WO2007124495A2 - Cathéter de support rigidifiant et ses procédés d'utilisation - Google Patents

Cathéter de support rigidifiant et ses procédés d'utilisation Download PDF

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Publication number
WO2007124495A2
WO2007124495A2 PCT/US2007/067237 US2007067237W WO2007124495A2 WO 2007124495 A2 WO2007124495 A2 WO 2007124495A2 US 2007067237 W US2007067237 W US 2007067237W WO 2007124495 A2 WO2007124495 A2 WO 2007124495A2
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WO
WIPO (PCT)
Prior art keywords
catheter
guidewire
stiffening
lumen
distal end
Prior art date
Application number
PCT/US2007/067237
Other languages
English (en)
Other versions
WO2007124495A3 (fr
Inventor
Randolf Von Oepen
Lorcan Coffey
Thomas Reith
Richard Newhauser
Travis Yribarren
Marc Gianotti
Bernhard Uihlein
Ian J. Clark
Original Assignee
Abbott Laboratories
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/738,386 external-priority patent/US20070250149A1/en
Priority claimed from US11/738,384 external-priority patent/US7993303B2/en
Application filed by Abbott Laboratories filed Critical Abbott Laboratories
Publication of WO2007124495A2 publication Critical patent/WO2007124495A2/fr
Publication of WO2007124495A3 publication Critical patent/WO2007124495A3/fr

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Classifications

    • 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
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • 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
    • A61M2025/0183—Rapid exchange or monorail catheters
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip

