Abstract:
A staple delivery applicator for delivering radioactive staples during brachytherapy medical treatment has an actuating device for attaching source staples located distally thereform. The actuating device is removably attachable to an actuator arm on a proximal end. A staple applicator cartridge holder is attached to the actuator arm on a distal end. The staple applicator cartridge is mountable in the holder and has slots for mounting of radioactive source staples therein. An anvil therein crimps the staples. The staple applicator cartridge holder is removably mountable in a connector and the connector is also removably mounted to a surgical staple holder. A trigger device has a control for closing the anvil of the cartridge holder and for firing of the source staples in the cartridge therein to cause the staples to crimp, and a control for opening the anvil and releasing the trigger device from the actuator arm.

Description:
REFERENCE TO FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     NIH Grant Numbers 1R43CA125999-01A1, 2R44CA125999-02, 5R44CA125999-03, and 3R44CA125999-03S1 
    
    
     CROSS REFERENCES TO RELATED APPLICATIONS 
     NA 
     REFERENCE TO JOINT RESEARCH AGREEMENTS 
     NA 
     REFERENCE TO SEQUENCE LISTING 
     NA 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to medical treatment, and, in particular, relates to the medical treatment by use of: brachytherapy, and, in greater particularity, relates to medical treatment by the use of multiple sources of radiation using a staple applicator. 
     2. Description of the Prior Art 
     The use of stapling devices for lung resection is necessary due to the complex nature of the lung and the treatment where there is poor pulmonary health or other medical issues that do not allow lobectomy. 
     When removing non-small cell lung cancers, the most prevalent form of lung cancer, for example, the use of radioactive sources near the cancer site provides another mode of treatment. One issued patent discloses the use of staples containing a radioactive material and the attachment of these staples near the surgical resection. These staples are placed in conventional staple cartridges and are thus placed near the resection. 
     The following references are incorporated by reference: U.S. Pat. Nos. 6,945,141; 7,494,039; 7,510,107; 7,604,151; and; 7,604,586. 
     Accordingly, there is an established need for a staple delivery applicator having means for accurate placement of the radioactive staples in surgical sites. 
     SUMMARY OF THE INVENTION 
     The present invention is directed at a staple delivery applicator for use with radioactive staples. 
     A staple delivery applicator for delivering radioactive staples during brachytherapy medical treatment has an actuating device for attaching source staples located distally from the actuating device. The actuating device is removably attachable to an actuator arm on a proximal end. A staple applicator cartridge holder is attached to the actuator arm on a distal end. The staple applicator cartridge is mountable in the holder and having a plurality of slots for mounting of radioactive source staples therein. An anvil therein crimps the staples. The staple applicator cartridge holder is removably mountable in a connector and the connector is also removably mounted to a surgical staple holder. In one embodiment a trigger device has a control for closing the anvil of the cartridge holder and for firing of the source staples in the cartridge therein to cause the staples to crimp, and a control for opening the anvil and releasing the trigger device from the actuator arm. 
     An object of the present invention is to provide a means for irradiating cancer tissue with the use or staples in lung, colorectal and gynecological cancers, for example. 
     It is another object of the present invention to provide an effective therapeutic modality for patients unable to undergo a surgical lobectomy; it is an alternative to external beam irradiation for patients who cannot tolerate further loss of lung function. 
     It is a further object of the present invention to provide a means to precisely deliver the brachytherapy sources intraoperatively to achieve the proper dose distribution and minimizing the radiation dose to the clinicians performing the procedure. 
     It is still a further object of the present invention to provide a means for precise placement of brachytherapy sources relative to the surgical margin, assuring the sources remain fixed in their precise positions for the duration of the treatment, overcoming the technical difficulties of manipulating the sources through the narrow surgical incision, and reducing the radiation dose to the clinicians. 
     It is yet a further object of the present invention to provide a delivery device having better shielding than the existing stapler cartridges, thereby providing greater safety to the physician and other operating room personnel. 
     It is yet a further object of the present invention, to provide a device that reduces the possibility of mis-locating sources by reducing and/or by limiting the number of: potential source positions to only dosimetrically useful positions, rather than all staple positions, and further locating the sources nearer to the center of the treatment volume rather than at its edge. 
