Abstract:
A safety-stop device for use with a trochar which is adjustably attachable to the trochar tube to prevent inadvertent cuts being made to a patient. The safety-stop device has retention component for retaining it onto the trochar tube; a registration component for registering a pre-determined insertion point of the trochar; a stop component for preventing additional insertion of the trochar after the pre-determined insertion point has been attained; and a plurality wings with apertures on the base for securely suturing the safety-stop to a patient by suturing through the apertures and into the patient.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part of my co-pending application, application Ser. No. 11/146,655, filed on Jun. 6, 2005. 
     
    
     STATEMENT REGARDING FEDERALLY-SPONSORED RESEARCH OR DEVELOPMENT  
       [0002]     Not applicable  
       BACKGROUND  
       [0003]     This safety-stop device relates to an improvement in safety features for trochar assemblies [also referred to as trochar], and more particularly to a safety-stop, attachable to a trochar, registerable on a trochar, and use on a trochar to permit puncture-movement of the trochar only to a pre-determined and pre-set depth.  
         [0004]     A trochar is sharp-pointed surgical instrument basically comprised of a stylet [the sharp cutting blades] and a cannula [a small tube for insertion into a body cavity or into a duct or vessel; also referred to herein as trochar tube or a sleeve] and is typically utilized to puncture a body cavity. The stylet is removably housed in the cannula and after the body cavity is punctured, the stylet is removed leaving the cannula in place and in communication with the body cavity whereby endoscopic, and similar, instruments can then be inserted through the cannula and into the body cavity.  
         [0005]     Specific forms of minimally invasive surgical procedures include endoscopic and laparoscopic surgery which typically involve using small incisions and optical instrumentation being inserted into the body cavity. Endoscopy refers to video-assisted surgery that is performed through several small incisions rather than a single large incision. Laparoscopy is endoscopy that is done in the abdominal cavity.  
         [0006]     The primary instrument used for the incisions necessary in these procedures is the trochar. The use of the trochar for these procedures greatly reduces the amount of cutting required in the course of surgery and, concomitantly, reduction of stress to the body. Reduction of stress to the body generally leads to faster recoveries and lower medical costs. Great care, however, must be exercised when performing such body cavity punctures with the trochar as the trochar blades are surgically sharp and the exertion of manual force is required for the blades to pierce and go through the skin and abdominal wall of the patient.  
         [0007]     A primary purpose of our safety-stop device is to prevent the sharp trochar blades from accidentally being inserted too deeply. The inherent act of inserting the trochar and attempting to place it where desired requires applying a great deal of initial force down toward the deep anatomic structures, without being able to visualize them, then by sensing a loss of resistance, discontinuing the thrust.  
         [0008]     All of this is generally done within a fraction of a second. Patient tissue-variability, in thickness and strength, further complicates the estimation of how much force is required, and for how long, to attain safe penetration.  
         [0009]     Excess force, however minimal, or unforeseen factors within the body cavity could lead to piercing or cutting internal organs or other internal structures which could lead to inadvertent and severe life-threatening surgical complications. It has been known that some surgeons extend and use their finger, placed along the sleeve of the trochar, as a makeshift stop. This is awkward, inaccurate, and dangerous.  
         [0010]     Trochars manufactured with shielded tips covering the blades; i.e., a safety shield, provide some aid in preventing inadvertent second cuts. While shielded trochar systems vary in their design, all generally have a spring-loaded retractable shield that covers the cutting tip on the blades of the trochar. The shields are either retracted prior to placement of the trochar in the wound or automatically retract during the placement. Once the sharp tip of the trochar&#39;s blades penetrates an abdominal wall and enters the abdominal cavity, the spring-loaded safety shield automatically deploys, covering the cutting tip and locking in place.  
         [0011]     Theoretically, this prevents or decreases the incidence of damage to the bowel and the major vessels. Injuries can still occur, however, if the trochar is not used properly, if there is a malfunction of the safety shield, or with the presence of bowel adhesions to the anterior abdominal wall. Even with this improvement to the trochar, insertion of the primary trochar blades still remains a blind procedure.  
         [0012]     Laparoscopy is a very commonly performed procedure throughout the world. In the U.S. alone, some 6 million cases are performed annually. The total number of cases is growing, as more specialties (general surgery, urology, gynecology) convert procedures over to the laparoscopic approach. Notwithstanding the safety features developed over the years for the trochar, laparoscopy has a background serious complication rate of approximately three to five per 1,000, due to trochar placement. These include intestinal damage, bladder damage, and most seriously large blood vessel (vascular) injury. Of the vascular injuries, which stand at one to two per 1,000, approximately 23% will die.  
