US20130253266A1 - Fluid management catheter and methods of using same - Google Patents

Fluid management catheter and methods of using same Download PDF

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Publication number
US20130253266A1
US20130253266A1 US13/427,232 US201213427232A US2013253266A1 US 20130253266 A1 US20130253266 A1 US 20130253266A1 US 201213427232 A US201213427232 A US 201213427232A US 2013253266 A1 US2013253266 A1 US 2013253266A1
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United States
Prior art keywords
shaft
catheter
lumen
tip portion
distal
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Abandoned
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US13/427,232
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English (en)
Inventor
Alan J. Dextradeur
Daniel McCusker
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DePuy Spine LLC
DePuy Synthes Products Inc
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Codman and Shurtleff Inc
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Priority to US13/427,232 priority Critical patent/US20130253266A1/en
Assigned to CODMAN & SHURTLEFF, INC. reassignment CODMAN & SHURTLEFF, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DEXTRADEUR, ALAN J., MCCUSKER, DANIEL
Priority to CA2809948A priority patent/CA2809948C/en
Priority to AU2013201683A priority patent/AU2013201683A1/en
Priority to JP2013057941A priority patent/JP6339317B2/ja
Priority to EP13160705.3A priority patent/EP2641528B1/en
Assigned to HAND INNOVATIONS LLC reassignment HAND INNOVATIONS LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DEPUY SPINE, LLC
Assigned to DEPUY SPINE, INC. reassignment DEPUY SPINE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CODMAN & SHURTLEFF, INC.
Assigned to DePuy Synthes Products, LLC reassignment DePuy Synthes Products, LLC CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: HAND INNOVATIONS LLC
Publication of US20130253266A1 publication Critical patent/US20130253266A1/en
Assigned to DEPUY SPINE, LLC reassignment DEPUY SPINE, LLC CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE'S NAME PREVIOUSLY RECORDED AT REEL: 030341 FRAME: 0689. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: CODMAN & SHURTLEFF, INC.
Priority to US14/513,692 priority patent/US9848764B2/en
Assigned to DePuy Synthes Products, Inc. reassignment DePuy Synthes Products, Inc. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: DePuy Synthes Products, LLC
Priority to AU2017248500A priority patent/AU2017248500B2/en
Abandoned legal-status Critical Current

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    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
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    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
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    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/2005—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser with beam delivery through an interstitially insertable device, e.g. needle
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Definitions

  • the invention relates to a device and methods for managing bodily fluids in a patient and more particularly to an implantable catheter having an optically useful tip.
  • gray and white matter are suspended in cerebrospinal fluid and nourished by blood delivered through cerebral arteries.
  • the gray matter has closely spaced cell bodies of neurons, such as in the cerebral cortex, and the underlying white matter contains densely packed axons that transmit signals to other neurons.
  • Human brain tissue has different densities and comprises approximately eighty percent of the intracranial content, with blood and cerebrospinal fluid each normally comprising approximately ten percent.
  • Cerebrospinal fluid is produced in several connected chambers known as ventricles and typically is renewed four to five times per day. Cerebrospinal fluid in a healthy human flows slowly and continuously through the ventricles, propelled by pulsations of the cerebral arteries. The fluid flows around the brain tissues and the spinal column, and then through small openings into the arachnoid membrane, which is the middle layer of the meninges surrounding the brain parenchyma and ventricles, where the fluid is finally reabsorbed into the bloodstream.
  • the brain is compliant as long as a person's auto-regulatory mechanism can compensate for any change in volume. As soon as the brain's auto-regulation or compensatory mechanisms fail, blood and cerebrospinal fluid cannot be displaced, and the brain can no longer adapt to any increase in fluid volume. A reduction in cerebral compliance eventually will lead to an undesired increase in intracranial pressure, also known as hydrocephalus. As more fluid volume is added, a threshold is reached beyond which small increases in volume lead to dramatic and unhealthy increases in intracranial pressure.
  • a typical device to treat fluid conditions such as hydrocephalus is a ventricular catheter disclosed by Watson et al. in U.S. Pat. No. 5,738,666.
  • ventricular catheter 22 has a slit 60 in a distal tip 58 .
  • a terminal end 40 of a rigid introducer cannula 34 is inserted through the slit 60 during final placement of the ventricular catheter within a selected ventricle.
  • a Tuohy-Borst adaptor 32 is secured to the proximal end of the introducer cannula 34 .
