SOFT TISSUE ANCHORS AND IMPLANTATION TECHNIQUES

• US 20150351910A1
• Filed: 01/09/2014
• Published: 12/10/2015
• Est. Priority Date: 01/09/2013
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: GILMORE, Michael, MURPHY, Charlotte, TOBIS, Idan
• Granted Patent: US 9,788,948 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A tissue anchor (20) comprises a helical tissue-coupling element (30) disposed about a longitudinal axis (32) thereof and having a distal tissue-penetrating tip (34). The helical tissue-coupling element (30) has: a first axial stiffness along a first axial portion (60) of the helical tissue-coupling element (30); a second axial stiffness along a second axial portion (62) of the helical tissue-coupling element (30) more distal than the first axial portion (60), which second axial stiffness is greater than the first axial stiffness; and a third axial stiffness along a third axial portion (64) more distal than the second axial portion (62), which third axial stiffness is less than the second axial stiffness. Other embodiments are also described.

Claims

1. Apparatus comprising a tissue anchor, which comprises a helical tissue-coupling element disposed about a longitudinal axis thereof and having a distal tissue-penetrating tip, wherein the helical tissue-coupling element has:

a first axial stiffness along a first axial portion of the helical tissue-coupling element,

a second axial stiffness along a second axial portion of the helical tissue-coupling element more distal than the first axial portion, which second axial stiffness is greater than the first axial stiffness, and

a third axial stiffness along a third axial portion more distal than the second axial portion, which third axial stiffness is less than the second axial stiffness.

2. The apparatus according to claim 1, wherein the helical tissue-coupling element has:

a first axial yield strength along the first axial portion of the helical tissue-coupling element,

a second axial yield strength along the second axial portion of the helical tissue-coupling element, which second axial yield strength is greater than the first axial yield strength, and

a third axial yield strength along the third axial portion, which third axial yield strength is less than the second axial yield strength.

3. The apparatus according to claim 1,

wherein the first and the second axial portions are shaftless helical portions of the helical tissue-coupling element, and

wherein the helical tissue-coupling element has:

a first axial thickness along the first axial portion, and

a second axial thickness along the second axial portion, which second axial thickness is greater than the first axial thickness, the first and second axial thicknesses being measured along the axis.

4. The apparatus according to claim 3, wherein the helical tissue-coupling element has a third axial thickness along the third axial portion, which third axial thickness is less than the second axial thickness, the third axial thickness being measured along the axis.

5. The apparatus according to claim 1, wherein the tissue anchor is shaped so as to define a head at a proximal end thereof, and wherein the first axial portion extends to the head.

6. The apparatus according to claim 1, wherein the tissue anchor is shaped so as to define a head at a proximal end thereof, and the apparatus further comprises a flexible longitudinal member, which is coupled to the head.

7. The apparatus according to claim 1,

wherein the distal tissue-penetrating tip is at a distal end of the tissue anchor, and the tissue anchor is shaped so as to define a longitudinal channel extending from a proximal end of the anchor to the distal end, and

wherein the apparatus further comprises a depth-finding tool, which comprises a radiopaque bead shaped so as to define a hole therethrough, which bead is positioned within the channel, such that the bead is slidable along the channel.

8. The apparatus according to claim 7, wherein the depth-finding tool further comprises a shaft that is removably positioned within the channel, such that the shaft passes through the hole of the bead, and such that the bead is slidable along the shaft and along the channel.

9. The apparatus according to claim 8, wherein a distal tip of the shaft is sharp.

10. The apparatus according to claim 8, wherein the helical tissue-coupling element is shaped so as to define a distal stopper that prevents the radiopaque bead from advancing distally off of the shaft.

11. The apparatus according to claim 1,

wherein the tissue anchor is shaped so as to define a head at the proximal end thereof,

wherein the helical tissue-coupling element is shaped so as to define and radially surround an empty space that extends along at least 75% of an axial length of the helical tissue-coupling element,

wherein a distal portion of the channel coincides with the empty space,

wherein a proximal portion of the channel is defined by the head,

wherein the distal portion of the channel is wider than the proximal portion of the channel, and

wherein the bead is positioned within the distal portion of the channel, in the empty space.