     These and other objects, features, and advantages of the present invention will become more readily apparent from the attached drawings and the detailed description, of the preferred embodiments, which follow. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The preferred embodiments of the invention will hereinafter be described in conjunction with the appended drawings provided to illustrate and not to limit the invention, where like designations denote like elements, and in which: 
         FIG. 1A  is a left side perspective view of an applicator of the present invention; 
         FIG. 1B  is right side perspective view of the applicator of FIG. A of the present invention; 
         FIG. 1C  is a right side perspective view of the applicator of  FIG. 1B  showing an anvil of a cartridge in the open position of the present invention; 
         FIG. 2  is a right side view of a cartridge unit separated from a trigger of  FIG. 1A  of the present invention; 
         FIG. 3A  is a right side view of the applicator of  FIG. 1A  having a right side housing removed. from the trigger of the present invention; 
         FIG. 3B  is a left side view of the applicator having a left side housing removed from the trigger of the present invention, showing the back of the toggle knob on the right side of the applicator of  FIG. 1B ; 
         FIGS. 3C to 3D  show a reverse switch. mechanism that interacts with the toggle rods of the toggle knob for changing the direction of cable movement; this being one possible mechanism; 
         FIG. 4A  is a partial perspective view of the cartridge unit of  FIG. 2  along side of a surgical staple cartridge with a connector located below in the present invention; 
         FIG. 4B  is a partial perspective view as in  FIG. 4A  but showing the connector installed on the cartridges; 
         FIG. 5A  is a partial side view of the cartridge unit of  FIG. 2  with the anvil open showing by x-ray view an inside of the cartridge unit of the present invention; 
         FIG. 5B  shows the anvil closed as compared to  FIG. 5A  of the present invention; 
         FIGS. 6A to 6D  shows by perspective views one embodiment of the connector of the present invention; 
         FIGS. 7A to 7B  shows by perspective views the embodiment of both modular units being installed together; and 
         FIGS. 8A and 8B  illustrate several actuating devices in addition to the trigger device as shown above for operating the cable attached to the cartridge unit. 
     
    
    
     Like reference numerals refer to like parts throughout the several views of the drawings. 
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention is directed at a radioactive staple delivery applicator applicable to surgical procedures having the need for attaching radioactive devices. 
     The incidence of lung cancer has been rising over the last half century, although the rate has decreased somewhat over the last decade because of increased publicity about the health risks. The American Cancer estimates the number of new cases in 2009 to exceed 219,000. Lung cancer is the leading cause of cancer deaths in the United States among both men and women, expected to reach 159,000 in 2009, claiming more lives than colon, prostate and breast cancer combined. i  (See IDS for references) 
     Non-small cell lung cancer (NSCLC) is the most commonly diagnosed form of the disease, affecting 4 out or 5 patients. In United States, ˜23% of patients present with early-stage (T1, T2) disease. ii  In most cases, early stage NSCLC can be treated successfully with surgery if the cancer has not spread beyond the chest. Surgical resection is the definitive treatment and lobectomy is the procedure of choice. iii,iv,v  Lobectomy is the most common type of lung cancer surgery, involving removal of an entire lobe of one lung. For these early stage NSCLC patients, lobectomy yields a 5-year survival rate of 65-77%. Locoregional recurrence occurs in 28% of T1N0 tumors submitted to thoractomy, with the highest initial failure rates detected in the ipsilateral hemithorax. vi, iii    
     Unfortunately, some patients with this disease are poor candidates for lobectomy due to poor pulmonary health or other medical issues. 
     Stage I NSCLC patients with compromised. cardiopulmonary status may undergo limited surgical resections in an attempt at lung preservation while achieving adequate resection margins. vii  However, lesser resections have been associated with an increased risk of local recurrence, even for small peripheral tumors. viii  Nonetheless, limited resection is viewed as an acceptable alternative for patients with poor physiologic reserve or of advanced age. vii, ix    
     Though sublobar resection alone is associated with an increased incidence of post-operative disease recurrence, it is still advocated for high-risk patients in the absence of a good alternative. External beam radiation therapy has been used successfully to reduce the risk of local recurrence in these compromised patients. x  However, external beam radiation therapy further reduces pulmonary function because it generally requires the beam to pass through normal lung tissue to reach the target lesion. Some studies suggest that adding brachytherapy to the regimen can make a dramatic difference in outcomes. 
