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WO2008036842A2 - Dispositif et procédé pour faciliter l'introduction de cathéters - Google Patents

Dispositif et procédé pour faciliter l'introduction de cathéters Download PDF

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Publication number
WO2008036842A2
WO2008036842A2 PCT/US2007/079075 US2007079075W WO2008036842A2 WO 2008036842 A2 WO2008036842 A2 WO 2008036842A2 US 2007079075 W US2007079075 W US 2007079075W WO 2008036842 A2 WO2008036842 A2 WO 2008036842A2
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
guidewire
guide structure
lumen
guide
Prior art date
Application number
PCT/US2007/079075
Other languages
English (en)
Other versions
WO2008036842A3 (fr
Inventor
David R. Miller
Michael Smith
Original Assignee
Kyphon Sarl
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 US11/764,029 external-priority patent/US20080312637A1/en
Priority claimed from US11/771,768 external-priority patent/US20080082051A1/en
Application filed by Kyphon Sarl filed Critical Kyphon Sarl
Priority to EP07842908A priority Critical patent/EP2068996A4/fr
Publication of WO2008036842A2 publication Critical patent/WO2008036842A2/fr
Publication of WO2008036842A3 publication Critical patent/WO2008036842A3/fr

Links

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
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/0046—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable
    • A61B2017/00469—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/0046—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable
    • A61B2017/00473—Distal part, e.g. tip or head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3933—Liquid markers

Definitions

  • the present invention is related generally to medical apparatus and methods.
  • the invention is directed at structures and methods for introducing medical catheters into tissue.
  • a wide variety of medical procedures require placing a catheter or other medical device over a guidewire. Many of these procedures are performed in the vasculature, including angioplasty, atherectomy, stent delivery, and the like. Many other procedures are performed in non-vascular lumens, including urinary procedures in the urethra and ureter, and the like. Of particular interest to the present invention are those procedures performed with very small diameter catheters which must be introduced over very small guidewires, such as the Functional Anesthetic Discography (FAD), a procedure in the spinal disc space, which utilizes a guidewire, which utilizes a guidewire typically having a diameter of about 0.009 inches, and a diameter of a guidewire lumen in a catheter of about 0.011 inches.
  • the guidewires are placed under sterile conditions in the operative environment where introduction of guidewires into the catheter can be difficult, particularly when very small catheters and guidewires are involved.
  • the present invention provides apparatus and methods for facilitating the introduction of a medical catheter.
  • embodiments may be particularly useful for placement of very small guidewires, which may have, for example, diameters of about 0.009 inches or below, into very small guidewire lumens, which may have, for example, diameters of about 0.011 inches or below.
  • the apparatus of the present invention comprises guidewire structures for loading a guidewire into the lumen of a catheter.
  • the guidewire structures comprise a body (also referred to as "guide-body") having a receiving end, an attachment end, and a guide channel therebetween.
  • the attachment end removably attaches to an end of the guidewire such that the guidewire lumen of a catheter is aligned with the guide channel.
  • the receiving end of the guide structure body receives an end of the guidewire such that the guidewire can be advanced through the guide channel and into the lumen of the catheter.
  • the guide structure may further comprise a handle on the body to facilitate manipulation during the guidewire introduction.
  • the guidewire may be conveniently located to project laterally from a location at or near the attachment end of the body, although it could also be at other locations.
  • the attachment end of the body of the guide structure is flared to provide an enlarged target area for capturing the catheter and guiding the catheter into the guide channel.
  • a catheter may be inserted into the guide structure at the attachment end of the guide body and through the guide channel.
  • a portion of the guide channel may be shaped to conform to the shape of an outer distal end of the catheter to, for example, form a tapered section or, a "stop” or “limiting stop” that engages and aligns the lumen of the catheter with the guide channel..
  • the receiving end of the guide body may also be flared to provide an enlarged target area for receiving the guidewire.
  • the flare is generally conical in shape and coaxially positioned around an axis of the guide channel.
  • a transition region may be provided in the guide channel for aligning the guidewire as it is advanced through the guide channel at the open end or port of the guidewire lumen in the catheter.
  • the guide body may be adapted to laterally release the catheter and guidewire from the guide structure or remove the guide structure from the catheter and guidewire assembly.
  • the guide body may be axially slit or splittable along a wall of the guide channel. A slit would permit the catheter and guidewire to be pulled from the channel while leaving the guide body intact. Splittable guide bodies will allow the user to pull the guide body apart and remove the guide structure from the catheter and guidewire.
  • the guide body may be open along one side of the guide channel so that the catheter and guidewire may be pulled from the channel with minimum effort. With such open channel configurations, detents, protrusions, or other simple components may be provided to hold the catheter in place as the guidewire is advanced.
  • Methods according to the present invention for inserting a guidewire into the lumen of a catheter comprise removably attaching a guide structure onto an end of the catheter.
  • the guide structure includes a channel which aligns with a guidewire port on the lumen when the catheter is in place in the channel. After the catheter has been placed in the guide structure, an end of the guidewire is introduced through the channel of the guidewire structure and into the lumen of the catheter. After the guidewire is in place in the catheter, the guide structure may be removed from the catheter.