12. The apparatus according to claim 1, wherein the depth-finding tool further comprises a wire, which is at least partially disposed within the channel, and which couples the bead to the a proximal portion of the tissue anchor, thereby preventing the bead from exiting the distal end of the tissue anchor.

13. The apparatus according to claim 12, wherein the wire is shaped as a helical spring.

14-16. -16. (canceled)

17. Apparatus comprising:

a tissue anchor, which (a) comprises a helical tissue-coupling element which has a distal tissue-penetrating tip at a distal end of the tissue anchor, and (b) is shaped so as to define a longitudinal channel extending from a proximal end of the anchor to the distal end; and

a depth-finding tool, which comprises a radiopaque bead shaped so as to define a hole therethrough, which bead is positioned within the channel, such that the bead is slidable along the channel.

18. The apparatus according to claim 17, wherein the depth-finding tool further comprises a shaft that is removably positioned within the channel, such that the shaft passes through the hole of the bead, and such that the bead is slidable along the shaft and along the channel.

19. The apparatus according to claim 18, wherein a distal tip of the shaft is sharp.

20. The apparatus according to claim 18, wherein the helical tissue-coupling element is shaped so as to define a distal stopper that prevents the radiopaque bead from advancing distally off of the shaft.

21. The apparatus according to claim 17,

wherein the tissue anchor is shaped so as to define a head at the proximal end thereof,

wherein the helical tissue-coupling element is shaped so as to define and radially surround an empty space that extends along at least 75% of an axial length of the helical tissue-coupling element,

wherein a distal portion of the channel coincides with the empty space,

wherein a proximal portion of the channel is defined by the head,

wherein the distal portion of the channel is wider than the proximal portion of the channel, and

wherein the bead is positioned within the distal portion of the channel, in the empty space.

22. The apparatus according to claim 17, wherein the depth-finding tool further comprises a wire, which is at least partially disposed within the channel, and which couples the bead to the a proximal portion of the tissue anchor, thereby preventing the bead from exiting the distal end of the tissue anchor.

23. The apparatus according to claim 22, wherein the wire is shaped as a helical spring.

24-70. -70. (canceled)

71. A method comprising:

providing a tissue anchor, which includes a helical tissue-coupling element disposed about a longitudinal axis thereof and having a distal tissue-penetrating tip, wherein the helical tissue-coupling element has (a) a first axial yield strength along a first axial portion of the helical tissue-coupling element, (b) a second axial yield strength along a second axial portion of the helical tissue-coupling element more distal than the first axial portion, which second axial yield strength is greater than the first axial yield strength, and (c) a third axial yield strength along a third axial portion more distal than the second axial portion, which third axial yield strength is less than the second axial yield strength; and

advancing the helical tissue-coupling element into soft tissue.

72. The method according to claim 71,

wherein providing the tissue anchor comprises providing the tissue anchor in which the helical tissue-coupling element has (a) a first axial yield strength along the first axial portion of the helical tissue-coupling element, and (b) a second axial yield strength along the second axial portion of the helical tissue-coupling element, which second axial yield strength is greater than the first axial yield strength, and

wherein the method further comprises:

applying tension to a proximal head of the tissue anchor; and

sensing elongation of the first axial portion while applying the tension.

76. The method according to claim 71, further comprising applying tension to a proximal head of the tissue anchor.

77. The method according to claim 76, wherein applying the tension comprises sensing elongation of the first axial portion while applying the tension.

78. The method according to claim 77, wherein sensing the elongation comprises sensing the elongation using imaging.

79. The method according to claim 77, wherein sensing the elongation comprises sensing the elongation using tactile feedback.

