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Apparatus and methods for accessing and dilating bone structures using a narrow gauge cannula

  • US 9,814,510 B2
  • Filed: 06/03/2016
  • Issued: 11/14/2017
  • Est. Priority Date: 03/25/2011
  • Status: Active Grant
First Claim
Patent Images

1. A catheter/expandable element assembly with proximal and distal assembly ends for medical applications comprising a catheter shaft having a long axis and proximal and distal catheter portions, an expandable element comprising a conforming balloon portion suitable for treating vertebral fractures and related Kyphoplasty-type procedures with a balloon interior and also comprising a proximal neck portion bonded at a bond juncture to the distal catheter portion wherein a proximal end of the proximal neck portion is bonded to a terminal end of the distal catheter portion, and a fluid passageway extending from the proximal catheter portion to the balloon interior, the assembly being characterized by one or more of the following features:

  • (a) the expandable element comprises a conforming balloon suitable for Kyphoplasty-type procedures which can be stretched, folded and/or wrapped to a maximum diameter of less than 0.092 inches before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure;

    (b) the assembly includes both a stretched, folded and/or wrapped balloon portion and a bond juncture between the catheter shaft and the proximal neck portion that will fit through the interior of a standard 11-gauge medical cannula before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure;

    (c) the assembly includes both a stretched, folded and/or wrapped balloon portion and a bond juncture between the catheter shaft and the proximal neck portion that will fit through the interior of a standard 11-gauge medical cannula before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure without the use of any lubricant or similar friction-reducing substance;

    (d) the expandable element can be stretched, folded and/or wrapped to sufficiently reduce the cross-sectional profile of the assembly before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure to be compatible with the use of a narrow gauge cannula;

    (e) the expandable element can be stretched folded and/or wrapped to sufficiently reduce the cross-sectional profile of the assembly before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure to be compatible with the use of an 11-gauge or smaller-diameter cannula;

    (f) the catheter shaft is a single lumen catheter shaft and the assembly includes both a stretched, folded and/or wrapped balloon portion and a bond juncture between the catheter shaft and the proximal neck portion that will fit through the interior of a standard 11-gauge medical cannula before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure;

    (g) the proximal neck portion is butt-jointed by an adhesive bonding procedure, a solvent bonding procedure and/or a thermal bonding procedure to a terminal end of the distal catheter portion;

    (h) the expandable element comprises a distal neck portion having a sealed tip, and the sealed tip contains the only radiopaque marker along the expandable element;

    (i) the expandable element comprises one or more bands of a radiopaque material under the balloon portion with or without radiopaque material at a distal tip of the expandable element;

    (j) the assembly comprises a feature selected from features (a) to (g), and additionally comprises a floating mandrel element that extends through the distal catheter portion, and through the expandable element to an interior distal portion of the expandable element;

    (k) the assembly comprises a feature selected from features (a) to (g), and additionally comprises a floating mandrel element that extends through the distal catheter portion, and through the expandable element to an interior distal portion of the expandable element and further wherein the mandrel element has a free, unbonded proximal mandrel end and a distal mandrel end bonded to the interior distal portion of the expandable element;

    (l) the assembly comprises a feature selected from features (a) to (g), and additionally comprises a catheter bifurcation assembly at a proximal end of the catheter shaft;

    (m) the assembly comprises a feature selected from features (a) to (g), and additionally comprises a catheter bifurcation assembly at the proximal assembly end having an inflation arm portion in fluid communication with the balloon interior;

    (n) the assembly comprises a feature selected from features (a) to (g), and additionally comprises a sleeve section of the distal catheter portion that accommodates limited axial movement of a mandrel inside the sleeve section and the free, unbonded proximal end of the mandrel is of an enlarged size such that the proximal end of the mandrel is retained in the sleeve;

    (o) the assembly comprises a feature selected from features (a) to (g), and additionally comprises a floating mandrel element for actively or passively applying axial and/or rotational forces to the balloon portion, following a balloon inflation and treatment procedure and subsequent deflation but prior to withdrawing the balloon portion, causing the balloon portion to stretch axially and/or to wrap at least in part around the mandrel element to reduce the profile of the balloon portion and thereby facilitate a withdrawal procedure;

    (p) the assembly comprises a feature selected from features (a) to (g), and additionally comprises a floating mandrel element that extends through the distal catheter portion, and through the expandable element to an interior distal wall portion of the expandable element, and further wherein a distal mandrel end is bonded to the distal end of the assembly and an unbonded proximal mandrel end has an enlarged geometrical feature such that the mandrel can move axially along or parallel to the long axis of the catheter shaft but only within an assembly portion that is bounded by a mandrel retaining structure;