     Intraoperative brachytherapy has been shown to be an effective therapeutic modality for patients unable to undergo a surgical lobectomy; it is an alternative to external beam irradiation for patients who cannot tolerate further loss of lung function. xi, xii    
     The use of brachytherapy has been shown in several studies to have a clinical benefit for compromised lung cancer patients for whom more traditional surgical procedures, such as a lobectomy, are not an option. This is now the subject of a NTH-sponsored Phase III Clinical trial. xiii    
     Use of Brachytherapy: These candidate patients would. undergo limited (sublobar) surgical resection. (wedge resection) in an attempt at lung preservation while achieving adequate resection margins, followed by brachytherapy. Currently, brachytherapy is performed using  125 Iodine seeds delivered at the time of surgery. Seeds have been deployed by a variety of techniques such as manually suturing stranded seeds, xiv  manually delivering loose seeds via a Mick® applicator, thoracoscopic placement of vicryl mesh imbedded with  125 Iodine radioactive seeds, and seed placement in the wedge resection margin using the da Vinci robotic system. xvi    
     The problem with all of these techniques is the difficulty in precisely delivering the brachytherapy seeds intraoperatively to achieve the proper dose distribution and minimizing the radiation dose to the clinicians performing the procedure. 
     The present invention will facilitate the precise placement of brachytherapy sources relative to the surgical margin, assure the sources remain fixed in their precise positions for the duration of the treatment, overcome the technical difficulties of manipulating the sources through the narrow surgical incision, and reduce the radiation dose to the clinicians. 
     The Source: The present invention provides “staple-like” sources that will be secured in position directly adjacent to the surgical resection and will be immobile. They will be precisely located relative to the resection, placed by a very convenient method eliminating the difficulties of working through the narrow surgical incision. The source position will be rigidly fixed, assuring the dose distribution will not uncontrollably change over the duration of the treatment. This method will permit the dose distribution to be precisely planned prior to the surgery to achieve the desired result. This technique will, also significantly reduce the dose to the clinician. 
     Turning to the drawings, wherein like components are designated by like reference numerals throughout the various figures, attention is initially directed to  FIG. 1A , which illustrates by a perspective view a staple delivery applicator  10  constructed according to the present invention. 
     The staple delivery applicator  10  is composed of a trigger device  12  and a cartridge unit  14 ,  FIG. 1A , with a source staple cartridge  16  mounted in a cartridge holder  74 . The cartridge holder  74  is mounted to a distal end  20  of an actuator arm  22  by a cartridge holder  74 /actuator arm connector  107 ,  FIG. 5A . The cable  36 /sled connector  118 ,  FIGS. 5A and 5B , allows flexible movement between the cable  36  and the sled  102  within the actuator arm  22 . The actuator arm  22  is removably mounted to the trigger device  12  at a proximal end  24  by a release lever  34 . The trigger device  12  has multiple controls thereon to operate the attachment of the staples, not shown. The trigger device  12  has a lever  26 , a handle  28 , and a release knob  30  as shown in  FIG. 1A , and a toggle knob  32 ,  FIG. 1B . 
       FIG. 1B  shows the right side of the applicator  10  and the trigger  12  having the toggle knob  32  thereon.  FIG. 1C  shows the applicator  10  having an. anvil  61  in the open position.  FIG. 2  shows the actuator arm  22  removed from the trigger  12  with a cable  36  extending from a tube  40  at the proximal end  24 . The spring loaded, release lever  34  allows the actuator arm  22  to be removed from the trigger  12  as needed. 
     Referring to  FIG. 3A , a right side housing  38  is removed from the trigger  12  to show partially the interior thereof. A gear  42  is mounted to a central shaft  44 . The gear  42  translates/acts upon the cable  36  that is supported within cable guides  48 . The back of the toggle knob  32 ,  FIG. 3B , has a pair of toggle rods  100  that act upon a toggle switch  46 ,  FIG. 3A . When the toggle switch  46  is reversed by the turning of the toggle knob.  32 , the release knob  30  can be then turned to translate the cable  36  out of the trigger  12  to be released.  FIG. 3D  shows one embodiment of a reverse switch mechanism  120 . The reverse switch mechanism  120  allows the gear  42  to reverse direction such as in a wrench ratchet As shown in  FIG. 3D , a reverse switch mechanism  120  is comprised of a ratchet  137 , which is connected to the central shaft  44 , and a pawl  133 . A spring  135  biases a lever  131  to hold the pawl  133  in place. The rotating member  138  is connected to the toggle switch  46 ,  FIG. 3C . The pair of toggle rods  100  are shown in  FIG. 3C  with a travel line in dashes as the toggle knob  32  is turned. In operation, if the right toggle rod  100  is turned. clockwise, it will push the bottom of the toggle switch  46  clockwise to the position as shown in  FIG. 3C . As a result, turning of the central shaft  44  in a counterclockwise direction is prohibited since the teeth of the ratchet and pawl are engaged  134  and the pawl hits a wall  136 , preventing movement. Clockwise rotation is possible as this motion moves the ratchet  137  clockwise, pushing the pawl  133  into the lever  132  and compressing the spring  135 . When the right toggle rod  100  is rotated counterclockwise, it pushes the bottom of the toggle switch  46  clockwise and the detent mechanism functions in the opposite direction. Clearly other embodiments of such a reverse switch are possible in light of the present invention and in light of the incorporated patents. 
