TISSUE SPECIMEN ISOLATING AND DAMAGING DEVICE AND METHOD

Abstract

A device and method for treatment of a tissue specimen disposed in surrounding tissue has a tissue specimen isolating toot and a tissue specimen damager. The tissue specimen isolating tool isolates the tissue specimen from the surrounding tissue. The tissue specimen damager damages the tissue, with a possible end result being necrosis. The severing tool may have a cutting member that is extendable to an outwardly radially bowed position about device. The tissue specimen is isolated by rotating the cutting member about the tissue specimen. The cutting member may be functionally connected to a cutting member radio frequency generation source. The tissue specimen damager may damage the tissue specimen using ionizing radiation, cutting devices, thermal treatment devices, chemical treatment devices, or sealing an outer boundary of the tissue specimen.

Claims

1-18. (canceled)

19. A tissue collection apparatus for collecting a tissue specimen, comprising: a separating device configured to separate the tissue specimen from surrounding tissue; a plurality of tissue specimen damaging elements configured to engage and damage the separated tissue specimen, and configured for operation independent from the separating device; and an encapsulating device configured to encapsulate the separated and damaged tissue specimen, the encapsulating device configured for operation independent from the separating device and the plurality of tissue specimen damaging elements.

20. The tissue collection apparatus of claim 19, further comprising a radiofrequency generator coupled to the plurality of tissue specimen damaging elements.

21. The tissue collection apparatus of claim 20, comprising a wand to which the plurality of tissue specimen damaging elements is coupled, each tissue specimen damaging element of the plurality of tissue specimen damaging elements being a wire having a free end, the free end oriented to extend at an acute angle with respect to a longitudinal extent of the wand when the wire is in the extended position.

22. The tissue collection apparatus of claim 21, wherein the wand is configured to move the plurality of tissue specimen damaging elements from a retracted position to an extended position so as to enter the separated tissue specimen.

23. The tissue collection apparatus of claim 20, wherein the plurality of tissue specimen damaging elements is a plurality of wires, and the radiofrequency generator configured to apply radiofrequency energy to each wire of the plurality of wires.

24. The tissue collection apparatus of claim 23, wherein each wire of the plurality of wires has a free end.

25. The tissue collection apparatus of claim 23, wherein each wire of the plurality of wires has a free end that is extendable from a retracted position to an extended position to engage the separated tissue specimen.

26. The tissue collection apparatus of claim 20, wherein the plurality of tissue specimen damaging elements extend outwardly from a wand when in an extended position, and are retracted into the wand when in a retracted position.

27. The tissue collection apparatus of claim 19, wherein: the separating device includes a wand and a radially bowed wire having a proximal end and a distal end, and each of the proximal end and the distal end being coupled to the wand, the separating device configured for rotation to create a periphery channel that is formed between the tissue specimen and the surrounding tissue; and the plurality of tissue specimen damaging elements are extendable outwardly from the wand to an extended position located within an interior region defined by the periphery channel.

28. The tissue collection apparatus of claim 27, wherein the wand is configured to retract the plurality of tissue specimen damaging elements into the wand to a retracted position.

29. The tissue collection apparatus of claim 27, further comprising a radiofrequency generator coupled to the radially bowed wire and to the plurality of tissue specimen damaging elements.

30. The tissue collection apparatus of claim 28, wherein each tissue specimen damaging element of the plurality of tissue specimen damaging elements is a wire having a free end, the free end oriented to extend at an acute angle with respect to a longitudinal extent of the wand when the wire is in the extended position.

31. A tissue collection apparatus for collecting a tissue specimen, comprising: a separating device configured to separate the tissue specimen from surrounding tissue; a plurality of electrical tissue specimen damaging elements configured to engage and damage the separated tissue specimen, and configured for operation independent from the separating device; an electrical source electrically coupled to each of the separating device and the plurality of electrical tissue specimen damaging elements; and an encapsulating device configured to encapsulate the separated and damaged tissue specimen, the encapsulating device configured for operation independent from the separating device and the plurality of electrical tissue specimen damaging elements.