Definitions

  • the present invention generally relates to the field of medical devices. More specifically, the present invention relates to support catheters or catheters that can be manipulated during deployment.
  • intravascular devices to treat cardiovascular diseases are well known in the field of medicine.
  • the need for a greater variety of devices to address different types of circumstances has grown tremendously as the techniques for using intravascular devices has progressed.
  • One type of intravascular device is a catheter.
  • an intravascular catheter is delivered into the body by first using a guide catheter that can be routed through the proper vessels in the body's vascular network in order to arrive at a site in need of a diagnostic or therapeutic technique.
  • support and guide catheters have been relatively simple and have been made of biocompatible plastics forming a shaft with a hollow internal lumen.
  • the shaft is generally formed by one or more concentric tubes that are congruent to each other, where one tube typically provides support and the other tube(s) provide biocompatibility.
  • most guide catheters include a hub that is connected to a proximal end of the shaft in order to provide a mechanism for connecting another device, such as an inflation device or syringe.
  • the tip of the support or guide catheter is flexible and/or shaped in order to allow for deployment and placement in the tortuous vasculature network.
  • the tip of the catheter can be soft and flexible to prevent damage to the vasculature as the catheter is pushed or advanced therethrough.
  • the existing catheters are stiff enough to be advanced through a blood vessel, yet include the flexible tip to aid with directing the catheter through or around various bends or junctions.
  • Catheters having flexible distal ends have experienced increased instances of guide catheter "back out” during insertion or delivery of the support catheter.
  • Guide catheters back out when a load is transmitted from a guidewire or device e.g. support catheter, stent delivery system, PTCA balloon, etc.
  • a guidewire or device e.g. support catheter, stent delivery system, PTCA balloon, etc.
  • the guide disengages from its preferred positioning, thereby decreasing guidewire support and creating the need for the medical professional to re-position the guiding catheter.
  • a guidewire or device e.g. support catheter, stent delivery system, PTCA balloon, etc.
  • ridged support catheters are ridged in order to prevent back out problems.
  • ridged support catheters can be traumatic to the patient's vasculature due to the rigidity being more susceptible to puncturing or otherwise damaging the inner surface of the vessel.
  • Certain procedures, such as valve replacements, valve repairs, and patent foramen ovale treatments in the heart require that the treatment site be accessed by a guidewire that must pass from one side of heart to the other. After that is accomplished, a catheter device may be passed over the guidewire to access the treatment site on the second side of the heart. This requires that the guidewire pass through the septum, the wall of tissue that separates the right and left sides of a heart.
  • the area of the septum that divides the two upper chambers is referred to as the atrial or interatrial septum and the area of the septum that divides the two lower chambers is referred to as the ventricular or interventricular septum. Puncturing the septum, however, is difficult and often leads to buckling of the guidewire. Other procedures, such as treating arteries for disease often requires that a treatment site be accessed by a guidewire. For example, in the case of treating carotid arteries, the guidewire must travel from the aortic arch into the opening of the carotid artery (the carotid artery ostium). This passage may be complicated by the severity of the arch and the placement of the ostium.
  • a support catheter that has the properties of flexibility and rigidity and at times when such properties are necessary. More particularly, it would be advantageous to have a support catheter that resists the temptation to backing out, buckling or prolapse under conditions where it would otherwise likely occur. In addition, it would be advantageous to have a support catheter that has these improved qualities for the purpose of puncturing a heart septum. Further, it would be advantageous to have a support catheter that has these improved qualities for the purpose of accessing difficult to reach arteries, e.g., accessing carotid or renal arteries from the aorta under difficult circumstances.
  • the support catheter includes a catheter body having a proximal end, a distal end, and an interior wall surface defining a first lumen extending from the proximal end toward the distal end.
  • a second lumen is disposed between the interior wall surface and an outer surface of the catheter body.
  • a plurality of stiffening members is disposed around the second lumen, the plurality of stiffening members being engageable to selectively stiffen the catheter body.
  • the second lumen may be adapted to receive fluid such that the support catheter can be stiffened by means of the fluid.
  • the second lumen is defined by a first elastomeric member and a second elastomeric member spaced apart from the first elastomeric member.
  • the movement of the elastomeric members aid with the engagement of the stiffening members to increase the catheter's stiffness.
  • the catheter further comprises a second plurality of stiffening members disposed between the first lumen and the second lumen. The stiffening members can be disposed radially and/or axially.
  • the support catheter comprises a catheter body having a proximal end, a distal end, and an interior wall surface defining a first lumen extending from the proximal end toward the distal end.
  • a second lumen is disposed between the interior wall surface and an outer surface of the catheter body, and a plurality of stiffening members is disposed between the first lumen and the second lumen.
