Bone fastener

• US 5,725,529 A
• Filed: 12/06/1993
• Issued: 03/10/1998
• Est. Priority Date: 09/25/1990
• Status: Expired due to Term

• Current Assignee: Innovasive Devices Inc. (Johnson & Johnson)
• Original Assignee: Innovasive Devices Inc. (Johnson & Johnson)
• Inventors: Rice, John, Hart, Rickey D., Nicholson, James E.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/163,130
• Time in Patent Office: 1,555 Days
• Field of Search: 606/61-78, 623/16-23
• US Class Current: 606/232
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/82 for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0408 Rivets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0424 the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0425 the anchor or the separate member comprising threads, e.g. a set screw in the anchor
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 : Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0835 : with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2002/0841 : Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire
• CPC Class Codes: A61F 2002/0852 : Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
• CPC Class Codes: A61F 2002/0858 : Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0864 : Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• CPC Class Codes: A61F 2002/0882 : Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2002/0888 : Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• CPC Class Codes: Y10S 606/916 : Tool for installing or removing orthopedic fastener

Abstract

A bone fastener including an expandable member having an axial channel and an elongated element insertable into the axial channel is described. The expandable member is configured to be insertible into a bore drilled in bone. The distal end of the expandable member also may include a structure for axially releasing the expandable member from an emplacement device that places the expandable member into a bone opening. In one embodiment, the structure for axially releasing includes a frangible membrane capable of being severed from the expandable member during emplacement of the expandable member in a bone opening. A rivet for coupling an object to bone for use with an expandable member is also described. The distal end of the elongated element is shaped into a radially projecting portion adapted for engagement with a washer that contacts the object to be coupled. The washer, having upper and lower surfaces and a bore defined between the surfaces, is disposed around a portion of the shaft. The elongated element is adapted for movement independent of the washer since the radial projection of the element has a different radius of curvature than the washer. An apparatus for use within an endoscope is described. The apparatus includes an elongated, substantially hollow holding means for emplacing a bone fastener of the invention in a bone opening. The expandable member includes a structure for axially releasing the expandable member from the holding means. A method of attaching soft tissue to bone is also described. The invention also includes a surgical fastener kit.

Claims

1. A fastener for coupling an object to bone comprising,

an substantially cylindrical member of expandable material for insertion into an opening in a bone, the member including an outer surface having structure for expandable engagement with an inner surface of the bone opening, said expandable member having an axial channel defined therein extending at least partially between proximal and distal ends thereof, the distal end of the expandable member includes a radially-outwardly projecting portion for engagement with the object to be coupled to the bone,

a washer having defined therein a central bore, a portion of the insertion element disposed within said bore, said washer being adapted for movement on said shaft, wherein said washer and said projecting portion each have a surface in facing relationship, each of said surfaces having a different radius of curvature to allow for the washer to move relative to the insertion element, and

an elongated element for insertion into said expandable member, the insertion element including a channel for engagement with a suture, at least a portion of said insertion element including an outer diameter greater than an inner diameter of the axial channel of the expandable member for expansion thereof upon engagement therewith, whereby, by insertion of said insertion element, the expandable member is irreversibly expanded to obtain a pressure fit with said opening in said bone.

2. A rivet for coupling an object to bone for use with an expandable member capable of insertion into an opening in a bone, the rivet comprising:

an elongated element for insertion into a distal end of said expandable member, the element having a shaft with proximal and distal ends, the distal end of said elongated element including a radially projection portion and an outer surface of said shaft including a radially outward projecting portion adapted to expand said expandable member;

a washer having upper and lower surfaces, said surfaces defining a bore therebetween, said bore disposed around a portion of the shaft of the elongated element, wherein said washer is adapted for movement independent of said elongated element, wherein said washer includes means for enhancing tissue proliferation on said rivet, wherein said means includes at least one toughened portion of at least said upper surface of said washer.

3. The fastener of claim 2, wherein each said upper surface of said washer and said projecting portion of said element respectively have a different radius of curvature to allow for the element to move relative to the projecting portion.

4. In combination,

a bone;

an opening defined in the bone;

an expandable member inserted into the opening in the bone, the member including an outer surface in expanded secured engagement with an inner surface of the bone opening;

an axial channel defined within said expandable member, said channel extending at least partially between proximal and distal ends of said expandable member;

an elongated element inserted into said distal end of said expandable member, the insertion element including proximal and distal ends, an outer surface of the insertion element having a projection engaged with an inner surface of the channel of said expandable member, said projection arranged to expand said member upon insertion into said distal end of said expandable member; and

at least part of a frangible membrane integral with the distal end of the expandable element, the frangible membrane adapted to break and axially release the expandable member from a holding means also integral with the frangible membrane.

