Patent Application
20070203428
Breast cancer is a major threat and concern to women. Early detection and treatment of suspicious or cancerous lesions in the breast has been shown to improve long term survival of the patient. The trend is, therefore, to encourage women not only to perform monthly self-breast examination and obtain a yearly breast examination by a qualified physician, but also to undergo annual screening mammography commencing at age 40. Mammography is used to detect small, nonpalpable lesions which may appear opaque densities relative to normal breast parenchyma and fat or as clusters of microcalcifications. The conventional method for diagnosing, localizing and excising nonpalpable lesions detected by mammography generally involves a time-consuming, multi-step process. First, the patient goes to the radiology department where the radiologist finds and localizes the lesion either using mammography or ultrasound guidance. Once localized, a radio-opaque wire is inserted into the breast. The distal end of the wire may include a small hook or loop. Ideally, this is placed adjacent to the suspicious area to be biopsied. The patient is then transported to the operating room.
Under general or local anesthesia, the surgeon may then perform a needle-localized breast biopsy. In this procedure, the surgeon, guided by the wire previously placed in the patient's breast, excises a mass of tissue around the distal end of the wire. The specimen is sent to the radiology department where a specimen radiograph is taken to confirm that the suspicious lesion is contained within the excised specimen. Meanwhile, the surgeon, patient, anesthesiologist and operating room staff, wait in the operating room for confirmation of that fact from the radiologist before the operation is completed. The suspicious lesion should then be excised in toto with a small margin or rim of normal breast tissue on all sides. Obtaining good margins of normal tissue using conventional techniques is extremely dependent upon the skill and experience of the surgeon, and often an excessively large amount of normal breast tissue is removed to ensure that the lesion is located within the specimen. This increases the risk of post-operative complications, including bleeding and permanent breast deformity. As 80% of breast biopsies today are benign, many women unnecessarily suffer from permanent scarring and deformity from such benign breast biopsies.
More recently, less invasive techniques have been developed to sample or biopsy the suspicious lesions to obtain a histological diagnosis. The simplest of the newer techniques is to attempt visualization of the lesion by external ultrasound. If seen by external ultrasound, the lesion can be biopsied while being continuously visualized. This technique allows the physician to see the biopsy needle as it actually enters the lesion, thus ensuring that the correct area is sampled. Current sampling systems for use with external ultrasound guidance include a fine needle aspirate, core needle biopsy or vacuum-assisted biopsy devices.
Another conventional technique localizes the suspicious lesion using stereotactic digital mammography. The patient is placed prone on a special table that includes a hole to allow the breast to dangle therethrough. The breast is compressed between two mammography plates, which stabilizes the breast to be biopsied and allows the digital mammograms to be taken. At least two images are taken 30 degrees apart to obtain stereotactic views. The x, y and z coordinates targeting the lesion are calculated by a computer. The physician then aligns a special mechanical stage mounted under the table that places the biopsy device into the breast to obtain the sample or samples using fine needle aspiration, core needle biopsy, vacuum-assisted core needle biopsy or other suitable method. Fine needle aspiration uses a small gauge needle, usually 20 to 25 gauge, to aspirate a small sample of cells from the lesion or suspicious area. Core needle biopsy uses a larger size needle, usually 14 gauge to sample the lesion. Tissue architecture and histology are preserved with this method. Multiple penetrations of the core needle through the breast and into the lesion are required to obtain an adequate sampling of the lesion. Over 10 samples have been recommended by some. The vacuum-assisted breast biopsy system is a larger semi-automated side-cutting device. It is usually 11 gauge in diameter and is more sophisticated than the core needle biopsy device. Multiple large samples can be obtained from the lesion without having to reinsert the needle each time. A vacuum is added to suck the tissue into the trough. The rapid firing action of the spring-loaded core needle device is replaced with an oscillating outer cannula that cuts the breast tissue off in the trough. The physician controls the speed at which the outer cannula advances over the trough and can rotate the alignment of the trough in a clockwise fashion to obtain multiple samples.
