Patent Application
20090163870
1. Technical Field
The present disclosure relates to the field of medical devices and more particularly to a targeting obturator.
2. Background
Medical procedures have advanced to stages where less invasive or minimally invasive surgeries, diagnostic procedures and exploratory procedures have become desired and demanded by patients, physicians, and various medical industry administrators. To meet these demands, improved medical devices and instrumentation have been developed, such as cannulas or micro-cannulas, medical introducers, vacuum assisted biopsy apparatus, and other endoscopic related devices.
In the field of tissue biopsy, minimally invasive biopsy devices have been developed that require only a single insertion point into a patient's body to remove one or more tissue samples. One such biopsy device incorporates a “tube-within-a-tube” design that includes an outer piercing needle having a sharpened distal end and a lateral opening that defines a tissue receiving port. An inner cutting member is slidingly received within the outer piercing needle, which serves to excise tissue that has prolapsed into the tissue receiving port. A vacuum is used to draw the excised tissue into the tissue receiving port and aspirates the excised tissue from the biopsy site once severed. Exemplary “tube-within-a-tube” biopsy devices are disclosed in pending U.S. patent application Ser. Nos. 09/707,022, 09/864,031, and 11/516,277, which are owned by the assignee of the present invention. Among other features, the exemplary biopsy devices can be used in conjunction with Magnetic Resonance Imaging (MRI). This compatibility is due to the fact that many of the components of the biopsy devices are made of materials that do not interfere with operation of MRI apparatus or are otherwise compatible therewith. It is desirable to perform biopsies in conjunction with MRI because it is a non-invasive visualization modality capable of defining the margins of a tumor.
While the exemplary MRI compatible biopsy devices have proven effective in operation, in some procedures it is desirable to create a pathway to the biopsy site for precise introduction of the biopsy device and other medical treatments into the patient. To ensure that the biopsy device is accurately placed, it is desirable to utilized a targeting obturator. However, known targeting obturators fail to indicate the potential location of a cutting portion of the biopsy device.
A medical target confirmation device, such as a targeting obturator, is disclosed. In one exemplary embodiment, the medical targeting device includes an elongated body member extending between a distal end and a proximal end and includes a targeting region formed adjacent to the distal end. The targeting region further includes a contrast agent. A method for using the medical targeting device is also disclosed.
Embodiments of the disclosure will now be described, by way of example, with reference to the accompanying drawings, wherein:
Referring now to the drawings, illustrative embodiments of the present disclosure are shown in detail. Although the drawings represent embodiments of the present disclosure, the drawings are not necessarily to scale and certain features may be exaggerated to better illustrate and explain the disclosure. Further, the embodiments set forth herein are not intended to be exhaustive or otherwise limit or restrict the disclosure to the precise forms and configurations shown in the drawings and disclosed in the following detailed description.
Referring to
An embodiment of introducer stylet 22 and outer cannula 24 may be found in co-pending U.S. patent application Ser. No. 10/649,068, the contents of which are incorporated herein by reference in its entirety.
In a particular configuration, introducer stylet 22 includes a stylet portion 30 that has a distal end with a tissue piercing tip 32, such as a trocar tip, to facilitate penetration of stylet portion 30 into a patient's tissue. In addition to, or in place of trocar tip 32, it will be appreciated that stylet portion 30 may include other devices for piercing the patient's tissue, including without limitation, devices that use a laser or radio frequencies (RF) to pierce tissue. The length of stylet portion 22 is generally denoted by the reference character “A” in
Referring to the embodiment shown in
Referring to
Handle 47 may abut outer cannula 24 when body member 29 is fully inserted within outer cannula 24. Handle 47 is sized so as to be at least slightly larger than an inner lumen 40 of cannula 24 such that the entire obturator 26 may not be interposed with outer cannula 24 or delivered into a patient's body. In some configurations, handle 47 may also include a luer-style fitting or other suitable feature for interfacing, but not necessarily connecting, targeting obturator 26 with outer cannula 24. Handle 47 may further include gripping members 39 to aid in the handling of targeting obturator 26. In one embodiment, gripping members 39 include a series of alternating grooves and ridges.
