Device and Method for Inserting Implants
This application is a continuation-in-part application of U.S. Patent Application No. 09/425,077, filed October 21, 1999, which was a continuation-in- part of U.S. Patent Application Serial No. 09/245,282 filed Feb. 5, 1999, which was a continuation of U.S. Patent Application Serial No. 08/873,852 filed June 14, 1997, now U.S. Patent No. 5,868,758, which was a continuation-in-part of U.S. Patent Application Serial No. 08/561,018 filed Nov. 21, 1995, now U.S. Patent No. 5,792, 169, which was a continuation-in-part of U.S. Patent Application Serial No. 08/395,455 filed Feb. 28, 1995, now U.S. Patent No. 5,643,308, which are incorporated herein by reference.
BACKGROUND As discussed in the above-referenced patent applications and issued U.S. patents, a device for inserting implants into tissue may comprise a base, one or more guides extending downwardly from the base, each guide having a guide passage therethrough. The device may also comprise a depressor movable with respect to the guides and the base, from which one or more spikes extend downwardly. Each of these spikes may be movable into a corresponding guide passage so that they may be movable to a spike position where the spikes and the guides cooperate to dilate a cavity in the tissue. Furthermore, the spikes may be movable to engage the implants and push them through the guides into the cavities. The device may also include a cartridge having one or more bores, and the spikes are moveable to engage the implants and push the implants through the bores. Other implantation devices, which do not use cooperative dilation of a cavity in the tissue, are also known in the art.
In certain implantation applications, the precise location of the implant within the tissue is important. For example, in radiation seed (or pellet) implantation, the precise lateral, longitudinal, and depth location of each implant must be controlled. As a result, the use of prior art implantation devices to place implants in a controlled manner requires a great deal of skill by the operator of the device.
Radiation seed therapy for the treatment of prostate cancer, which involves the individual placement of approximately 80-200 seeds into the prostate per case, is time consuming, difficult, and tedious. The current methodology of delivery of radiation seeds consists of singular trocar needle within a metal 18g needle, or the Mik Implanter, which inserts individual seeds with the use of a "gun". The surgery for implantation consists of general anesthesia for the patient, and subsequently with the use of a computer, determining the grid placement of the seeds. A typical spacing between seeds is 0.5 cm. Currently the seeds are than hand loaded with the needle-trocar method and individually placed by the radiation oncologist into the grid of the prostate under flouroscopy control. A corresponding metal grid is paced outside the perineum of the patient as is used to help stabilize and guide the trocar-needle containing the radiation seed through the skin and into the respective grid sections of the prostate. The major drawbacks of the Mik Implanter are its cost, stability of holding the gun, and jamming during insertion.
SUMMARY A device for indexing an implanter for inserting implants into tissue is provided. The device includes a carriage indexably attached to the implanter, and a base indexably attached to the carriage. In use, the operator indexes the implanter with respect to the carriage, and indexes the carriage with respect to the base, to preselected longitudinal distances and depths. The implant is then inserted into the tissue.
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is an exploded orthographic view of one embodiment of the indexable implantation device of the present invention.
Figure 2 is a lateral cross-sectional elevation of an embodiment of the indexable implantation device of the present invention showing dilation of cavities in the tissue.
Figure 3 is a longitudinal cross-sectional elevation view of an embodiment of the indexable implantation device of the present invention showing an implant about to be inserted into the tissue. Figure 4 is an exploded orthographic view of another embodiment of the indexable implantation device of the present invention.
DETAILED DESCRIPTION OF THE DRAWINGS Figures 1-3 show an embodiment of the indexable implantation device of the present invention. An implanter 1 is rigidly held in a yoke 2. Yoke 2 is indexably attached to indexing carriage 3, which is in turn indexably attached to indexing base 4.
In one embodiment, implanter 1 includes implanter base 11 having one or more guides 12 extending downwardly therefrom, each guide having a guide passage 13 therethrough. The implanter 1 may also include a depressor 14, movable with respect to the implanter base 11 and guides 12, from which one or more spikes 15 extend downwardly. Each of spikes 15 are movable with respect to a corresponding guide passage 13 so that spikes 15 are movable to a spike position where the spikes 15 and guides 12 cooperate to dilate a cavity 5 in the tissue 6. The spikes 15 are moveable to engage implants 7 through the guides 12 and into the cavities 5. The implanter 1 also includes a cartridge 16 having one or more bores 17 for containing implants 7, where the spikes 15 are movable within the bores 17, and the spikes 15 are movable to engage the implants 7 and push them
through the bores 17. Guides 12 may have a sharp wall, a tapered wall, or an entirely tapered end. A typical spacing S between spikes 15 (and, correspondingly, guides 12) is approximately 0.5 cm.
In another embodiment, implanter 1 may be held in implanter yoke 2 by C-clamps 21a, 21b having respective yoke screws 22a, 22b.
