Not applicable.
1. Field of Invention
The present invention relates to an apparatus to provide delivery of medical treatment to and within tissue or bone. In particular the present invention related to a minimally invasive and particularly small treatment delivery system including a drill and treatment delivery passage. Additionally, the present invention relates to a minimally invasive and particularly small apparatus for drilling of passages in bone for other purposes, such as the imposition of screws or other devices to fix a bone or bone portion in position.
2. Description of the Related Art
Delivery of medical treatments to tissue within bone is particularly difficult. Historically treatment has been delivered through the entire body in sufficient application amounts to ensure the necessary treatment amount reaches the tissue within the bone. As can be expected, this requires application amounts far in excess of the treatment amount necessary and can result in damage to other parts of the body as well as increased costs. Various solutions have been developed to attempt to reduce the application amount, typically by attempting to isolate the affected area from the body, including shunting of blood flow in the affected limb through a heart/lung machine to allow continued circulation within the limb while isolating the blood flow from the rest of the body. Similarly accessing bone to directly apply any treatment amount or to drill into the bone, such as drilling a passage for screws to fix a bone or bone particle in position, has historically been quite difficult and invasive. Moreover, such passages have generally been no smaller than 0.15875 cm (0.0625 inches). Likewise, drilling such passages has resulted in significant fracturing of the bone itself
The need therefore exists for apparatus to provide delivery of medical treatment to and within bone which permits direct application of only the necessary treatment amount and for a system to access bone to directly apply any treatment amount or to drill into the bone such as drilling a passage for screws to fix a bone or bone particle in position, with minimal invasion. A need further exists for an apparatus which may be used with tissue rather than bone.
Such a need may be particularly important in the treatment of osteosarcoma and similar cancers of bone.
The present invention overcomes the foregoing drawbacks of previous systems.
The present invention provides an improved apparatus to provide delivery of medical treatment to tissue, which may be within a bone, specifically by providing an improved drill. The directional drilling apparatus includes a miniature shaft, a bit, first shaft-mounted thrust ring, second shaft-mounted thrust ring, a tubing jacket surrounding the shaft and intermediate the first and second shaft-mounted thrust rings, and a guide tube encapsulating the tubing jacket. The guide tube may be straight or may have a curvature at the end where the guide tube contacts or is very close proximity to the bone, so that as the bit rotates and is advanced from the guide tube, the shaft and tubing jacket are deformed consistent with the guide tube. As a result, straight or curved holes may be drilled, targeted towards a cancerous lesion within the tissue within the bone. The guide tube may comprise, in part, a hypodermic needle.
After removal of the directional drilling apparatus, treatment may be introduced through the particularly small hole created by the directional drilling apparatus. Due to the small diameter of the tubing jacket and the drill, the drill is particularly small, such as 0.04318 cm (0.017 inches).
When the guide tube includes a hypodermic needle, the drill bit, shaft, tubing jacket, and a portion of the guide tube other than the hypodermic needle may be removed after the hole has been drilled, and a capillary inserted through the hypodermic needle portion of the guide tube to the tissue to be treated.
In another aspect of the present invention, the present invention provides an improved method of delivering medical treatment to and into bone.
In another aspect of the present invention, by using a very smooth bore tube to guide a flexible drill hard enough to cut through the bone, but not likely to break-off with the bone or to fracture the bone, provided with a relatively short cutting tip compared to the length of the overall tool, a drilling apparatus is provided capable of drilling directly, angled or even curved passages through bone to access the cancerous lesion from inside the bone without deleterious affects on the patient.
The foregoing and other objectives, features, and advantages of the invention will be more readily understood upon consideration of the following detailed description of the invention, taken in conjunction with the accompanying drawings.
So that the manner in which the described features, advantages and objects of the invention, as well as others which will become apparent, are attained and can be understood in detail, more particular description of the invention briefly summarized above may be had by reference to the embodiments thereof that are illustrated in the drawings, which drawings form a part of this specification. It is to be noted, however, that the appended drawings illustrate only typical preferred embodiments of the invention and are therefore not to be considered limiting of its scope as the invention may admit to other equally effective embodiments.
