Expandable element delivery system

• US 7,097,648 B1
• Filed: 01/27/2000
• Issued: 08/29/2006
• Est. Priority Date: 01/27/1999
• Status: Expired due to Term

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Disc-O-Tech Medical Technologies Limited (Medtronic Plc)
• Inventors: Shenhav, Boaz, Globerman, Oren, Shavit, Ronen
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/890,318
• Time in Patent Office: 2,406 Days
• Field of Search: 606/99, 606/53, 606/90, 606/97, 606/86, 606/80, 606/61, 623/17.16, 623/17.11, 623/16.11, 623/11.11
• US Class Current: 606/99
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30724 Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 : for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/446 : having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4603 : for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/48 : Operating or control means, e.g. from outside the body, control of sphincters
• CPC Class Codes: A61F 2002/0086 : for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/009 : for hindering or preventing attachment of biological tissue of bone tissue onto implantable joints A61F2002/30932
• CPC Class Codes: A61F 2002/2817 : Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 : Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30004 : the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30014 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30052 : differing in electric or magnetic properties
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2002/30082 : radioactive
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30113 : circular
• CPC Class Codes: A61F 2002/3013 : figure-"8"- or hourglass-shaped
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30136 : undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30153 : rectangular
• CPC Class Codes: A61F 2002/30154 : square
• CPC Class Codes: A61F 2002/30156 : triangular
• CPC Class Codes: A61F 2002/30158 : trapezoidal
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30324 : differing in thickness
• CPC Class Codes: A61F 2002/30326 : differing in height or in length
• CPC Class Codes: A61F 2002/30327 : differing in diameter
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30405 : made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30484 : Mechanically expandable devices located on the first prosthetic part for locking into or onto the second prosthetic part
• CPC Class Codes: A61F 2002/30485 : plastically deformable
• CPC Class Codes: A61F 2002/30495 : using a locking ring
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/3052 : unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30545 : for adjusting a diameter
• CPC Class Codes: A61F 2002/30546 : for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30594 : slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30617 : Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/30668 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2002/3067 : for data transfer
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30906 : shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/3093 : for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30932 : for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4485 : comprising three or more adjacent spinal implants
• CPC Class Codes: A61F 2002/4619 : for extraction
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4638 : Tools for performing screwing, e.g. nut or screwdrivers, or particular adaptations therefor
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2210/0019 : operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0028 : cooled
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2210/0095 : radioactive
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/001 : Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0021 : square
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0002 : for data transfer
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0012 : for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0037 : differing in height or in length
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0043 : differing in electric properties, e.g. in electrical conductivity, in galvanic properties
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

Apparatus for controlling the deformation of an implant during deployment thereof, comprising: a force application mechanism for applying deformation force to the implant, by motion of a force applicator against the implant; and a restraint element positioning mechanism that positions a restraining element such that the deformation of the implant is controlled by restraint of the restraining element on allowable deformation; and a synchronizer that synchronizes the motion of the restraining element and the force applicator, to achieve a desired deformation of the implanted.

Claims

1. Apparatus for controlling the deformation of an implant during deployment thereof, comprising:

a force application mechanism for applying deforming force to the implant, by axial motion of a force applicator against the implant; and

a restraint element positioning mechanism that positions a restraining element such that the deformation of the implant is controlled by restraint of the restraining element on allowable deformation; and

a synchronizer that synchronizers the motion of the restraining element and the force applicator, to achieve a desired deformation of the implant.

2. Apparatus according to claim 1, comprising a force input which receives continuous motion and couples it to the force application mechanism and to the restraint element positioning mechanism.

3. Apparatus according to claim 2, wherein said continuous motion is reciprocating motion.

4. Apparatus according to claim 3, wherein said restraint positioning mechanism moves said restraint element during one stroke of said reciprocating motion.

5. Apparatus according to claim 4, wherein said one stroke comprises a retraction of said restraint mechanism from said implant.

6. Apparatus according to claim 3, wherein said force application mechanism moves said force applicator during one stroke of said reciprocating motion.

7. Apparatus according to claim 6, wherein said one stroke comprises a retraction of said force applicator from said implant.

8. Apparatus according to claim 6, wherein said one stroke comprises an advance of said force applicator towards said implant.

9. Apparatus according to claim 2, wherein said force application mechanism comprises a selective coupler that selectively couples said input motion to said force applicator.

10. Apparatus according to claim 2, wherein said element positioning mechanism comprises a selective coupler that selectively couples said input motion to said restraining element.

11. Apparatus according to claim 2, wherein said synchronized motion is repetitive, comprises a plurality of cycles of positioning said restraining element and applying said force.