32. The tissue collection apparatus of claim 31, wherein the electrical source is a radiofrequency generator.

33. The tissue collection apparatus of claim 31, comprising a wand to which the plurality of electrical tissue specimen damaging elements is coupled, wherein the plurality of electrical tissue specimen damaging elements extend outwardly from the wand when in an extended position, and are retracted into the wand when in a retracted position.

34. The tissue collection apparatus of claim 33, wherein the wand is configured to move the electrical tissue specimen damaging elements from the retracted position to the extended position so as to enter the tissue specimen.

35. The tissue collection apparatus of claim 33, wherein each tissue specimen damaging element of the plurality of tissue specimen damaging elements is a wire having a free end, the free end oriented to extend at an acute angle with respect to a longitudinal extent of the wand when the wire is in the extended position.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 shows a side view tissue specimen isolating and damaging device using radio frequency energized wires according to an embodiment of the invention;

[0022] FIG. 2 shows a sectional view of the device of FIG. 1 in a breast after isolation of the tissue specimen and prior damaging the tissue specimen;

[0023] FIG. 3 shows the same sectional view as does FIG. 2 but after damaging the tissue specimen by thermal treatment;

[0024] FIG. 4 is a nonexclusive chart of treatment methods for damaging the tissue specimen according to embodiments of the invention; and

[0025] FIGS. 5-8 are side views of tissue specimen isolating and damaging devices according to various embodiments of the invention.

[0026] FIGS. 9 and 10 show tissue specimen encapsulation devices which may be used in conjunction with the invention.

[0027] FIG. 11 is a sectional radial view of the device shown in FIGS. 9 and 10 in a target body with the sheath deployment members being partially deployed in a periphery margin surrounding the tissue specimen.

[0028] FIG. 12 is a perspective view of the device of FIGS. 9 and 10 shown without an outer sleeve and with sheath deployment members and a cutting member bowed radially outward.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Referring now to the figures, and specifically to FIG. 1, a tissue specimen isolating and damaging device 10 comprises a wand 12 having a proximal end 14 shown to the right and a distal end 16 shown to the left. The device 10 is used to isolate a tissue specimen while the tissue specimen is disposed in surrounding tissue and then damage the tissue specimen (see FIGS. 2 and 3). The isolation step may encompass isolating the tissue specimen from circulation and/or may encompass generally severing of the tissue specimen from the surrounding tissue. After the damaging step, the tissue specimen may remain in the body, turn into fibrotic tissue, and/or be removed from the body during the process or at a later time.

[0030] While isolating the tissue specimen may result in necrosis, the device 10 damages the tissue specimen to insure necrosis occurs. The necrosis of the tissue specimen results in reducing or eliminating the transfer of malignant or diseased tissue from the tissue specimen. The necrosis of the tissue specimen also dissuades the patient's body from repairing the tissue specimen. The shown embodiment of the invention utilizes a radio frequency generator 18 to perform the procedure. Other embodiments of the invention may use other methods, examples of which are non-exclusively discussed below.

[0031] Located at the distal end 16 of the wand 12 is an operational portion 20 of the device 10. The operational portion 20 is involved with both isolating and damaging the tissue specimen. In the shown embodiment, an outwardly radially bowed wire 22 isolates the tissue specimen. The wire 22 is disposed at the operational portion 20 and rotationally connected to the wand 12. In the shown embodiment of the invention, the wire 22 is initially in a retracted position against the wand 12 (not shown) to reduce trauma to surrounding tissue during placement of the device 10. The wire 22 is extended outward radially after the operational portion 20 is disposed in or proximate to the tissue specimen.

[0032] The wire 22, which is a tissue specimen isolating tool of the device 10, is powered by the radio frequency generator 18 and rotated to isolate the tissue specimen. As the wire 22 is rotated, a periphery channel (see FIG. 2) is formed between the tissue specimen and the surrounding tissue, thus severing the two. Other embodiments of the invention may have the wire 22 be fixedly and not rotatably connected to the wand 12, thus the whole wand is rotated to isolate the tissue specimen and not just the bowed wire 22.

[0033] Embodiments of the invention may comprise other tissue specimen isolating tools with cutting members, such as is disclosed in commonly assigned U.S. patent applications to Burbank et al. entitled Breast Biopsy System and Method, U.S. patent application Ser. No. 09/057,303 and Tissue Specimen Encapsulation Device and Method Thereof, U.S. patent application Ser. No. 09/208,535, both of which are herein incorporated by reference in their entireties. Embodiments of the invention may only partially sever the tissue specimen from the surrounding tissue.