  • Removably attaching the guide structure to the catheter may comprise inserting an end of the catheter through a flared attachment end of the guide structure channel.
  • the catheter will be captured in a shaped portion of the channel where it engages a stop for final positioning.
  • Introducing an end of the catheter typically comprises inserting the guidewire end through a flared receiving end of the guide structure channel after the guide structure has been attached to the catheter.
  • the flared receiving end has a generally conical shape.
  • Removing the guide structure from the catheter may comprise pulling the catheter and guidewire laterally from the guide structure.
  • the guidewire and catheter may be pulled through an axial slit which is preformed in the guide structure.
  • the guidewire and catheter may be pulled through a pre-formed discrete opening in the channel.
  • the guide structure may be removed from the catheter and guidewire by splitting the guide structure, typically by pulling the guide structure apart at one end so that the structure separates into two pieces which may then be pulled away from the catheter and guidewire.
  • the guide structure could be radially expanded facilitating removal from the catheter by passing it over the proximal end of the catheter.
  • the guide structure is utilized for placement of a catheter over the proximal portion of an elongated and flexible guidewire having its distal end inserted within a patient's body.
  • a physician first inserts the distal portion of a flexible and elongated guidewire into a patient's body through one of various methods that are well known to one of ordinary skill in the art. The physician then places a guide structure over the distal portion of a catheter. The distal widened-end (e.g., funnel-shaped opening) of the guide structure is then placed over the proximal end of the flexible guidewire. With the guide structure directing the distal tip of guidewire, the catheter is advanced over the proximal portion of the guidewire. Once the catheter is placed over a portion of the guidewire, the physician may then remove the guide structure. The physician can further propell the catheter along the length of the guidewire until the distal portion of the catheter enters the patients body.
  • the guide structure is preloaded on the catheter, and provided to the physician in a sterile package, such that the physician may place the catheter onto the guidewire right out of the package without the need to further position and/or orient the guide structure.
  • the catheter may have a penetrating tip (e.g., a stiffened and/or tapered tip portion) and/or an anchoring mechanism (e.g., an expandable balloon) at the distal tip portion.
  • the guide structure may be configured to be preloaded on the distal portion of the catheter to provide protection for the penetrating tip and/or the anchoring mechanism.
  • the inner lumen of the guide structure is configured with a profile for receiving the penetrating tip and/or the anchoring mechanism.
  • inventions of the present invention provide an apparatus.
  • the apparatus comprises a guide structure, and a catheter.
  • the apparatus comprises a sterile package with the guide structure pre-loaded on the catheter within a sterile package.
  • the catheter may be on the catheter within the sterile package such that a user may place the catheter onto a guidewire.
  • the catheter can be positioned within a guide channel of the guide structure, and the guide structure can be removably attached to the catheter.
  • the catheter comprises a balloon and a penetrating tip.
  • the guide structure can be configured to protect the penetrating tip of the catheter and the balloon of the catheter.
  • the apparatus comprises a guidewire.
  • the guidewire may comprise a diameter of about 0.009 inches or below.
  • the catheter may comprise a lumen with a diameter of about 0.011 inches or below.
  • the guide structure comprises a guide body having a receiving end, an attachment end, and a guide channel extending therebetween.
  • the receiving end may comprise a diameter of about 0.25inches.
  • the receiving end comprises a diameter in a range from about 0.20 to about 0.27 inches.
  • the guide channel may comprise a diameter within a range from about 0.035 to about 0.038 inches.
  • the guide channel diameter may be sized from about 0.0001 inches to about 0.010 inches smaller than a diameter of the catheter so as to form an interference fit.
  • the guide channel comprises a guidewire section with a diameter within a range from about 0.010 inches to about 0.014 inches.
  • the attachment end may comprises a diameter from about 0.035 inches to about 0.05 inches.
  • the guide structure and method of use thereof may be implemented in combination with the devices and methods described in U.S. Patent Publication No. 2005/0234425, which is incorporated herein by reference in its entirety for all purposes.
  • the method comprises placing the distal portion of an elongated (e.g., 12 inches or longer) and flexible guidewire percutaneously into a spinal disc in a patient's body.
  • the distal widened end of a guide structure, which is attached to the distal portion of a catheter is placed over the distal tip of the guidewire.
  • a transition region within the guide structure aligns the guidewire with the lumen of the catheter.
  • the physician may then remove the guide structure through various methods described herein.
  • the catheter can be advanced distally such that the guide structure contacts an introducer device, for example an introducer needle, and the guide structure is released from the end of the catheter.
  • the distal portion of the catheter is further advanced over the guidewire and into the patients body, followed by penetration into the spinal disc.
  • an optional anchoring mechanism on the catheter may be deployed to secure the distal portion of the catheter within the disc.
  • Embodiments of the present invention provide flexibility with many of the usage situations described above, can facilitate evaluation of spinal discs, and in at least some instances may permit less invasive FAD and other forms of discography.
  • system typically in the form of a kit, is provided which allows the user to select how to perform the disc diagnosis with the components of the system.
  • the system components may include a FAD catheter, a guidewire and stylet, in which both the guidewire and stylet are compatible with the catheter. The user may select to insert the catheter into the disc with a stylet included in the system.