         [0013]     The majority of serious injuries occur when the stylet of the trochar, with cannula attached, is inserted too deeply, damaging the deeper structures within the body. Only 5 cm. maximum length is necessary, to enter the peritoneal cavity at the umbilicus, the most common entry site. However, trochars are 12 to 15 cm. in length, as a one size fits all device. The deep structures, most significantly major blood vessels, can be damaged at 7 to 10 cm., depending on the size of the patient, the degree of gas insufflation raising the abdominal wall, and the angle of thrust executed by the health-care provider.  
         [0014]     Our safety-stop device will function to reduce injuries and deaths to patients undergoing laparoscopic surgery. Moreover, our safety-stop device can be made of any material though, for cost considerations, any form of plastic is best suited. Furthermore it can, but need not, be disposable for further patient safety as a one-time use.  
         [0015]     Additionally, the safety-stop also has a plurality of wings [extensions] as a base support and at least one aperture adjacent to the ends of the wings. The purpose of this structure is to permit the user to secure the base to the patient by suturing the base to the patient through the apertures on the wings. This more effectively and efficiently secures the base to the patient thereby freeing up the user&#39;s hand by not requiring the user to steadily hold the base onto the patient without movement; a difficult position to maintain.  
         [0016]     It also facilitates introduction of surgical instruments through the tube upstanding from the base without fear of excess movement by the user. The base, sutured to the patient, holds fast, without movement, facilitating the procedures to follow.  
         [0017]     Some unique features of our safety-stop device include:  
         [0018]     a. shortening the effective length of the dangerous sharp trochar/sleeve, by gripping the outer sleeve, with a wider diameter cuff;  
         [0019]     b. it can be used with any of the major trochar/sleeve manufacturers&#39; current product-lines;  
         [0020]     c. it does not impede appropriate surgical trochar/sleeve entry, only inadvertent deep entry;  
         [0021]     d. it does not impede performance of the remainder of the surgery;  
         [0022]     e. it is compatible with any other “safety-features” built into other areas of the trochar/sleeve;  
         [0023]     f. it can be placed anywhere along the sleeve, to shorten the effective length, at the surgeon&#39;s discretion, for that particular-sized patient;  
         [0024]     g. it does not require abandoning current surgeon preferences of trochar/sleeve;  
         [0025]     h. it provides a secure entry point for the introduction of surgical instruments for use on the patient;  
         [0026]     i. it does not require new or further training to use;  
         [0027]     j. it will be inexpensive to manufacture and will not thereby add significant cost to a surgical case; 
        k. it can, and will, save lives; and     l. it will save the health-care system millions of dollars in patient disability, emergency rescue surgery, and malpractice exposure.        
 
         [0030]     The foregoing has outlined some of the more pertinent objects of the safety-stop device. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the safety-stop device. Many other beneficial results can be attained by applying the disclosed safety-stop device in a different manner or by modifying the safety-stop device within the scope of the disclosure.  
         [0031]     Accordingly, other objects and a fuller understanding of the safety-stop device may be had by referring to the summary of the safety-stop device and the detailed description of the preferred embodiment in addition to the scope of the safety-stop device defined by the claims taken in conjunction with the accompanying drawings.  
       SUMMARY  
       [0032]     The above-noted problems, among others, are overcome by the safety-stop device. Briefly stated, the safety-stop device contemplates a device for use with a trochar and which is adjustably attachable to the trochar tube to prevent inadvertent cuts being made to a patient. The safety-stop device has retention means for retaining it onto the trochar tube; a registration means for registering a pre-determined insertion point of the trochar; and a stop means for preventing additional insertion of the trochar after the pre-determined insertion point has been attained.  
         [0033]     An additional important feature also includes the structure of the base, with wings and associated apertures, to permit the base to be secured to the patient by suturing the base to the patient.  
