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

• Current Assignee: Nordson Corporation
• Original Assignee: Nordson Corporation
• Inventors: Saab, Mark A., Barbere, Michael D.
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US15/172,408
• Publication Number:
  US 20160278837A1
• Time in Patent Office: 529 Days
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: B01L 2300/0848 Specific forms of parts of containers
• CPC Class Codes: B01L 2300/0858 Side walls
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence

Abstract

Systems, apparatus and methods are disclosed for medical treatment comprising bone access and dilatation and/or cavity creation or enlargement using a narrow gauge, preferably 11-gauge or smaller, cannula wherein a catheter/expandable element assembly meeting medical protocols is designed, adapted and fabricated to fit through the interior of the associated 11-gauge or smaller cannula.

Claims

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.

2. A system for carrying out a medical dilatation and/or a cavity creation, enlargement or treatment procedure at an internal body site comprising a catheter/expandable element assembly according to any combination of characterizing features of claim 1 in combination with an 11-gauge or smaller diameter cannula having a cannula interior for delivering the expandable element from outside the body, through the cannula interior, to the desired internal body site and, following a treatment procedure, for withdrawing the deflated expandable element from the body site through the cannula interior.

3. A system according to claim 2 wherein the cannula interior is free of any lubricant and also wherein no lubricant is applied to the catheter/expandable element assembly.

4. A method for carrying out a medical treatment that includes a dilatation and/or a cavity creation, enlargement or treatment procedure using a system according to claim 2, the method comprising the steps of:

(A) positioning the cannula in a body location so that a distal end of the cannula is proximate to the intended treatment site;

(B) inserting at least the expandable element portion of the assembly through the cannula interior to position the expandable element in the interior of a bone or body site without the use of any lubricants;

(C) inflating the balloon portion of the expandable element inside the interior of the bone or body site to a size and/or inflation pressure and for a time sufficient to complete the treatment;

(D) deflating the balloon portion of the expandable element; and

, (E) withdrawing the expandable element including the deflated balloon portion of the assembly through the cannula interior without the use of any lubricants.

5. A method for carrying out a medical treatment that includes a dilatation and/or a cavity creation, enlargement or treatment procedure that is performed with an expandable conforming balloon using a catheter/expandable element assembly according to any combination of characterizing features of claim 1, the method comprising the steps of:

(A) inserting at least the expandable element portion of the assembly through the interior of a previously-placed 11-gauge or smaller diameter cannula to position the expandable element including a distal tip of the expandable element in the interior of a bone or body site;

(B) inflating the balloon portion of the expandable element inside the interior of the bone or body site to a size and/or inflation pressure and for a time sufficient to complete the treatment;

(C) deflating the balloon portion of the expandable element; and

(D) withdrawing the expandable element including the deflated balloon portion of the assembly through the interior of the 11-gauge or smaller diameter cannula.

6. A method according to claim 5 additionally comprising a step of stretching, folding and/or wrapping the balloon portion of the expandable element following step (C) and prior to step (D).

7. A method according to claim 5 wherein the assembly includes a mandrel and additionally comprising a step, between steps (A) and (C), of temporarily deflecting the distal tip of the expandable element out of alignment with the long axis of the catheter shaft by applying axial tensioning to a hooked mandrel distal tip that engages at least some of the coils of a coiled spring element surrounding the portion of the mandrel inside the expandable element, where the distal end of the spring element is bonded to the distal tip of the expandable element.

8. A method according to claim 7 further comprising a step, before step (D), of relaxing the axial tensioning of the mandrel and allowing the distal tip of the expandable element to return to alignment with the long axis of the catheter shaft by action of the spring element.

9. A method of manufacturing the assembly of claim 1 by bonding the terminal end of the distal catheter portion to the proximal end of the proximal neck portion, the method comprising the steps of butting the terminal end of the distal catheter portion against a similarly-sized proximal end of the proximal neck portion followed by an adhesive bonding procedure, a solvent bonding procedure or a thermal bonding procedure for securing the two abutting ends to one another thereby creating a fluid passageway through the interior of the catheter shaft and into the balloon portion of the expandable element.