  • the user may select to insert the catheter into the disc with a guidewire included in the system, for example after the guidewire has been placed with a rigid needle.
  • Some embodiments of the present invention can utilize needles that have already been placed to introduce the FAD catheter quickly and safely, so as to avoid additional needle penetration and associated pain. For example, a clinician may access the disc with a standard needle and use this needle to place the catheter, even if a standard discography is not performed.
  • inventions of the present invention provide a system for accessing an interior of an intervertebral disc.
  • the system comprises an intervertebral disc access catheter having at least one lumen for introducing one or more substances into the interior of the intervertebral disc.
  • the system also comprises a stylet that is removably receivable in the at least one lumen.
  • the stylet has a tissue-penetrating distal tip, which extends from a distal end of the catheter when the stylet is in place in the lumen.
  • the tip will usually comprise an integrated sharpened end, but could alternatively comprise a radiofrequency electrode (capable of applying cutting current), a removably or separately formed sharpened end, or the like.
  • a removable guidewire that is receivable in the at least one lumen is also included in the system
  • a user can select to advance percutaneously the access catheter to the disc interior using the stylet, or the user can select to remove the stylet and introduce the access catheter over a guidewire to the disc interior.
  • the intervertebral disc access catheter comprises an elongate flexible catheter body.
  • the catheter body may have a proximal portion and a distal portion.
  • the disc access catheter may comprise an inflatable anchoring balloon on the distal portion of the catheter body and an injection tube or lumen in the elongate body.
  • the injection tube or lumen may be adapted to removably receive either the guidewire or the stylet.
  • the intervertebral disc catheter may comprise an inflation tube or lumen in the elongate body.
  • the intervertebral disc access catheter has an outer diameter in the range from 0.4 mm to 1.5 mm, and an injection lumen diameter in the range from 0.08 mm to 0.8 mm.
  • the disc access catheter may have an inflation lumen diameter in the range from 0.08 mm to 0.8 mm, and a length in the range from 10 cm to 62 cm.
  • the guidewire may have a diameter in the range from 0.02 mm to 0.8 mm, and the stylet may have a diameter in the range from 0.02 mm to 0.8 mm and a length in the range from 20 cm to 80 cm.
  • the guidewire may has a length in a range from about 20 cm to about 80 cm.
  • embodiments of the present invention provide a method for accessing the interior of an intervertebral disc.
  • the method may comprise providing a system as described above, and the access catheter may be advanced to the disc interior using the stylet.
  • a method for accessing the interior of an intervertebral disc may comprise providing a system as described above.
  • a needle may be percutaneously advanced into the interior of the intervertebral disc, and the catheter may be advanced over the guidewire so that a distal end of the catheter is positioned in the disc.
  • a method for assessing the condition of an intervertebral disc may be provided.
  • the method may comprise percutaneously advancing a needle into an intervertebral disc.
  • the condition ofthe disc may be assessed using X-ray.
  • a guidewire may be advanced through the needle in response to the condition assessed with X-ray, and the needle may be removed over the guidewire in response to the condition assessed with X-ray.
  • a catheter may be advanced over the guidewire in response to the condition assessed with X-ray, so that a distal end ofthe catheter is positioned in the disc.
  • At least one anesthetic or analgesic may be introduced through the catheter.
  • the condition ofthe disc may be further assessed based on the patient's response to the anesthetic or analgesic.
  • a method for assessing the condition of an intervertebral disc having an annulus and a nucleus comprising a needle, a catheter, a stylet and a guidewire.
  • the stylet is provided inside a lumen ofthe catheter. Either the guidewire or the stylet is selected to position a distal end ofthe catheter through the annulus into the nucleus. The distal end ofthe catheter is advanced into the nucleus with either the guidewire or the stylet in response to the selection.
  • the needle can be selected in response to a location ofthe disc in the patient, and the needle can be selected in response to a previously placed catheter.
  • the system is comprised within a sterile package comprising a kit, and a plurality of sterile kits are provided to the physician for assessing a plurality of discs, hi specific embodiments, each kit of the plurality of kits corresponds to an evaluated disc of the plurality of discs.
  • Fig. 1 illustrates one embodiment of the guide structure constructed in accordance with the principles of the present invention.
  • Figs. 2A-2D illustrate the steps in introducing a guidewire into a catheter using the exemplary guide structure of Fig. 1.
  • FIG. 3 illustrates the guide structure used with an FAD catheter comprising an anchor, according to embodiments of the present invention.
  • Fig. 4 illustrates dimensions of the guide structure, according to embodiments of the present invention.
  • FIG. 5 A shows a kit, according to embodiments of the present invention.
  • Figs. 5B and SC show components of the kit as in Fig. 5 A in detail, according to embodiments of the present invention.
  • FIGs. 6A-6D show a method of accessing the interior of an intervertebral disc with components of a kit as in Fig. 5 A, in which an access catheter can be advanced into the interior of the disc with a stylet, according to embodiments of the present invention.
  • Figs. 7A-7K show a method of accessing the interior of an intervertebral disc with components of a kit as in Fig. 5 A, in which a needle can be percutaneously advanced to the interior of the disc and a catheter can be advanced over a guidewire positioned with the needle, according to embodiments of the present invention.