         [0034]     The foregoing has outlined the more pertinent and important features of the safety-stop device in order that the detailed description that follows may be better understood so the present contributions to the art may be more fully appreciated. Additional features of the safety-stop device will be described hereinafter which form the subject of the claims. It should be appreciated by those skilled in the art that the conception and the disclosed specific embodiment may be readily utilized as a basis for modifying or designing other structures and methods for carrying out the same purposes of the safety-stop device. It also should be realized by those skilled in the art that such equivalent constructions and methods do not depart from the spirit and scope of the safety-stop device as set forth in the appended claims.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0035]     For a fuller understanding of the nature and objects of the safety-stop device, reference should be had to the following detailed description taken in conjunction with the accompanying drawings in which:  
         [0036]      FIG. 1  is perspective view of a typical trochar assembly.  
         [0037]      FIG. 2  is an elevation, cross-sectional, exploded view of a first embodiment of the safety-stop device.  
         [0038]      FIG. 3  is a plan view of the cap component of the safety-stop device as taken on line  3 - 3  of  FIG. 2 .  
         [0039]      FIG. 4  is a cross-section view of the opposite side, rotated 180°, of the insert  40  as illustrated in  FIG. 2 .  
         [0040]      FIG. 5  is a plan view of the insert as taken on line  5 - 5  of  FIG. 4 .  
         [0041]      FIG. 6  is an elevation view of a second embodiment of the safety-stop device.  
         [0042]      FIG. 7  is a cross-section elevation view of the cap illustrated in  FIG. 6 .  
         [0043]      FIG. 8  is a plan view of a first embodiment of the base of the safety-stop device as taken on line  8 - 8  of  FIG. 6 .  
         [0044]      FIG. 9  is a perspective exploded view of a third embodiment of the safety-stop device.  
         [0045]      FIG. 10  is perspective view of a typical trochar assembly with a second embodiment of the base of the safety-stop attached.  
         [0046]      FIG. 11  is a plan view of the second embodiment of the base of the safety-stop device as taken on line  8 - 8  of  FIG. 8 . 
     
    
     DETAILED DESCRIPTION  
       [0047]     Referring now to the drawings in detail and in particular to  FIG. 1 , a typical trochar assembly  50 , and reference character  10  of  FIG. 2  which generally designates a safety-stop device constructed in accordance with a preferred embodiment thereof.  
         [0048]     The trochar assembly  50  has a set of blades  58  attached to a knob  62  which, after the trochar assembly  50  is used, is removable from the cannula  54  [trochar tube]. The cannula  54 , having a width W, is attached to a head assembly  60  with its components [reference characters  64 ,  66 ,  68 ] thereon. A blade shield  56  with an shield opening  52  at its far end covers the blades  58  to facilitate safe handling of the trochar assembly  50  and to prevent accidental cuttings.  
         [0049]     Typically once the trochar assembly  50  has been used to execute the surgical procedure, the surgeon grasps the knob  62  and pulls the blades  58  with blade shield  56  out from the cannula  54 . The cannula  54  remains and is in communication with the body cavity into which the trochar assembly  50  penetrated. Suitable hoses [not shown], for example, are connected to the inlet/outlet  66  on valve  64 , and the valve lever  66  is positioned on/off [arrows A, B] to, for example, force air or gas into the patient as, and if, necessary to the procedure.  
         [0050]     The safety-stop device  10  has a base component  12 , an insert component  40 , and a cap component  30 . The base  12  has a stem  13  [upstanding member] attached thereto and a base channel  14  which is bore completely therethrough from the bottom [point Z 1 ] of the base to and out of the top of the upstanding member  13  [point Z 3 ].  
         [0051]     The width of the channel  14  at the bottom of the base is X 3 -Y 3 . The width at the opening on the top of the upstanding member  13  is X 5 -Y 5 . Width X 5 -Y 5  is greater than width X 3 -Y 3  in that the channel  14  initiates an outward angling  14 ′ above the bottom of the base  14  at approximately point Z 2  which bears a width X 7 -Y 7  and terminates at the top [point Z 3 ] of the upstanding member  13  defining an opening thereat having width X 5 -Y 5  wherein width X 5 -Y 5  is greater than width X 7 -Y 7  and wherein width X 7 -Y 7  could be equal to or greater than width X 3 -Y 3 . The width of the base  12  [X 9 -Y 9 ] is substantially greater than the width of the upstanding member  13  [X 8 -Y 8 ]. It is this base width [X 9 -Y 9 ] which functions as a stop. The external surface of upstanding member  13  is threaded.  