[0034] At the distal end 16 is a radio frequency wire 24 that is energized during the step of inserting the wand 12 into the surrounding tissue. Other embodiments may have other means for inserting the wand into the surrounding tissue, such as a nonenergized piercing tool or some other form of energized piercing tool. Still other embodiments of the invention may not have a piercing tool at the distal end 16, but rather enter the surrounding tissue through a pre-existing passage.

[0035] In the shown embodiment, the tissue specimen is ablated or otherwise damaged after isolation (see FIG. 3). The damaging of the tissue sample results in necrosis. The damage may be caused by ionizing radiation that disrupts cellular functions. The tissue specimen may be damaged through mechanical means, such as cutting or otherwise morcellating the tissue specimen. Tissue specimen damage may be the result of thermal or chemical treatment.

[0036] Continuing to refer to FIG. 1, radio frequency wires 28 that extend from the operational portion 20 of the device 10 are used to damage the tissue specimen. The wires 28 are initially in a retracted position in wand 12 or disposed on the wand 12. Either before, during, or after the isolation of the tissue specimen, the wires 28 are extended as shown and enter the tissue specimen. In a preferred embodiment of the invention, the wires 28 are disposed in the wand 12 and are extended prior to isolation of the tissue specimen. The extended wires 28 anchor the device 10 in the tissue specimen, resulting in a more precise isolation of the specimen. Other embodiments of the invention may have other methods or mechanisms for anchoring, the device 10 in the tissue specimen.

[0037] The radio frequency wires 28, which comprise the tissue specimen damager of device 10, are shown extending toward the distal end 16 of the wand 12. Other embodiments of the invention may have wires 28 extending in any suitable direction. The wires 28 are shown extending almost to the radially bowed wire 22, resulting in the wires 28 being distributed throughout the tissue specimen. Other embodiments of the invention may have the wires 28 extending into a portion of the tissue specimen.

[0038] When energized, the radio frequency wires 29 damage the tissue specimen by causing the water molecules in the tissue specimen to vibrate and rapidly vaporize. The rapid vaporization results in the destruction of cells in the tissue specimen, thus damaging the specimen. The rapid vaporization is a form of thermal treatment. The radio frequency wires may be mono- or bi-polar.

[0039] After treatment, the wires 28 may be retracted into the wand 12. Other embodiments of the invention may not have the wires 28 being retracted, but rather the wires 28 remain extended and slide out of the tissue specimen during removal of the wand 12 from the surrounding tissue. The distally leaning wires 28 facilitate their sliding out of the tissue specimen during wand removal.

[0040] The severing and isolation of the tissue specimen results in a more controlled and simpler process to damage the specimen. In the case of thermal treatment, a non-isolated tissue specimen is cooled or heated by blood circulating through the specimen. The thermal treatment of an isolated tissue specimen is not competing with the cooling or heating effects of blood circulation. Without competing with the effects of blood circulation through the specimen, the thermal treatment is shorter and more restricted to the immediate tissue specimen. Further, the isolation reduces thermal damage to the surrounding tissue.

[0041] Functionally connected to the proximal end 14 of the wand 12 is a control system 30. In the shown embodiment, the control system 30 manipulates the cutting wire 22 and the radio frequency wires 28. In some embodiments of the invention, the control system 30 may control the insertion and removal of the wand 12 from the tissue specimen and the surrounding tissue. The control system 30 is functionally connected to the radio frequency generator 18 that supplies energy to the wires 22 and 28. In the embodiments of the invention in which the radially bowed wire 22 is in a fixed position on the wand 12, the control system 30 rotates the wand 12 to isolate the tissue specimen. In other embodiments of the invention, the components of the device are manipulated by hand.