  • the present invention has many applications. The following, which is not meant to be limiting, are some examples.
  • the support catheter of the present invention can be used to treat a chronic total occlusion ("CTO"), i.e., recanalizing a CTO by for example, crossing the proximal cap of a CTO with a guidewire or other device, or exploiting the micro channels of a CTO.
  • CTO chronic total occlusion
  • the support catheter of the present invention can be used to treat carotid arteries because of the angles they may come off of the aortic arch, as well renal arteries, which also may be difficult to access because of the difficult angles in which they may come off the descending aorta.
  • the support catheter of the present invention is applicable where a medical professional needs to puncture a septum of a heart with a guidewire. Various procedures require this maneuver, such as valve replacements, valve repairs, and patent foramen ovale treatments.
  • the support catheter of the present invention also is applicable to patent foramen ovale ("PFO") treatments.
  • PFO is the term used for a heart septum that is not completely closed (particularly a flap or tunnel in the septum), and a PFO treatment contemplated herein is where a medical professional uses catheters and particularly a support catheter of the present invention to close the PFO.
  • the support catheter of the present invention also is applicable to annuloplasty valve repair. Annuloplasty is one way to do a mitral valve repair. A medical professional places a catheter around the annulus of the cardiac valve and then deploys anchors around the annulus so that the tension is exerted on the anchors to then close the mitral valve down.
  • the support catheter of the present invention can be used in this procedure because can allow a medical professional to track along a guidewire into the anullus to stiffen it to deploy an anchor, and make it flexible again to retract the catheter to a different point, and then stiffen it again to deploy another anchor, and continue the same procedure for as many anchors as is necessary.
  • Figure IA illustrates a side view of an improved support catheter according to the present invention.
  • Figure IB illustrates a schematic cross-sectional view of the improved support catheter of Figure 1.
  • Figure 2 shows a partial cross-sectional side view of an alternate embodiment of a support catheter according to the present invention.
  • Figure 3 A illustrates a schematic view of an attempt at puncturing of a heart septum with a lone guidewire.
  • Figure 3B illustrates a schematic view of the catheter of Figure IA in cooperation with a guidewire, advanced over the guidewire, wherein the catheter is in a flexible state.
  • Figure 3 C illustrates a schematic view of the catheter of Figure IA in cooperation with the guidewire of Figure 3B, advanced over the guidewire, wherein the catheter is in a stiffened state.
  • Figure 3D illustrates a schematic view of puncturing a heart septum with the guidewire of Figure 3B after the catheter of Figure 3B has been actuated and removed.
  • Figure 4A shows a schematic view of an attempt at accessing a carotid artery from an aortic arch.
  • Figure 4B shows a schematic view of a catheter in cooperation with a guidewire, advanced over the guidewire, wherein the catheter is in a flexible state.
  • Figure 4C shows a schematic view of the catheter of Figure 4B in its inflated state, advanced over a guidewire, wherein the guidewire has a treatment device on its distal end.
  • the support catheter is employed in placing a guidewire within a body lumen of a patient, such as, but not limited to, the lumen of a coronary artery.
  • a body lumen of a patient such as, but not limited to, the lumen of a coronary artery.
  • this description is exemplary only, and it should be appreciated that embodiments of the present catheter can be employed for multiple other purposes, including, but not limited to, the piercing of a blockage in a variety of body lumens, including the urinary tract, bile duct, esophagus and tracheo-bronchial tree, neurovascular, peripheral vascular, cardiac, and renal catheters, among others.
  • Extra support is particularly beneficial during treatment of chronic total occlusions ("CTOs"), i.e., in recanalizing a CTO, crossing the proximal cap of CTO with a guidewire or other device or exploiting the micro channels of a CTO because the occlusion provides significant backload that is transmitted from the guidewire to the guide catheter that can lead to back out.
  • CTOs chronic total occlusions
  • the present invention is related to support catheters.
  • the support catheter can be configured so that a medical professional can position the support catheter through tortuous pathways while reducing the amount of guide catheter backup, buckling or prolapse of the catheter.
  • the support catheter of the present invention will allow for a medical professional to puncture a heart septum with a guidewire without buckling.
  • Figure IA illustrates a view of a catheter system that includes a support catheter
  • the support catheter 10 functions or acts as a stiffening support catheter that can be used, from among other applications, to aid with puncturing a heart septum with a septal puncture needle, or to support a needle used to puncture the hepatic vein and hepatic portal vein and/or the liver as part of a Transjugular Intrahepatic Portosystemic Shunt, or "TIPS" procedure.
  • TIPS Transjugular Intrahepatic Portosystemic Shunt
  • the support catheter 10 has a proximal end 12 and a distal end 14; the body of the catheter or catheter body 16 extends from the proximal end 12 toward the distal end 14.
  • the support catheter 10 includes a distal portion 20, with a lumen 22 adapted to receive a structure 30 to be supported during a procedure, such as, but not limited to, a guidewire, a needle, or other flexible medical devices, that extends from the distal end 14 and terminates distal to the proximal end 12 of the catheter body 16.
