A spinal disc preparation tool is provided that includes an elongate shaft having an inner lumen extending therethrough along a longitudinal axis between proximal and distal ends thereof. A lower jaw is located on a distal end of the elongate shaft for receiving tissue and delivering tissue to the inner lumen, and an upper jaw is pivotally movable relative to the lower jaw. The tool can include various features to facilitate removal and/or collection of tissue.

Patent
   RE47172
Priority
Jan 14 2009
Filed
Jun 11 2015
Issued
Dec 25 2018
Expiry
Jan 14 2029
Assg.orig
Entity
Large
0
77
currently ok
0. 33. A spinal disc preparation tool, comprising:
an elongate shaft having an inner lumen extending therethrough along a longitudinal axis between proximal and distal ends thereof;
a lower jaw formed integrally with the elongate shaft, the lower jaw extending distally from the elongate shaft, the lower jaw having a cutting feature at an outer periphery of the lower jaw configured to cut tissue by proximal and distal translating movement of the shaft; and
a projection extending from a midpoint of the inner surface of the lower jaw, the projection being configured to cut tissue.
0. 41. A spinal disc preparation tool, comprising:
an elongate shaft having an inner lumen extending therethrough along a longitudinal axis between proximal and distal ends thereof; and
a tissue receiving opening disposed at the distal end of the tool and in fluid communication with the inner lumen,
wherein a distal-facing exterior wall of the tool disposed at a distal-most end of the tool has concave surfaces that taper to a narrowed tip at the center of said exterior wall, the narrowed tip being configured to cut tissue; and
wherein the narrowed tip extends inwardly from an inner surface of a projection formed on the elongate shaft, the inner surface of the projection facing the tissue-receiving opening.
0. 26. A spinal disc preparation tool, comprising:
an elongate shaft having an inner lumen extending therethrough along a longitudinal axis between proximal and distal ends thereof;
at least one aspiration hole in fluid communication with the inner lumen and formed in the elongate shaft; and
a tissue receiving cavity disposed at the distal end of the tool and in fluid communication with the inner lumen, an upper surface of the cavity having a pointed projection formed at a center thereof, the projection having a downward-facing surface that faces the cavity,
wherein a distal-facing exterior wall of the tool has concave surfaces that taper to a narrowed tip, the narrowed tip protruding downward from the downward-facing surface of the projection, the narrowed tip being configured to cut tissue.
0. 25. A spinal disc preparation tool, comprising:
an elongate shaft having an inner lumen extending therethrough along a longitudinal axis between proximal and distal ends thereof;
a lower jaw located on a distal end of the elongate shaft for receiving tissue and delivering tissue to the inner lumen;
an upper jaw pivotally movable relative to the lower jaw; and
a handle coupled to a proximal end of the elongate shaft, the handle having formed therein an aspiration hole in fluid communication with the inner lumen;
wherein the aspiration hole is positioned such that the aspiration hole is blocked by a portion of a monolithic actuator handle when the actuator handle is actuated, the actuator handle being pivotally coupled to an actuator shaft coupled to the upper jaw for pivoting the upper jaw relative to the lower jaw; and
wherein the upper jaw includes one or more holes formed therein and the lower jaw includes one or more holes formed therein, the holes in the upper and lower jaws allowing gas to pass therethrough to aid in aspiration of cut tissue through the inner lumen.
1. A spinal disc preparation tool, comprising:
an elongate shaft having an inner lumen extending therethrough along a longitudinal axis between proximal and distal ends thereof;
a lower jaw located on a distal end of the elongate shaft for receiving tissue and delivering tissue to the inner lumen;
an upper jaw pivotally movable relative to the lower jaw; and
a handle coupled to a proximal end of the elongate shaft, the handle having formed therein an aspiration hole in fluid communication with the inner lumen;