[0042] Referring now to FIG. 2, the device 10 is shown disposed in a breast 50 with the operational portion 20 being disposed in a tissue specimen 52. In this embodiment, the breast 50 may be considered the surrounding tissue. The tissue specimen 52 contains a tumor 54, which is shown cross-hatched. The cutting wire 22 is shown in the outwardly radially bowed position. The cutting wire 22 has already been rotated, thereby forming a periphery channel 56 and isolating the tissue specimen 52. Note the radio frequency wires 28 are not shown extended in FIG. 2. In a preferred embodiment of the invention, the wires 28 are extended into the tissue specimen 52 prior to isolation.

[0043] Referring now to FIG. 3, the tissue specimen 52 of FIG. 2 has been damaged, resulting in damaged tissue specimen 60 through thermal treatment by the device 10. The radio frequency wires 28 of the device 10 are shown extended into the tissue specimen 60. The wires 28 had been energized, resulting in the vaporization of the water molecules, disruption of the cells of the tissue specimen, heating the specimen, and the ultimate damaging of it. The amount and time of the treatment may be predetermined or the device may comprise a feed back system (not shown) that indicates when the treatment has been completed. In a further step, the device 10 is removed from the breast 50, either without or without retracting the radio frequency wires 28 into the device 10.

[0044] Referring now to FIG. 4, Chart 100 is a non-exclusive list of possible methods for damaging the in vivo tissue specimen besides thermal treatment through radio frequency devices. Listed as forms of thermal treatments 102 are laser, hot fluids, cold fluids, radio frequency energy and other electrosurgery techniques, microwave, focussed ultrasound, mechanical ultrasound, shock waves, resistive heating, cryosurgery using liquid or gas, cauterizing, and the application of a heated object. An example of a heated object is disclosed in U.S. Pat. No. 4,773,413 to Hussein et al. entitled Localized Heat Applying Medical Device, which is incorporated herein by referenced in its entirety. Other embodiments of the invention may use any suitable thermal treatment system to damage the tissue specimen.

[0045] The mechanical treatment list 104 includes morcellators and other cutting devices. The ionizing radiation treatment list 106 includes treatment with x-rays, including x-ray needles, gamma rays, and Brachytherapy seeds, which are forms of ionizing radiation directors. The chemical treatment list 108 includes treatment with ethanol, sotradechol, an acid, a base, various chemical compounds, various chemical mixtures, a catalyst, a sealing agent that seals the outside of the tissue specimen, and a photoreactive chemical that is used in conjunction with a light or laser system. Other embodiments of the invention may use any suitable chemical treatment system to damage the tissue specimen.

[0046] Referring now to FIG. 5, a tissue specimen isolating and damaging device 200 has a laser device 202 at an operational portion 204. The laser device 202 damages a tissue specimen through thermal treatment. The shown embodiment of the invention has two outwardly radially bowed cutting wires 206. Embodiments of the invention may have one or more cutting wires 206 regardless of the treatment to damage the tissue specimen. Note that a cutting tip 210 is located at a distal end 212 of the device 200.

[0047] Referring now to FIG. 6, a tissue specimen isolating, and damaging device 220 has a morcellator 222 at an operational portion 224. The morcellator 222 is used to morcellate a tissue specimen. The tissue specimen may be morcellated after encapsulation of the tissue specimen. Encapsulation of the tissue specimen is disclosed in the previously referenced and incorporated U.S. patent application Ser. No. 09/208,535 entitled Tissue Specimen Encapsulation Device and Method Thereof. The tissue specimen may be encapsulated with non-biodegradable or biodegradable material. Note that there is not a piercing tool on this embodiment of the invention. Other morcellating devices may have a piercing tool. Also note that the cutting wire is in a retracted position and not visible.

[0048] In an embodiment of the invention, the tissue specimen is damaged by encapsulation. The damage is the result of the tissue specimen being physically isolated from the surrounding tissue. In an embodiment of the invention, a sheath may at least partially surround the tissue specimen (not shown). In another embodiment of the invention (not shown), the tissue specimen may be physically isolated by encapsulation accomplished with a chemical that flows into the periphery channel about the tissue specimen and seals specimen's outside surface. Suitable techniques known in the art for ensuring a continuous distribution of the sealing chemical may be employed, such as pressurizing the periphery channel.