  • the support catheter 10 is thus illustrated in a rapid exchange configuration, however, it will be understood that the distal portion 20 can extend from the distal end 14 to the proximal end 12, and therefore function as over the wire support catheter.
  • both ends of the distal portion 20 of the support catheter 10 contain radiopaque markers 18 so that they are visible under fluoroscopy, i.e., each end is marked with radiopaque material 18.
  • the support catheter 10 also includes a proximal portion 24 that acts as a fluid conduit with a portion of the distal portion 20.
  • the proximal portion 24 includes a fluid lumen 26 that extends into a portion of the distal portion 20 and can provide a fluid, such as a liquid, gas, or combination thereof, to a portion of the distal portion 20.
  • a port assembly 28 Disposed at the proximal end 12 and/or proximal portion 24 is a port assembly 28 disposed at the proximal end 12.
  • the port assembly 28 can optionally operate or function as a handle for a physician or clinician to manipulate the support catheter 10.
  • the port assembly 28 includes a first port 32 usable to actuate or de-activate the support catheter 10 to decrease and/or increase the flexibility of the support catheter 10.
  • the inflation device 40 can be coupled to the first port 32 to fluidly communicate with the support catheter 10.
  • the inflation device 40 can be any of a variety of different inflation structures or systems, including but not limited to, fixed or movable powered or manually operated fluid injection systems or devices typically associated with the injection of a fluid into a medical device.
  • the inflation device 40 has the form of a manually operated syringe, however, mechanically operated or other powered systems or devices are possible.
  • the inflation device 40 can allow pressure or volume to control the introduction of fluid into the device 40.
  • Exemplary inflation devices are produced by B. Braun, Merit Medical, and Cook, and typically have pressure ranges of 0 to 30 atm. It is contemplated that inflation pressures of approximately 10 atm are suitable for this invention, but this may be varied to reach different stiffness levels. Systems utilizing a canister of compressed gas, e.g., compressed CO 2 , as long as it satisfies the required pressure ranges, also are possible. In general, a higher pressure will yield a stiffer catheter.
  • compressed gas e.g., compressed CO 2
  • the port assembly 28 can also includes a second port 34.
  • the structure 30, such as a guidewire or other medical device can be placed and positioned through port 32 and port 34 is provided for the inflation device 40.
  • the port assembly 28 can include additional ports as needed to accomplish the desired operation and usability of the support catheter 10.
  • the support catheter 10 includes an outer jacket layer 50 that defines an outer surface of the support catheter 10 and its catheter body. Disposed within the jacket layer 50, and forming the wall of the support catheter 10, are a first stiffening coil layer 52, a first stiffening band layer 56, an annular lumen 60 (or channel), a second stiffening band layer 68, and a second stiffening coil layer 70.
  • the first stiffening coil layer 52 and the first stiffening band layer 56 can be considered, collectively, a first stiffening layer, while the second stiffening band layer 68 and the second stiffening coil layer 70 can be considered, collectively, as a second stiffening layer. It will be understood that although the illustrated embodiment includes both coil and band layers, each of the first and second stiffening layers can include only one of a coil or band layer, or both the first and second stiffening layers can be the same in that each can include either a coil or band layer.
  • This lumen 22 can receive the structure 30, such as a guidewire or other medical device during use of the support catheter 10.
  • an outer wall 60 and an inner wall 64 Surrounding annular lumen 62, and optionally defining the annular lumen 62, is an outer wall 60 and an inner wall 64.
  • the outer wall 60 and inner wall 64 are capable of flexing to enable the dimensions of the annular lumen 62 to change and thereby change the orientation and position of the layers 52, 56, 68, and 70 to change the stiffness of the support catheter 10.
  • the outer wall 60 and inner wall 64 can be both made of an elastomeric material such as polyurethane, silicone or C-Flex ® , the last of which can be manufactured by STI Components, Inc. of Morrisville, North Carolina, for example. More generally, the outer wall 60 and/or inner wall 64 can be fabricated from a polymeric material, a synthetic material, a natural material, or other material that provides the desired flexibility.
  • the outer jacket layer 50 defines the outer surface of the support catheter 10. As such, it may be desirable for the outer jacket layer 50, whether alone or in combination with another layer, to present a biocompatible surface to a body lumen within which it may be disposed.
  • the outer jacket layer 50 can be made of a biocompatible material, such as a biocompatible polymeric material.
  • suitable materials include polyimide, PEEK, polytetrafluorethylene, polyvinylidene fluoride, and polyamide.
  • a biocompatible coating may be applied to any material that the catheter 10 may be composed of. For example, Heparin, which prevents blood clotting, may be used as such a biocompatible coating.
  • the first stiffening coil layer 52 and the second stiffening coil layer 70 of the support catheter 10 can be similar and can include one or more coiled wires 54, such as metallic or polymeric coils, positioned in radial directions.
  • the first stiffening band layer 56 and the second stiffening band layer 68 can be similar and can include one or more bands 58, such as metallic or polymeric bands, positioned in axial directions.
  • first and second stiffening layers generally include one or more structures that cooperate together to change the stiffness of the support catheter 10, whether or not the sub-layers, i.e., first stiffening coil layer 52, first stiffening band layer 56, second stiffening coil layer 70, and second stiffening band layer 68, include coils, bands, ribbons, or other structures.