wherein the aspiration hole is positioned such that the aspiration hole is blocked by a portion of a monolithic actuator handle when the actuator handle is actuated, the actuator handle being pivotally coupled to an actuator shaft coupled to the upper jaw for pivoting the upper jaw relative to the lower jaw; and
wherein the upper jaw includes one or more holes formed in a top surface thereof and the lower jaw includes one or more holes formed in a bottom surface thereof, the holes in the upper and lower jaws allowing gas to pass therethrough to aid in aspiration of cut tissue through the inner lumen.
20. A spinal disc preparation tool, comprising:
an elongate shaft having an inner lumen extending therethrough along a longitudinal axis between proximal and distal ends thereof;
a lower jaw disposed on the distal end of the elongate shaft;
an actuator shaft extending along an external surface of the elongate shaft and coupled to an upper jaw for pivoting the upper jaw relative to the lower jaw, the upper jaw being movable relative to the lower jaw to cut tissue therebetween and deliver tissue to the inner lumen of the elongate shaft; and
a handle coupled to a proximal end of the actuator shaft, the handle having formed therein an aspiration hole in fluid communication with the inner lumen;
wherein the aspiration hole is positioned such that the aspiration hole is blocked by a portion of a monolithic actuator handle when the actuator handle is actuated, the actuator handle being pivotally coupled to the actuator shaft; and
wherein at least one of the upper and lower jaws has a proximal portion that is pivotally coupled to the elongate shaft or to the actuator shaft, and a distal portion that is removably and replaceably coupled to the proximal portion, the distal portion having a cutting blade formed thereon.
2. The tool of claim 1, wherein the upper and lower jaws define a tissue receiving cavity having a maximum cross-sectional area taken transverse to the longitudinal axis that is less than a cross-sectional area of the inner lumen of the elongate shaft taken transverse to the longitudinal axis at a distal opening of the inner lumen, the cross-sectional area of the tissue-receiving cavity being about 50% less than the cross-sectional area of the inner lumen at the distal opening of the inner lumen.
3. The tool of claim 2, wherein the inner lumen has a cross-sectional area taken transverse to the longitudinal axis that increases from the distal opening to a proximal end of the inner lumen.
4. The tool of claim 3, wherein the cross-sectional area at the proximal end of the inner lumen is about twice the cross-sectional area at the distal opening of the inner lumen.
5. The tool of claim 1, wherein at least one of the upper jaw and lower jaw include an inner surface having a coating for aiding in aspiration of cut tissue through the inner lumen.
6. The tool of claim 5, wherein the coating is hydrophilic and provides a lubricated surface within at least one of the upper jaw and lower jaw.
7. The tool of claim 5, wherein the coating is hydrophobic such that the coating repels fluid and prevents adhesion of cut tissue to the upper jaw and lower jaw.
8. The tool of claim 1, wherein the actuator shaft extends along an external surface of the elongate shaft.
9. The tool of claim 1, further comprising a tissue collection housing coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen, the tissue collection housing having a tissue collector disposed therein and configured to separate cut tissue from fluid.
10. The tool of claim 1, further comprising at least one bone cutting element formed on at least one of the upper and lower jaws.
11. The tool of claim 1, further comprising a cutting septum formed in the upper jaw and configured to cut and separate cut tissue into two portions.
12. The tool of claim 1, wherein the elongate shaft includes an articulating joint formed therein for allowing angular articulation of the distal end of the shaft.
13. The tool of claim 1, wherein at least one of the upper and lower jaws has a first portion that is pivotally coupled to the elongate shaft or to the actuator shaft, and a second portion that is removably and replaceably coupled to the first portion, the second portion having a cutting blade formed thereon.
14. The tool of claim 1, wherein the upper jaw has a width that is equal to or greater than a width of the lower jaw.