12. Apparatus according to claim 2, wherein said motion is applied simultaneously to said restraint element positioning mechanism and to said force application mechanism.

13. Apparatus according to claim 2, wherein said motion is applied alternately to said restraint element positioning mechanism and to said force application mechanism.

14. Apparatus according to claim 13, comprising an alternating locking mechanism that alternately couples the motion form the force input to the restraint element positioning mechanism and to the force application mechanism.

15. Apparatus according to claim 2, wherein said force input comprises a manual force input.

16. Apparatus according to claim 2, wherein said force input comprises a motorized force input.

17. Apparatus according to claim 1, wherein said synchronizer is integrated with said mechanisms.

18. Apparatus according to claim 1, wherein said synchronizer is manual, providing an indication to an operator to switch between the mechanisms.

19. Apparatus according to claim 1, wherein said synchronizer is automatic, switching by itself between the mechanisms.

20. Apparatus according to claim 1, wherein said synchronizer comprises a pin extractor for decoupling a pin from one mechanism and coupling the pin to another mechanism.

21. Apparatus according to claim 20, wherein said synchronizer comprises a spring for urging said pin towards one of said mechanisms and an inclined plane for withdrawing said pin from said one mechanism and urging said pin towards said other mechanism.

22. Apparatus according to claim 1, wherein said synchronizer blocks the motion of one of said mechanisms when a desired motion effect of said mechanism is achieved.

23. Apparatus according to claim 22, comprising a pin that engages an aperture to effect said locking.

24. Apparatus according to claim 1, wherein said restraint mechanism comprises an unevenly surfaced element for coupling said motion to said restraint element.

25. Apparatus according to claim 1, wherein said force application mechanism comprises an unevenly surfaced element for coupling said motion to said force applicator.

26. Apparatus according to claim 24, wherein said unevenly surfaced element comprises a nubbed plate.

27. Apparatus according to claim 26, wherein said nubs are one-way nubs that allow an arm element of said mechanisms to slip over them when the arm travels in one direction relative to the nubs and engages the arm when the arm travels in the opposite relative direction.

28. Apparatus according to claim 24, wherein said unevenly surfaced element comprises an apertured plate.

29. Apparatus according to claim 24, wherein said uneven surface comprises even surface portions separated, by uneven surface portions, a plurality of separation distances defined by said separation of surface portions.

30. Apparatus according to claim 29, wherein said separation distances determine the deformation of said implant.

31. Apparatus according to claim 29, wherein said separation distances take into account a plastic deformation of said implant.

32. Apparatus according to claim 29, wherein said separation distances take into account an elastic deformation of said implant.

33. Apparatus according to claim 29, wherein said separation distances take into account a spring-back of said implant.

34. Apparatus according to claim 1, wherein said force applicator and said force application mechanism are substantially restricted to a straight, narrow, elongate volume, thereby reducing moments on the force application mechanism.

35. Apparatus according to claim 1, wherein said force applicator pushes against said implant.

36. Apparatus according to claim 1, wherein said force applicator pulls a base against a far side of said implant.

37. Apparatus according to claim 1, wherein said force applicator exhibits axial motion, along an axis connecting the force applicator and the implant.

38. Apparatus according to claim 1, wherein said force applicator exhibits rotational motion, around an axis connecting the force applicator and the implant.

39. Apparatus according to claim 37, wherein said force applicator exhibits only axial motion, along an axis connecting the force applicator a nd the implant.

40. Apparatus according to claim 1, wherein said restraint element exhibits axial motion, along an axis connecting the force applicator and the implant.

41. Apparatus according to claim 1, wherein said restraint element exhibits rotational motion, around an axis connecting the force applicator and the implant.

42. Apparatus according to claim 40, wherein said force applicator exhibits only axial motion, during times when force is applied by it to the implant, along an axis connecting the force applicator and the implant.

43. Apparatus according to claim 1, wherein said force applicator applies at least 20 Kg to said implant.

44. Apparatus according to claim 1, wherein said force applicator applies at least 40 Kg to said implant.

45. Apparatus according to claim 1, wherein said force applicator applies at least 60 Kg to said implant.

46. Apparatus according to claim 1, wherein said force applicator applies at least 100 Kg to said implant.

47. Apparatus according to claim 1, wherein said restraint element and said force applicator are elongate elements.

48. Apparatus according to claim 47, wherein said restraint element and said force applicator are cylindrical elements.

49. Apparatus according to claim 47, wherein said cylindrical elements are tubes.

50. Apparatus according to claim 1, wherein said force applicator comprises two concentric elements, an outer element which applies force away from said apparatus towards said implant and an inner counter force element that applies force from said implant towards said apparatus.