         [0052]     The insert  40 , a collet-like component, is configured to fit and seat into the base channel  14 ,  14 ′ at approximately point Z 2  with its exterior surface  44 ′ bearing an angle approximately equal to angle  14 ′. In this regard, the insert  40  has a height [Z 2 ′ to Z 3 ′] which is slightly larger than the distance from point Z 2  to point Z 3 . The insert  40  has a bore  44  vertically disposed therethrough [insert channel]. The width of the insert channel  44  is X 2 -Y 2 . The width of the top of the insert  40  is X 4 -Y 4  and the width at the bottom of the insert  40  is X 6 -Y 6 . As the insert  40  is structured to seat into the base channel  14 , width X 4 -Y 4  is slightly greater than width X 5 -Y 5 , and width X 6 -Y 6  is slightly greater than width X 7 -Y 7 .  
         [0053]     As illustrated in  FIGS. 2 and 4 , the insert  40  may have one or more vertical slots  46 A on the bottom [ FIG. 2 ] or one or more vertical slots  46 B on the top or any combinations thereof. The slots may be extend upward or downward, respectively, partially or, as illustrated in  FIG. 5 , vertically extend the full distance from top to bottom [reference character  46 C].  
         [0054]     The cap  30  has a hollow interior with threading  38  on the interior surface thereof. The interior threading [female threading]  38  of the cap  30  corresponds with the exterior threading  18  [male threading] of the upstanding member  13 . Once the insert  40  is seated into the upstanding member  13  and the cap  30  threaded over the upstanding member  13  a sealing, retaining, and registering unit is formed. On the top of the cap  30  is a cap aperture  34  which has a width X 1 -Y 1 .  
         [0055]     In this embodiment widths X 1 -Y 1 , X 2 -Y 2 , X 3 -Y 3  are approximately equal and each are approximately equal to or slightly greater than the trochar tube  56 , width W. In operation, there are many methods of attaching the safety-stop device  10  to the trochar assembly  50 ; i.e., whether the trochar assembly  50  is inserted into the safety-stop device  10  after the safety-stop device  10  has been assembled as a unit or before such assembly as a unit, or whether the assembled or unassembled safety-stop device  10  is inserted onto the trochar assembly  50 , or any combinations there.  
         [0056]     The final configuration will have the cap  30  distal from the shield opening  52  with the threaded interior  38  facing the shield opening  52 . Next is the insert  40 , wider end first, followed by the base  12  with its bottom facing the shield opening  52 . The insert  40  is seated into the upstanding member  13  and the cap  30  and the upstanding member  13  are connected. In view of the larger size of the insert  40 , this connection causes the insert  40  to press against the cannula  54  and tighten and secure around it. The slots  46 A,  46 B,  46 C, depending on which configuration of insert  40  is being used, are squeezed and close or pinch in the process. The tighter the connection between cap  30  and base/upstanding member unit  12 ,  13 , the more securely the safety-stop device  10  is contained on the cannula  54 .  
         [0057]     Loosening the connection between the base/upstanding member unit  12 ,  13 , loosens the connection between the safety-stop device  10  and the cannula  54  to thereby permit the safety-stop device  10  to translate back and forth on the cannula  54  to any desired point for a pre-determined depth in execution. Once that pre-determined point is established, the safety-stop device  10  is secured to the cannula  54 , the trochar assembly is ready to use, and the base  12  acts as a stop once it contacts the skin of the patient to prevent further penetration into the patient&#39;s body cavity.  
         [0058]      FIGS. 6-8  illustrate a slightly different safety-stop device  10  configuration without an insert  40 . Here the base  12  and upstanding member  13  unit are configured externally basically as described above. In this embodiment the upstanding member  13  has one or more vertically disposed slots  16 , no internally angled walls  14 ′, and a width W 3 -W 4  at the top. The cap  30  is basically identical except that is has one or more vertically disposed fins  32  on its exterior surface to aid the user in tightening the cap  30  onto the base/upstanding member unit  12 ,  13 . The threading  38  on the inside surface is somewhat tapered in that the width W 1 -W 2  at the top is less than width W 3 -W 4  at the top of the upstanding member  13 .  
         [0059]     The cap aperture  34  has a width X 1 -Y 1  and the channel aperture  14  at the bottom of the base  12  has a width X 3 -Y 3 . Each of these widths [X 1 -Y 1  and X 3 -Y 3 ] are equal to or slightly greater than the trochar tube  54  width W.  