In one exemplary embodiment, distal tip 46 may be pointed to facilitate entry into the patient's body. However, other exemplary embodiment may include a rounded tip or even a trocar tip.
In one exemplary embodiment, a three-dimensional targeting region, or volume, 48 may be included at distal end 31 of targeting obturator 26. Targeting region 48 may be disposed, at least in part, along an outer surface 32 of the body member 29 and may extend inwardly therefrom into a portion of body member 29. Targeting region 48 generally provides an image enhancement and may further include a contrast agent. The shape of the targeting region 48 may be configured to be the approximate size of a tissue receiving opening 60 in a biopsy device 50 (see, e.g.,
In one particular configuration, the longitudinal center of targeting region 48 is provided a distance “C” from handle 47, as shown in
While being able to image the longitudinal length of targeting region 48, identified by the length between edges 48a and 48b, may be advantageous, it may be also be desirable to image a three-dimensional region, or volume, approximating the tissue sample size that will be removed. As will be discussed in more detail below, tissue 80 may be coerced into tissue receiving opening 60 via vacuum suction. As a portion of the target tissue 80 is drawn into tissue receiving opening 60, an inner cannula 58 having a cutting edge disposed on a distal end thereof, moves distally across the tissue receiving opening 60, thereby severing tissue 80 and trapping a portion within an inner lumen 65 of inner cannula 58. To assist in approximating the size of the tissue samples taken by the biopsy device, the targeting region 48 may be sized and configured to be a shape generally corresponding to the size of the tissue receiving opening 60 and approximating the volume of tissue to be taken by the inner cannula 58.
An exemplary biopsy apparatus 50, which is suitable for use with medical system 20 of the present invention, is generally shown in
A particular embodiment of the working end of cutting element 52 is depicted in
As discussed above, the tissue 80 may only penetrate the inner lumen 65 in the region nearest the tissue-receiving opening 60. Accordingly, targeting region 48 may be radially spaced apart or offset from a longitudinal axis of body member 29. In one exemplary embodiment, targeting region 48 may encompass an elongated arcuate volume. This arcuate volume may be bounded by a substantially rectangular base surface 35, first 48a′ and second 48b′ upright side surfaces, and an arcuate surface 49. The base surface 35 may be defined by first and second longitudinally extending edges and first and second transverse edges. First and second upright side surfaces 48a′, 48b′ may extend from said transverse edges. Additionally, the respective angles between upright side surfaces 48a′, 48b′ and base surface may exceed 90 degrees. The arcuate surface 49 may extend between said first and second upright side surfaces 48a′, 48b′ and said first and second longitudinally extending edges of base surface 35. Base surface 35 may be spaced radially from said longitudinal axis.
Targeting region 48 may include a solid contrast agent or may include a reservoir for a liquid contrast agent. In both exemplary approaches, the targeting region may be integrally formed with body member 29 of targeting obturator 26. Where body member 29 is produced by a molding process, targeting region 48 may be integrally molded into body member 29. Solid contrast agents may include a magnetic resonance imaging (MRI) identifiable metallic material, such as Inconel® 625, titanium or other material with similar magnetic characteristics. Alternatively, a liquid contrast agent may be utilized. Suitable liquid contrast agents include fluro-deoxyglucose (FDG), technicium 99, Gadolinium, and other MRI compatible contrast agents. These radioactive isotopes are visible under imaging modalities such as PET (positron emission tomography), gamma cameras, or scintimammography. The contrast agent generally shows up as a bright area under the imaging modalities. Once the obturator 26 has been placed in the body, the contrast agent will be easily visible under the imaging modalities, thereby indicating a target site where a biopsy instrument may be placed, and more specifically may correspond to the shape of the tissue sample that is to be removed.