    (q) the assembly additionally comprises a mandrel element that extends through the distal portion of the catheter shaft, and through the expandable element, to an interior distal end of the assembly, wherein a distal portion of the mandrel element beginning inside the catheter shaft and extending through the expandable element is of a reduced diameter relative to a proximal portion of the mandrel element;

    (r) the assembly additionally comprises a mandrel element that extends through the distal portion of the catheter shaft, and into the expandable element, wherein at least the portion of the mandrel element inside the expandable element tapers to a flattened distal mandrel end that terminates in an unbonded angled or hooked mandrel tip at a location proximate to the distal end of the balloon portion;

    (s) the assembly additionally comprises a mandrel element that extends through the distal portion of the catheter shaft, and into the expandable element, wherein at least the portion of the mandrel element inside the expandable element tapers to a flattened distal mandrel end that terminates in an unbonded angled or hooked mandrel tip at a location proximate to the distal end of the balloon portion, and additionally comprising an elongated spring element with spring coils that surround the mandrel element beginning at a location proximal of the expandable element and extending into and through the expandable element to a distal tip of the expandable element where the distal end of the spring is bonded, and furthermore wherein the hooked mandrel tip engages one or more of the spring coils;

    (t) the assembly additionally comprises a mandrel element that extends through the distal portion of the catheter shaft, and into the expandable element, wherein at least the portion of the mandrel element inside the expandable element tapers to a flattened distal mandrel end that terminates in an unbonded angled or hooked mandrel tip at a location proximate to the distal end of the balloon portion, and additionally comprising an elongated spring element with spring coils that surround the mandrel element beginning at a location proximal of the expandable element and extending into and through the expandable element to a distal tip of the expandable element where the distal end of the spring is bonded, and furthermore wherein the hooked mandrel tip engages one or more of the spring coils, and also wherein there is greater spacing between adjacent spring coils along a distal spring portion than along a proximal spring portion;

    (u) the assembly additionally comprises a mandrel element that extends through the distal portion of the catheter shaft, and into the expandable element, wherein at least the portion of the mandrel element inside the expandable element tapers to a flattened distal mandrel end that terminates in an unbonded angled or hooked mandrel tip at a location proximate to the distal end of the balloon portion, and additionally comprising an elongated spring element with spring coils that surround the mandrel element beginning at a location proximal of the expandable element and extending into and through the expandable element to a distal tip of the expandable element where the distal end of the spring is bonded, and furthermore wherein the hooked mandrel tip engages one or more of the spring coils, and also wherein the spring is covered by a polymeric sleeve;

    (v) the assembly additionally comprises a mandrel element that extends through the distal portion of the catheter shaft, and into the expandable element, wherein at least the portion of the mandrel element inside the expandable element tapers to a flattened distal mandrel end that terminates in an unbonded angled or hooked mandrel tip at a location proximate to the distal end of the balloon portion, and additionally comprising an elongated spring element with spring coils that surround the mandrel element beginning at a location proximal of the expandable element and extending into and through the expandable element to a distal tip of the expandable element where the distal end of the spring is bonded, and furthermore wherein the hooked mandrel tip engages one or more of the spring coils, and also wherein the mandrel can be axially tensioned so as to compress the spring where the hooked mandrel tip engages the spring coils causing the distal end of the expandable element to deflect from an axial orientation while the mandrel is axially tensioned; and

    ,(w) the assembly additionally comprises a mandrel element that extends through the distal portion of the catheter shaft, and into the expandable element, wherein at least the portion of the mandrel element inside the expandable element tapers to a flattened distal mandrel end that terminates in an unbonded angled or hooked mandrel tip at a location proximate to the distal end of the balloon portion, and additionally comprising an elongated spring element with spring coils that surround the mandrel element beginning at a location proximal of the expandable element and extending into and through the expandable element to a distal tip of the expandable element where the distal end of the spring is bonded, and furthermore wherein the hooked mandrel tip engages one or more of the spring coils, and also comprising a mandrel tensioning assembly consisting of two threadably-engaged mandrel tensioning elements whereby the threadably-engaged tensioning elements provide an axial channel in which one of the mandrel tensioning elements can slide such that rotating one tensioning element relative to the other causes one of the tensioning elements to move in a proximal direction relative to the second tensioning element thereby applying axial tensioning to the mandrel and causing deflection of the hooked mandrel tip and the distal tip of the expandable element while the axial tensioning is applied.

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