of body 304 ), wherein controller 320 is configured to apply a relative rotational force between the body segments to cause the tubular body to enter the second state.
  • two body segments includes an outer layer, an inner layer, and a torsionally-responsive structure provided therebetween.
  • the torsionally-responsive structure comprises a substantially cylindrical braided structure.
  • body 304 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.
  • body 304 is at least partially filled with a medium 1404 (for example, within individual chambers as illustrated) that together can alter the stiffness metric of catheter 300 .
  • the medium 1404 is injected through accessory lumens 1402 .
  • Medium 1404 may be a substance that hardens relatively quickly, such as a silicone or polyurethane. If medium 1404 requires a catalyst to activate, that catalyst may already reside within the walls of the body 304 or within the material of catheter 300 itself.
  • medium 1404 is a slurry of particles suspended in solution as depicted in FIG. 15 .
  • the walls of body 304 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 carrier liquid e.g., the chamber and/or catheter body walls
  • 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.
  • the activation means includes at least one metallic structure having shape-memory properties provided within body 304 and communicatively coupled to a power source (e.g. a voltage and/or current source located within controller 320 ).
  • a power source e.g. a voltage and/or current source located within controller 320 .
  • the shape-memory metallic structure comprises a Ni/Ti alloy (nitinol).

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US13/326,093 2011-01-06 2011-12-14 Methods and apparatus for an adjustable stiffness catheter Abandoned US20120179097A1 (en)

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US13/326,093 US20120179097A1 (en) 2011-01-06 2011-12-14 Methods and apparatus for an adjustable stiffness catheter
JP2013548413A JP6050251B2 (ja) 2011-01-06 2011-12-16 調整可能剛性のカテーテルのための方法及び装置
PCT/US2011/065515 WO2012094135A2 (en) 2011-01-06 2011-12-16 Methods and apparatus for an adjustable stiffness catheter
EP23165255.3A EP4218883B1 (en) 2011-01-06 2011-12-16 Apparatus for an adjustable stiffness catheter
CN201180064326.5A CN103313749B (zh) 2011-01-06 2011-12-16 可调节刚度导管的方法和设备
CA2822355A CA2822355A1 (en) 2011-01-06 2011-12-16 Methods and apparatus for an adjustable stiffness catheter
EP11804888.3A EP2661302B1 (en) 2011-01-06 2011-12-16 Apparatus for an adjustable stiffness catheter
BR112013016319A BR112013016319A2 (pt) 2011-01-06 2011-12-16 métodos e aparelhos para um cateter de rigidez ajustável
AU2011353629A AU2011353629B2 (en) 2011-01-06 2011-12-16 Methods and apparatus for an adjustable stiffness catheter
RU2013136529/14A RU2013136529A (ru) 2011-01-06 2011-12-16 Способы и устройство для катетера с регулируемой жесткостью
ES11804888T ES2952411T3 (es) 2011-01-06 2011-12-16 Aparato para un catéter de rigidez regulable
US14/294,008 US9889273B2 (en) 2011-01-06 2014-06-02 Methods and apparatus for an adjustable stiffness catheter
US16/790,551 USRE49557E1 (en) 2011-01-06 2020-02-13 Methods and apparatus for an adjustable stiffness catheter

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US13/326,093 US20120179097A1 (en) 2011-01-06 2011-12-14 Methods and apparatus for an adjustable stiffness catheter

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US20140276642A1 (en) 2014-09-18
JP2014508564A (ja) 2014-04-10
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WO2012094135A3 (en) 2012-08-30
CA2822355A1 (en) 2012-07-12
EP4218883A1 (en) 2023-08-02
CN103313749A (zh) 2013-09-18
AU2011353629B2 (en) 2015-07-16
WO2012094135A2 (en) 2012-07-12
CN103313749B (zh) 2016-04-06
EP2661302B1 (en) 2023-05-10
RU2013136529A (ru) 2015-03-10
EP4218883B1 (en) 2025-10-22
ES2952411T3 (es) 2023-10-31
AU2011353629A1 (en) 2013-07-04
US9889273B2 (en) 2018-02-13
USRE49557E1 (en) 2023-06-20
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EP2661302A2 (en) 2013-11-13
US20170189645A9 (en) 2017-07-06

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