  • a fiber-optic shaft 66 of an endoscope is advanced through the adaptor 32 and the cannula 34 until a fiber-optic terminal end 28 emerges past ventricular catheter terminal end 58 and aligns with introducer terminal end 40 .
  • Fiber-optic shaft 66 is then interlocked relative to introducer cannula 34 .
  • the aligned tips of the fiber-optic shaft 66 and the introducer cannula are then retracted proximally within catheter 22 during advancement through tissue until a selected ventricle is reached.
  • visualization does not occur during navigation of the Watson et al. catheter through the brain tissue and at least some of a selected ventricle.
  • the doctor or other user is “blind” until the fiber-optic shaft is advanced through the slit in the ventricular catheter.
  • Complications which may arise during placement of a ventricular catheter include injury to vascular structures such as the choroid plexus, injury to neurological structures, and improper positioning of the distal tip of the catheter.
  • cerebrospinal fluid There are a number of brain disorders that arise from neurotoxins or other pathogenic substances which can accumulate in cerebrospinal fluid. For example, it has long been recognized that aggregation of the protein amyloid-beta, which can be found in cerebrospinal fluid, contributes to the degenerative condition known as Alzheimer's disease. Microscopic damage to brain tissue leads to atrophy and a general decline in brain function known as dementia.
  • Delivery of a substance or certain wavelengths of optical radiation may be beneficial for some medical conditions.
  • Introducing one or more compounds to treat Alzheimer's disease is described, for example, by DiMauro et al. in U.S. Patent Publication No. 2010/0286585.
  • Introduction of red light through the cribriform plate portion of a nasal cavity to treat Alzheimer's disease is disclosed in U.S. Pat. No. 7,351,253 by DiMauro et al. It is therefore desirable to have a simpler and more accurate device and technique for managing bodily fluids, especially cerebrospinal fluid.
  • An object of the present invention is to enable continuous visualization during insertion of a fluid management catheter in a patient, particularly within a fluid-filled region.
  • Another object of the present invention is to minimize exposure of the distal tip of an endoscope to tissue during placement of the catheter without impairing visualization.
  • This invention features a catheter having an elongated shaft with a distal end and a proximal end.
  • the shaft defines at least one lumen extending substantially therethrough, the shaft further defining a plurality of drainage holes along a distal portion of the shaft, with the drainage holes in fluid communication with the lumen.
  • the catheter further has a substantially transparent tip portion attached to the distal end of the shaft with an outer distal leading surface that is substantially rounded to assist insertion through tissue.
  • the tip portion defines at least one opening in fluid communication with (i) the shaft lumen, (ii) an irrigation lumen, or (iii) both the shaft lumen and the irrigation lumen.
  • the irrigation lumen is defined by the shaft separately from the shaft lumen in some embodiments and, in other embodiments, is defined by independent structure such as a fiber-optic shaft or other optical conduit.
  • the opening is substantially arcuate.
  • At least one substantially transparent insert is disposed along the distal portion of the shaft, and the shaft carries an optical conduit in optical communication with the at least one insert.
  • the optical conduit is fixed in one embodiment and is removable in another embodiment.
  • the tip portion includes a wide angle lens such as a fisheye-type lens.
  • This invention may also be expressed as a method for managing fluid within a brain of a patient by selecting a catheter having an elongated shaft with a distal end and a proximal end, the shaft defining at least one lumen extending substantially therethrough, the shaft further defining a plurality of drainage holes along a distal portion of the shaft, and the drainage holes being in fluid communication with the lumen.
  • the catheter further has a substantially transparent tip portion attached to the distal end of the shaft with an outer distal leading surface that is substantially rounded to assist insertion through tissue.
  • the method further includes inserting the catheter through brain tissue to enter a selected ventricle, and visualizing through the tip portion of the catheter while positioning the tip portion within the selected ventricle.
  • the tip portion defines at least one opening in fluid communication with one of the shaft lumen and an irrigation lumen defined by the shaft.
  • the method further includes delivering fluid into the brain through at least the opening in the tip portion.
  • the method includes placing a distal end of a fiber-optic shaft into the lumen of the catheter and against the tip portion to view, indirectly and substantially continuously through the tip portion, tissue within the selected ventricle. In certain embodiments, the method further includes removing the fiber-optic shaft from the catheter after the tip portion has been positioned at a desired location. In some embodiments, force is applied to the fiber-optic shaft to assist insertion of the distal tip through tissue. In yet other embodiments, therapeutic optical radiation is delivered through at least the tip portion.