15. The tool of claim 1, further comprising a tissue collection housing coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen, the tissue collection housing having a tissue collecting module disposed therein and effective to collect tissue cut by the upper and lower jaws, the tissue collection housing including indicia to measure the amount of cut tissue.
16. The tool of claim 1, further comprising a tissue collection housing coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen, the tissue collection housing having a tissue collecting module disposed therein and effective to collect tissue cut by the upper and lower jaws, the tissue collecting module comprising a mesh bag configured to collect cut tissue therein.
17. The tool of claim 1, further comprising a tissue collection housing coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen, the tissue collection housing having a tissue collecting module disposed therein and effective to collect tissue cut by the upper and lower jaws, the tissue collecting module comprising a mesh bag configured to collect cut tissue on an external surface thereof.
18. The tool of claim 1, further comprising a tissue collection housing coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen, the tissue collection housing having a tissue collecting module disposed therein and effective to collect tissue cut by the upper and lower jaws, the tissue collection housing being removably coupled to the elongate shaft.
19. The tool of claim 1, further comprising at least one tissue cutting surface feature formed on at least one of the upper and lower jaws.
21. The tool of claim 20, wherein the distal portion comprises a removable hood having the cutting blade formed thereon for cutting tissue.
22. The tool of claim 20, wherein the distal portion comprises a removable insert having the cutting blade formed thereon for cutting tissue.
23. The tool of claim 20, wherein the proximal portion includes a mating element formed thereon for mating with a complementary mating element formed on the distal portion.
0. 24. The tool of claim 1, wherein the upper jaw includes a single aspiration hole formed in a middle portion thereof and wherein the lower jaw includes a first aspiration hole formed in a distal portion thereof and a second aspiration hole formed in a proximal portion thereof.
0. 27. The tool of claim 26, wherein the projection is formed at a terminal, distal-most end of the tool.
0. 28. The tool of claim 26, wherein the projection is adjacent to an inlet of the inner lumen.
0. 29. The tool of claim 26, further comprising a vacuum coupled to a proximal end of the elongate shaft to aspirate tissue through the inner lumen.
0. 30. The tool of claim 26, further comprising a tissue collector coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen.
0. 31. The tool of claim 26, wherein the elongate shaft includes a bent portion at the distal end thereof.
0. 32. The tool of claim 26, wherein at least a portion of the projection extends proximally towards the inner lumen.
0. 34. The tool of claim 33, further comprising an upper jaw pivotally coupled to the elongate shaft.
0. 35. The tool of claim 33, wherein the projection is formed at a terminal, distal-most end of the lower jaw.
0. 36. The tool of claim 33, wherein the projection is adjacent to an inlet of the inner lumen.
0. 37. The tool of claim 33, further comprising a vacuum coupled to a proximal end of the elongate shaft to aspirate tissue through the inner lumen.
0. 38. The tool of claim 33, further comprising a tissue collector coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen.
0. 39. The tool of claim 33, wherein the distal end of the elongate shaft is arced.
0. 40. The tool of claim 33, wherein at least a portion of the projection extends proximally towards the inner lumen.
0. 42. The tool of claim 41, wherein the narrowed tip is formed in an upper jaw pivotally coupled to the elongate shaft.
0. 43. The tool of claim 41, wherein the narrowed tip is adjacent to an inlet of the inner lumen.
0. 44. The tool of claim 41, further comprising a vacuum coupled to the proximal end of the elongate shaft to aspirate tissue through the inner lumen.
0. 45. The tool of claim 41, further comprising a tissue collector coupled to the proximal end of the elongate shaft and in fluid communication with the inner lumen.
0. 46. The tool of claim 41, wherein the distal end of the elongate shaft is curved.

