Self closing tissue fastener

Abstract

A self-closing tissue fastener for use in wound closure and surgery has, in an annular configuration, a central ring; tissue-piercing spines projecting from a first side of the ring; and stabilizing members projecting from a second side of the ring. The fastener can be carried on the inside of a tube, where it is stable without additional restraint, as well as on the outside of a tube or mandrel. The device can be compressed from a planar state, as fabricated, to the annular state by compressing the stabilizers (or, if they are on the outside in the planar form, the barbs). Unlike present devices, which are not as stable in the annular state, the inventive device and an applicator therefore provide an open channel to a site of surgery, for passage of endoscopes or various endoscopic and similar instruments. In particular, the fastener can be delivered under endoscopic monitoring.

Description

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 and 2 show a first embodiment of the tissue fastener of the invention, having only one tissue-affixing projection.

FIGS. 3 and 4 illustrate a second embodiment of the fastener.

FIGS. 5A, and 6 illustrate a preferred embodiment of the fastener. FIG. 5B is an axial view of the device of FIG. 5A.

FIGS. 7 and 8 illustrate the preferred embodiment residing within a representative endoscopic instrument delivery system.

FIGS. 9 and 10 illustrate a preferred embodiment in which vacuum is used to immobilize tissue for fixation with the fastener of the invention.

Claims

1. A device for fastening tissue, wherein the device has a first, planar state and a second, annular state, wherein the device is changed from its planar state to its annular state by application of torsional energy, wherein in its annular state the device comprises a generally annular ring, and multiple functional zones each extending along part of the circumference of the ring, the zones comprising: a) a plurality of first zones having sufficient elasticity to be able to sustain a 90 degree or more torsional bend without failure;b) one or more second zones, each second zone having at least one tissue-engaging projection, each second zone being connected on each side to a first zone, and said tissue-engaging projections all emerging from a first side of the ring, and projecting approximately normally to the plane of the ring;c) one or more third zones, which may be the same as or different than said second zones, each third zone having at least one stabilizing projection, each third zone connected on each side to a first zone, and said stabilizing projections all emerging in a direction approximately normal to the plane of the ring from a second side of the ring, which is the opposite side of the ring from the side from which the tissue-engaging projections emerge.

2. The device of claim 1, further comprising at least two fourth zones, each fourth zone disposed between two first zones, wherein said fourth zones have a torsional modulus that is the same as or greater than the torsional modulus of said first zones.

3. The device of claim 2 where the fourth zones are composed of a material that is the same as the material of one or both of the third zones and second zones.

4. The device of claim 1 where the device is made from a single highly flexible material having sufficient elasticity to be able to sustain a 90 degree or more torsional bend without failure.

5. The device of claim 1 wherein the tissue-engaging projections have tissue-holding subsidiary projections.

6. The device of claim 1 wherein the highly flexible material having sufficient elasticity to be able to sustain up to a 90 degree torsional bend or more without failure, further has the property that up to a 90 degree torsional bend or more is substantially reversible upon release from a bent state.

7. The device of claim 6 wherein the reversibility is sufficient to reverse at least about 45 degrees of a 90 degree bend.

8. The device of claim 1 wherein the device is bent from a first planar state to a second annular shape by being forced onto a mandrel with an outer circumference that is in the range of about 90% to 105% of the inner circumference of the device.

9. The device of claim 1 wherein the device is bent from a first planar state to a second annular shape by forcing those members which project outward from the ring in the planar state together until the device converts from the planar state to the annular state.

10. The device of claim 1 wherein the stabilizing projections are long enough that the device can be stably held in the annular configuration on the inside of a tube without additional restraints, the inside circumference of said tube being in the range of about 95% to about 120% of the outside circumference of the device in its annular state.

11. The device of claim 1 where the device is made from one or more materials selected from stainless steels, inconel, nitinol, Monel, Hastalloy, Eligloy, tungsten, titanium, thermoplastic polymers, elastomeric polymers, thermoset polymers, polymeric blends, and alloys, mixtures, laminates, composites and combinations thereof.

12. The device of claim 1, where elasticity is provided by making at least the first zones from a material selected from materials used to form springs, and super-elastic materials.

13. A method of fastening tissue endoscopically using a fastener, said fastener having a first planar state and a second annular state, the annular state having a higher energy and being unstable against reversion to the planar state; the method comprising: providing an instrument having a stabilizing tube, and a fastener stabilized in the annular conformation inside said stabilizing tube at the distal end of said tube;providing means for withdrawing said stabilizing tube from the stabilized fastener;placing the distal end of said tube against tissue to be fastened;partially withdrawing said stabilizing tube to expose tissue-piercing members of said fastener;pressing the device to force said tissue-piercing members at least partially into aid tissue; andcompleting the withdrawal of said stabilizing tube, thereby releasing said fastener so that it will return to its planar state, thereby fastening said tissue.

14. The method of claim 13 wherein the stabilized fastener inside the tube is of sufficiently low profile to an endoscope to reside within or pass through the open area inside said fastener.

15. The method of claim 14 wherein the open area inside the fastener is at least about 75% of the area of the tube at its outer diameter.

16. The method of claim 13 wherein the tube is sealed sufficiently against vacuum to permit the tissue to be fastened to be drawn into the tube by vacuum, before the fastener is released to seal the tissue.

17. The method of claim 13 wherein the tissue to be fastened is drawn into the tube by mechanical force derived from one or more surgical instruments residing either within said tube, or outside said tube, before the fastener is released to seal the tissue.

18. The method of claim 13 wherein the tube and the means for device delivery have the capability to store and deliver more than one fastener to fasten one or more tissue locations.

19. The method of claim 13 wherein the means to deliver the device into the tissue and out of the tube comprise at least: a retaining tubular outer shell member, which restrains the fastener residing within;an inner tubular member residing at least partially within outer shell, said inner tubular member having a distal end against which the proximal end of said fastener abuts;and means connected to said outer shell to allow said outer shell to be withdrawn sufficiently, in a direction proximally of said fastener, so that it no longer restrains said fastener.

20. A combination of a tissue fastener and a delivery device for said fastener, wherein the tissue fastener has a first, low energy planar state and a second, twisted, high energy annular state, and wherein said fastener in its annular state comprises a ring, and one or more first tissue penetrating projections protruding from a first side of said ring, and one or more second stabilizing projections protruding from a second side of said ring; and wherein the delivery device has a first tubular shell which restrains the fastener in the fastener's annular state in its interior; a second tube which has a distal end against which the proximal end of the fastener abuts; and means for withdrawal of the first tubular shell in a direction proximally of said axial configuration of the fastener, thereby releasing said fastener, said release enabling said fastener to fasten tissue proximate to the distal end of the fastener as the fastener changes shape from its twisted annular state to its lower energy planar state.