If a fine needle aspirate, needle core biopsy or vacuum-assisted biopsy shows malignancy or a specific benign diagnosis of atypical hyperplasia, then the patient needs to undergo another procedure, the traditional needle-localized breast biopsy, to fully excise the area with an adequate margin of normal breast tissue. Sometimes the vacuum-assisted device removes the whole targeted lesion. If this occurs, a small titanium clip should be placed in the biopsy field. This clip marks the area if a needle-localized breast biopsy is subsequently required for the previously mentioned reasons.
Another method of biopsying the suspicious lesion utilizes a large end-cutting core device measuring 0.5 cm to 2.0 cm in diameter. This also uses the stereotactic table for stabilization and localization. After the lesion coordinates are calculated and local anesthesia instilled, an incision large enough is permit entry of the bore is made at the entry site with a scalpel. The breast tissue is cored down to and past the lesion. Once the specimen is retrieved, the patient is turned onto her back and the surgeon cauterizes bleeding vessels under direct vision. The incision, measuring 0.5 to larger than 2.0 cm is sutured closed. The newer conventional minimally invasive breast biopsy devices have improved in some ways the ability to diagnose mammographically detected nonpalpable lesions. These devices give the patient a choice as to how she wants the diagnosis to be made.
According to an embodiment thereof, the present invention is a device for cutting tissue having a bowed cutting element. The device may include a shaft having a central axis; and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the cutting element moving generally in a first plane when moving between the collapsed and expanded positions; the shaft having a first thickness and a second thickness relative to the central axis of the shaft, the first and second thicknesses lying in a second plane which is generally parallel to the first plane, the second thickness being at least 1.25 times larger than the first thickness and the side of the shaft having the second thickness leading the cutting element during rotation.
The second thickness may be at least 1.5 times larger than the first thickness. The tissue cutting device may have a tissue collection element which holds the tissue volume cut free from the surrounding tissue.
According to another embodiment thereof, the present invention is also a device for cutting tissue using a bowed cutting element, comprising: a shaft; and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions; the shaft may be at least 1.25 times thicker on a leading side than on a trailing side, the thickness being measured along a second plane perpendicular to the first plane, the cutting device being rotated during cutting so that the leading side leads the cutting element.
The shaft may be at least 1.5 times thicker on the leading side than on the trailing side. The shaft may be thicker on the leading side adjacent to the cutting element and may be substantially the same as the trailing side at substantially all other parts of the shaft.
According to yet another embodiment thereof, the present invention is a method of cutting tissue using a bowed cutting element, comprising the steps of: providing a tissue cutting device having a shaft and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions, the shaft has a first and second thicknesses lying in a second plane which may be generally parallel to the first plane, the second thickness being on a side of the shaft from which the tissue cutting element expands, the second thickness being at least 1.25 times larger than the first thickness; introducing the tissue cutting device into tissue; expanding the tissue cutting element toward the expanded position; rotating the tissue cutting device so that the cutting element moves through the tissue to cut the tissue, the cutting device being rotated in a direction in which a side having the second thickness leads the cutting element during rotation; moving the tissue cutting element back toward the collapsed position to cut a tissue volume free from the surrounding tissue.
The providing step may be carried out with the second thickness being at least 1.5 times larger than the first thickness. The providing step may be carried out with the tissue cutting device having a tissue collection element which holds the tissue volume cut free from the surrounding tissue. The providing step may be carried out with the shaft having at least the second thickness adjacent to the cutting element.
According to yet another embodiment, the present invention is a method of cutting tissue using a bowed cutting element, comprising the steps of providing a tissue cutting device having a shaft and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions, the shaft may be at least 1.25 times thicker on a first side defined in the direction in the cutting element expands than a second side opposite the first side; introducing the tissue cutting device into tissue adjacent to a tissue volume to be removed; expanding the tissue cutting element toward the expanded position; rotating the shaft so that the cutting element moves through the tissue to cut around the tissue volume to be removed, the cutting device being rotated in a direction in which the first side of the shaft leads the cutting element during rotation; and moving the tissue cutting element back toward the collapsed position to cut a tissue volume free from the surrounding tissue.
The providing step may be carried out with the shaft being at least 1.5 times thicker on the first side than on the second side. The providing step may be carried out with the shaft being thicker on the leading side adjacent to the cutting element and being substantially the same as the trailing side at substantially all other parts of the shaft which may be introduced into the tissue.