As shown in FIG. 16B, the upper jaw 16 can include a tip 61.

In yet another exemplary embodiment, either or both of the upper and lower jaws 16, 18 can include a coating, laminate, sheath, or other covering formed on an inner surface thereof for aiding in the aspiration of cut tissue through the inner lumen. The coating can be formed from a variety of materials, including but not limited to hydrophilic coatings to lubricate the upper and/or lower jaws 16, 18 and hydrophobic coatings such that the coating repels fluid and prevents adhesion of the cut tissue to the inner surface of the upper and/or lower jaws 16, 18. A person skilled in the art will appreciate that any coating, laminate, or sheath can suffice that can facilitate movement of the cut tissue out of the upper and lower jaws 16, 18 and into the inner lumen of the elongate shaft 12. A person skilled in the art will also appreciate that any of the aspiration aides described above can be used in any combination to aid in the aspiration of cut tissue into and through the inner lumen of the elongate shaft 12.

The upper and lower jaws 16, 18 can also include tissue cutting surface features that can be configured to prepare a vertebral endplate for insertion of an implant between adjacent vertebrae after the removal of the cut tissue. For example, the tissue cutting surface features can be configured to remove tissue along a surface of a vertebral endplate, or they can be adapted to cut into the surface of the vertebral endplate. The tissue cutting surface features can be formed on either or both of the upper and lower jaws 16, 18 and on any location of the jaws 16, 18 in order to facilitate preparation of the endplate. The tissue cutting surface features can also have a variety of configurations. In one exemplary embodiment shown in FIGS. 16A-16B, the tissue cutting surface features are in the form of a rasp 60. The rasp 60 can include a plurality of teeth adapted to remove tissue and cut into the surface of the vertebral endplate. The rasp 60 can include any number of teeth, and the teeth can be formed on any location of the lower jaw 18, although in the illustrated embodiment the teeth are formed on an exterior lower surface thereof. In another exemplary embodiment shown in FIGS. 17A-17B, the tissue cutting surface features are in the form of a curette 64 formed on an exterior surface of the lower jaw 18. The curette 64 is in the form of a cylindrical protrusion 66 formed on the lower jaw 18 that is adapted to cut and/or scrape tissue from vertebral endplates. The protrusion 66 can include an opening 68 therethrough that is in fluid communication with the tissue-receiving cavity formed by the upper and lower jaws 16, 18 to allow the tissue that is cut and/or scraped from the endplate to be aspirated through the tissue-receiving cavity and into the inner lumen of the elongate shaft 12. In another exemplary embodiment, the tissue cutting surface features can be in the form of a protrusion formed on an exterior surface of the lower jaw 18 and adapted to push or pull tissue on the vertebral endplate depending on the shape and angle of the protrusion, as shown in FIGS. 18A-18B. The protrusion 70 is angled away from the distal end of the lower jaw 18 and can thus also scoop the tissue scraped off the vertebral endplate. The upper and lower jaws 16, 18 can also include additional tissue cutting surface features formed at any location thereon. For example, as shown in FIG. 18A, the upper and lower jaws 16, 18 can include one or more 72 edge abraders formed on opposed lateral sides of the upper and lower jaws 16, 18. A person skilled in the art will appreciate that any type of tissue cutting surface features can be formed on the upper and/or lower jaws 16, 18 at any location thereon for preparing vertebral endplates.

In use, the tool 10 can be connected to an aspiration device, for example, by connecting the port 14 to a vacuum that can be activated manually or automatically controlled to aspirate the cut tissue from the tissue-receiving cavity through the inner lumen and out the proximal end of the tool 10. A person skilled in the art will appreciate, however, that the cut tissue can also be passed through the inner lumen without an aspiration device. For example, subsequently cut tissue can push previously cut tissue out of the tissue-receiving cavity and into the inner lumen. The movement of the tissue from the tissue-receiving cavity between the upper and lower jaws through the inner lumen of the elongate shaft can be facilitated by the use of a reduced cross-sectional area in the tissue-receiving cavity, as well as with the additional optional features described above to improve aspiration of the tissue.

The tool 10 can also optionally include features to aid in the collection of the tissue cut by the upper and lower jaws 16, 18. In one exemplary embodiment, the tool 10 can include a tissue collector 50 that can be coupled to the proximal end of the elongate shaft 12 and that can be in fluid communication with the inner lumen of the elongate shaft 12 such that the tissue collector 50 is effective to collect tissue that is cut by the upper and lower jaws 16, 18. The tissue collector 50 can have a variety of configurations, but in one embodiment shown in FIGS. 19A and 20A it can include a housing 52 adapted to couple to the proximal end 12p of the elongate shaft 12. The housing 52 can include an inlet 53 to allow for fluid communication with the inner lumen of the elongate shaft 12, and an outlet 55 to allow for fluid collected in the tissue collector 50 to exit the housing 52. The tissue collector 50 can be coupled to the elongate shaft in a variety of ways. For example, the tissue collector 50 can be removably coupled to the elongate shaft 12, or the tissue collector can be unitary with the elongate shaft 12. While the illustrated embodiment shows a tissue collector 50 configured to couple to the shaft 12 with an in-line configuration, the tissue collector 50 can be located at numerous locations, including separate from the elongate shaft 12 as long as the tissue collector 50 remains in fluid communication with the inner lumen of the elongate shaft 12. In the illustrated embodiment, the tissue collector 50 includes an elongate member 57 that is configured to interlock with an exit port on the inner lumen of the tool 10. The housing 52 can be removably mated to a cap 54 on the elongate member 57 having an o-ring therein. The elongate member 57 can be part of the tool 10, for example, by being formed on the proximal end 12p of the elongate shaft 12, or the elongate member 57 can be a separate component that is removably matable to the elongate shaft 12 and/or the housing 52.