In the drawings:
The invention may be further understood by the following non-limiting examples. Although the description herein contains many specificities, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of the invention. For example, thus the scope of the invention should be determined by the appended claims and their equivalents, rather than by the examples given. In general the terms and phrases used herein have their art-recognized meaning, which can be found by reference to standard texts, journal references and contexts known to those skilled in the art. The following definitions are provided to clarify their specific use in the context of the invention. All references cited herein are hereby incorporated by reference to the extent not inconsistent with the disclosure herewith.
Referring to the
Referring to
A shaft 200, having an outer diameter 201 slightly sufficiently smaller than the inner diameter 301 of the tubing jacket 300, is inserted through the tubing jacket 300. The mandrel used to form the tubing jacket 300 may be retained as the shaft 200. Alternatively, any ductile rod having an outer diameter 201 smaller than the inner diameter 301 of the tubing jacket 300 may be used. The shaft 200 therefore has a quite small outer diameter. In the preferred embodiment, the outer diameter 201 of the shaft 200 is in the area of 0.02286 cm (0.009 inches).
Referring to
Unlike standard drill bits, which have high strength and brittleness, the bit 100 is quite ductile. As can be appreciated, the loss of such a drill bit, likely with a brittle drill bit, in the body is to be avoided.
Referring to
Referring to
Referring to
Referring again to
Referring to
Referring to
Referring to
In an alternative embodiment in
The bone 600 is relatively soft when drilled in this manner, thus the drilling apparatus 10 is capable of drilling through the bone 600 without deleterious effects on the surrounding bone. Moreover, the drilling apparatus 10 produces a uniform, clean and particularly small diameter passage 602 through the bone 600. As a result of the small passage 602 directed toward the cancerous lesion 603 any of the various treatments known in the art, such as chemotherapy, radiochemical therapy, directed energy, may be provided without damage of adjacent tissue.
Referring to
In either embodiment, the bit 100 drills through the bone 600 to provide for application of the medical treatment 700, as illustrated in
Alternatively, the treatment 700 may be directed toward the cancerous lesion 603 by a charge-driven application. Thus it may be possible to enhance the flow of the treatment 700 by applying a direct current potential between the treatment delivery system 800 and an electrode in conductive contact with the exterior of the limb placed as closely as possible to the region of the treatment delivery system 800. In one embodiment, a very fine liquid aerosol is generated and applied through electrostatic charging. In one embodiment, a liquid is passed through a nozzle, wherein a plume of droplets is generated by electrically charging the liquid to a very high voltage. The charged liquid in the nozzle becomes unstable as it is forced to hold more and more charge. Soon the liquid reaches a critical point, at which it can hold no more electrical charge and at the tip of the nozzle it blows apart into a cloud of tiny, highly charged droplets. These tiny droplets are particularly small, and fly about searching for a potential surface to land on that is opposite in charge to their own. Such droplets would be attracted to the cancerous lesion due to electrical differential. The apparatus may employ a sharply pointed hollow metal tube, such as a syringe needle, with liquid pumped through the tube. A high-voltage power supply may then be connected to the outlet of the tube and the tube positioned proximate a cancerous lesion 603. When the power supply is turned on and adjusted for the proper voltage, the liquid being pumped through the tube transforms into a fine continuous mist of droplets that fly rapidly toward the cancerous lesion 603.
Alternatively, if the treatment 700 consists of direct energy to be applied to the cancerous lesion 603, an optical tube sheathed in a metal, such as nickel, may be used to direct the treatment 700.
Additionally, via a passage 602, it is possible to visually observe cancerous lesion 603, such as with appropriately-sized fiber-optic or laparoscopic devices.
