Apparatus and methods for treating bone structures, tissues and ducts using a narrow gauge cannula system

• US 9,782,572 B2
• Filed: 03/13/2013
• Issued: 10/10/2017
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Nordson Corporation
• Original Assignee: Nordson Corporation
• Inventors: Saab, Mark A., Barbere, Michael D.
• Primary Examiner(s): Anderson, Gregory
• Application Number:
  US13/800,197
• Publication Number:
  US 20130197563A1
• Time in Patent Office: 1,672 Days
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/4677 using a guide wire
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

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 for such procedures is designed, adapted and fabricated to fit through the interior of the associated 11-gauge or smaller cannula, and further including apparatus and methods for wrapping and/or folding the expandable element either before or after a procedure to reduce its profile to fit through the cannula.

Claims

1. 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 after deflation of the balloon portion after a treatment procedure;

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

,

a mandrel element extending through the distal catheter portion and the expandable element wherein a distal mandrel portion beginning inside the catheter shaft and extending through the expandable element is of a reduced diameter relative to a proximal mandrel portion.

2. An assembly according to claim 1 further comprising a passive balloon tensioning and/or balloon wrapping device.

3. An assembly according to claim 1 further comprising an 11-gauge or smaller diameter cannula wherein at least one end of the balloon portion extends into or completely through said cannula when the balloon portion is positioned in a cavity to be dilated.

4. A catheter/expandable element assembly according to claim 1 additionally wherein the proximal neck portion is butt-jointed by a bonding procedure selected from the group consisting of an adhesive bonding procedure, a solvent bonding procedure and a thermal bonding procedure to the distal catheter portion.

5. A catheter/expandable element assembly according to claim 1 wherein the assembly has a maximum diameter of less than 0.092 inches at the bond juncture.

6. A catheter/expandable element assembly according to claim 1 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.

7. A catheter/expandable element assembly according to claim 1 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.

8. A catheter/expandable element assembly according to claim 7 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.

9. A catheter/expandable element assembly according to claim 1 wherein the only catheter shaft is a single lumen catheter.

10. A catheter/expandable element assembly according to claim 1 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.

11. A catheter/expandable element assembly according to claim 1 wherein the mandrel element is 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.

12. An assembly according to claim 1 further comprising an active balloon tensioning and/or balloon wrapping device.

13. 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 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.

14. A system according to claim 13 wherein the cannula interior is free of any lubricant and also wherein no lubricant is applied to the catheter/expandable element assembly.

15. 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 13, 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.

16. 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 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.

17. A method according to claim 16 additionally comprising a step of stretching, folding and/or wrapping the expandable element following step (B) and prior to step (D).

18. 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 suitable for treating vertebral fractures and related Kyphoplasty-type procedures with a balloon interior and also comprising a proximal neck portion butt-jointed at a bond juncture to the distal catheter portion, and a fluid passageway extending from the proximal catheter portion to the balloon interior, the assembly being characterized by:

(A) a balloon having the following properties;

(i) the balloon has expansion properties that enable the expansion of the balloon inside a targeted bone region to press against and compress surrounding cancellous bone, or to move cortical bone to a prefracture or other desired condition, or both, prior to failure of the balloon wall, when the balloon is expanded to an elongation at least 50% greater than before expansion;

(ii) the balloon has shape properties that enable the balloon to predictably deform during expansion to an expanded shape whereby a desired expanded shape inside the targeted bone region can be selected based on prior analysis of the morphology of the targeted bone region; and

,

(iii) the balloon has toughness properties that enable the balloon to resist surface abrasion, tearing and puncture when it is expanded and in contact with cancellous bone, including the properties of;

a Taber Abrasion value of less than approximately 200 mg loss; and

/or an Elmendorf Tear Strength of at least approximately 150 lb.-ft./in.; and

/or a Shore Hardness of less than approximately 75 D; and

,

(B) the assembly also being characterized by one or more of the following features;

(a) the expandable element comprises a balloon which can be stretched, folded and/or wrapped to a maximum diameter of less than 0.092 inches before inflation of the balloon and after deflation of the balloon after a treatment procedure;

(b) the assembly includes both a stretched, folded and/or wrapped balloon 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 and after deflation of the balloon after a treatment procedure;

(c) the assembly includes both a stretched, folded and/or wrapped balloon 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 and after deflation of the balloon 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 and after deflation of the balloon 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 and after deflation of the balloon 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 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 and after deflation of the balloon after a treatment procedure;

(g) the proximal neck portion is butt jointed to the distal end of the distal catheter portion by a bonding procedure selected from the group consisting of an adhesive bonding procedure, a solvent bonding procedure and a thermal bonding procedure;

(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 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 an interior distal portion of the expandable element;

(l) 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 a 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 section;

(m) 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 a distal end of the mandrel is bonded to a distal portion of the expandable element and an unbonded proximal end of the mandrel has an enlarged geometrical feature that can move axially along or parallel to the axis of the catheter shaft but only within a sleeve section bounded by a mandrel retaining structure;

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

(o) the assembly additionally comprises a mandrel element that extends through the distal catheter portion, and into the expandable element, wherein at least a portion of the mandrel 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;

(p) 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 a 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, 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 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;

(q) 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 a 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, 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 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;

(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 a 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, 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 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;

(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 a 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, 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 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 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

,

(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 a 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, 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 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 while the axial tensioning is applied.