The housing 52 can also include a collecting module 58 disposed therein for collecting the cut tissue and separating the cut tissue from other material, such as fluid, that may pass through the inner lumen of the elongate shaft 12. The collector module 58 can be configured to collect tissue in various configuration. In one exemplary embodiment, the collector module 58 can be configured to collect cut tissue therein, as illustrated in FIGS. 19A and 19B. The collector module 58 can thus be configured to be in fluid communication with the inner lumen of the elongate shaft to allow the tissue to travel through the inner lumen and into the collector module 58 through the open end of the collector module 52. The fluid can pass from the collector module 58 into the housing 52 to separate the fluid from the cut tissue, and can exit the housing 52 through the outlet. In another exemplary embodiment, a collector module 58′ can be configured to collect tissue on an external surface thereof, as illustrated in FIGS. 20A and 20B. The collector module 58′ can thus be configured such that the housing 52 is in fluid communication with the inner lumen of the elongate shaft 12 and receives cut tissue and fluid therefrom. The tissue will collect on the outside of the collector module 58′ while the fluid will pass from the housing 52 into the collector module 58′ to separate the fluid from the cut tissue, and can then exit the collector module 58′ through the outlet formed in the housing 52. Various techniques can be employed to collect the cut tissue. For example, the cut tissue can be collected by removing it from the outside of the collector module 58′ or the cut tissue can be collected by inverting the collector module 58′ to contain the cut tissue therein.

The collecting module 58 can have any shape and size adapted to fit inside the housing 52 and collect tissue, and it can be made from any material that facilitates collection of the cut tissue while allowing any fluid to be separated therefrom. For example, the collecting module 58 can be in the form of a mesh bag having an open end with the mesh including holes therein that are sized and shaped to allow fluid but not the cut tissue to pass therethrough. In order to increase the surface area of the collecting module 58 to increase the amount of tissue that can be collected therein or thereon, the collecting module 58 can have a variety of cross-sectional shapes. FIGS. 21-22 illustrate various examples of cross sections of the collecting module 58 that can be used to increase the surface area across which fluid can flow, including an angled cross section shown in FIG. 21, or a star-shaped cross-section shown in FIG. 22. A person skilled in the art will appreciate that the collecting module can have any cross section that can facilitate passage of fluid therethrough, including but not limited to pleats or flutes.

The collecting modules 58 and 58′ can also include features adapted to measure the amount of cut tissue collected therein. For example, the collecting modules 58 can include indicia for measuring the amount of tissue collected therein, as shown in FIG. 19B, or for measuring the amount of tissue collected on an external surface of the collecting module 58′, as shown in FIG. 20B.

The present invention also provides methods for cutting tissue. In one exemplary embodiment, the distal end of the elongate shaft 12 of the tool 10 can be inserted into the disc space between adjacent vertebrae for cutting the tissue therebetween, for example, a spinal disc which can be removed to be replaced with a spinal disc implant. The distal end of the elongate shaft can be positioned adjacent to the tissue to be cut such that the upper and lower jaws 16, 18 are placed adjacent the tissue. A distal portion of the elongate shaft 12 can also be articulated to help facilitate positioning of the upper and lower jaws 16, 18 relative to the tissue. The actuator 22 pivotally coupled to the handle 20 of the tool 10 can be actuated to cause the upper jaw 16 to move and pivot relative to the lower jaw 18 to cut tissue therebetween. Either using an aspiration device coupled to the tool 10, the force of previously cut tissue pushing subsequently cut tissue, or both, the cut tissue is moved from the tissue-receiving cavity formed between the upper and lower jaws 16, 18 into the inner lumen of the elongate shaft 12. The cut tissue moves proximally through the inner lumen until it either exits the proximal end of the tool 10 or is collected in the tissue collector 50 associated with a proximal end of the elongate shaft 12 and in fluid communication with the inner lumen. The cut tissue can be collected either inside or on the outside of the collector module housed inside the housing of the tissue collector, and can be measured if the collector module includes indicia thereon. As the tissue is being cut and removed, for example from the disc space between adjacent vertebrae, one or more tissue cutting surface features formed on the upper and/or lower jaws 16, 18 can be utilized to cut the vertebral endplates or scrape tissue therefrom to prepare the endplates for insertion of a spinal disc implant into the disc space between the adjacent vertebrae.

One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Hawkins, John Riley, Upal, Anwar M., O'Neil, Michael, Slivka, Michael A., Serhan, Hassan A., Tannoury, Tony

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