  • first stiffening coil layer 52 first stiffening band layer 56
  • second stiffening coil layer 70 second stiffening coil layer 70
  • second stiffening band layer 68 include coils, bands, ribbons, or other structures.
  • the structures forming the stiffening coil layers and the stiffening band layers whether individually, or collectively, can be considered as stiffening members.
  • stiffening layers could be formed from coiled wire with diameter 0.001 to 0.005 inch, and bands with thickness of 0.001 to 0.005 inch and width of 0.003 to 0.020 inch.
  • Materials for the stiffening layers could include stainless steel, Nitinol, cobalt chrome, gold, platinum, eligloy, other metals, nylon, other polymers, and any combination thereof. Spacing between bands and coil turns can vary, but would likely be in the range of 0.003 to 2.0 inches, depending on the catheter location.
  • the support catheter 10 of the present invention overcomes the difficulties of existing support catheters through providing structures that enable a physician or clinician to vary the stiffness of the support catheter 10 as desired. Varying the quantity of fluid within the annular lumen 62 varies the stiffness of the support catheter 10. For instance, during a procedure using a guidewire as the structure 30, the guidewire 30 can be placed in position by itself. Then, at the location and time when the guidewire 30 needs stiffening, the remaining parts of the support catheter 10 are placed in position over the guidewire 30 by advancing it over the guidewire 30 until it reaches the desired location. Then, the annular lumen 62 is filled with a fluid by way of the fluid inflation device 40 ( Figure IA) to inflate a portion of the catheter 10. With the aid of inflation device 40, an amount of fluid is infused into the lumen 62. In general, the inflation procedure is similar to the inflation step in a procedure that would be used by a physician performing a PTCA balloon angioplasty procedure.
  • the elastomeric walls 60 and 64 press against stiffening layers 52, 56, 68, and 70.
  • the elastomeric walls 60 and 64 move in the direction of arrows A, as shown in Figure IB.
  • the stiffening layers 52, 56, 68, and 70 they move against each other and create friction or engage with each other so that they are prohibited from recovering to their original position.
  • the coiled wires 54 and the bands of wire 58 of the stiffening layers 52, 56, 68, and 70 will shift in various directions, as represented by arrows B.
  • the coiled wires 54 and the bands of wires 58 will intermesh with each other at adjacent layers as well as within each layer. More specifically, inflation imparts forces on layers 56 and 68 such that bands of wires 58 in layers 56 and 68 move in various directions B and particularly into adjacent layers 56 and 68. In response to these forces, the coiled wires 54 move in various directions B into and particularly into adjacent layers 52 and 70. This intermeshing process is aided by the elastomeric material of walls 60 and 64 that forces its way into the gaps of any stiffening layers 52, 56, 68, and 70. Thus, the stiffening layers 52, 56, 68, and 70 become locked in their new positions, optionally even after the annular lumen 62 is deflated.
  • the stiffening layers 52, 56, 68, and 70 may optionally return to their original positions after the annular lumen 62 is deflated. In this way, the support catheter 10 may be removed from a treatment site more easily and with less chance of bodily injury than if the annular lumen 62 had not been deflated prior to removal.
  • a valve may be disposed on the port assembly 28 such that the inflation device 40 may be decoupled from the support catheter 10 and removed.
  • FIG. 2 shows a partial cross-sectional side view of an alternate embodiment of a support catheter 1OB according to the present invention.
  • Support catheter 1OB comprises a plurality of conically-shaped members or truncated cones 72 that are movably linked by two cables 74, which pass through holes or respective passageways 76 in each conically- shaped member 72.
  • the plurality of conically-shaped members 72 are situated on the port assembly 28, which contains a first port 32, out of which emanate the two cables 74.
  • the truncated cones 72 are generally concentric in that they fit inside one another, as shown in Figure 2.
  • the truncated cones 72 are forced closer together, and in turn, the arrangement and thereby the support catheter 1OB becomes stiffen Accordingly, in practice, the alignment of truncated cones 72 is used as a support catheter 1OB just as support catheter 10 can be used as described above.
  • the cables 74 can be any thin elongated material suitable for working inside the body, such as wire, line, cord, or the like.
  • the catheter 1OB can be advanced over the structure 30.
  • the relative stiffness of the support catheter 1OB can be adjusted by the medical professional by means of the cables 74.
  • the cables 74 are shown in the embodiment of Figure 2, only one cable 74 is necessary and more than two cables 74 may be utilized.
  • the truncated cones 72 of support catheter 1OB of Figure 2 are shown in various modes of alignment. That is, those truncated cones 72 on the distal end of catheter 1OB are shown in relatively tight engagement, whereas those shown on the proximal end of the catheter 1OB are shown separated from each other for illustrative purposes.
  • the truncated cones 72 would be aligned similar to those shown on the distal end of catheter 1OB, as friction between the truncated cones 72 and the cables 74 holds the catheter 1OB together and allows it to both advance over the structure 30, but also to provide support to the structure 30.
  • the truncated cones 72 may also have modified surfaces to increase the friction therebetween. That is, they may be coated with a material having a higher friction than the core, such as silicone, or they may be roughened or knurled to increase friction.
  • the truncated cones 72 of catheter 1OB may be manufactured from any number of materials.