In another embodiment, yoke 2 is indexably attached to indexing carriage 3 having carriage rails 31a, 31b. Carriage screws 33a, 33b, which contact or engage carriage indexing holes 32a, 32b in carriage rails 31a, 31b respectively, contact or engage yoke 2 and allow yoke 2 (and thus implanter 1) to be positioned so that implants 7 may be implanted at precise and different depths in tissue 6. A typical depth spacing D (e.g., the distance between carriage indexing holes 32a, 32b) is approximately 0.5 cm.
In a further embodiment, indexing carriage 3 is indexably attached to indexing base 4 having base rails 41a, 41b. Base screws 43a, 43b, which contact or engage base indexing holes 42a, 42b in base rails 41a, 41b respectively, contact or engage carriage 3 allow carriage 3 (and thus implanter 1) to be positioned so that implants 7 may be implanted at precise and different longitudinal distances in tissue 6. A typical longitudinal spacing L (e.g., the distance between base indexing holes 42a, 42b) is approximately 0.5 cm. Carriage rails 31a, 32b and base rails 41a, 41b may include grooves and/or rudders to stabilize the yoke 2 with respect to the carriage 3, and the carriage 3 with respect to the base 4. The terms yoke screws 22a, 22b, carriage screws 33a, 33b, and base screws 43a, 43b, as used in this specification, may include pins, tabs, clips, or other through-hole removable fixation devices known to those skilled in the art.
Figure 4 shows an exploded isometric view another embodiment in which yoke 200 includes yoke rudders 210a, 210b which mate with corresponding
carriage grooves 310a, 310b of carriage 300. Yoke rudders 210a, 210b may be placed in carriage grooves 310a, 310b so that implanter 1 may be positioned at precise and different longitudinal distances in tissue 6. Likewise, carriage 300 includes carriage rudders 330a, 330b which mate with corresponding base grooves 410a, 410b in base rails 420a, 420b of base 400. Carriage rudders 330a, 330b may be placed in base grooves 410a, 410b so that implanter 1 may be positioned at precise and different depths in tissue 6.
Rudders may take the place of grooves and, correspondingly, grooves may take the place of rudders to perform the stabilization and indexing functions. For each of the embodiments discussed above, it should be understood that the carriage rails and base rails may be constructed so as to be continuously indexable, e.g., a screw, pin, tab, or clip may hold the yoke (and thus the implanter) anywhere along the length of the carriage rails, and the carriage similarly may be held at any location along the length of the base rails. It should also be understood that each of the embodiments may be mechanized by motorizing the implanter/ carriage and carriage/base indexing through the use of rack-and-pinion, lead screw, pneumatic or hydraulic slides, or other motorized translational mechanisms known to those skilled in the art. Furthermore, such mechanized embodiments may be automated by robotic control, i.e., the desired depth and longitudinal position may be entered into a remote terminal, and computer- controlled implanter/ carriage and carriage/base indexing may be automatically accomplished.
A method of using the embodiments of the present invention depicted in Figs. 1-4 is as follows. A surgeon or other operator places the base of the indexable implantation device on the tissue 6 and selects a longitudinal distance and depth for implantation. The operator adjusts the position of the yoke in the carriage, and
the carriage in the base, so that the implanter is adjusted to place the implants in the selected longitudinal distance and depth.
For the embodiment shown in Figs. 1-3, the operator adjusts the implanter to the selected depth by inserting carriage screws 33a, 33b into appropriate carriage indexing holes 32a, 32b to contact or engage yoke 2. The longitudinal distance is adjusted to that selected by inserting base screws 43a, 43b into the appropriate base indexing holes 42a, 42b to contact or engage carriage 3.
For the embodiment shown in Fig. 4, the operator adjusts the implanter 1 to the selected depth by inserting carriage 300 including carriage rudders 330a, 330b into the appropriate set of base grooves 410a, 410b, of base 400. The longitudinal distance is adjusted to that selected by inserting yoke 200 including rudders 210a, 210b into the appropriate carriage grooves 310a, 310b of carriage 300.
After adjusting the indexable implantation device to the selected depths and longitudinal distance, the implanter is activated to insert the implant into the tissue according to the method used for that particular implanter. For the implanter shown in Figs 1-4, the depressor 14 is depressed so that the tips of spikes 15 extend from the ends of guides 12. Spikes 15 and guides 12 then cooperate to dilate a cavity 5 in the tissue 6 as depicted in Fig. 2. The depressor 14 is then retracted, and a cartridge 16 containing implants 7 is installed in implanter 1 as depicted in Fig. 3. Depressor 14 is again depressed, pushing implants 7 through bores 17 and guide passages 13 into cavity 5. The entire implanter is then removed from the tissue 6. Cartridge 16 may be removed and reloaded with further implants, and the indexable implantation device may be adjusted for another selected depth and longitudinal position. It is to be understood that the above-described embodiments are merely illustrative of the principles of the invention of the principles of the invention and
that other arrangements may be devised by those skilled in the art without departing from the spirit and scope of the invention.