  • the present invention provides apparatus and methods for facilitating the introduction of a guidewire into a guidewire lumen in a medical catheter.
  • Embodiments of the invention may be particularly useful for placement of very small guidewires, which may have, for example , diameters of about 0.009 inches or below, into very small guidewire lumens, which may have, for example, diameters of about 0.011 inches or below.
  • the apparatus may comprise guidewire structures for loading a guidewire into the lumen of a catheter.
  • the guidewire structures comprise a body having a receiving end, an attachment end, and a guide channel therebetween.
  • the attachment end removably attaches to an end of the guidewire such that the guidewire lumen of a catheter is aligned with the guide channel.
  • the receiving end of the guide structure body receives an end of the guidewire such that the guidewire can be advanced through the guide channel and into the lumen of the catheter.
  • the guide structure may further comprise a handle on the body to facilitate manipulation during the guidewire introduction.
  • the guidewire may be conveniently located to project laterally from a location at or near the attachment end of the body, although it could also be at other locations.
  • the flared receiving end of the guide structure channel typically has an opening or "target area” that is substantially larger than the lumen in the catheter, often having a diameter of about 5 to about 1000 times larger than the guidewire diameter.
  • the opening flare or funnel is configured with a diameter of about 0.25 inches and tapers down to an area about the size of the lumen in the catheter that accepts the guidewire.
  • the tapered down diameter of the flare is the same size or slightly larger than the guidewire and preferably the same size or slightly smaller than the lumen in the catheter that accepts the guidewire.
  • the included angle of the interior guidewire flare or funnel could be between about 5 and about 120
  • the catheter may be back-loaded over a guidewire that is already in place in the patient, and the guide structure may be trapped at the distal end of the catheter after the catheter has been place over the guidewire.
  • the guide structure may be adapted to be removed from the guidewire and catheter assembly.
  • the guide structure may be (a) adapted for splitting or peeling the guide structure longitudinally into two or more parts or (b) have an axial slit or opening such that the guidewire and catheter assembly can be pulled through the slit or opening.
  • Such slit in the channel may be, for example, a substantially straight slit, a spiral cut, or a combination of a straight slit or spiral cut.
  • the slit for example, could also be complete or intermittent (also referred to as perforated). Such a perforated slit would allow the guide structure to function like an intact tube, but still allow removal of the guide structure from the catheter and guidewire assembly by splitting the slit.
  • the guide structure may have one or more pull tabs that assist in its removal from the catheter and guidewire assembly, particularly by splitting. Such pull tabs may be located on the guide structure and may be sized such that the pull tabs may be easily grasped.
  • Other optional features of the guide structure include an interior tapered section or "stop" that engages and aligns the lumen of the catheter with the channel. This tapered section allows for proper alignment between the guide structure and the catheter for catheters with lumens that are not in the middle of the device and for variations in size and construction of the catheter or guide structure.
  • the included angle of the interior tapered section could be between about 5 and about 120 degrees. In a preferred aspect, the angle of the interior tapered section could be about 60 degrees.
  • the guide structure may be secured to the catheter by an interference fit (also known as press fit or friction fit) such that after the guidewire is introduced into the lumen of the catheter the guide structure and catheter are securely held together by the friction between two components, yet the guide structure and catheter may be are easily separable by use of moderate force.
  • the interference fit may be formed by sizing the guide channel to have an inside diameter of about 0.0001" to 0.010" smaller than the outside diameter of the catheter.
  • An interference fit may also be formed by small ribs in the channel or may be formed by different shapes for the channel and catheter (for example one straight, one curved, or one straight, one corkscrew shaped).
  • the catheter may have a balloon near its distal tip.
  • the balloons may require having a sleeve or cover over them during storage and shipment which may, for example, protect the balloon from damage and/or keep the balloon pleats compressed in order to minimize the passing profile of the balloon.
  • the guide structure is integrated into a balloon cover. Examples of balloons useful in embodiments of the present invention are described in U.S. Pub. No. 2005/0234425, the full disclosure of which has been previously incorporated herein by reference.
  • the guide structure may be made out of a soft material such as a polymer extrusion.
  • Polymer extrusion materials that may be used include, but are not limited to nylon 11, nylon 12, high-densily polyethylene, low-densily polyethylene, PEEK, urethane, and polyurethane.
  • the guide structure could also be injection molded.
  • the guide structure is formed out of extruded high-density polyethylene.
  • the material used to make the guide structure may comprise or contain a material that is radiopaque.
  • a radiopaque material may allow the physician to visualize the guide structure using fluoroscopy.
  • the material of the guide structure could consist of or contain a material that may glow or luminate in the dark or under light or visibility. This would allow the physician to more easily place, locate, and manipulate the structure in a dark room or room which is under low light or limited visibility.
  • the material used to make the guide structure may comprise or contain, or be coated with a material that is highly lubricious. Such a material would allow for (a) easier assembly of the guide structure onto the catheter, (b) easier removal of the guide structure from the catheter, or (c) easier passage of the guidewire through the guide structure and into the catheter.
  • a material may be, for example, a hydrophilic or hydrophobic coating, a dry lubricant like parylene, or a material from the Teflon family such as PTFE, ePTFE, or FEP.