Another embodiment of a targeting obturator 126 is shown in
Distal end 31 of body member 27 may be formed with a laterally extending chamber 48. Chamber 48 is generally sized and shaped to correspond to the size and shape of a tissue sample to be taken by biopsy device 50. For example, edges 48a and 48b define the margins of chamber 48. A suitable imaging material is received within chamber 48. For example, a solid contrast agent may be disposed within chamber 48, such as Inconel® 625, titanium, or other suitable material. Alternatively, a liquid contrast agent may be disposed within chamber 48. Suitable liquid contrast agents include fluro-deoxyglucose (FDG), technicium 99, Gadolinium, and other MRI compatible contrast agents.
Chamber 48 is closed off by a distal end cap 46. In one embodiment, distal end cap 46 is formed with a distal tip to facilitate entry into a patient's body. The distal tip may be pointed, rounded, or may be formed with a sharp trocar tip. Distal end cap 46 is secured to distal end of body member 27 in such a manner so as to seal off chamber 48. In one embodiment, distal end cap 46 is provided with a mounting portion that is threaded that is received within and engages corresponding threads (not shown) within chamber 48. In another embodiment, the mounting portion is press fit within chamber 48. Distal end cap may also be fixedly secured, via welding or other suitable securing operation to seal off chamber 48.
Alternative embodiments of targeting obturators 226 and 326 are depicted in
In yet another alternative embodiment, referring to
Referring to
Referring to
In an embodiment, reference structure 82 includes a support grid having a number of holes therethrough. Each hole is sized to allow passage of outer cannula 24. The hole through which outer cannula 24 is ultimately inserted is determined by the location of target tissue 80 relative to reference structure 82 along the X and Y axes. The patient and reference structure 82 are viewed using a medical imaging system, such as MRI, to determine the location of the target tissue relative to reference structure 82.
After application of anesthesia, the stylet portion of introducer stylet 22 and a portion of outer cannula 24 are inserted through the support grid and into the patient's body, creating a pathway 84 to the target tissue 80 (see, e.g.,
Fluids may be inserted into or removed from the patient's body through inner lumen 40 via a fluid conduit 42. These fluids may include, for example, additional anesthetics and/or saline solution to cleanse pathway 84 and remove blood. Accumulated blood and other fluids within pathway 84 may be aspirated through fluid conduit 42 or by inserting aspirating wand 68 prior to insertion of targeting obturator 26.
Once introducer stylet 22 is removed from outer cannula 24, targeting obturator 26 or 126 may be inserted into the patient's body through the port created by outer cannula 24 (see, e.g.,
Once the desired position is achieved, a depth limiting member 39 is moved against reference structure 82 to inhibit movement of outer cannula 24 further into the patient. When no reference structure 82 is used, depth limiting member may be moved directly against the patient's skin. Targeting obturator 26 or 126 is then removed from outer cannula 24 and biopsy device 50 is inserted into outer cannula 24 until handpiece 54 abuts proximal end 36 of outer cannula 24. In the embodiment illustrated in
After completion of the biopsy, the biopsy site can be aspirated using aspirating wand 68 (see, e.g.,
Among other features, the medical system of the present invention localizes the target biopsy site in a manner that allows confirmation of the target biopsy site under MRI or other visualization modality, and allows positioning of a biopsy device to ensure the cutting element of the biopsy device can be accurately placed at the target biopsy site. The medical system of the present invention also facilitates the introduction and removal of fluids from the target site, including without limitation, anesthesia and blood, but minimizes the exposure of the fluids to the adjacent equipment and medical staff. In addition to allowing the medical staff to identify the presence of significant bleeding and to introduce a biopsy device into the patient, the medical system provides access to the target site to introduce a medical treatment, such as a site marker, tamponade or other haemostatic agent, after removal of the tissue.
The present disclosure has been particularly shown and described with reference to the foregoing embodiments, which are merely illustrative out of the disclosure. It should be understood by those skilled in the art that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure without departing from the spirit and scope of the disclosure as defined in the following claims. It is intended that the following claims define the scope of the invention and that the method and apparatus within the scope of these claims and their equivalents be covered thereby. This description of the disclosure should be understood to include all novel and non-obvious combinations of elements described herein, and claims may be presented in this or a later application to any novel and non-obvious combination of these elements. Moreover, the foregoing embodiments are illustrative, and no single feature or element is essential to all possible combinations that may be claimed in this or a later application.