19. An assembly according to claim 18 further including a mandrel element wherein active and/or passive forces can be applied to the mandrel element for tensioning and/or wrapping the balloon portion.

20. An assembly according to claim 19 wherein the distal end of the balloon portion is sealed, and the mandrel element extends to the sealed distal end of the balloon portion.

21. An assembly according to claim 19 wherein the mandrel element is not attached to the balloon portion.

22. An assembly according to claim 19 wherein the mandrel element is attached to or otherwise engages the balloon portion.

23. An assembly according to claim 19 further wherein rotational force can be applied manually or automatically to rotate the mandrel element causing the balloon portion at least in part to wrap around the mandrel element.

24. An assembly according to claim 19 wherein said mandrel element is positioned sufficiently in a distal direction to cause axial tensioning and elongation of the balloon portion.

25. An assembly according to claim 19 wherein said mandrel element is rotated sufficiently to cause wrapping and rotational tensioning of the balloon portion.

26. An assembly according to claim 19 wherein said mandrel element is positioned sufficiently in a distal direction and is rotated sufficiently to cause both axial and rotational tensioning of the balloon portion.

27. An assembly according to claim 19 wherein said mandrel element comprises a knob at the proximal end of the mandrel element.

28. An assembly according to claim 19 wherein the mandrel element is hydraulically or pneumatically actuated.

29. An assembly according to claim 19 wherein said mandrel element is adjustable in length.

30. A catheter/expandable element assembly according to claim 18 wherein the assembly comprises a mandrel element that has a distal mandrel portion beginning inside the catheter shaft and extending through the expandable element of a reduced diameter relative to a proximal mandrel portion and also wherein the balloon portion can be stretched, folded and/or wrapped to a maximum diameter of less than 0.092 inches before inflation of the balloon portion and after deflation of the balloon portion after a treatment procedure.

31. A catheter/expandable element assembly according to claim 30 additionally wherein the mandrel element has a free, unbonded proximal mandrel end and a distal mandrel end bonded to an interior distal portion of the expandable element.

32. A catheter/expandable element assembly according to claim 31 additionally 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.

33. A catheter/expandable element assembly according to claim 31 additionally 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.

34. A catheter/expandable element assembly according to claim 33 additionally 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.

35. A catheter/expandable element assembly according to claim 34 additionally wherein the only catheter shaft is a single lumen catheter.

36. A catheter/expandable element assembly according to claim 30 additionally wherein the proximal neck portion is butt-jointed by a bonding procedure selected from the group consisting of an adhesive bonding procedure, a solvent bonding procedure and a thermal bonding procedure to the distal catheter portion.

37. A catheter/expandable element assembly according to claim 30 additionally 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.

38. A catheter/expandable element assembly according to claim 30 additionally 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.

39. A catheter/expandable element assembly according to claim 38 additionally 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.

40. A catheter/expandable element assembly according to claim 39 additionally wherein the only catheter shaft is a single lumen catheter.

41. 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 18 in combination with a narrow gauge 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.

42. A system according to claim 41 wherein the cannula interior is free of any lubricant and also wherein no lubricant is applied to the catheter/expandable element assembly.

43. 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 41, 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.

44. 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 18, the method comprising the steps of:

(A) inserting at least the expandable element portion of the assembly through the interior of a previously-placed narrow gauge 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 narrow gauge cannula.

45. A method according to claim 44 additionally comprising a step of stretching, folding and/or wrapping the expandable element following step (B) and prior to step (D).

46. 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 18 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.

47. 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 balloon using a catheter/expandable element assembly according to any combination of characterizing features of claim 18, 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.

48. 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 balloon using a catheter/expandable element assembly according to any combination of characterizing features of claim 18, the method comprising the steps of:

(A) inserting at least the expandable element portion of the assembly through the interior of a previously-placed narrow gauge 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 narrow gauge cannula.

