TARGET IDENTIFICATION TOOL FOR INTRA-BODY LOCALIZATION

Abstract

A marker device that aids in the subsequent identification of a particular area is equipped with an anchoring device that prevents migration once placed in the tissue of that particular area. The device may include a chemical agent or drug that adds a therapeutic function to the marker device.

Claims

1. (canceled)

2. An identification device, comprising: a body portion configured to mark a location in a patient's body; and an anchoring portion coupled to an outer surface of the body portion and disposed axially around a longitudinal axis defined by the body portion, the anchoring portion having a plurality of sharpened portions extending in a first direction and configured to be inserted into tissue upon movement of the body portion in the first direction to removably anchor the body portion to the tissue.

3. The identification device according to claim 2, wherein the anchoring portion comprises a plurality of rings encircling the body portion and longitudinally spaced from each other along the longitudinal axis.

4. The identification device according to claim 3, wherein each of the plurality of sharpened portions of one of the plurality of rings is collinear with a respective one of the plurality of sharpened portions of another of the plurality of rings along the longitudinal axis defined by the body portion.

5. The identification device according to claim 2, wherein the body portion extends between a closed proximal end and a closed distal end.

6. The identification device according to claim 2, wherein the body portion extends between a rounded proximal end and a rounded distal end.

7. The identification device according to claim 2, wherein the plurality of sharpened portions are evenly spaced around the longitudinal axis defined by the body portion.

8. The identification device according to claim 2, wherein the plurality of sharpened portions are tapered in the first direction and terminate in a sharpened tip configured to pierce tissue.

9. The identification device according to claim 8, wherein the sharpened tips of the plurality of sharpened portions are disposed proximal to a distal end of the body portion.

10. The identification device according to claim 2, wherein the plurality of sharpened portions are flexible.

11. The identification device according to claim 2, wherein the body portion includes an energy source configured to emit energy selected from the group consisting of light, heat, radiation, electromagnetic, and sound.

12. An identification device, comprising: a body portion configured to mark a location in a patient's body and defining a longitudinal axis; a plurality of rings coupled to an outer surface of the body portion and disposed axially around the longitudinal axis defined by the body portion; and a plurality of sharpened barbs extending distally from each of the plurality of rings parallel to the longitudinal axis defined by the body portion, the plurality of sharpened barbs configured to be inserted into tissue upon movement of the body portion in a proximal to distal direction to removably anchor the body portion to the tissue.

13. The identification device according to claim 12, wherein each of the plurality of sharpened barbs of one of the plurality of rings is collinear with a respective one of the plurality of sharpened barbs of another of the plurality of rings along the longitudinal axis defined by the body portion.

14. The identification device according to claim 12, wherein the body portion includes an energy source configured to emit energy selected from the group consisting of light, heat, radiation, electromagnetic, sound, and cryo.

15. The identification device according to claim 12, wherein the body portion extends between a closed proximal end and a closed distal end.

16. The identification device according to claim 12, wherein the plurality of sharpened barbs are evenly spaced around the longitudinal axis defined by the body portion.

17. The identification device according to claim 13, wherein the plurality of sharpened barbs are tapered in the distal direction and terminate in a sharpened tip configured to pierce tissue.

18. The identification device according to claim 13, wherein the plurality of sharpened barbs are flexible.

19. An identification device, comprising: at least one ring having a plurality barbs extending distally therefrom; and a body portion configured to mark a location in a patient's body, the body portion disposed axially through the at least one ring and having an outer surface coupled to an inner surface of the at least one ring, the plurality of barbs extending parallel to a longitudinal axis defined by the body portion, wherein movement of the body portion in a proximal to distal direction advances at least one of the plurality of barbs into tissue to removably anchor the body portion to the tissue.

20. The device according to claim 19, wherein the at least one ring comprises a plurality of rings longitudinally spaced from each other along the longitudinal axis defined by the body portion.

21. The device of claim 19, wherein the plurality of barbs include a sharpened distal tip disposed proximal to a distal end of the body portion.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG. 1 is a side view of an embodiment of the device of present invention;

[0023] FIG. 1a is a side view of an embodiment of the device of the present invention;

[0024] FIG. 2 is a side view of the embodiment of the device of FIG. 1 implanted into body tissue;

[0025] FIG. 3 is a perspective view of an embodiment of the device of the present invention;

[0026] FIG. 4 is a perspective view of the embodiment of the device of FIG. 3 implanted into body tissue;

[0027] FIG. 5 is a perspective view of an embodiment of the device of the present invention;

[0028] FIG. 6 is a perspective view of the embodiment of the device of FIG. 5 implanted into body tissue;

[0029] FIG. 7 is a perspective view of an embodiment of the device of the present invention;

[0030] FIG. 8 is an end view of the embodiment of the device of FIG. 7 of the present invention;

[0031] FIG. 9 is a side view of an embodiment of the device of the present invention;

[0032] FIG. 10 is an end view of the embodiment of the device of FIG. 9;

[0033] FIG. 11 is a perspective view of an embodiment of the device of the present invention being injected into body tissue;

[0034] FIG. 12 is a side view of the embodiment of the device of FIG. 11 implanted in tissue;

[0035] FIG. 13 is a side elevation of an embodiment of the device of the present invention; and,

[0036] FIGS. 14 and 15 are side elevations of the device of FIG. 13 being implanted into tissue.

