Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not Applicable 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       THE NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    Not Applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0004]    Not Applicable 
       BACKGROUND OF THE INVENTION 
       [0005]    1. Field of the Invention 
         [0006]    The invention relates to surgical markers. 
         [0007]    2. Description of the Related Art 
         [0008]    Laparoscopic surgery, also called minimally invasive surgery (MIS), bandaid surgery, or keyhole surgery, is a surgical technique in which operations in the abdomen are performed through small incisions (usually 0.5-1.5 cm) as opposed to the larger incisions needed in traditional laparotomy. 
         [0009]    Laparoscopic surgery provides a number of advantages to the patient versus an open procedure. These include reduced pain due to smaller incisions and hemorrhaging, and shorter recovery time. 
         [0010]    A disadvantage of laparoscopic surgery is that the surgeon cannot see the targeted tissue directly. Several tools and techniques enable surgeons to locate the targeted tissue. 
         [0011]    One such device is an endoscope. An endoscope is an instrument used to examine the interior of a hollow organ or cavity of the body. The endoscope is inserted through the small incision and delivered to the tissue that is to be observed. An endoscope typically includes a rigid or flexible tube, a light delivery system to illuminate the organ or object under inspection, a lens system transmitting the image from the objective lens to the viewer, an eyepiece, and an additional channel to allow entry of medical instruments or manipulators. 
         [0012]    An example of a laparoscopic procedure is the connection of pacemaker leads during insertion of a diaphragmatic pacemaker. A diaphragmatic pacemaker, in medicine, is a surgically implanted device used to help patients breathe following complications from spinal cord injuries. The device works through pacing of the diaphragm. Diaphragm pacing originally required a surgical opening of the chest cavity (thoracotomy) to implant the electrodes. It is now done by laparoscopy through small openings in the abdominal cavity. Patients undergo laparoscopic implantation of electrodes in the muscle of the diaphragm and initial electrical stimulation. 
         [0013]    An endoscope is used to observe the nerves on the diaphragm. Next, the intended connection points of the leads on the nerves are mapped onto a monitor displaying an image being recorded and transmitted by the endoscope. The image on the display is a live image that is continuously updated. However, the mapped points are only mapped on the display, and not on the anatomy. As the patient and or endoscope move with respect to each other, the mapped points become less and less accurate. 
         [0014]    To mark tissue during laparoscopic procedures, make-shift markers have been improvised. Typically, a surgical marking pen is disassembled by the surgeon to remove the nib of the marker. The nib is held by an existing surgical grabber. The grabber with the nib is delivered to the target tissue and the tissue is marked. The nib often dislodges from the grabber. The nib can dislodge during delivery or retraction through the cannula. The nib can dislodge when it contacts tissue in the body. The nib can dislodge if it snags the edge of the cannula during retraction. If the nib is dislodged within a patient, the nib is very difficult to locate. The surgeon is faced with two undesirable alternatives: leaving the nib within the patient or enlarging the incision to search the patient more closely. 
         [0015]    Most laparoscopic surgical product lines include a blunt dissector. Blunt dissection, as opposed to sharp dissection, involves the use of a blunt surface to break through the tissue, thereby preventing the damage and bleeding caused by lasers and scalpels, the tools of sharp dissection. Hard surgical sponges, generally known as peanuts or Kittner sponges, or a surgeon&#39;s fingers are often used as blunt dissectors. A peanut is a tightly wound ball of absorbent material, such as gauze or other woven cotton, which typically is gripped with forceps. The weave of the material acts to abrade the tissue being dissected so that the dissection can be performed by either pulling on the tissue or by forcing the peanut through the tissue. The peanut is usually placed on a peg that is located at the distal end of a rod. 
         [0016]    In light of the existing lines of surgical tools, a need exists to provide a surgical marker that can be connected to rods in existing lines of surgical products. 
         [0017]    Phillips, US 2006/0167471, teaches a surgical marker. No detail is provided regarding the connection of the nib to the rod. In addition, the ink in the nib of the marker has significant risk of drying because the nib is so small and is not connected to a reservoir. 