49. 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 suitable for treating vertebral fractures and related Kyphoplasty-type procedures with a balloon interior and also comprising a proximal neck portion butt-jointed at a bond juncture to the distal catheter portion, and a fluid passageway extending from the proximal catheter portion to the balloon interior, the assembly being characterized by:

(A) a balloon having the following properties;

(i) the balloon has expansion properties that enable the expansion of the balloon inside a targeted bone region to press against and compress surrounding cancellous bone, or to move cortical bone to a prefracture or other desired condition, or both, prior to failure of the balloon wall, when the balloon is expanded to an elongation at least 50% greater than before expansion;

(ii) the balloon has shape properties that enable the balloon to predictably deform during expansion to an expanded shape whereby a desired expanded shape inside the targeted bone region can be selected based on prior analysis of the morphology of the targeted bone region; and

,

(iii) the balloon has toughness properties that enable the balloon to resist surface abrasion, tearing and puncture when it is expanded and in contact with cancellous bone, including the properties of;

a Taber Abrasion value of less than approximately 200 mg loss; and

/or an Elmendorf Tear Strength of at least approximately 150 lb.-ft./in.; and

/or a Shore Hardness of less than approximately 75 D;

(B) 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 an interior distal portion of the expandable element and

(C) the assembly also being characterized by one or more of the following features;

(a) the expandable element comprises a balloon which can be stretched, folded and/or wrapped to a maximum diameter of less than 0.092 inches before inflation of the balloon and after deflation of the balloon after a treatment procedure;

(b) the assembly includes both a stretched, folded and/or wrapped balloon 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 and after deflation of the balloon after a treatment procedure;

(c) the assembly includes both a stretched, folded and/or wrapped balloon 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 and after deflation of the balloon 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 and after deflation of the balloon 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 and after deflation of the balloon 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 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 and after deflation of the balloon after a treatment procedure;

(g) the proximal neck portion is butt jointed to the distal end of the distal catheter portion by a bonding procedure selected from the group consisting of an adhesive bonding procedure, a solvent bonding procedure and a thermal bonding procedure;

(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 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 sleeve section of the distal catheter portion that accommodates limited axial movement of a mandrel inside the sleeve section and a 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 section;

(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 a distal end of the mandrel is bonded to a distal portion of the expandable element and an unbonded proximal end of the mandrel has an enlarged geometrical feature that can move axially along or parallel to the axis of the catheter shaft but only within a sleeve section bounded by a mandrel retaining structure;

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

(m) the assembly additionally comprises a mandrel element that extends through the distal catheter portion, and into the expandable element, wherein at least a portion of the mandrel 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;

(n) 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 a 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, 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 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;

(o) 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 a 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, 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 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;

(p) 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 a 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, 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 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;

(q) 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 a 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, 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 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 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

,

(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 a 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, 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 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 while the axial tensioning is applied.

50. An assembly according to claim 49 wherein the assembly additionally comprises a mandrel element that extends through the distal catheter portion, and into the expandable element, wherein at least a portion of the mandrel 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.

51. An assembly according to claim 49 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 a 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, 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 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.

52. An assembly according to claim 49 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 a 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, 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 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.

53. An assembly according to claim 49 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 a 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, 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 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.

54. An assembly according to claim 49 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 a 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, 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 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 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.

55. An assembly according to claim 49 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 a 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, 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 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 while the axial tensioning is applied.

56. 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 49 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.

57. 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 balloon using a catheter/expandable element assembly according to any combination of characterizing features of claim 49, 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.

58. 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 balloon using a catheter/expandable element assembly according to any combination of characterizing features of claim 49, the method comprising the steps of:

(A) inserting at least the expandable element portion of the assembly through the interior of a previously-placed narrow gauge 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 narrow gauge cannula.

59. 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 terminal end of 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 after deflation of the balloon portion after a treatment procedure, and also wherein the distal catheter portion and the proximal neck portion are butt-jointed and bonded to each other at the bond juncture;

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 portion beginning inside the catheter shaft and extending through the expandable element of a reduced diameter relative to a proximal mandrel portion, a distal end of the mandrel is bonded to the expandable element and a proximal end of the mandrel is a free, unbonded end, and the floating mandrel can move axially within a limited range of axial movement along or parallel to the long axis of the catheter shaft.

60. 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 claim 59 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.

61. 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 balloon using a catheter/expandable element assembly according to claim 59, 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.

62. 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 after deflation of the balloon portion after a treatment procedure;

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

,

a mandrel element extending through the distal catheter portion and the expandable element wherein a distal mandrel portion beginning inside the catheter shaft and extending through the expandable element is of a reduced diameter relative to a proximal mandrel portion;

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.

63. 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 after deflation of the balloon portion after a treatment procedure;

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

,

a mandrel element extending through the distal catheter portion and the expandable element wherein a distal mandrel portion beginning inside the catheter shaft and extending through the expandable element is of a reduced diameter relative to a proximal mandrel portion;

and further wherein the mandrel element is a floating mandrel that comprises a distal mandrel end bonded to the expandable element and a free, unbonded proximal mandrel end.

64. 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 balloon using a catheter/expandable element assembly according to claim 63, the method comprising the steps of:

(A) inserting at least the expandable element portion of the assembly through the interior of a previously-placed narrow gauge 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 narrow gauge cannula.