80. The method according to claim 76, wherein applying the tension comprises pulling on a flexible longitudinal member that is coupled to the proximal head.

81. The method according to claim 71, wherein advancing the helical tissue-coupling element into the soft tissue comprises advancing the second and the third axial portions completely into the soft tissue, and leaving at least a portion of the first axial portion outside of the soft tissue.

84. The method according to claim 71,

wherein providing the tissue anchor comprises providing the tissue anchor (a) in which the distal tissue-penetrating tip is at a distal end of the tissue anchor, and (b) which is shaped so as to define a longitudinal channel extending from a proximal end of the anchor to the distal end,

wherein the method further comprises providing a depth-finding tool, which includes a radiopaque bead shaped so as to define a hole therethrough, which bead is positioned within the channel, such that the bead is slidable along the channel, and

wherein advancing the helical tissue-coupling element into the soft tissue comprises advancing the helical tissue-coupling element into the soft tissue, such that the bead comes into contact with and remains at a surface of the soft tissue.

73-75. -75. (canceled)

82-83. -83. (canceled)

95. A method comprising:

providing a tissue anchor, which (a) includes a helical tissue-coupling element which has a distal tissue-penetrating tip at a distal end of the tissue anchor, and (b) is shaped so as to define a longitudinal channel extending from a proximal end of the anchor to the distal end;

providing a depth-finding tool, which includes a radiopaque bead shaped so as to define a hole therethrough, which bead is positioned within the channel, such that the bead is slidable along the channel; and

advancing the helical tissue-coupling element into soft tissue, such that the bead comes into contact with and remains at a surface of the soft tissue.

85. The method according to claim 95, wherein providing the depth-finding tool comprises providing the depth-finding tool further including a shaft that is removably positioned within the channel, such that the shaft passes through the hole of the bead, and the bead is slidable along the shaft and along the channel.

86. The method according to claim 85, further comprising proximally withdrawing the shaft from the channel, leaving the bead in the channel.

87. The method according to claim 85, wherein providing the depth-finding tool comprises providing the depth-finding tool in which a distal tip of the shaft is sharp.

88. The method according to claim 87, further comprising advancing the shaft into the soft tissue while advancing the helical tissue-coupling element into the soft tissue.

89. The method according to claim 88, further comprising, after fully advancing the helical tissue-coupling element into the soft tissue, proximally withdrawing the shaft from the channel, leaving the bead in the channel.

90. The method according to claim 87, further comprising, before advancing the helical tissue-coupling element into the soft tissue, inserting the sharp distal tip of the shaft into the soft tissue slightly, in order to prevent sliding of the depth-finding tool and the anchor on a surface of the soft tissue before advancing the anchor into the tissue.

91. The method according to claim 95, further comprising:

viewing the bead and a proximal portion of the soft tissue anchor using imaging; and

assessing a depth of penetration of the helical tissue-coupling element into the soft tissue by estimating a distance between the bead and the proximal portion of the tissue anchor.

92. The method according to claim 95, wherein providing the depth-finding tool comprises providing the depth-finding tool further including a wire, which is at least partially disposed within the channel, and which couples the bead to the a proximal portion of the tissue anchor, thereby preventing the bead from exiting the distal end of the tissue anchor.

93. The method according to claim 92, wherein providing the depth-finding tool comprises providing the depth-finding tool in which the wire is shaped as a helical spring.

94. The method according to claim 95,

wherein providing the tissue anchor comprises providing the tissue anchor in which:

the tissue anchor is shaped so as to define a head at the proximal end thereof,

the helical tissue-coupling element is shaped so as to define and radially surround an empty space that extends along at least 75% of an axial length of the helical tissue-coupling element,

a distal portion of the channel coincides with the empty space,

a proximal portion of the channel is defined by the head, and

the distal portion of the channel is wider than the proximal portion of the channel, and

wherein providing the depth-finding tool comprises providing the depth-finding tool in which the bead is positioned within the distal portion of the channel, in the empty space.