5. The combination of claim 4, wherein the expandable member is formed out of it biocompatible material.

6. The combination of claims 4, wherein the insertible element is formed out of a bioabsorbable material.

7. The of claim 4, further comprising a suture engaged with said insertion element.

8. An expandable member for use in a bone fastener, comprising a substantially cylindrical outer surface for engagement with an opening in a bone, said member having proximal and distal ends;

said member having defined therein an axial channel extending at least partially between said ends and defining an inner surface of said member, said axial channel susceptible to enlargement by a compressive force acting substantially orthogonal to said inner surface of said expandable member;

a plurality of projections extending radially outwardly from said outer surface for contacting the bone within said opening upon enlargement of said channel; and

means engaged with said distal end of said expandable member for axially releasing said member from an elongated holder, wherein said means for axially releasing includes a frangible membrane capable of being severed from the expandable member during emplacement of said expandable member in a bone opening.

9. An apparatus for use within an endoscope comprising:

an elongated, substantially hollow holding means for emplacing a bone fastener in a bone opening, said holding means having distal and proximal ends;

an expandable member having a proximal end and a distal end, wherein the distal end is integral with the proximal end of the holding means via a frangible membrane, said member comprising;

a substantially cylindrical outer surface for engagement with an opening in a bone;

an axial channel defined between said ends extending at least partially between said ends and defining an inner surface of said member, said axial channel having an inside diameter susceptible to enlargement by a compressive force acting substantially orthogonal to said inner surface of said expandable member; and

a plurality of projections extending radially outwardly from said outer surface for contacting the bone within said opening.

10. A method of attaching soft tissue to bone, comprising

providing an expandable member for insertion into an opening in a bone, the member having defined therein an axial channel having a diameter, said expandable member also including a means for axially releasing said expandable member from an emplacement means;

engaging said expandable member at a distal end thereof by way of said emplacement means;

inserting said expandable member into said soft tissue and bone while maintaining engagement with said distal end of the expandable member;

applying a continuous, compressive force to said expandable member to expand the diameter of the axial channel so that an outer surface of said expandable member engages with the bone; and

activating the means for axially releasing, so that said expandable member is released from the emplacement means when the continuous force stops, wherein the means for axially releasing includes a frangible membrane integral with said distal end of said expandable member and a proximal end of said emplacement means.

11. The method of claim 10, wherein the step of activating the means for axially releasing includes severing the frangible membrane.

12. A method for establishing a fastener in an opening in a bone, comprising

providing an expandable member having a proximal end for insertion into an opening in a bone and a distal end integral with a holding means by way of a frangible membrane, the expandable member having an axial channel of a certain diameter;

inserting the expandable member into the opening by way of the holding means;

inserting a proximal end of an elongated element into the axial channel of the expandable member at a distal end thereof, the element having a projecting portion;

continuously, axially advancing the element into the axial channel so that the projecting portion of the element exerts a force substantially orthogonal to said axial channel and expands the diameter of the axial channel into the bone opening;

disengaging the expandable member from the holding means by severing the frangible membrane.

13. Apparatus for placing a bone fastener in an opening in a bone, comprising in combination:

an expandable member with an axial channel defined therein;

an elongated, substantially hollow holder for the expandable member, the holder constructed to maintain the expandable member in position within the bone opening;

an element for engagement with an inner surface of the axial channel;

means intermediate the expandable element and holder for axially releasing said expandable member from said holder when said expandable element is fully expanded within said bone opening;

means adapted for co-axial movement relative to the holder for placing the element into the axial channel of the expandable member, and

means co-axially moveable within the hollow body for activating the means for axially releasing the expandable member from the holder.

14. The apparatus of claim 13, wherein the means for axially releasing includes a membrane severably attached to the expandable member at an end thereof.

15. A fastener for coupling an object to bone comprising,

a substantially cylindrical member of expandable material for insertion into an opening in a bone, the member including an outer surface having structure for expandable engagement with an inner surface of the bone opening, said expandable member having an axial channel defined therein extending at least partially between proximal and distal ends thereof, wherein the distal end of the expandable member further comprises means for axially releasing the expandable member from a holding means, wherein the means for axially releasing comprises at least a portion of a frangible membrane.

an elongated element for insertion into said expandable member, the insertion element including a channel defined in a direction substantially orthogonal to the longitudinal axis of the element for engagement with an intermediate portion of a suture,

wherein at least a portion of the insertion element includes an outer diameter greater than an inner diameter of the axial channel of the expandable member for expansion thereof upon engagement therewith, whereby, by insertion of said insertion element, the expandable member is irreversibly expanded to obtain a pressure fit with said opening in said bone.