  • catheter 1OB may further comprise an outer jacket layer 78, as shown in phantom lines in Figure 2.
  • the outer jacket layer 78 may be made of a biocompatible material, such as a biocompatible polymeric material.
  • Suitable biocompatible polymeric materials for the outer jacket layer 78 may include polyimide, PEEK, polytetrafluorethylene, polyvinylidene fluoride, and polyamide, although other materials are possible.
  • Figure 3 A shows a schematic view of an attempt at puncturing a heart septum 80, i.e., the wall of tissue that separates one side 82 from the other side 84 of a heart that can benefit from using the catheter of the present invention.
  • the following discussion will be directed to advancing a needle 38 as the structure supported by the catheter 10 through the septum 80.
  • the septum 80 is relatively substantial tissue.
  • the needle 38 buckles.
  • Figure 3B shows a schematic view of the catheter 10 in cooperation with the needle 38.
  • the needle 38 is first positioned to the point where the distal end reaches the desired destination. In this case, the desired location is where the needle 38 abuts the septum 80.
  • the catheter 10 is advanced over the needle 38 until the catheter 10 reaches almost the same point, i.e., almost to the septum 80, and situated against resting points within the heart, as shown in the schematic view of Figure 3C. Stated another way, the catheter 10 is advanced along the needle 38 until the distal end 14 is proximal to the distal end of the needle 38.
  • the catheter 10 is then actuated or stiffened.
  • fluid is passed along the lumen 26 to the annular lumen 62 to inflate a portion of the distal portion 20.
  • the stiffening layers 52, 56, 68, and 70 engage and stiffen the catheter 10. Accordingly, with the support catheter 10 providing support to the needle 38, and particularly situated against the rest points within the heart, the catheter 10 prevents any buckling and reduces any backlash of the needle 38.
  • the needle 38 can be advanced within the catheter 10 and into the second side 84 of the heart.
  • the support catheter 10 can then be deflated by removing fluid from the annular lumen 62 and removed over the needle 38.
  • any treatment devices can be positioned in place by being advanced over the needle 38.
  • the guidewire 30 can be supported by the catheter 10 as it is advanced through the puncture formed by the needle 38.
  • the guidewire 30 can be supported by the catheter 10 in those instances when the guidewire 30 can be used to puncture tissue.
  • the catheter 10 can support a guidewire, such as guidewire
  • the catheter 10 can be used to support any structure for which it may be possible to reduce backlash or back up of the structure.
  • FIGS 4A-4C shows a schematic view of the catheter 10 being used to access a carotid artery 90 from an aortic arch 92.
  • the guidewire 30 enters from the descending aorta 94 and enters the carotid artery ostium 96, which may be difficult to navigate.
  • navigating the remainder of the carotid artery 90 may be difficult, or it subsequently can be difficult to pass a treatment device into the artery 90 because the difficult angles may prevent adequate support for delivery of the device, resulting in the guidewire 30 falling out of position, i.e., guidewire prolapse.
  • support for the guidewire 30 is desirable.
  • the guidewire 30 is first positioned to the point where the distal end reaches the desired destination such as shown in Figure 4A.
  • the desired location is at the opening of the target vessel, or more preferably, just past the opening of the target vessel, i.e., in this case, where the guidewire 30 has just passed the carotid artery ostium 96.
  • Figure 4B shows a schematic view of the catheter 10 in cooperation with the guidewire 30.
  • the catheter 10 is advanced over the guidewire 30 until the catheter 10 reaches almost the same point in the target vessel.
  • This advancement of the support catheter 10 is made easier because the support catheter is still in its flexible state during tracking.
  • it is then actuated or stiffened. That is, the annular lumen 62 ( Figure IB) is then inflated as described above.
  • Figure 4C shows a schematic view of the stiffening catheter 10 in its inflated state. Once inflated, the catheter 10 assumes the shape that it was in prior to inflation. With the stiffening catheter 10 providing support to the guidewire 30, the catheter 10 and disclosed method prevents any prolapse and allows for proper advancement of the guidewire 30 and proper delivery of a treatment device. As noted above, renal arteries have similarly difficult access angles. Accordingly, this invention has applicability there as well.
  • a treatment device 100 such as a balloon catheter, stent delivery system, embolic protection device, ultrasonic diagnostic device, atherectomy device such as a rotoblator or other plaque removal device can be advanced through the catheter 10, over the guidewire 30, extended out of the distal end of the support catheter 10 and into the carotid artery 90 or other target location, as shown in Figure 4C.
  • the guidewire 30 may be replaced with a guidewire having a different stiffness.
  • the guidewire 30 may be advanced more directly into a vessel, i.e., to a treatment site farther into the carotid artery 90 without contacting or damaging walls of the carotid artery 90.
  • a catheter may be used with the same method for puncturing a septum 80 or accessing difficult to reach arteries as the methods described herein with catheter 10.
  • the present invention provides a stiffening support catheter 10 than can provide support to a guidewire 30 so that it may puncture a heart septum 80 or access difficult to reach arteries in order to access a treatment site, and methods for utilizing the same. In doing so, the present invention discloses an improved stiffening support catheter 10 that can be used in other applications where a support catheter is needed or helpful.
  • the stiffening support catheter of the present invention changes between a flexible and a stiffened state.