[0049] Now referring to FIG. 7, a tissue specimen isolating and damaging device 240 has outlets 242 at the operational portion 244. The outlets 242 permit the flow of a chemical into the tissue specimen, thus transforming the tissue specimen through a chemical reaction or other chemical treatment. The isolation of the tissue specimen reduces the amount of chemicals transferring to the surrounding tissue.

[0050] In other embodiments of the invention, hollow needles may extend from the operational portion 244 such that the chemical may be injected into the tissue specimen through the needles. Other embodiments of the invention may include slicing tools that make slits in the surface of the tissue specimen that is in contact with the wand 246. The slits facilitate infusion of the chemical. The slits may also be made by the cutting wire 248. The cutting wire 248 is rotated and partially extended into the tissue specimen at periodic intervals either before or after the tissue specimen has been isolated.

[0051] Referring now to FIG. 8, a tissue specimen isolating and damaging device 260 cryogenically treats the tissue specimen 262 disposed at the operational portion 264 of the wand 266. A cryogenic fluid is flowed to the operational portion 264 through a feed line 268 and is returned to the control system (not shown) via a return line 270, both of which is disposed in the wand 266. The tissue specimen 262 is frozen and damaged through thermal treatment with the cryogenic fluid.

[0052] Encapsulation of the tissue specimen may be accomplished by use of a tissue specimen encapsulation device as shown in FIG. 9. The figure depicts a tissue specimen encapsulation device 310 which is comprised of a wand assembly 312, a sheath 314, and a guide assembly 316. The wand assembly 312 defines an axis 318, and axial direction 320, and a plurality of radial directions 322. The wand assembly 312 also has a proximal end 324, shown to the left in FIG. 9, and a distal end 326, shown to the right in FIG. 9. A midsection 328 extends between the ends 324 and 326. The proximal end 324 is the end that is held by a user of the device 310. The proximal end 324 may be functionally connected to an actuator system, such as a control box or the equivalent, that manipulates the device 310 per the directions of the user (not shown). The distal end 326 is inserted into a target body (not shown) and proximate to a tissue specimen to be encapsulated by the device. The wand assembly 312 may be rigid or flexible, and may be articulatable so that it may be steered. The wand assembly 312 comprises a shaft core 329, shaft 330, a sheath sleeve 332 and an outer sleeve 334. The shaft core 329, shaft 330 and sleeves 332 and 334 are co-axially aligned and nested such that the shaft core 329 is inside the shaft 330 that is inside the sheath sleeve 332 that is inside the outer sleeve 334. The shaft core 329 and the shaft 330 extend proximally and distally beyond the sleeves 332 and 334 with the shaft core extending proximally beyond the shaft. The sheath sleeve 332 extends proximally beyond the outer sleeve 334 but the outer sleeve 334 extends distally beyond the sheath sleeve 332. In the device as shown, the distal end 326 of the device has a tip 338 with a radio frequency (RF) powered member 340 extending diametrically across the tip. The RF powered member 340 may be energized such that the device moves through tissue via ablation or electrosurgical incision, thus enabling the device to be inserted into the target body containing a tissue specimen to be encapsulated. The device also may enter the biological target via other means, such as lasers or other focussed light techniques, high pressure water, cutting with a sharp implement, cryogenic techniques, etc. In addition, the device may not have a component analogous to the RF powered member 340 but the distal end 326 may be inserted into the target body through a pre-existing passage (not shown). The device also has a sheath deployment rod deployment end 342 extending from the proximal end 324 of the wand assembly 312. The sheath deployment member deployment end 342 is pulled proximally in the axial direction 320 to deploy the sheath 314 about a tissue specimen. In FIG. 10, the sheath deployment members 448 are shown deployed about the tissue specimen 492. At the axial center of the wand 412 is the sheath deployment member deployment rod 456. The sheath deployment member deployment rod 456 extends distally through the sheath deployment member cap 454 and terminates at the stop 488. The stop 488 is located distally and adjacent to the cap top 476. The sheath deployment member cap 454 is located at the distal end 426 of the wand assembly 412 with the axial extensions 478 extending proximally. The axial extensions 478 are disposed against the interior surface of the shaft core 429. The sheath deployment member deployment ends 474 are looped around the sheath deployment member ring 482, which is located proximal to the cap top 476. The sheath deployment members 448 extend from the sheath deployment member ring 482 and radially out of the distal end 426 of the shaft 430. As shown in FIG. 10, the sheath deployment member deployment rod 456 is centrally located within the shaft core 429. The push rods 452 are disposed in grooves 458 in the outer surface of the shaft core 429. The shaft 430 surrounds the shaft core 429. The tissue specimen 492 is disposed about the shaft 430 toward the shaft's distal end 426. The outer sleeve 434 is shown surrounding the shaft 430 and is located proximally from the tissue specimen 492. The sheath 414 is disposed between the shaft 430 and the outer sleeve 434 with the second portion 446 distally extending from under the outer sleeve. The sheath deployment members 448 are deployed about the tissue specimen 492 but have not been released from the wand assembly 412. The end balls 470 of the sheath deployment members 448 are disposed in the ball-holders 466. The push rods 452 have been pushed to a position proximal of ball openings 402. The ball openings 402 are located at the proximal end of each sheath deployment member slot 472 and extend through the shaft 430. The ball openings 402 generally correspond with the proximal end of the tissue specimen 492. The sheath deployment members 448 extend from the end balls 470, through the ball openings 402, through ligatures 449 extending from the sheath second portion 446, and into the periphery margin 498 about the tissue specimen 492.