A method of cutting a tissue mass free from surrounding breast tissue, according to still another embodiment of the present invention, may include steps of providing a tissue cutting device and a guide element, the tissue cutting device having a tissue cutting element movable from a collapsed position to an expanded position; inserting the guide element into a breast; advancing the tissue cutting device into the breast, the tissue cutting device being slidably coupled to the guide element so that the guide element guides advancement of the tissue cutting device into the breast; and cutting breast tissue with the tissue cutting device, the cutting step being carried out with the guide element indicating a cutting parameter for the cutting device.
The cutting step may be carried out with the guide element providing an indication of a depth of penetration during the advancing step. A step may be carried out of indicating a first angular position relative to a longitudinal axis of the guide element. The indicating step may be carried out by also indicating a second angular orientation, the tissue area of interest lying between the first and second angular orientations for use during the cutting step. The advancing step may be carried out with the tissue cutting device being advanced over the guide element. The advancing step may be carried out with the tissue cutting device being advanced through the guide element. The providing step may be carried out with the guide element being a tube; the inserting step may be carried out with the tube having a sharp tip which pierces the breast tissue; and the advancing step may be carried out with the tissue cutting device being introduced into the tube. A step of removing hot gasses generated during the cutting step through the tube may also be carried out. The removing step may be carried out by removing the hot gasses through a space between the tube and the tissue cutting device.
Still another embodiment of the present invention is a method of removing breast tissue, comprising the steps of providing a tissue cutting device and an insertion device having a sharp tip, the tissue cutting device having a cutting element which may be movable from a collapsed position to an expanded position, the cutting element being bowed outward when in the expanded position; inserting the insertion device into a breast with the sharp tip of the insertion device piercing the breast tissue during insertion; coupling the tissue cutting device to the insertion device so that the tissue cutting device may be slidably coupled to the insertion device; advancing the insertion device into the breast tissue while being slidably coupled to the insertion device; moving the tissue cutting element toward the expanded position after the withdrawing step; rotating the tissue cutting device to cut around the tissue to be removed; and removing the tissue which has been cut free from the surrounding tissue by the tissue cutting device.
The providing step may be carried out with the insertion device having a tubular body, the sharp tip may be removable. A step of removing the cutting element after the inserting step may also be carried out; the coupling step being carried out by introducing the cutting device into the insertion device and advancing the cutting device through the tubular body. The guide member may be secured to the tissue structure to hold the angular orientation of the guide member after completing the inserting step. The securing step may be carried out using an adhesive strip which may be adhered to a surface of the tissue through which the cutting device may be inserted. The insertion device may be withdrawn after the advancing step to expose the tissue cutting element. A step of removing gas through a space between the tubular body and the cutting device may also be carried out. The removing step may be carried out by removing the tissue through a separate incision from an incision through which the tissue cutting element extends. An angular indicator may be set on the guide member, which provides an indication of an angular extent of the tissue to be removed.
Another embodiment of the present invention is a method of forming an RF-energized bowed cutting element. The method may include steps of providing a tissue cutting device having a cutting element coupled to a shaft, the cutting element being movable from a collapsed position to an expanded position, the cutting element being in a substantially straight configuration when collapsed and bowing outwardly from the shaft when in the expanded position; and marking a first location on the cutting element corresponding to a position on the cutting element where an apex occurs when the cutting element may be bowed outwardly, the location being marked for visualization using ultrasound.
The marking step may be carried out by also marking a second location corresponding to a proximal end and a third location corresponding to a distal end of the cutting element when the cutting element may be collapsed.
A device for cutting tissue, according to yet another embodiment of the present invention, may include a shaft; a cutting element coupled to the shaft, the cutting element being movable from a substantially straight position to an expanded position, the cutting element having an apex corresponding to a maximum radial extension of the cutting element when in the expanded position; a first ultrasound marker on the cutting element positioned on the cutting element at a position corresponding to the apex when in the collapsed position; a second ultrasound marker which marks a proximal location of the cutting element, and a third ultrasound marker which marks a distal location on the cutting element.
The first ultrasound marker may be closer to the distal location than the proximal location. The second and third ultrasound markers may be located at proximal and distal ends of the cutting element when the cutting element is in the collapsed position.