In operation, the drilling apparatus 10 is applied to or in close proximity to the bone 600 at the first end 401 of the guide tube 400. The shaft 200 and the bit 100 are rotated via rotation of the drive tube 240. Force is linearly applied to the shaft 200, which drives the bit 100 into the bone 600 and through the bone wall 601 to create a passage 602. Additionally, it is possible to direct the guide tube 400 against the bone 600 towards the cancerous lesion 603 from the opposite side of the cancerous lesion 603. The maximum penetration of the bit 100 into and through the bone 600 may be restricted by limiting the distance between the second end 403 of the guide tube 400 and the position of the drive tube 240. Alternatively, any stop having an outer diameter greater than the inner diameter 404 of the guide tube 400 may be affixed to the shaft 200.
The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding equivalents of the features shown and described or portions thereof.
The priority of PCT Application No. PCT/US2008/054085, filed on Feb. 15, 2008, is hereby claimed, and the specification thereof is incorporated herein by reference. PCT Application No. PCT/US2008/054085 claims the benefit of U.S. Provisional Patent Application No. 60/890,831 entitled, “Directional Bone Drilling and Methods of Treatment” filed on Feb. 20, 2007 in the United States Patent and Trademark Office and U.S. Provisional Patent Application No. 60/891,183 entitled, “Directional Bone Drilling and Methods of Treatment” filed on Feb. 22, 2007 in the United States Patent and Trademark Office, and both specifications thereof are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/US2008/054085 | 2/15/2008 | WO | 00 | 2/20/2008 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2008/103606 | 8/28/2008 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
550783 | Elliott et al. | Dec 1895 | A |
1630239 | Binley et al. | May 1924 | A |
2958349 | McNutt | Nov 1960 | A |
2960892 | Spravka | Nov 1960 | A |
3016073 | Broussard et al. | Jan 1962 | A |
3388505 | Dreiling | Jun 1968 | A |
3617143 | McKee | Nov 1971 | A |
4265231 | Scheller, Jr. et al. | May 1981 | A |
4541423 | Barber | Sep 1985 | A |
4941466 | Romano | Jul 1990 | A |
5002546 | Romano | Mar 1991 | A |
5017057 | Kryger | May 1991 | A |
5387218 | Meswania | Feb 1995 | A |
5395188 | Bailey et al. | Mar 1995 | A |
5509918 | Romano | Apr 1996 | A |
5569197 | Helmus et al. | Oct 1996 | A |
5700265 | Romano | Dec 1997 | A |
5709511 | Esmailzadeh | Jan 1998 | A |
5772661 | Michelson | Jun 1998 | A |
5779708 | Wu | Jul 1998 | A |
5928241 | Menut et al. | Jul 1999 | A |
6018094 | Fox | Jan 2000 | A |
6039127 | Myers | Mar 2000 | A |
6257808 | Groot | Jul 2001 | B1 |
6309396 | Ritland | Oct 2001 | B1 |
6322565 | Garner et al. | Nov 2001 | B1 |
6391017 | Bays | May 2002 | B2 |
6511266 | Groot | Jan 2003 | B1 |
6740090 | Cragg et al. | May 2004 | B1 |
6790210 | Cragg et al. | Sep 2004 | B1 |
6818001 | Wulfman et al. | Nov 2004 | B2 |
7066942 | Treace | Jun 2006 | B2 |
7488322 | Brunnett et al. | Feb 2009 | B2 |
7569056 | Cragg et al. | Aug 2009 | B2 |
7604636 | Walters et al. | Oct 2009 | B1 |
8251999 | Stearns et al. | Aug 2012 | B2 |
20030032939 | Gibbs | Feb 2003 | A1 |
20030130664 | Boucher et al. | Jul 2003 | A1 |
20030220646 | Thelen et al. | Nov 2003 | A1 |
20040220577 | Cragg et al. | Nov 2004 | A1 |
20050236189 | Rankin, III | Oct 2005 | A1 |
20050267481 | Carl et al. | Dec 2005 | A1 |
20060067883 | Krom et al. | Mar 2006 | A1 |