[0053] FIG. 11 shows the final sheath deployment member, sheath deployment member 448d, partially radially expanded into the channel 494 with 315 degrees of the periphery margin 498 having been formed. The remainder of the method of deploying the sheath deployment members 448 and forming the periphery margin 498 comprises fully extending the sheath deployment member 448d to point 496 and rotating the device until the cutting member 488 reaches point 496, thereby fully forming the periphery margin 498 and separating the tissue specimen 492 from the target body 491. At this point the cutting member 488 may remain bowed or may retracted at least partially back to the shaft 430 by proximally pulling its respective push rod (not shown in FIG. 6).

[0054] Referring to FIG. 12, the sheath deployment members 448 are bowed radially outward. The bowing of the sheath deployment members 448 occurs as the respective push rods 452 are distally pushed while the distally located looped deployment end 474 (not shown, see FIG. 5) of each sheath deployment member 448 remains static. The pushing of the rods 452 moves the end balls 470 distally in the grooves 458 and forces the sheath deployment members 448 radially outward. The sheath deployment members 448 extend through ligatures 449 attached to the second portion 446 of the sheath 414. As the sheath deployment members 448 bow outwardly, the sheath deployment members slip through the holes provided until the end balls 470 comes up against the ligatures 449. The ligature 449 is a looped end of a cord 485 that is embedded in the sheath second portion 446. The ligature 449 is sized such that the end ball 470 cannot slide through it. Other embodiments of the invention may have other equivalent mechanisms and arrangements for attaching the sheath deployment member attachment end 471 to the sheath 414.

[0055] Also shown in FIG. 12 is a bowed cutting member 488 which may be a radiofrequency powered tissue cutting element. The bowed cutting member 488 is shown as being similar to the four sheath deployment members 448. The cutting member 488 is disposed and arranged in the device 410 similar to the sheath deployment members 448. Initially, the cutting member 488 is not fully bowed. Using the fifth push rod 452, the cutting member 488 is forced radially outward through slot 451. In the shown embodiment of the invention, the cutting member 488 is RF powered, as is the member 440 on the tip 438. Other embodiments of the invention may have cutting members that cut through tissue using other means. In some embodiments of the invention, the cutting member may be permanently attached to the distal end of the push rod 452. In other embodiments of the invention, the cutting member 488 may also function similar to the sheath deployment members 448 in drawing the sheath 414 over the tissue specimen as described below. In still other embodiments of the invention, there may not be element of the device 10 that functions equivalently to the cutting member 488.

[0056] Embodiments of the invention have suitable control systems incorporated into the tissue specimen isolating and damaging device. Further, the embodiments of the invention are suitably configured for different treatment methods and different tissue specimen shapes and sizes.

[0057] Although presently preferred embodiments of the present invention have been described in detail hereinabove, it should be clearly understood that many variations and/or modifications of the basic inventive concepts herein taught, which may appear to those skilled in the pertinent art, will still fall within the spirit and scope of the present invention, as defined in the appended claims.