A still further embodiment is a suction sleeve for a soft tissue interventional device that may include a shaft, the suction sleeve comprising a tapered portion defining a predetermined extent, the tapered portion defining a first external surface and a first internal surface, the first internal surface defining an internal axial lumen spanning the predetermined extent, the internal axial lumen being configured to receive the shaft, the first external surface defining a suction port and a plurality of openings that open to the internal axial lumen.
According to a still further embodiment, the present invention is a method for cutting a specimen of soft tissue, comprising the steps of providing a device including a handle, a shaft coupled to the handle and defining a first end and a second end, a cutting element coupled to the second end of the shaft, and a suction sleeve disposed coaxially around the shaft between the first end of the shaft and the cutting element, the suction sleeve defining a suction port and a plurality of openings near the work element, the suction sleeve being configured to enable suction in through the plurality of openings and out through the suction port; inserting the device in the soft tissue; cutting the tissue specimen using the cutting element, and applying suction to the suction port during the cutting step.
Another embodiment is a method of excising breast tissue, comprising the steps of providing a guide element and a cutting device, the cutting device having a deployable cutting element mounted on a shaft; introducing the guide element into a patient's breast; advancing the cutting device into the patient's breast, the cutting device being slidably coupled to the guide element so that the guide element guides the cutting device as the cutting device may be advanced into the patient's breast; deploying a cutting element on the cutting device after the advancing step; rotating the shaft so that the cutting element severs breast tissue; and removing the breast tissue which has been severed by the cutting element.
The rotating step may be carried out with the shaft rotating less than 180 degrees relative to the guide element. The providing step may be carried out with the guide element being a needle. The providing step may be carried out with the guide element having at least one indicator for indicating an angular orientation with respect to a longitudinal axis of the guide element. The rotating step may be carried out using the angular orientation indicated by the at least one indicator. The rotating step may be carried out with at least two angular orientations indicated on the guide element at least one of which being selected by the user. The removing step may be carried out with the severed breast tissue being contained in a collection element carried by the cutting device. The removing step may be carried out with the collection element surrounding and isolating the severed tissue from the surrounding tissue.
A still further embodiment of the present invention is a system for removing breast tissue, comprising: a guide element; and a cutting device, the cutting device having a deployable cutting element mounted on a shaft, the cutting device being configured to be slidably coupled to the guide element.
The guide element may be or include a needle. The guide element may have a first indicator for indicating an angular orientation. The cutting element may be deployed by bowing an elongate cutting element. The cutting element may be coupled to a source of RF energy. The system may further include a tissue collection element carried by the cutting device, the tissue collection element surrounding the severed tissue.
Another embodiment of the present invention is a method of cutting a piece of breast tissue, comprising the steps of: providing a tissue cutting device having shaft and a cutting element, the cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outward when moving from the collapsed position to the expanded position; introducing the tissue cutting device into a breast; expanding the cutting element toward the expanded position; rotating the shaft so that the cutting element cuts the breast tissue; and partially collapsing the cutting element after the expanding and rotating steps so that a portion of the tissue remains trapped between the cutting element and the shaft.
The cutting element may be locked in the partially collapsed position. The tissue with the tissue cutting device may be manipulated while the cutting element is partially collapsed. The method may include a step of manipulating the tissue with the tissue cutting device while the cutting element is partially collapsed. The tissue may be moved into a tissue collection element while the tissue is trapped by the partially collapsed cutting element. A tissue removing channel may be cut through breast tissue while the tissue is trapped between the cutting element and the shaft. The introducing step may be carried out with the tissue cutting device extending along an introduction path separate from the tissue removing channel.
These and other aspects of the present invention will become apparent from the following drawings and description.
Referring to
The needle 2 may also have one or more indicators 14 to mark an angular position relative to the longitudinal axis 16 of the needle 2. The indicator 14 extends radially outward from the needle at a angle selected by the user. The indicator 14 may also simply be a longitudinal stripe 18 or other marking on the shaft which indicates a particular angular orientation on the needle 2. The indicator 14 may provide information to the user regarding various parameters depending upon the procedure being performed. For example, when using the device 6 described above, the angular position, or positions, provides the user with the angular extent of the tissue to be removed.