51. Apparatus according to claim 50, wherein said inner element is mechanically coupled to said implant.

52. Apparatus according to claim 50, wherein said outer element is mechanically coupled to said implant.

53. Apparatus according to claim 50, wherein said motion of said force applicator comprises motion of only one of said concentric elements relative to said apparatus.

54. Apparatus according to claim 53, wherein said inner element retracts towards said apparatus during said motion of said force applicator.

55. Apparatus according to claim 53, wherein said outer element advances away from said apparatus during said motion of said force applicator.

56. Apparatus according to claim 50, wherein said inner element is decoupled from said implant by unscrewing it.

57. Apparatus according to claim 56, wherein said inner element extends substantially all the way through said apparatus.

58. Apparatus according to claim 1, comprising a handle for holding said apparatus by an operator.

59. Apparatus according to claim 1, comprising means for fixing said apparatus to said patient.

60. Apparatus according to claim 1, comprising means for fixing said apparatus to a bed on which said patient lies.

61. Apparatus according to claim 1, wherein said synchronizer adapts said apparatus for deforming a particular implant from a set of same types of implants having different geometries.

62. Apparatus according to claim 1, wherein said synchronizer synchronizes said force applicator to apply force to said implant after said implant is completely expanded.

63. Apparatus according to claim 1 wherein said restraint element has an outer diameter of less than 7 mm.

64. Apparatus according to claim 1 wherein said restraint element has an outer diameter of less than 6 mm.

65. Apparatus according to claim 1 wherein said restraint element has an outer diameter of less than 5 mm.

66. Apparatus according to claim 1 wherein said restraint element has an outer diameter of less than 4 mm.

67. Apparatus according to claim 1, wherein said implant is a spinal implant for fusing adjacent vertebrae.

68. Apparatus according to claim 1, wherein said implant is an axially contracting and radially expanding implant.

69. Apparatus according to claim 1, wherein said implant comprises a slotted tube, which as it contracts, radially extends a plurality of spikes and wherein said restraining element encloses said tube and prevents the extension of at least one of said spikes.

70. Apparatus according to claim 1, wherein said implant comprises a slotted tube, to which force is applied against an end of said tube, to deform the tube.

71. Apparatus according to claim 1, wherein said implant radially expands by said deforming at least by a ratio of two.

72. Apparatus according to claim 1 wherein said implant radially expands by said deforming at least by a ratio of four.

158. Apparatus according to claim 58, wherein said apparatus is configured so that a distal end of said implant does not move relative to said handle during said applying.

73. A method of controlling the deformation of an implant, comprising:

providing a medical implant;

positioning a restraining element relative to said implant, which restraining element prevents deformation of at least some of said implant;

applying a deformation force to said implant using at least one tube;

controlling the deformation of the implant using the restraining element;

moving said restraining element to a new position; and

repeating said applying, said controlling and said moving, a plurality of times, such that in each repetition a different portion of the implant is prevented from deforming by the restraining element.

74. A method according to claim 73, wherein said deformation comprises radial expansion.

75. A method according to claim 73, wherein said restraining element is inside said implant.

76. A method according to claim 73, wherein said restraining element is outside said implant.

77. A method according to claim 73, wherein said motion of said restraining element is controlled using a mechanism external to the implant.

78. A method according to claim 77, wherein said external mechanism receives a continuous motion input from an operator.

79. A method according to claim 78, comprising converting said continuous motion into discrete motion of said restraining element.

80. A method according to claim 78, comprising converting said continuous motion into discrete application of force to said implant.

81. A method according to claim 73, wherein said motion and said force application do not overlap in time.

82. A method according to claim 73, wherein said motion and said force application do overlap in time.

83. A method of controlling the deformation of an implant, composing:

providing an axial implant having a plurality of spikes extending radially thereto, arranged along the implant'"'"'s axis, which implant is in a collapsed state where said spikes do not extend;

enclosing said implant with a collar that restrains the extension of said spikes;

inserting said implant into a desired location;

retracting said collar to allow at least one spike to extend; and

repeating said retracting until substantially all of said spikes are extended.

84. A method according to claim 83, wherein said spikes extend as a result of forces stored within said implant.

85. A method according to claim 84, wherein said implant is formed of a super-elastic material.

86. A method according to claim 84, wherein said implant is formed of a shape-memory material.

87. A method according to claim 83, wherein said spikes extend as a result of forces applied externally to said implant.

88. A method according to claim 87, wherein said forces are axially applied to said implant.

89. A method according to claim 88, comprising applying an axial force to said implant after all of said spikes are extended.