  • FIG. 1 is a partial cross-sectional coronal view of a patient showing a ventricular catheter according to the present invention being implanted within the brain according to one embodiment of the present invention;
  • FIG. 2 is an enlarged side view of the distal portion of a ventricular catheter according to another embodiment of the present invention within a ventricle;
  • FIG. 3 is an enlarged side view of the distal portion of another embodiment of a ventricular catheter according to the present invention within a ventricle;
  • FIG. 3A is an enlarged end view of the distal tip of the catheter of FIG. 3 ;
  • FIG. 4 is a flow chart of one implantation technique according to the present invention.
  • This invention may be accomplished by a catheter having an elongated shaft with a distal end and a proximal end.
  • the shaft defines at least one lumen extending substantially therethrough, the shaft further defining a plurality of drainage holes along a distal portion of the shaft, with the drainage holes in fluid communication with the lumen.
  • the catheter further has a substantially transparent tip portion attached to the distal end of the shaft with an outer distal leading surface that is substantially rounded to assist insertion through tissue, preferably by blunt dissection to minimize trauma to the brain tissue.
  • the head of a patient P is illustrated in coronal cross-section in FIG. 1 with a ventricular catheter 10 according to the present invention inserted through incision I in soft tissue and skin SN and through burr hole BH at an upper region of skull SL.
  • a distal portion 12 of catheter 10 is shown positioned within a lateral ventricle V after passing through cerebral cortex CC, white matter WM and corpus callosum CM along surgical tract ST formed by the insertion of catheter 10 .
  • a fiber-optic shaft 20 is positioned within a lumen 16 extending through shaft 14 of catheter 10 to establish a visualization assembly 22 .
  • Housing 30 enables force to be applied by a surgeon or other user to fiber-optic shaft 20 as described in more detail below.
  • Cable 32 optically connects fiber-optic shaft 20 with an optics module during insertion of catheter 10 . In some constructions, cable 32 also delivers illuminating light during insertion and, in other constructions, delivers therapeutic optical radiation after insertion of catheter 10 .
  • fiber-optic shaft 20 also defines an irrigation lumen as described in more detail below.
  • One suitable fiber-optic shaft with irrigation lumen is the NeuroPEN endoscope available from Medtronic PS Medical.
  • Handle 30 has a luer-lock port 34 to which a syringe 40 , with plunger 42 , can be mated to deliver injection fluid IF such as a saline solution for irrigation or a mixture including one or more compounds for therapeutic purposes.
  • FIG. 2 illustrates one construction of a ventricular catheter 10 a according to the present invention with a distal portion 12 a positioned within a ventricle V and having substantially optically transparent inserts 50 , 52 , 54 , 56 , 58 , 60 , 62 and 64 as well as fluid management openings 51 , 53 , 55 , 57 , 59 and 61 .
  • One advantage of the illustrated configuration of alternating inserts and openings is that optical radiation can be directed over a large volume while still enabling withdrawal or delivery of fluid over a significant amount of the distal portion 12 a.
  • the inserts 50 , 52 . . . 64 and distal tip 18 a are formed of a medical grade PMMA (polymethyl methacrylate) such as FDA-approved Polycast PMMA, preferably with a low roughness value.
  • PMMA polymethyl methacrylate
  • the PMMA preferably is exposed to a gas plasma of a fluorinated carbon or otherwise treated in a manner similar to ophthalmic lenses.
  • heparin surface modifications reduce adherent cells and debris.
  • the catheter shaft 10 is formed of a silicone elastomer in one construction and is formed of other flexible, medical-grade polymers in other constructions.
  • One or more antimicrobial agents may be coated onto the shaft 10 or incorporated into the shaft material during manufacture.
  • the pattern of projected optical radiation through distal tip 18 a and the inserts 50 , 52 . . . 64 is pre-determined by the curvature of the inner and outer surfaces of those elements.
  • a plano-convex or bi-convex lens will converge or focus optical radiation, especially if the radiation is substantially collimated such as produced by a laser.
  • a plano-concave or bi-concave lens will diverge or spread imaging and illumination over a larger area.
  • Optical radiation is shown diverging through the inserts and the distal tip in FIG. 2 into the cerebral spinal fluid within ventricle V.