     The trigger device  12  as shown above is one embodiment of an actuating means or device for operating the cable  36  in the actuating arm  22 . Referring to  FIGS. 8A and 8B ,  FIG. 8A  illustrates a manual means for operating the cable  36  by attaching a handle  130  to the cable  36 . It should be understood that the cable  36  has appropriate teeth thereon to engage the gear  42 , but this is not required in that other actuating means may be used to move the cable  36 . As shown, the handle  130  is attached to the cable  36  that extends from the actuating arm  22 . The cable  36  is secured in the handle  130  by a locking means  132 . The operator would then grasp the handle  130  and the tube  40  of the actuating arm  22  and move the cable  36  as desired and in a manner consistent with the movement noted above, Another embodiment of the actuating means is shown in  FIG. 8B  that is an electric actuating means  140  that is connected onto the actuating arm  22  by a release lever  34  such as shown on the trigger device  12 . A power source  144  such as batteries or an external source provides power to a reversible electric motor  142  that is geared to mesh with the cable  36 . A forward or reverse switch  146  is used to control the movement of the cable  36  within the actuating arm  22 . 
     To better understand the operation of the applicator  10 ,  FIGS. 1A ,  3 A, and  4 A, the source cartridge  52  is loaded, into the source cartridge holder  74 . With the cartridge  52  in place, the actuator sled  102 ,  FIGS. 5A and 5B , is pushed toward the proximal end of the cartridge holder  74  and into the proximal end of the anvil  61  and causes the source anvil  61  to open as shown in  FIG. 5A . The source anvil  61  is a part of the source staple cartridge holder  74  and is pivoted, at a pivot  104 . An upper spring  106  forces an end  108  of the source anvil  61  into a first detent  110  to open. As the attached cable  36  is slightly retracted, the end  108  rides up an inclined, groove to a top  112  of the actuator sled  102  and closes the anvil  61 ,  FIG. 5B . Further pulling of the lever  26  in a clockwise direction, to further retract the cable  36  causes a sled. hammer  114  to push up on the bottom of inclined pushers  109  that push up on the bottom of the source staples therein crimping them. After the crimping is completed, the end  108  fails into a second detent  116  in the sled  102  and then opens the anvil  61 . The source cartridge  52  then can be removed. At that point, the cable  36  is fully retracted. In order to reverse the cable  36  movement in direction, at any time, the toggle knob  32  is rotated to cause the toggle rods  100 ,  FIG. 3B , to change the position of the reverse switch  46 . Then, toe release snob  30  is rotated to push the cable  36  back and the actuator sled.  102  back into the cartridge holder  74 . The toggle knob  32  must then be reset to its initial setting so that the cable  36  can be retracted. Manual operation of the applicator  10  may be obtained by allowing the cable  36  to extend from a rear of the trigger  12  with the attachment of a handle thereon. The handle can be pulled to retract the cable  36  and pushed in to return the cable  36 . The toggle knob  32  would have to be also appropriately turned in the manual operation. 