20060206131 | Conquergood et al. | Sep 2006 | A1 |
20060241630 | Brunnett et al. | Oct 2006 | A1 |
20060264896 | Palmer | Nov 2006 | A1 |
20060264957 | Cragg et al. | Nov 2006 | A1 |
20070055259 | Norton et al. | Mar 2007 | A1 |
20070093840 | Pacelli et al. | Apr 2007 | A1 |
20070196275 | Li et al. | Aug 2007 | A1 |
20070231329 | Lazar et al. | Oct 2007 | A1 |
20080154275 | Assell et al. | Jun 2008 | A1 |
20090187191 | Carl et al. | Jul 2009 | A1 |
20090228014 | Stearns et al. | Sep 2009 | A1 |
Number | Date | Country |
---|---|---|
2008103606 | Aug 2008 | WO |
Entry |
---|
Thomas Dunn, International Preliminary Report on Patentability, Aug. 7, 2009, 7 pages, United States Patent and Trademark Office as International Preliminary Examining Authority, Alexandria, Virginia, US. |
Young, Lee W., International Search Report—PCT/US08/02026, Jun. 11, 2008, 2 pages, United States Patent and Trademark Office as International Search Authority, Alexandria, Virginia, US. |
Young, Lee W., Written Opinion of the ISA—PCT/US08/02026, Jun. 11, 2008, 6 pages, United States Patent and Trademark Office as International Search Authority, Alexandria, Virginia, US. |
Lee W. Young, International Search Report—PCT/US08/54085, Aug. 7, 2008, 2 pages, United States Patent and Trademark Office as International Search Authority, Alexandria, Virginia US. |
Lee W. Young, International Search Report—PCT/US08/54085, Aug. 7, 2008, 6 pages, United States Patent and Trademark Office as International Search Authority, Alexandria, Virginia US. |
Thomas Dunn, Notification of Transmittal of International Preliminary Report on Patentability, Aug. 10, 2009, 2 pages, United States Patent and Trademark Office as International Preliminary Examining Authority, Alexandria, Virginia, US. |
Thomas Dunn, International Preliminary Report on Patentability, Aug. 7, 2009, 2 pages, United States Patent and Trademark Office as International Preliminary Examining Authority, Alexandria, Virginia, US. |
Nicholas W. Woodall, Office Action of Jan. 18, 2012—U.S. Appl. No. 12/437,910, Jan. 18, 2012, 10 pages, United Patent & Trademark Office, Alexandria, Virginia, USA. |
Linda Sholl, International Preliminary Report on Patentability—PCT/US10/33511 and Notification of Transmittal, May 25, 2011, 7 pages, United States Patent & Trademark Office as Examining Authority, Alexandria, Virginia, USA. |
Blaine R. Copenheaver, International Search Report—PCT/US10/33511, Jul. 13, 2010, 2 pages, United States Patent & Trademark Office as Examining Authority, Alexandria, Virginia, USA. |
Blaine R. Copenheaver, Written opinion—PCT/US10/33511, Jul. 13, 2010, 4 pages, United States Patent & Trademark Office as Examining Authority, Alexandria, Virginia, USA. |
Nicholas W Woodall, Non-Final Office Action, U.S. Appl. No. 12/437,910, Apr. 6, 2012, 31 pages, United States Patent and Trademark Office, Alexandria, United States. |
Nicholas W. Woodall, Notice of Allowance—U.S. Appl. No. 12/437,910, Jun. 11, 2012, 7 pages, United States Patent and Trademark Office, Alexandria, Virginia, US. |
Lee W. Young, International Preliminary Report on Patentability—PCT/US08/02026, Nov. 8, 2010, 3 pages, United States Patent and Trademark Office as International Search Authority, Alexandria, Virginia, US. |
Number | Date | Country | |
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20100256644 A1 | Oct 2010 | US |
Number | Date | Country | |
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60890831 | Feb 2007 | US | |
60891183 | Feb 2007 | US |