10. A method of manufacturing an assembly according to claim 9 further including positioning a mandrel inside the assembly and providing a mandrel retention structure for restricted axial movement of the mandrel, the method also comprising the steps of bonding the distal end of the mandrel to the inside distal end of the expandable element and providing an unbonded proximal end of the mandrel with an enlarged geometrical feature that retains the mandrel inside a sleeve section of the assembly.

11. The method of claim 10 wherein the enlarged geometrical feature at the proximal end of the mandrel cannot pass through an aperture of the mandrel retention structure to retain the enlarged proximal end of the mandrel in the sleeve section.

12. An assembly according to claim 1 wherein 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.

13. An assembly according to claim 1 wherein 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.

14. An assembly according to claim 1 wherein 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.

15. An assembly according to claim 1 wherein 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.

16. An assembly according to claim 1 wherein 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.

17. An assembly according to claim 1 wherein 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.

18. An assembly according to claim 1 wherein 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.

19. 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 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 an outer diameter of the distal catheter portion and an outer diameter of the proximal neck portion at the bond juncture are substantially the same size so as to form a smooth, uninterrupted outer surface at the bond juncture and the balloon portion and the bond juncture can be passed through an 11-gauge or smaller diameter medical cannula before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure;

a fluid passageway extending from the proximal catheter portion through the distal catheter portion to the balloon interior; and

,

a floating mandrel that extends through the distal catheter portion and through the expandable element to a distal portion of the expandable element, wherein the floating mandrel comprises a distal mandrel end bonded to the expandable element and a free, unbonded proximal mandrel end whereby the floating mandrel has a limited range of axial movement along or parallel to the long axis of the catheter shaft.

20. An assembly according to claim 19 wherein the assembly has a maximum diameter of less than 0.092 inches at the bond juncture.

21. An assembly according to claim 19 wherein the fluid passageway has a generally circular cross-section with a fluid passageway diameter defined by an inner wall of the catheter shaft and wherein the fluid passageway diameter on either side of the bond juncture is substantially the same size as an inner diameter of the distal catheter portion at the bond juncture.

22. An assembly according to claim 19 wherein an inner diameter of the distal catheter portion, a diameter of the fluid passageway, and an inner diameter of the proximal neck portion at the bond juncture are substantially the same size.

23. An assembly according to claim 22 wherein the only catheter shaft is a single lumen catheter.

24. An assembly according to claim 19 wherein the distal catheter portion and the proximal neck portion are butt-jointed and bonded to each other at the bond juncture.

25. A catheter/expandable element assembly with proximal and distal assembly ends for medical applications comprising:

a single catheter shaft having a long axis and proximal and distal catheter portions;

an expandable element comprising a balloon portion suitable for treating vertebral fractures and related Kyphoplasty-type procedures with a balloon interior and also comprising a proximal neck portion butt jointed and bonded at a bond juncture to the distal catheter portion wherein the balloon portion and the bond juncture can be passed through an 11-gauge or smaller diameter medical cannula before inflation of the balloon portion and also following inflation and subsequent deflation of the balloon portion after a treatment procedure; and

,

a fluid passageway extending from the proximal catheter portion to the balloon interior,

and further wherein an inner diameter of the distal catheter portion, a diameter of the fluid passageway, and an inner diameter of the proximal neck portion at the bond juncture are substantially the same size, and also wherein an outer diameter of the distal catheter portion and an outer diameter of the proximal neck portion at the bond juncture are substantially the same size so as to form a smooth, uninterrupted outer surface at the bond juncture.

26. An assembly according to claim 25 further comprising a floating mandrel that extends through the distal catheter portion and through the expandable element to a distal portion of the expandable element, wherein the floating mandrel comprises a distal mandrel end bonded to the expandable element and a free, unbonded proximal mandrel end.

27. An assembly according to claim 25 wherein the assembly has a maximum diameter of less than 0.092 inches at the bond juncture.

28. An assembly according to claim 25 wherein the only catheter shaft is a single lumen catheter.