DETAILED DESCRIPTION

[0037] In general, the present invention includes an identification or therapeutic device comprising a body portion and an anchoring portion, which is introducible into an intra-body structure (e.g., a mass or lesion) and/or an anatomical space to mark a location of interest (e.g., a tissue layer and/or lumen of a body cavity). The identification device of the present invention may include a power source, either external to the body or internally at or near the body portion or some combination thereof. It is understood that any of the various anchoring portions described below may be used with any of the body portions. It is also understood that the body portions may give off energy, such as light energy (i.e. glow-in-the-dark materials, LEDs, incandescent devices, etc.), thermal energy, radiation, RF energy, acoustic energy, or cryoenergy.

[0038] Furthermore, the various embodiments of the body portions may be constructed of various application-specific materials. For example, the body portions may be loaded with chemicals or dyes that enhance localization. Non-limiting examples include: BaSO4, bismuth, copper, gold, and platinum. Also, the body portions could be loaded with drugs and/or chemotherapy agents for treatment and have features such as controlled elution and diffusion rates. Non-limiting examples of these agents include antineoplastics, antiobiotics and others.

[0039] One embodiment of the present invention is shown in FIGS. 1, 1a, and 2 which illustrate an identification or therapeutic device 10, including a body portion 12 and anchoring portion 14. The body portion 12 may be any energy source or simply a marker or a focusing element for RF energy, as described above. If an energy source is used, it is understood that appropriate additional equipment will be used in order to receive and identify the energy being transmitted. The body portion 12 may also comprise a hollow body in the event that the device 10 is implanted in an airway.

[0040] The anchoring portion 14 is shaped and oriented to render it introducible into or adjacent to an intra-body structure. The anchoring portion 14, may also include hooks or barbs 15, to improve the anchoring ability of the anchoring portion 14. Preferably, the barbs 15 are small enough to allow removal with minimal tissue damage. As shown in FIG. 2, the anchoring portion of the identification or therapeutic device 10 is inserted into an intra-body structure (e.g., a tissue layer) 16. The anchoring portion 14 leaves the body portion 12 oriented adjacent to the tissue layer 16, providing fixed, yet removable illumination or therapy. (Illumination is being used in a general sense to include acoustic energy, radioactive energy, electromagnetic energy or other form of energy and should not be construed as being limited to casting visible light on a subject.) In this illustration of the embodiment, the device 10 may be pulled out of the tissue layer and removed from the body or the tissue may be excised with the identification device 10 still affixed thereto.

[0041] Another embodiment of the present invention is shown in FIG. 3, in which an identification or therapeutic device 20 includes a body portion 12 and at least one anchoring mechanism 24. The anchoring portion 24 is one or more barbed rings encircling the device 20. The barbs on the rings may be evenly spaced around the device 20, thereby providing ease of implantation as orientation-specific deployment is not necessary. Preferably, the barbs are strong enough to penetrate tissue yet flexible enough to lay flat in a deployment catheter. If the device 20 is intended to be non-permanent, the barbs should be short and flexible enough to allow removal without excessive tissue damage. FIG. 4 illustrates the device 20 inserted into an adjacent tissue layer 26 via the at least one anchoring mechanism 24.

[0042] Yet another embodiment of the present invention is shown in FIG. 5, in which an identification or therapeutic device 30 includes a body portion 12 and an anchoring portion 34. The anchoring portion 34 includes, for example, a mesh and/or tissue adhesive affixed on at least a portion of the surface of the body portion 12. The mesh may be bioreactive. The anchoring portion 34 adheres to a tissue layer 36. The anchoring portion 34 is large enough to connect with the tissue layer 36, such that it will remain attached until some amount of applied force is used to remove the identification device 30 from the tissue layer 36. FIG. 6 illustrates the identification device 30 affixed to a tissue layer 36.

[0043] Another embodiment of the present invention is shown in FIGS. 7 and 8, in which an identification or therapeutic device 40 includes a body portion 12 and an anchoring portion 44. In this embodiment, the anchoring portion 44 is disposed within a body lumen and may or may not penetrate the surrounding tissue layer 46. One example of the anchoring portion 44 contemplated for use in this embodiment of the invention would include a coil or stent 44 with a body portion 12 attached to an inside surface of the stent 44. The anchoring portion 44 expands, either via balloon or self-expanding design, to fit the surrounding tissue layer 46. The anchoring portion 44 is deliverable by any known or unknown methods. For example, the anchoring portion 44 may be collapsed to fit in or around a delivery catheter (not shown) and delivered and expanded in a desire location.