     In one embodiment as best shown in  FIGS. 4A and 4B , the delivery applicator  10  may be attached in a parallel manner to an existing surgical staple device  50  such as disclosed in U.S. Pat. No. 7,494,039. The applicator  10  may also be positioned in a parallel manner next to the surgical stapler cartridge as shown in  FIG. 4B . The applicator cartridge  52  contains radioactive sources/staples, not shown (see U.S. Pat. No. 7,604,586 showing radioactive staples which is incorporated by reference) in predetermined positions  54 : two rows with staggered slots  56 ,  FIG. 4A . Other configurations of the slots  56  are clearly appropriate and would be designed based upon the medical need for such. There may be a standard set of slots such as shown in  FIG. 4A , but the source staples could be placed therein as desired. After deployment of the conventional surgical staples, not shown also, the applicator staples would be independently deployed by use of the trigger  12  immediately adjacent to the surgical staples. The fixed relationship by use of a connector  58  on the applicator cartridge  52  to the surgical staple cartridge  50  assures an accurate fixed position of the source/staples relative to the surgical staples, and therefore the surgical resection margin created by the surgical staple device having a cutting means therein. 
     Currently, surgical staples are delivered by a wedge-shaped driving element within the cartridge which presses a piston through the cartridge cavity causing the staples to be pressed against, an anvil  60  causing the staple legs to be bent over within an anvil bending device such as seen in a common stapler. 
     The applicator cartridge holder  74  is attached to either the right-hand or left-hand side of the surgical stapler cartridge  50  so as to be useful on either leg/side of a typical wedge resection. Source positioning will not be restricted to the typical. “1-centimeter” spacing that is currently used. The ability to have closer source positioning, especially at the ends of the line of sources, will afford the opportunity to differentially load the cartridge (i.e. have greater activity at the ends) to compensate for the dose “drop-off” typical of such an array of sources/seeds. 
     One embodiment of the present invention has a one-piece connector  58 ,  FIGS. 6A to 6D  and  FIGS. 4A and 4B , for holding both the conventional surgical staple cartridge  50  and the applicator cartridge  52  in parallel alignment so that radioactive applicator staples can be applied directly along side of the conventional staples. This provides accurate placement of the radioactive applicator staples near possible cancerous tissues. The other embodiment of the connector is a modular connector  62 ,  FIGS. 7A and 7B , for holding the applicator cartridge  52 , which is connected to the conventional staple cartridge  50  also being held in the modular connector  62 . 
     The staple delivery applicator  10  may use the connector  58 ,  FIGS. 6A to 6D , being the one-piece connector  58  having two parallel channels  64  and  66  for holding the applicator cartridge  52  in channel  66  and the conventional staple cartridge  50  in the channel  64  such as shown in FIG.  4 B. Sets of tabs  68 ,  FIGS. 6C and 6D , in each channel align the cartridge holder  74  to detentes thereon wherein the front ends  70 ,  72 ,  FIG. 4A , of each of the cartridges  FIGS. 6A to 6D  show the one-piece connector  58  in various views. This one-piece connector  58  may fit upon the carrier portion  250  as mentioned and shown in patent &#39;039 above in  FIG. 19 . It should be noted that the surgical staple cartridge channel  64  is wider than the source/staple cartridge channel  66  since there are  6  slot rows in the surgical staple cartridge  50  as compared to  2  in the source cartridge  52 . Further, the width of a separating wall  76  may be varied based on medical requirements. The connector is typically made of plastic and further may include radiation shielding material. The cartridges  50  and  52  are mounted in cartridge holders  74  and  51  that are then pushed. into the channels  64 / 66 . The applicator holder  74  is connected to the actuator arm  22  as to the present invention. 
     The modular applicator connector  78  is shown in  FIGS. 7A and 7B .  FIG. 7A  shows the modular applicator connector  80  being inserted/connected/mounted to one side of a staple device connector  82 . The applicator connector  80  may be attached to either side of the staple device connector  82 .  FIG. 7A  shows On a portion of a male attachment  84  having a row  86  of flexible triangles  88  mounted on the applicator connector  80  vertical side  90 . The other portion of a female attachment  92  being the complement of the male attachment  84  is shown. Both sides  94 ,  96  of the staple device connector  82  have the female attachments  92  so that the applicator connector  80  may be mounted to either side as required during surgery. The modular connector  78  in  FIG. 7B  shows the applicator connector  80  fully inserted onto the device connector  82 . 
     The staple delivery applicator  10  further includes radiation shielding in either the staple cartridge  52  itself or on the applicator connector  58 , preferably in the applicator cartridge  52  since the radioactive staples would be mounted there. The shielding material may be a part of the composition of the cartridge  52  or be a layer of shielding mounted thereabout. The anvil  61  of the cartridge unit  14  may also be shielded to fully prevent exposure from radiation to the operators of the staple applicator  10 . The shielding would minimize the radiation dose to the physician deploying the device as well as to the other personnel in the operating room. The shielding will permit safe storage of this device in the Operating Room until it is time for use. The device will also be designed for sterilization, and resterilization, using steam, ethylene oxide and gamma radiation to provide total flexibility to the hospital. 