  • the distal tip is configured to magnify images viewed through it, or provide a wide angle view such as a fisheye-type expanded view.
  • a wide angle lens such as a fisheye-type lens is desirable to increase the field of view for a user while minimizing distortion.
  • Different types of lenses can be utilized according to the present invention for inserts 50 . . . 64 and distal tip 18 a such as lenses disclosed for ophthalmic implants by Grendahl and Isaacson et al. in U.S. Pat. Nos. 4,759,762 and 5,152,788, respectively, and for catheters by Farr et al. in 5,782,825.
  • a rounded, substantially bullet-shaped outer surface is preferred for the distal tip to facilitate blunt dissection of tissue as the catheter is advanced through brain tissue.
  • a distal tip according to the present invention provides an effective viewing lens larger than the inner diameter of the catheter and, therefore, larger than is possible for any endoscope insertable through the catheter.
  • the inserts and distal tip are secured to the shaft of the catheter with a biocompatible adhesive, an ultrasonic welding technique, or other suitable procedure.
  • the distal tip has a proximally extending lead or post which mates with the inner diameter of the shaft 10 a .
  • an optical conduit is carried by the shaft in optical communication with the at least one insert. The optical conduit is fixed in one construction and is removable in another construction.
  • FIGS. 3 and 3A Another construction of a ventricular catheter 10 b is shown in FIGS. 3 and 3A .
  • a distal portion 12 b defines at least rows 70 and 72 of openings through which fluid enters into a central shaft lumen 16 b and is withdrawn proximally.
  • a distal tip 18 b defines arcuate openings 74 and 76 through which irrigation fluid or therapeutic fluid can be directed. Having at least one opening in the distal tip 18 b also enables cerebrospinal fluid or other bodily fluid to be selectively withdrawn from the distal-most region of catheter 10 b , together with or independently of optical radiation being directed through tip 18 b , according to physician preference.
  • distal portion 12 b carries a radiographic marker 78 formed of a radiopaque material such as tantalum.
  • a radiopaque material may be incorporated into the transparent material of one or more inserts shown in FIG. 2 and/or the transparent material of distal tips 10 a , 10 b.
  • a procedure according to the present invention for fluid management within a brain of a patient is represented by the flow chart of FIG. 4 .
  • a shaft of an endoscopic device is inserted, step 80 , into a lumen of a ventricular catheter according to the present invention to establish a visualization assembly.
  • This assembly is established inside an operating room in one procedure and is established outside of the operating room in other procedures.
  • the visualization assembly referred to as the catheter in step 82 , is advanced through brain tissue until a selected ventricle is reached.
  • Step 84 shown in phantom, represents optional irrigation of at least a portion of the outer surface of the distal tip, such as for the ventricular catheter illustrated in FIGS. 3 and 3A . Irrigating through the distal tip flushes debris from the line of sight of the endoscope. Irrigation can also be utilized to maintain a positive pressure within the catheter to reduce ingress of cellular debris.
  • enabling viewing through an optically transparent tip of a ventricular catheter when a selected ventricle is reached is likely to minimize damage to sensitive tissue during placement of the ventricular catheter, step 86 .
  • the viewing may be considered as indirect visualization through the optically transparent distal tip, which protects the endoscope shaft from direct contact with brain tissue during placement of the catheter.
  • complications which may arise during conventional placement of a ventricular catheter include injury to vascular structures such as the choroid plexus, injury to neurological structures, and improper positioning of the distal tip of the catheter.
  • Advancing the catheter through brain tissue, step 82 , and positioning the catheter in a ventricle, step 86 preferably utilizes the endoscope shaft as a stylet.
  • the distal tip of the catheter acts as a stop, that is, prevents axial translation of the endoscope shaft relative to the catheter, so that force applied to the endoscope shaft is directly transmitted to the distal tip to advance the catheter, preferably via blunt dissection of brain tissue.
  • therapeutic optical radiation is delivered through at least the distal tip.
  • a catheter having longitudinal inserts such as catheter 10 a , FIG. 2 , enables therapeutic optical radiation to be delivered through inserts 50 , . . . 64 over a large volume of fluid.

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EP2641528B1 (en) 2018-10-03
AU2017248500B2 (en) 2019-05-09
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EP2641528A1 (en) 2013-09-25
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AU2013201683A1 (en) 2013-10-10
AU2017248500A1 (en) 2017-11-09

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