  • a guide structure may be manufactured in a variety of different ways.
  • the guide structure may be formed from an extruded tube, by using methods such as heating and using specialized tooling to create the desired interior and exterior features, or the guide structure may be injection molded or machined into its final form.
  • a slit in the guide structure or in a portion of the guide structure may be created using a variety of techniques known in the art such as using a laser, using a heated element, or using a cutting tool. The resulting slit may be about 0.0001" to about 0.050" in width.
  • the guide structure may be biased to close after the slit is formed which may result in a slit width of zero width unless the slit is forcibly opened.
  • the slit may have a width that varies over its length.
  • the guide structure 10 comprises a body 12 having a receiving end 14 and an attachment end 16.
  • a guide channel 18 (best seen in Fig. 2A) extends between the receiving end 14 and attachment end 16.
  • a handle 20 may be provided, typically projecting laterally from near the attachment end of the guide structure.
  • an axial slit 22 extends the entire length of the guide structure 10 so that the assembly of the catheter and guidewire may be pulled from the guide structure after the loading procedure is completed.
  • the receiving end 14 of the guide structure is typically formed as a conical extension or funnel 24 having an open end or target area 26 through which the physician inserts a guidewire into the catheter.
  • the attachment end 16 of the guide structure may be flared, for example having a pair of diverging sections 28 which help channel the catheter into the channel.
  • the amount of flaring on the attachment end 16 of the guide structure 10 need not be as great or as large as the diameter of the receiving end 14.
  • a catheter C (Fig. 2B) is introduced through the flared section 28 of the guide structure 10 and is received in a section 30 of channel 18 which is configured to conform closely to the distal end of the catheter.
  • a stop section 32 is formed in the channel, where the stop is typically tapered to conform to the distal end DE of the catheter, as shown in Fig. 2B.
  • the dimensions and alignments of the conforming section 30 and stop 32 are selected so that a distal guidewire port (not shown) in catheter C will be aligned with guidewire section 34 of the channel 18.
  • the guidewire GW is inserted through the target area 26 of the conical structure 24 in the direction of arrow 40, as shown in Fig. 2C.
  • the guidewire GW is directed into the guidewire section 34 of channel 18, as shown in Fig. 2D.
  • the guidewire GW may be further or fully advanced into the catheter. After such advancement, it will usually be necessary to remove the guide structure 10 from the assembly of the catheter C and guidewire GW. In the illustrated embodiment, this can be achieved by pulling the catheter and guidewire through the axial slit 22 in the direction of the arrows shown in Fig.
  • the guide structure could be axially split, or the slit could be spiral or have other configurations.
  • the guide structure could be removed by passing the guide structure proximally off of the catheter by pulling tab 20 or pushing in a proximal direction on the target area 26 or any portion of the guide catheter. Once the guide structure 10 has been removed, the catheter may be advanced into the patient over the guidewire in a conventional manner.
  • Fig. 3 illustrates the guide structure used with an FAD catheter 300 comprising an anchoring mechanism 310, according to embodiments of the present invention.
  • the guide structure as described above is shown with an FAD catheter, as describe in U.S. Patent Publication No. 200S/023442S, the full disclosure of which has been previously incorporated herein by reference.
  • Catheter 300 may comprise a penetrating tip 320.
  • the guide structure can preloaded on the catheter, and provided to the physician in a sterile package, such that the physician may place the catheter onto the guidewire right out of the package without the need to further position and/or orient the guide structure.
  • penetrating tip 320 may comprise, a stiffened and/or tapered tip portion.
  • Anchoring mechanism 310 may comprise an expandable balloon at the distal tip portion.
  • the guide structure may be configured to be preloaded on the distal portion of the catheter to provide protection for the penetrating tip and/or the anchoring mechanism.
  • the inner lumen of the guide structure is configured with a profile for receiving the penetrating tip and/or the anchoring mechanism
  • guide structure may be removed by advancing the catheter distally such that the guide structure contacts an introducer device 330, or introducer needle, as described in U.S. Patent Publication No. 2005/0234425, previously incorporated herein by reference.
  • Contact between the guide structure and introducer device 330 can split open the slit in the guide structure so as to release the guide structure from the distal end of the catheter, for example by falling off the distal end of the catheter.
  • Fig. 4 illustrates dimensions of the guide structure 400, according to embodiments of the present invention.
  • the guide structure comprises a guide body 402 having a receiving end 404, an attachment end 406, and a guide channel 408 extending therebetween.
  • the receiving end comprises a diameter 440 within a range from about 0.20 to about 0.27 inches, for example about 0.25 inches.
  • the guide channel comprises a diameter 410 within a range from about 0.035 to about 0.038 inches.
  • the guide channel diameter is sized from about 0.0001 inches to about 0.010 inches smaller than a diameter of FAD catheter 300so as to form an interference fit
  • the guide channel comprises a guidewire section 409 with a diameter 430 within a range from about 0.010 inches to about 0.014 inches.
  • Attachment end 406 comprises a diameter 420 within a range from about 0.035 inches to about 0.05 inches.
  • Receiving end 404 extends for the body at an angle 460 within a range from about 55 to 65 degrees, for example about 60 degrees.