Abstract

L'invention concerne un cathéter de support permettant de perforer un septum cardiaque à l'aide d'un fil guide sans déformation. Ce cathéter peut accéder à des artères difficiles à atteindre, notamment une artère carotide ou rénale à partir de l'aorte, dans des circonstances difficiles. Ce cathéter de support comprend un corps de cathéter présentant une extrémité proximale, une extrémité distale et une surface de paroi intérieure définissant une première lumière s'étendant de l'extrémité proximale jusqu'à l'extrémité distale. Une seconde lumière est située entre la surface de paroi intérieure et une surface extérieure du corps de cathéter. Une pluralité d'éléments rigidifiants sont disposés autour de la seconde lumière, la pluralité d'éléments rigidifiants pouvant s'emboîter afin de rigidifier sélectivement le corps de cathéter. Dans une autre configuration, le cathéter comprend également une seconde pluralité d'éléments rigidifiants disposés entre la première lumière et la seconde lumière.
PCT/US2007/067237 2006-04-21 2007-04-23 Cathéter de support rigidifiant et ses procédés d'utilisation WO2007124495A2 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US79378106P 2006-04-21 2006-04-21
US60/793,781 2006-04-21
US11/738,384 2007-04-20
US11/738,386 US20070250149A1 (en) 2006-04-21 2007-04-20 Stiffening Support Catheters and Methods for Using the Same
US11/738,384 US7993303B2 (en) 2006-04-21 2007-04-20 Stiffening support catheter and methods for using the same
US11/738,386 2007-04-20