         [0060]     As before, once the safety-stop device  10  and the trochar assembly  50  are attached, tightening the cap  34  over the upstanding member  13 , with its smaller width W 1 -W 2 , squeezes the upstanding member  13  tightly [in the directions of Arrows D] over the trochar tube  54 . Loosening the cap  34  permits the user to slide the safety-stop device  10  to any desired location on the trochar tube  54 , re-tighten the cap, and use the trochar assembly  50 .  
         [0061]     A third embodiment of the safety-stop-device  110  is illustrated in  FIG. 9 . Here the upstanding member  13  on the base  13  is not threaded. It has one or more vertically disposed slots  16  and may, but need not, have a collar  22  at the top of the upstanding member  13  to aid in retaining the clamp  20 . In operation, the clamp  20  generally is first placed on the trochar tube  54  followed by the base/upstanding member unit  12 ,  13  through the base channel  14 .  
         [0062]     Once the unit  12 ,  13  is slid on the trochar tube  54  where desired, the clamp  20  is placed over the upstanding member  13  and secured thereover. Any suitable clamping device will suffice. As illustrated in  FIG. 9 , an over-center clamp  20 , with lever  24 , is utilized because of its ease of use to lock and unlock the clamp  20 . Simply moving the lever  24  in the direction of Arrow C tightens the clamp  20  over the upstanding member  13 , and squeezes the upstanding member  13  tightly on the trochar tube  54 . The slots  16  in the upstanding member  13  cause the upstanding member  13  to be more flexible and, with the pressure of the clamp  20 , cause the upstanding member  13 , as with the slots described in the previous embodiment, to tightly hold the trochar tube  54 .  
         [0063]     The base  12  in any embodiment may be round, as illustrated in  FIG. 9 , or may have one or more side wings, as illustrated in  FIG. 8 , or may bear any geometric shape suitable for the intended purpose; i.e., to be a stop member. The safety-stop device  10  may be made of any suitable materials, including, but not limited to plastics.  
         [0064]     A variation to the first preferred embodiment described above relative to  FIGS. 2-5  [with insert  40 ] and  FIGS. 6-8  [without insert  40 ] is currently illustrated in  FIGS. 10 and 11 . The basic structures described above, components, and functions are typically the same for this safety-stop  210  with the difference being the plurality of wings  212  comprising the base component as opposed to the relatively oval base component of  FIG. 8  or relatively round base component of  FIG. 9 .  
         [0065]      FIG. 10  illustrates this safety-stop  210  on the cannula  54  with its upstanding threaded member  13  exposed; i.e., without the cap  30  thereon. Though so illustrated, this safety-stop  210 , as mentioned above, does have the same components as the other embodiments and functions in the same manner.  FIGS. 10 and 11  illustrate 3 wings  212  forming the base component, though there could be more. Three however have been found to accord the stability envisioned of this type base component and its functionality.  
         [0066]     The wings  212  generally are equally spaced around the axis of the base component. In this regard, where the base component has three such wings  212 , they are spaced approximately 120° apart from each other. Where the base component has four such wings  212 , for example, they are spaced approximately 90° apart from each other.  
         [0067]     As described above, once the trochar has penetrated the body and the cannula  54  inserted a passage has been formed by way of the cannula  54  for insertion and use of various surgical implements. For this purpose, the cannula  54  must be held steady with minimal, or preferably, no movement. The base component structures being relatively oval or round, though suited for the intended purpose, do not accord maximum stability.  
         [0068]     It has been found that a base component with three or more wing structures  212  accord greater stability of use. Moreover, the apertures  214  adjacent to the ends of the wings  212  accord the user even greater stability. With the safety-stop  210  held firmly in place, a user sutures the base component to the patient through the apertures  214 . Once the base component is secured to the patient, the user or the user&#39;s assistant is not required to manually hold the base component firmly against the patient. This thereby frees a hand for additional assistance and further provides for an extremely secured attachment.  
         [0069]     The present disclosure includes that contained in the present claims as well as that of the foregoing description. Although this safety-stop device has been described in its preferred forms with a certain degree of particularity, it is understood that the present disclosure of the preferred forms has been made only by way of example and numerous changes in the details of construction and combination and arrangement of parts and method steps may be resorted to without departing from the spirit and scope of the safety-stop device. Accordingly, the scope of the safety-stop device should be determined not by the embodiments illustrated, but by the appended claims and their legal equivalents.