  • a length 420 of a stop section 432 comprises a length of about 0.04 inches.
  • Guidewire section 409 comprises a length 480 of about 0.14 inches.
  • Receiving end 404 comprises a thickness 450 of about 0.12 inches.
  • a thickness of Ihe body wall is about 0.01 inches.
  • An overall length 491 of guide structure 400 may be within a range from about 0.9 to about 1.1 inches, for example about 1 inch.
  • Embodiments of the present invention can be used in many flexible ways to benefit clinical procedures, including Functional Anesthetic Discography (FAD) and traditional provocative discography (PD).
  • FAD Functional Anesthetic Discography
  • PD traditional provocative discography
  • a clinician may use kit components to place a FAD catheter at all disc levels being tested and perform a provocative discography with each placed FAD catheter.
  • the clinician may use the kit components to perform a traditional provocative discography and place a FAD catheter at the level of the disc in response to the disc testing is positive.
  • the FAD catheter anchor may be deployed and the functional portion of the FAD testing conducted in response to the positive test result of the disc.
  • the clinician may place a FAD catheter from the kit without performing the provocative discography, for example in response to physical exams, imaging studies such as x-ray or MRI, or previous discographies that have been performed.
  • Kit 500 comprises a catheter 510, a stylet 530 and a guidewire 540.
  • Catheter 510 may comprise an elongate and flexible catheter body 511.
  • Catheter body 511 comprises a proximal portion 512 and a distal portion 514.
  • An adapter 518A and an adapted 518B may be connected to catheter 510 near proximal portion 512.
  • Catheter 510 comprises a length 528.
  • Length 528 may comprise many suitable lengths, and length 528 may comprise a range of lengths from about 10 to 62 cm Stylet 530 passes though an opening 515 formed near the distal end of catheter 510.
  • Catheter 510 may comprise many suitable materials, for example braid reinforced polyimide tubing, and many materials as described in U.S. App. No. 10/825,961, the full disclosure of which has been previously incorporated by reference.
  • Anchor 516 is located near distal portion 514 of the catheter body.
  • Anchor 516 may comprise an expandable member, such as an expandable balloon, to anchor the catheter in the disc.
  • Anchor 516 may comprise many suitable structures that anchor the catheter in and/or near the disc.
  • anchor 516 may comprise an expandable balloon that can be inflated upon injection of a fluid through inflation tube 525.
  • Many suitable anchor structures are described in U.S. App. No. 10/825,961, the full disclosure of which has been previously incorporated by reference.
  • the expandable anchor may comprise flexible polyvinyl chloride (PVC), Polyethylene, Polyether Block Amide (PEBAX), Polyethylene Terepthalate (PET), Polyester, Nylon, Polyurethanes, Polyether Block Amide (PEBAX), Polyolefins or any suitable combination thereof.
  • Various adhesives may be used to attach anchor 516 to the catheter shaft or for any other suitable purpose.
  • Many suitable adhesive(s) may be used, such as but not limited to, light activated acrylics, light activated cyanoacrylates, light activated silicones, heat activated adhesives, ambient curing adhesives, cyanoacrylates, epoxy adhesives, and/or polyurethane adhesives.
  • Stylet 530 can be sized to pass through catheter SlO and may comprise a sharpened distal tip 532 adapted to penetrate tissue and permit catheter body 511 to enter tissue.
  • Stylet 530 comprises a cross-sectional size, for example a diameter 534, to permit stylet 530 to slide through connector 518 A and catheter body 511.
  • Outside diameter 534 of stylet 530 may comprise a range of diameters from about 25% to 75% of the overall outside diameter of catheter 510, for example from about 0.005" to about 0.035".
  • Stylet 530 comprises a length 536.
  • Length 536 may comprise many suitable lengths, and length 536 may comprise a range of lengths from about 20 to 80 cm.
  • stylet 536 may stiffen catheter 510 to facilitate placement.
  • Stylet 530 may comprise many suitable materials such as stainless steel, tungsten, tungsten alloys, cobalt chrome alloys, nitinol, molybdenum rhenium alloys, Eligloy, MP35N, or L605, 35NLT. Additionally the stylet could be treated with materials to enhance its radiopacity such as gold, platinum, iridium, or alloys thereof or materials to enhance it lubricity such as Teflon, PTFE, orparylene.
  • Guidewire 540 can be sized to pass through catheter 510.
  • catheter body 511 can be advanced over guidewire 540 when stylet 530 has been removed from catheter 510.
  • Guidewire 540 may be advanced into the disc and catheter 510 advanced over the guidewire to permit anchor 516 to attach to the disc.
  • Guidewire 540 may comprise a cross- sectional size, for example a diameter 542, and a length 544 when elongate, as shown in Fig. 5C.
  • Diameter 542 may comprise a range from about 0.02 mm to about 0.8 mm.
  • Length 544 may comprise a range from about 20 to 80 cm
  • catheter 510 may comprise an overall outside diameter of about 0.038" with an injection lumen of about 0.018" that can accommodate a 0.017" guidewire and a 0.017" stylet.