The indicators 14 may be coupled to one more anchors 20 which are deployed to anchor the needle 2. The anchor 20 is preferably curved, such as J- or C-shaped, and extends radially to lie within the same angular orientation as the indicator 14. An advantage of coupling the indicator 14 to the anchor 20 is that anchor 20 itself provides information regarding the relative orientation or the needle 2, anchor 20 and tissue area of interest. Thus, the anchor 20 itself may be one of the indicators 14. Although the anchor 20 and indicator 14 are preferably aligned at the same angular orientation, they may also be offset to account for the geometry of other devices used with the needle 2. As can be appreciated, of course, the indicators 14 may also be independent of any anchoring elements. For example, the needle 2 may be placed in the breast and the indicators 14 could then be moved to selected angular position(s). The needle 2 may also have depth markers 22 along the body. The anchor 20 is preferably a stainless steel wire having a sharpened tip to pierce through the tissue. The orientation of the anchor 20 is partially guided by the geometry of the arc-shaped lumens (not shown) receiving the anchors 20.
Use of the device is now described in connection with a tissue removal procedure with reference to
The stiffener 4 is then removed to provide the flexible proximal portion. The flexible proximal portion may be taped to the patient to prevent inadvertent contact as shown in
An incision into tissue is made with a blade;
The physician then inserts the assembly including the trocar 1102 into the tissue and pushes the combination introducer and suction sleeve 902 into the tissue through the incision into position under or near the lesion or targeted site within the tissue. The pointed and/or sharp distal tip 1104 of the trocar 1102 and the tapered profile of the combination introducer and suction sleeve 902 aid the assembly's advancement within the tissue;
The trocar 1102 may then be removed from the combination introducer and suction sleeve 902 and a desired (excisional RF, for example) device may then be inserted therethrough, with the shaft thereof disposed within and protruding from the internal lumen 916;
The combination introducer and suction sleeve 902 may then be pulled back until it contacts, snaps and/or otherwise locks onto the device, as shown at
A vacuum line, such as shown at 116, may then be attached to the suction port 908;
If needed, the device with the combination introducer and suction sleeve 902 attached thereto may then be repositioned at, near, under or within the target lesion, as desired. This repositioning may be carried out under ultrasound guidance, for example. The openings 906 may aid with the ultrasound visualization. The combination may include other features and/or markings to increase the visibility thereof under various imaging modalities, and
The physician may then continue with the intended procedure as per the instructions for use of the device utilized.
Alternatively, the trocar 1102 may be removed from the combination introducer and suction sleeve 902 and the desired RF device introduced and locked therein. The distal tip of the desired RF device protruding from the distal end of the combination introducer and suction sleeve 902 may then be used to reach the intended biopsy site.
Alternately still, a stopcock may be attached to the suction port 908 instead of the suction line 116 and one or more beneficial agents (e.g., antibiotics, fibrin, lidocaine) may be delivered to a target site through the openings 906.
The present combination vacuum sleeve and suction sleeve 902 may aid in positioning a biopsy or other interventional device where it is needed. For example, interventional devices that include a rather bulky or high-drag distal end may be readily positioned at the intended site by means of the introducer functionality of the combination 902. While the combination 902 is advantageous before the biopsy or other interventional procedure is started by easing the positioning of the biopsy instrument at or near the target site, it is also useful during the procedure itself, as it is effective in evacuating hot gasses and fluids from the biopsy cavity, thereby decreasing collateral tissue thermal damage. The same combination may then also be used to treat the cavity post-procedure by, for example, providing a ready-made pathway for the introduction of beneficial agents, compositions and/or cavity treatment devices to the cavity or lesion site.