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WO2007124495A2 true WO2007124495A2 (fr) 2007-11-01
WO2007124495A3 WO2007124495A3 (fr) 2008-01-31

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PCT/US2007/067244 WO2007124501A2 (fr) 2006-04-21 2007-04-23 Cathéter support raidisseur et procédés utilisant ledit cathéter

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EP0279959A1 (fr) * 1987-01-06 1988-08-31 Advanced Cardiovascular Systems, Inc. Cathéter dilatateur avec fil de guidage mince
WO1988008727A1 (fr) * 1987-05-06 1988-11-17 Jang G David Systemes de catheters pour angioplastie a ballon a geometrie en colimacon et procede de production
WO1996007448A1 (fr) * 1994-09-08 1996-03-14 Saab Mark A Catheters de dilatation a ballonnets a rigidite variable
US5702439A (en) * 1990-08-28 1997-12-30 Scimed Life Systems, Inc. Balloon catheter with distal guide wire lumen
WO1999017826A1 (fr) * 1997-10-02 1999-04-15 Boston Scientific Limited Catheter d'apport vasculaire peripherique
WO1999064098A1 (fr) * 1998-06-11 1999-12-16 Boston Scientific Limited Catheter comprenant un raidisseur composite
EP1607119A1 (fr) * 2004-06-15 2005-12-21 Biosense Webster, Inc. Mecanisme de guidage de cathéter bidirectionnel

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GB2143920B (en) * 1983-07-23 1986-09-03 Warner Lambert Tech Vertebra for articulatable shaft
IT1277690B1 (it) * 1995-12-22 1997-11-11 Bieffe Medital Spa Sistema di sostegno ed attuazione a vertebre in particolare per strumenti chirurgici e diagnostici
US5916147A (en) * 1997-09-22 1999-06-29 Boury; Harb N. Selectively manipulable catheter
US20040044350A1 (en) * 1999-04-09 2004-03-04 Evalve, Inc. Steerable access sheath and methods of use
EP1583462A4 (fr) * 2002-06-13 2008-04-02 Usgi Medical Inc Appareil a blocage de forme et procede permettant de faire progresser un instrument a travers une anatomie non supportee
US8298161B2 (en) * 2002-09-12 2012-10-30 Intuitive Surgical Operations, Inc. Shape-transferring cannula system and method of use

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Publication number Priority date Publication date Assignee Title
EP0279959A1 (fr) * 1987-01-06 1988-08-31 Advanced Cardiovascular Systems, Inc. Cathéter dilatateur avec fil de guidage mince
WO1988008727A1 (fr) * 1987-05-06 1988-11-17 Jang G David Systemes de catheters pour angioplastie a ballon a geometrie en colimacon et procede de production
US5702439A (en) * 1990-08-28 1997-12-30 Scimed Life Systems, Inc. Balloon catheter with distal guide wire lumen
WO1996007448A1 (fr) * 1994-09-08 1996-03-14 Saab Mark A Catheters de dilatation a ballonnets a rigidite variable
WO1999017826A1 (fr) * 1997-10-02 1999-04-15 Boston Scientific Limited Catheter d'apport vasculaire peripherique
WO1999064098A1 (fr) * 1998-06-11 1999-12-16 Boston Scientific Limited Catheter comprenant un raidisseur composite
EP1607119A1 (fr) * 2004-06-15 2005-12-21 Biosense Webster, Inc. Mecanisme de guidage de cathéter bidirectionnel

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EP2037995A2 (fr) 2009-03-25
WO2007124501A3 (fr) 2008-02-21
WO2007124495A3 (fr) 2008-01-31
WO2007124501A2 (fr) 2007-11-01

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