  • Guidewire 540 may comprise many suitable materials such as stainless steel, tungsten, tungsten alloys, cobalt chrome alloys, nitinol, molybdenum rhenium alloys, Eligloy, MP35N, or L605, 35NLT. Additionally the guidewire could be treated with materials to enhance its radiopacity such as gold, platinum, iridium, or alloys thereof or materials to enhance it lubricity such as Teflon, PTFE, or parylene.
  • catheter 510 is shown in detail near distal end portion 514, according to embodiments of the present invention.
  • Catheter body 511 comprises an inner lumen 511 L with an injection tube 520 disposed therein that extends from attachment 518A to distal portion 514.
  • Injection tube 520 comprises a lumen 521 with a size, for example, an inner diameter 522, to permit stylet 530 to slide through tube 520.
  • Injection tube 520 extends from attachment 518A to opening 515 such that fluids can be injected from attachment 518A to the disc through injection tube 520.
  • Inner diameter 522 may comprise a range of diameters, for example a range from about 0.08 to 0.8 mm.
  • Catheter body 511 may also comprise within lumen 11 IL an inflation tube 525, which comprises an inflation lumen 524.
  • Inflation tube 525 and inflation lumen 524 extend from attachment 518B to anchor 516.
  • Inflation lumen 524 comprises an inner size, for example a diameter 526.
  • Diameter 526 may comprise a range from about 0.08 to 0.8 mm.
  • Catheter 510 may comprise an overall outside diameter 529 in a range from about 0.38 mm (0.015 11 ) to about 1.5 mm (0.060").
  • Catheter injection lumen 521 may be sized to receive guidewire 540 and/or stylet 530. Such sizing of the tube lumen, stylet and guidewire provide flexible use of the kit components. For example, the user may select to insert catheter 510 with stylet 530. Guidewire 540 may also be used to insert catheter 510. The user may remove stylet 530 such that injection lumen 520 is available, and the user may insert guidewire 540 into lumen 521 and advance catheter 510 into the patient, with guidewire 540 inserted into injection lumen 520 so as to guide the catheter to the disc.
  • Kit 500 can be shipped to the clinician in many configurations. Kit 500 can be shipped to the clinician with stylet 530 positioned within catheter 510. In some embodiments, the kit can be shipped to the clinician with guidewire 540 and stylet 530 removed from catheter 510 and ready for placement within the catheter.
  • Provocative discography may be used with at least some embodiments of the present invention.
  • Provocative discography may provide anatomical and functional information about the evaluated disc.
  • Provocative discography may comprise an imaging procedure in which a contrast agent may be injected into the nucleus pulposus. Following injection, the disc can be evaluated on radiographs and/or computed tomography (CT).
  • CT computed tomography
  • Some embodiments of the present invention may use functional evaluation of the disc.
  • Functional evaluation may comprise pain provocation and careful assessment of the patient's response to pain.
  • a substance can be injected into the nucleus pulposus mat may reduce pain perceived by the patient. For example, if the patient reports a decrease in pain after injection of the substance into the disc, the disc may contribute to pain previously perceived by the patient and the defective disc may be corrected surgically.
  • an anesthetic such as hypotonic saline, isotonic saline or hypertonic saline
  • a supportive agent such as a hydrogel, ethylene-vinyl alcohol copolymer, Dimethyl Sulfoxide or Tantalum
  • a prolotherapy agent such as sodium morrhuate, cod oil, phenol, minerals or ethyl alcohol
  • other agents such as collagen, stem cells, Osteogenic Protein- 1, ethanol, alcohol, steroids, radio-opaque contrast agents, ultrasound contrast agent, Bone Morphogenetic Protein (BMP), BMP-2, BMP-4, BMP-6, BMP-7, BMP-12, Serotonin 5- HT2A receptor inhibitors, LMP-I, ⁇ MP-1, TGF-I, TGF-2, Rof
  • the substance can be injected to alter the pH of the nucleus.
  • raising the pH can make the nucleus and surrounding tissues more basic so as to lower the threshold of triggering nociceptive receptors.
  • pH lowering substances can also be injected into the patient in therapeutic embodiments.
  • FIGs 6A to 6D show a method 600 of accessing the interior of an intervertebral disc with an access catheter advanced into the interior of the disc with a stylet, according to embodiments of the present invention.
  • a step 610 delivers catheter 510 with a stiffened stylet 530 from a kit as described above.
  • a skin S is penetrated by stylet 530 and catheter 510, and the stylet and catheter are advanced distally past a vertebra V into a disc D.
  • Disc D comprises an annulus fibrosis AF, or annulus, and a nucleus pulposus NP, or nucleus.
  • stylet 530 penetrates the annulus fibrosis to enter the nucleus pulposus and anchor 516 is deployed at least partially within the nucleus pulposus.
  • a step 620 may remove the stylet and may deploy anchor 516 to anchor catheter 510 with anchor 516.
  • a step 630 may perform a provocative discography PD to assess disc D.
  • a traditional PD may be performed and a contrast agent 631 can be injected at adapter 518A to pass through the injection lumen into the disc.
  • a step 640 may perform a functional test.
  • the patient may be asked to assume a position that induces pain, and a substance such as an anesthetic and/or analgesic or the like introduced, and the patient asked if the pain has decreased to determine if the disc is the source of pain experienced by the patient.