Referring now to
The guide member 202 has a tubular body 206 and a removable penetrating element 208 having a sharp tip 210 for piercing tissue during introduction. The guide member 202 also has a port 212 coupled to a vacuum source 214 for removing hot gasses generated during cutting. The penetrating element 208 has a shaft 216 extending through a lumen 217 in the guide member 202. The guide member 202 may include one or more anchors 218 which holds the guide member 202 at the desired position. The anchor 218 may simply be an adhesive strip 220 which the user peels away from the body and adheres to the skin. The anchor 218 may also be another suitable anchor such as one or more needles 221 which are advanced into the tissue. The anchors 218 help to resist movement of the guide member 202 so that the guide member 220 may be used to guide longitudinal and even rotational positioning of the cutting device 204 as explained herein. Referring to
After the guide member 202 has been introduced to the desired depth, the penetrating element 208 is then removed and the tissue cutting device 204 is introduced and advanced into the guide member 220 (
Referring again to
Referring now to
The shaft 240 may be formed in any suitable manner. Referring to
Use of the system 200 is now described with reference again to
Once the guide member 202, 202A has been positioned properly relative to the desired cutting operation the tissue penetrating element 208 may be removed and the cutting device 204 is introduced into the guide member 202. The guide member 202 is then retracted a predetermined amount so that the guide member 202 is properly positioned to remove hot gases generated during RF cutting as described above. When using the guide member 202A having the cutting window 226, the guide member does not, of course, need to be retracted.
The cutting device 204 is then used to cut around the tissue to be removed. The tissue may be removed in a tissue collection element 10 (see
Referring now to
To accommodate the removable transducer core 400, the excisional device 100 of
In
A number of peripheral devices may be connected to the assembly 600. Examples of such include a core power source 480, which may be, for example, an electrical source for an ultrasound transducer, one or more data processing and display devices 550 on which the internal structure of the tissue imaged by the active element 440 of the core 400 may be displayed, suction means 490, a cutting tool power source (a variable RF energy source, for example or any suitable RF power source found in most operating rooms), and/or other devices 590. The suction device 490 may provide a suction force to the window 120 through an internal lumen to facilitate cutting of the tissue by the cutting tool 125. Any other suitable cutting or excisional device may be used in connection with the present invention such as those described in U.S. Pat. No. 7,044,956, issued May 16, 2006.
The vacuum means may be associated with the cutting tool 125 (
The tissue removal device 300 may be introduced through the same incision as the tissue cutting device 204 or may be introduced through a different incision. For example, the user may choose to introduce the cutting device 204 based primarily on the desired orientation of the cutting device 200 relative to the tissue area being removed. The user may then choose the removal incision based on other factors such as proximity to the skin or for cosmetic considerations. Referring to
Referring to
When removing the tissue, the tissue may be contained within a tissue collection element 320 released by the cutting device 204 when the tissue is severed or which is deployed by itself after excision of the tissue. The tissue collection element 320 may simply trail the cutting element 205 similar to the patents and applications incorporated by reference herein in which the tissue collection element remains coupled to the device.
Referring still to
Referring to
The tissue cutting device 204 may also mark the tissue sample and/or the tissue surrounding the tissue sample as shown in
The present invention has been described in connection with the preferred embodiments, however, it is understood that many alternatives are possible without departing from the scope of the invention.
This application is a divisional of application Ser. No. 10/923,511, filed Aug. 20, 2004, which is a continuation-in-part of application Ser. No. 10/732,670, filed Dec. 9, 2003, and a continuation-in-part of application Ser. No. 10/272,448, filed Oct. 16, 2002, now U.S. Pat. No. 6,936,014, issued Aug. 30, 2005, and a continuation-in-part of application Ser. No. 10/796,328, filed Mar. 8, 2004, which is a continuation of application Ser. No. 09/417,520, filed Oct. 13, 1999, now U.S. Pat. No. 6,423,081, issued Jul. 23, 2002, which is a divisional of application Ser. No. 09/146,743, filed Sep. 3, 1998, now U.S. Pat. No. 6,022,362, issued Feb. 8, 2000, all applications and patents of which are hereby incorporated herein by reference in their entireties and from which priority is hereby claimed under 35 U.S.C. §119(e) and §120.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10923511 | Aug 2004 | US |
| Child | 11740858 | Apr 2007 | US |
| Parent | 09146743 | Sep 1998 | US |
| Child | 09417520 | Oct 1999 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10732670 | Dec 2003 | US |
| Child | 10923511 | Aug 2004 | US |
| Parent | 10272448 | Oct 2002 | US |
| Child | 10923511 | Aug 2004 | US |
| Parent | 10796328 | Mar 2004 | US |
| Child | 10923511 | Aug 2004 | US |
| Parent | 09417520 | Oct 1999 | US |
| Child | 10796328 | Mar 2004 | US |