     Since any modifications, variations, and changes in detail can be made to the described embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.
       i  Jemal, Siegel, et al. “Cancer Statistics, 2009.” CA Cancer J Clin. 2009;59:225-249.     ii  American College of Surgeons. “National Cancer Database for 2003.” &lt;http://www.facs.org/cancer/ncdb/index.html&gt;.     iii  Ginsberg, R. J. and L. V. Rubinstein. “Randomized Tidal of Lobectomy Versus Limited Resection for T1 N0 Non-Small Cell Luna Cancer.” Lung Cancer Study Group Ann Thorac Surg. 1995 September; 60(3):615-22.
 
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     iv  Martini, Pains, et al. “Incidence of Local Recurrence and Second Primary Tumors in Resented Stage I Lung Cancer.” J Thorac Cardiovasc Surg. 1995 January;109(1):120-9     v  Ichinose, Yano, et al. “The Correlation Between Tumor Size and Lymphatic Vessel Invasion in Resented Peripheral Stage I Non-Small-Cell Lung Cancer.” A potential risk of limited resection. J Thorac Cardiovasc Surg. 1994 October;108(4):684-6.     vi  Choi, N. C. “Prospective Prediction of Postradiotherapy Pulmonary Function. With Regional Pulmonary Function Data: Promise and Pitfalls.” Int J Radiat Oncol Biol Phys. 1988 July;15(1):245-7.     vii  Landreneau, Sugarbaker, et al. “Wedge Resection Versus Lobectomy for Stage I (T1 N0 M0) Non-Small-Cell Lung Cancer.” J Thorac Cardiovasc Surg. 1997 April;113(4):691-8; discussion 698-700.     viii  Warren, W. H. and L. P. Faber. “Segmentectomy Versus Lobectomy in Patients With Stage I Pulmonary Carcinoma.” Five-Year Survival and Patterns of Intrathoracic Recurrence. J Thorac Cardiovasc Surg. 1994 April;107(4):1087-93.     ix  Kodama, Doi, et. al. “Intentional Limited Resection for Selected Patients With T1 N0 M0 Non-Small-Cell Luna Cancer: A Single-Institution Study.” J Thorac Cardiovasc Surg. 1997 September;114(3):347-53.     x  Miller, J. I. and C. R. Hatcher, Jr. “Limited Resection. of Bronchogenic Carcinoma in the Patient With Marked Impairment of Pulmonary Function.” Ann Thorac Surg. 1987 October;44(4):340-3.     xi  Hilaris, B. S. and D. Nori. “The Role of External Radiation and Brachytherapy in Unresectable Non-Small Cell Lung Cancer.” Surg Clin. North Am. 1987 October;67(5):1061-71.     xii  Fleischman, Kagan, et al. “Iodine125 Interstitial Brachytherapy in the Treatment of Carcinoma of the Lung.” J Surg Cocci. 1992 January;49(1):25-8.     xiii  National Cancer Institute. “Phase III Randomized Study of Sublobar Resection. With Versus Without intraoperative Brachytherapy in High-Risk Patients With Stage I Non-Small Cell Lung Cancer.” Protocol ID NCT00107172, ACDSOG-Z4032 SRCI. &lt;http://www.cancer.gov/clinicaltrials/ACOSOG-Z4032&gt;.     xiv  Lee, Daly, et al. “Limited Resection for Non-Small Cell Lung Cancer: Observed Local Control With Implantation of  125 I Brachytherapy Seeds.” Ann Thorac Surg. 2003 January;75(1):237-42.     xv  Chen, Galloway, et al. “Intraoperative  125 I Brachytherapy for High-Risk Stage I Non-Small Cell Lung Carcinoma.” Int J Radiat Oncol Biol Phys. 1999 July 15;44(5):1057-63.     xvi  Pisch, Beisley, et al. “Placement of  125 I Implants With the Da Vinci Robotic System After Video-Assisted Thoracoscopic Wedge Resection: A Feasibility Study.” Int J Radiat Oncol Biol Phys. 2004 Nov. 1;60(3):928-32.