  • FIGs 7 A to 7K show a method 700 of accessing the interior of an intervertebral disc with a needle percutaneously advanced to the interior of the disc, and a catheter advanced over a guidewire positioned with the needle, according to embodiments of the present invention.
  • a step 705 removes stylet 530 from catheter 510 of the kit as described above. Guidewire 540 remains separate from catheter 510.
  • a step 710 advances an introducer, or outer needle 712, and a stylet 714 through skin S of the patient.
  • a step 715 removes stylet 714 and passes an inner needle 716 into the disc space within disc D. Inner needle 716 may penetrate the annulus fibrosis and enter the nucleus pulposus.
  • a step 720 may perform a provocative discography, for example a traditional discography.
  • a contrast agent 722 that can be detected by fluoroscopy and/or X-rays, MRI or the like can be injected into disc D.
  • a step 725 may pass guidewire 540 from a proximal end of inner needle 716, through the inner needle, out a distal end of inner needle 716 and into the nucleus pulposus.
  • a step 730 may remove inner needle 716 while guidewire 540 remains positioned in the nucleus pulposus and outer needle 712 remains positioned through skin S.
  • a step 735 may remove outer needle 712 and guidewire 540 remains position through skin S and extends into the nucleus pulposus.
  • a step 740 may deliver catheter 510 with the guidewire through skin S, the annulus fibrosis and into the nucleus pulposus.
  • Catheter 510 can slide over guidewire 540 with guidewire 540 extending through adapter 518A.
  • adapter 518A may be removed while the catheter is advanced over the guidewire and attached after the catheter is placed in the disc.
  • a step 745 removes guidewire 540 and deploys anchor 516.
  • a step 750 may perform a provocative discography, for example if a traditional discography with a needle as described above has not been performed previously.
  • a contrast agent 752 can be injected through catheter 510 and the disc D imaged, for example with fluoroscopy.
  • a step 755 may perform a functional test that includes an injected substance as described above. For example, an anesthetic and/or analgesic substance may be injected through catheter 510 while anchor 516 is deployed, and patient response evaluated as described above.
  • Figs. 7A to 7K provide a particular method of accessing the interior of an intervertebral disc, according to an embodiment of the present invention.
  • Other sequences of steps may also be performed according to alternative embodiments.
  • alternative embodiments of the present invention may perform the steps outlined above in a different order.
  • the individual steps illustrated in Figs. 7A to 7K may include multiple sub-steps that may be performed in various sequences as appropriate to the individual step.
  • additional steps may be added or removed depending on the particular applications.
  • One of ordinary skill in the art would recognize many variations, modifications, and alternatives.
  • the needle can be selected in response to a location of the disc in the patient, and the needle can be selected in response to a previously placed catheter.
  • the system is comprised within a sterile package comprising a kit, and a plurality of sterile kits are provided to the physician for assessing a plurality of discs.
  • each kit of the plurality of kits corresponds to an evaluated disc of the plurality of discs.
  • three sterile kits can be provided to assess three adjacent discs. The decision to use either the needle or the stylet can be based on the catheter previously inserted into the adjacent disc. As the components of each kit are substantially similar, improved consistency in FAD catheter placement can be achieved.

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  • Life Sciences & Earth Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
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  • Heart & Thoracic Surgery (AREA)
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Abstract

L'objet de la présente invention qui constitue une structure de guide destinée à faciliter l'introduction d'un guide souple dans un cathéter comprend un corps doté d'un conduit de guidage. Une extrémité de fixation de la structure de guide est adaptée pour recevoir et aligner l'extrémité distale du cathéter dans le conduit de guidage. Une extrémité de réception de la structure de guide est adaptée pour recevoir et aligner un guide souple avec son extrémité dans le cathéter lorsque ledit cathéter se trouve dans la structure de guide.
PCT/US2007/079075 2006-09-21 2007-09-20 Dispositif et procédé pour faciliter l'introduction de cathéters WO2008036842A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07842908A EP2068996A4 (fr) 2006-09-21 2007-09-20 Dispositif et procédé pour faciliter l'introduction de cathéters

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US82647206P 2006-09-21 2006-09-21
US60/826,472 2006-09-21
US11/764,029 US20080312637A1 (en) 2007-06-15 2007-06-15 Device and Methods for Introducing a Catheter into an Intervertebral Disc
US11/764,029 2007-06-15
US11/771,768 2007-06-29
US11/771,768 US20080082051A1 (en) 2006-09-21 2007-06-29 Device and method for facilitating introduction of guidewires into catheters

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WO2008036842A2 true WO2008036842A2 (fr) 2008-03-27
WO2008036842A3 WO2008036842A3 (fr) 2008-09-04

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US10905783B2 (en) 2015-11-27 2021-02-02 Michal RIVLIN Glucosamine and derivatives thereof in imaging

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2952222A1 (fr) 2014-06-06 2015-12-09 B. Braun Melsungen AG Cathéter à ballonnet doté d'une aide d'introduction pour un fil de guidage
US10905783B2 (en) 2015-11-27 2021-02-02 Michal RIVLIN Glucosamine and derivatives thereof in imaging

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EP2068996A4 (fr) 2010-11-03
EP2068996A2 (fr) 2009-06-17

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