[0044] Another embodiment of the present invention is shown in FIGS. 9 and 10, in which an identification or therapeutic device 50 includes a body portion 12 and an anchoring portion 54. In this embodiment, the anchoring portion 52 is a staple that connects the device 50 to a tissue layer 56. Removal of the identification device 50 may occur via excision of all or part of the surrounding tissue layer 56.

[0045] The identification devices described above may be introduced and placed into the body by various delivery devices and methods. Such delivery devices and methods may include, alone or in combination, use of catheters, guiding catheters, guide wires, stents, balloons, needles, bronchoscopy procedures and tools and/or the superDimension localization system, as described in U.S. patent application Ser. No. 11/571,796 filed on Jan. 8, 2007, which is incorporated by reference herein in its entirety. In particular, such deliveries may be made into branches of the lungs, blood vessels and other points of interest (body cavities, lumens).

[0046] For example, one embodiment of a device 60 of the present invention that is injected into tissue is shown in FIGS. 11 and 12. The identification device 60 includes a body portion 12 that is injected into a tissue layer 64. The surrounding tissue layer 64 may effectively hold the identification device 60 in place. However, an additional anchoring portion may be added, such as any of the above described anchoring portions or merely a rough surface to prevent migration. FIG. 11 illustrates a needle 66 containing an identification or therapeutic device 60 prior to delivery into a tissue layer 64. FIG. 12 illustrates the placement of the identification device 60 within the tissue layer 64, post-injection.

[0047] FIGS. 13-15 illustrate an embodiment of a device 70 of the present invention that is specifically designed to be injected into tissue. The device includes a capsule 74 surrounding the body portion 72 to allow the device 70 to be smoothly injected into tissue 78. Once in contact with the tissue, the capsule 74 quickly dissolves, allowing the tissue 78 to close in around the body portion 72. Preferably, the body portion 72 includes one or more anchoring features 76, such as ridges, spikes, rough surfaces, barbs, or other shapes or mechanisms that would prevent the device 70 from migrating.

[0048] The capsule 74 is smooth such that minimal tissue trauma occurs during insertion. The capsule may be constructed, for example, of a quickly dissolving material such as many water-soluble polymers.

[0049] Another embodiment of the present invention includes a device that is specifically designed to be injected into the target location for external localization. The entire device may be dissolvable or biodegradable thus eliminating the necessity for removal. The biodegradable material may be impregnated with a material such as metallic particles specifically selected to for image-guidance. The rate of degradation could be dependent on a known therapeutic dose to control or affect the targeted disease tissue. Examples of some biodegradable polymers polymers include, but are not limited to: PEVA poly(ethyl-vinyl-acetate), PBMA poly(butyl-methylacrylate), PLGA poly(lactic-glycolic acid), PLA (Polylactide), PLGA/PLA combination, HA (hydroxyapetite), PLGA-PEG (polyethylene glycol), Tyrosine derivatives, Polyanhydrides, Polyorthoesters, PBMA, DLPLApoly(dl-lactide), LPLApoly(l-lactide), PGApolyglycolide, PDOpoly(dioxanone), PGA-TMCpoly(glycolide-co-trimethylene carbonate), PGA-LPLApoly(l-lactide-co-glycolide), PGA-DLPLApoly(dl-lactide-co-glycolide), LPLA-DLPLApoly(l-lactide-co-dl-lactide), PDO-PGA-TMCpoly(glycolide-co-trimethylene carbonate-co-dioxanone). Examples of metallic or other image-guidance materials include but are not limited to: radiopaque dyes or contrast agents such as BaSO4 or Ominpaque, metallic particles such as copper or gold particles.

[0050] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention.

[0051] For example, the above-described needle and syringe or plunger arrangement could be used to deliver an identification or therapeutic device internally, injecting said tool directly into a tissue layer from within the body cavity. Alternatively, a needle of sufficient construction both to penetrate the chest cavity (e.g., between the ribs of a patient) and accommodate the dimensions of an identification or therapeutic device such that can be injected from outside a patient's body into a desired location (e.g., directly into surrounding tissues near a body cavity; into a fibroid or tumor that is intended to be excised from the body; etc).

[0052] The identification device could be delivered via a bronchoscope having a catheter attached therethrough which is advanced through the lungs of a patient to a point of interest. The catheter will be equipped to push the identification device into a lumen of a body cavity near a tissue layer or into a tissue layer.

[0053] Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.