         [0018]    Accordingly, there is a need for a device that can mark tissue in laparoscopic procedures without risking leaving debris within a patient. In addition, such a device should work with existing lines of surgical products. Furthermore, the marker should be capable of being stored for typical times without risking of the ink in the marker drying. 
       BRIEF SUMMARY OF THE INVENTION 
       [0019]    An object of the invention is to provide a combined marker and dissector that overcomes the disadvantages of the devices of this general type and of the prior art. 
         [0020]    With the foregoing and other objects in view there is provided, in accordance with the invention, a surgical marker for marking tissue laparoscopically. The marker includes a connector and a nib. The connector has a socket formed therein for receiving a peg of a rod. Once connected, the rod is used to push and/or retract the marker from with the body of a patient via a cannula. The rod can be used to maneuver the marker to tissue that is to be marked for subsequent procedure. Once the tissue is marked, the marker can be removed from the patient by retracting the rod. The nib of the marker is configured to hold ink and dispense the ink onto tissue. The nib is connected to the proximal connector. The nib can be located distal to the connector so that the tip of the nib leads as the marker is pushed through the cannula. The nib should be secured to the connector to guarantee that the nib does not separate from the connector. 
         [0021]    The marker can be no wider than the rod. A typical rod has a diameter of 0.5 cm wide. In addition, the marker can have a smooth edge so that it does not get snagged during insertion or removal via a cannula. The marker and the connector can have a smooth connection when joined so that the marker and/or the rod do not get snagged during deployment or retraction. 
         [0022]    The nib can be made from made of porous, pressed fibers such as felt or synthetic fibers. The nib holds ink and dispenses the ink onto a surface when the nib contacts the surface. Both the nib and the ink can be sterilized and kept clean during manufacture. The ink should be in a color that contrasts tissue to allow it to be easily seen via a laparoscope, for example, blue. 
         [0023]    The marker can include a holder for securing the nib to the connector. The holder can have a hole formed therein. The holder can be configured to be placed over the nib to allow a tip of the nib to extend from the hole when the holder is fastened to the connector. The holder can fit over the connector to form a snug connection. A snug connection is defined as one that can be twisted by hand. 
         [0024]    An object of the invention is to provide a marker that is no wider than the rod used to insert and remove the marker. To meet this object, the connector can be configured to have a proximal wider portion and a distal narrower portion. An abutment is defined between the proximal wider portion and the distal narrower portion, where the diameter of the connector decreases. The holder has a proximal opening that can snugly fit over the narrower portion of the connector. The holder is slid onto the narrower portion until the proximal face of the holder contacts the abutment of the connector. The width of the abutment can be equal in size to the thickness of the holder wall. In this way, the outer surface of the holder is flush with the wider diameter of the connector when the holder is placed on the connector. 
         [0025]    The holder can work to sandwich the nib between the connector and the holder to hold the nib in place. 
         [0026]    The holder can include a passage from its proximal end to the hole in the holder, which is formed in the distal end of the holder. The passage can have a frustoconical shape to create a form locking connection with the nib to hold the nib within the holder but still allow the tip of the nib to emerge from the tip. 
         [0027]    As stated, the connector has a proximal socket formed in the connector. The proximal socket has a length, i.e. a depth, that is at least as long as a length of the peg of the rod. The socket can have a diameter that is at least as wide as a diameter of the peg. The socket and peg should be sized so that the socket and the beg form a snug fit when the peg of the rod is inserted in the connector. The peg can have a cylindrical shape and the socket have a complimentary cylindrical shape. 
         [0028]    The marker according to the invention can be combined with a rod for inserting and removing the marker into a patient via a cannula. The rod can have a distal peg. The peg is inserted in the socket of the connector. Once the marker is delivered to the target, the rod can be used to manipulate the marker to deposit ink on the target tissue. 