90. Apparatus for controlling the deformation of a tube having a slotted section, comprising:

a force application mechanism for applying deforming force to the slotted section, by axial motion of a force applicator against the slotted section;

a restraint element positioning mechanism that positions a restraining element such that the deformation of the slotted section is controlled by restraint of the restraining element on allowable deformation; and

a synchronizer that synchronizers the motion of the restraining element and the force applicator, to achieve a desired deformation of the slotted section.

91. An apparatus according to claim 90, wherein said slotted section is formed of plastic.

92. Apparatus according to claim 90, comprising a force input which receives continuous motion and couples it to the force application mechanism and to the restraint element positioning mechanism.

93. Apparatus according to claim 92, wherein said continious motion is reciprocating motion.

94. Apparatus according to claim 93, wherein said restraint positioning mechanism moves said restraint element during one stroke of said reciprocating motion.

95. Apparatus according to claim 94, wherein said one stroke comprises a retraction of said restraint mechanism from said slotted section.

96. Apparatus according to claim 93, wherein said force application mechanism moves said force applicator during one stroke of said reciprocating motion.

97. Appratus according to claim 96, wherein said one stroke comprises a refraction of said force applicator from said slotted section.

98. Apparatus according to claim 96, wherein said one stroke comprises an advance of said force applicator towards said slolled section.

99. Apparatus according to claim 92, wherein said force application mechanism comprises a selective coupler that selectively couples said input motion to said force applicator.

100. Apparatus according to claim 92, wherein said element positioning mechanism comprises a selective coupler that selectively couples said input motion to said restraining element.

101. Apparatus according to claim 92, wherein said synchronized motion is repetitive and comprises a plurality of cycles of positioning said restraining element and applying said force.

102. Apparatus according to claim 92, wherein said motion is applied simultaneously to said restraint element positioning mechanism and to said force application mechanism.

103. Apparatus according to claim 92, wherein said motion is applied alternately to said restraint element positioning mechanism and to said force application mechanism.

104. Apparatus according to claim 103, comprising an alternating locking mechanism that alternately couples the motion from the force input to the restraint element positioning mechanism and to the force application mechanism.

105. Apparatus according to claim 92, wherein said force input comprises a manual force input.

106. Apparatus according to claim 92, wherein said force input comprises a motorized force input.

107. Apparatus according to claim 90, wherein said synchronizer is integrated with said mechanisms.

108. Apparatus according to claim 90, wherein said synchronizer is manual, providing an indication to an operator to switch between the mechanisms.

109. Apparatus according to claim 90, wherein said synchronizer is automatic, switching by itself between the mechanisms.

110. Apparatus according to claim 90, wherein said synchronizer comprises a pin extractor for decoupling a pm from one mechanism and coupling the pin to another mechanism.

111. Apparatus according to claim 110, wherein said synchronizer comprises a spring for urging said pin towards one of said mechanisms and an inclined plane for withdrawing said pin from said one mechanism and urging said pin towards said other mechanism.

112. Apparatus according to claim 90, wherein said synchronizer blocks the motion of one of said mechanisms when a desired motion effect of said mechanism is achieved.

113. Apparatus according to claim 112, comprising a pin that engages an aperture to effect said locking.

114. Apparatus according to claim 90, wherein said restraint mechanism comprises an unevenly surfaced element for coupling said motion to said restraint element.

115. Appratus according to claim 90, wherein said force application mechanism comprises an unevenly surfaced element for coupling said motion to said force applicator.

116. Apparatus according to claim 114, wherein said unevenly surfaced element comprises a nubbed plate.

117. Apparatus according to claim 116, wherein said nubs are one-way nubs that allow an arm element of said mechanisms to slip over them when the arm travels in one direction relative to the nubs and engages the arm when the aim travels in the opposite relative direction.

118. Apparatus according to claim 114, wherein said unevenly surfaced element comprises an apertured plate.

119. Apparatus according to claim 114, wherein said uneven surface comprises even surface portions separated, by uneven surface portions, a plurality of separation distances defined by said separation of surface portions.

120. Apparatus according to claim 119, wherein said separation distances determine the deformation of said slotted section.

121. Appratus according to claim 119, wherein said separation distances take into account a plastic deformation of said slotted section.

122. Apparatus according to claim 119, wherein said separation distances take into account an elastic deformation of said slotted section.

123. Apparatus according to claim 119, wherein said separation distances take into account a spring-back of said slotted section.

124. Apparatus according to claim 90, wherein said force applicator and said force application mechanism are substantially restricted to a straight, narrow, elongate volume, thereby reducing moments on the force application mechanism.

125. Apparatus according to claim 90, wherein said force applicator pushes against said slotted section.

126. Apparatus according to claim 90, wherein said force applicator pulls a base against a far side of said slotted section.

127. Apparatus according to claim 90, wherein said force applicator exhibits axial motion, along an axis connecting the force applicator and the slotted section.

128. Apparatus according to claim 90, wherein said force applicator exhibits rotational motion, around an axis connecting the force applicator and the slotted section.

129. Apparatud according to claim 127, wherein said force applicator exhibits only axial motion, along an axis connecting the force applicator and the slotted section.

130. Apparatus according to claim 90, wherein said restraint element exhibits axial motion, along an axis connecting the force applicator and the slotted section.

131. Apparatus according to claim 90, wherein said restraint element exhibits rotational motion, around an axis connecting the force applicator and the slotted section.

132. Apparatus according to claim 130, wherein said force applicator exhibits only axial motion, during times when force is applied by it to the slotted section, along an axis connecting the force applicator and the slotted section.

133. Apparatus according to claim 90, wherein said force applicator applies at least 20 Kg to said slotted section.

134. Apparatus according to claim 90, wherein said force applicator applies at least 40 Kg to said slotted section.

135. Apparatus according to claim 90, wherein said force applicator applies at least 60 Kg to said slotted section.

136. Apparatus according to claim 90, wherein said force applicator applies at least 100 Kg to said slotted section.

137. Apparatus according to claim 90, wherein said restraint element and said force applicator are elongate elements.

138. Apparatus according to claim 137, wherein said restraint element and said force applicator are cylindrical elements.

139. Apparatus according to claim 137, wherein said cylindrical elements are tubes.

140. Apparatus according to claim 90, wherein said force applicator comprises two concentric elements, an outer element which applies force away from said apparatus towards said slotted section and an inner counter force element that applies force from said slotted section towards said apparatus.

141. Apparatus according to claim 140, wherein said inner element is mechanically coupled to said slotted section.

142. Apparatus according to claim 140, wherein said outer element is mechanically coupled to said slotted section.

143. Apparatus according to claim 140, wherein said motion of said force applicator comprises motion of only one of said concentric elements relative to said apparatus.

144. Apparatus according to claim 143, wherein said inner element retracts towards during said motion of said force applicator.

145. Apparatus according to claim 143, wherein said outer element advances away from said apparatus during said motion of said force applicator.

146. Apparatus according to claim 140, wherein said inner element extends substantially all the way through said apparatus.

147. Apparatus according to claim 90, comprising a handle for holding said apparatus by an operator.

148. Apparatus according to claim 90, comprising means for fixing said apparatus to said patient.

149. Apparatus according to claim 90, comprising means for fixing said apparatus to a bed on which said patient lies.

150. Apparatus according to claim 90, wherein said synchronizer synchronizes said force applicator to apply force to said slotted section after said slotted section is completely expanded.

151. Apparatus according to claim 90 wherein said restraint element has an outer diameter of less than 7 mm.

152. Apparatus according to claim 90 wherein said restraint element has an outer diameter of less than 6 mm.

153. Apparatus according to claim 90 wherein said restraint element has an outer diameter of less than 5 mm.

154. Apparatus according to claim 90 wherein said restraint element has an outer diameter of less than 4 mm.

155. Apparatus according to claim 90 wherein said slotted section radially expands by said deforming at least by a ratio of two.

156. Apparatus according to claim 90 wherein said slotted section radially expands by said deforrning at least by a ratio of four.

157. Apparatus according to claim 147, wherein said apparatus is configured that a distal end of said slotted section does not move relative to said handle during said applying.

159. Apparatus according to claim 90, wherein said slotted section is configured to expand to have a uniform radial diameter.

160. Apparatus according to claim 90, wherein said slotted section is configured to expand to have a radial diameter which varies along the tube axis.

161. Apparatus according to claim 90, wherein said slotted section comprises an end portion of an unslotted tube.

162. A method of controlling the deformation of a slotted tube, comprising:

providing an axial tube having at least a slotted end such that said slots are configured to expand as a plurality of spikes extending radially thereto, said spikes arranged along the tube axis, which slotted end is in a collapsed state where said spikes do not extend;

enclosing said slotted end with a collar that restrains the extension of said spikes;

inserting said tube into solid tissue;

retracting said collar relative to said slotted end to allow at least one spike to extend in said solid tissue; and

repeating said retracting until substantially all of said spikes are extended.

163. A method according to claim 162, wherein said slotted tube is formed of plastic.