         [0029]    In accordance with further objects of the invention, a cap for storing ink of a marker, in particular, a surgical marker is provided. An object of the invention is to provide a small marker that is stored with a large reservoir of ink to guarantee that the marker is sufficiently inked when used. To meet this object, a cap with an ink reservoir is provided. In this way, the marker can save the space that normally is taken by an ink reservoir that is proximally located relative to the tip of the marker. 
         [0030]    The cap includes an enclosure. The enclosure can have many shapes although a generally cylindrically shaped can be provided. The enclosure has an opening formed therein. The opening is configured to receive the distal end of a marker. When the enclosure receives the marker, the size of the opening should be such that the enclosure and the marker form an air-tight closure. The air-tight closure prevents the ink on the nib of the marker from drying. 
         [0031]    The cover includes an absorbent fiber block for holding ink. The absorbent fiber block is disposed in the enclosure. The block contacts the distal tip of the nib of the marker when the enclosure receives the marker. When the nib is in contact with the absorbent fiber block, ink stored in the absorbent fiber block can diffuse to the nib of the marker. 
         [0032]    The absorbent fiber block can have a dimple formed therein. The dimple is configured to receive a tip of a nib of the marker when the enclosure receives the marker. When the tip is seated in the dimple, the amount of surface area of the nib and the absorbent fiber block that are in contact with each other is increased. The increased surface area increase diffusion of ink and limits evaporation of ink from the nib. 
         [0033]    To secure the absorbent fiber block within the cap, the opening of the enclosure can include an inner proximal abutment. That is, the proximal abutment is proximal to the absorbent fiber block. The inner proximal abutment narrows the opening in the cap to a width that is narrower than a width of the absorbent fiber block. A distal plug can be placed on the cap. The absorbent fiber block is inserted via the distal end of the cap. Once inserted, the distal plug is placed on the cap to close the distal end of the cap and to secure the absorbent fiber block between the cap and the inner proximal abutment. 
         [0034]    In accordance with a further object of the invention, a method for assembling a surgical marker is encompassed within the invention. A first step of the method involves providing a surgical marker according to the invention. The next involves providing a rod having a distal peg. The next involves inserting the distal peg into the socket of the connector. 
         [0035]    In accordance with further objects of the invention, a method for marking tissue in a laparoscopic procedure is provided. The surgical marker according to the invention can be used in the procedure. The procedure includes the following steps. The first step is observing a target location in the patient with a laparoscope. The next step is connecting the marker to a rod by placing a peg on the rod in the socket formed in the connector of the marker. The next step is inserting a surgical marker to the target location by pushing the surgical marker with a rod through a cannula. The next step is identifying the target tissue by viewing the target tissue with the laparoscope. The marker can be manipulated and maneuvered using the rod while the surgeon views the tip of the market and the target tissue through the laparoscope. Additional steps in the procedure are possible. 
         [0036]    The general procedure can be applied to connect pacemaker leads. In such a case, the targeted tissue is the nerve locations on the patient&#39;s diaphragm. The targeted tissue is marked with the marker. Once marked, a pacemaker lead is connected to the marked target tissue while observing said marked target tissue with said laparoscope. 
         [0037]    Other features that are considered as characteristic for the invention are set forth in the appended claims. 
         [0038]    Although the invention is illustrated and described herein as embodied in a combined marker and dissector, the invention should not be limited to the details shown in those embodiments because various modifications and structural changes may be made without departing from the spirit of the invention while remaining within the scope and range of equivalents of the claims. 
         [0039]    The construction and method of operation of the invention and additional objects and advantages of the invention is best understood from the following description of specific embodiments when read in connection with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0040]      FIG. 1  is a diagrammatic, perspective view of a surgical marker according to the invention. 
           [0041]      FIG. 2  is a diagrammatic, perspective, partial view of the surgical marker shown in  FIG. 1  with a first embodiment of a cap shown in a detached position. 
           [0042]      FIG. 3  is a diagrammatic, exploded, perspective view of the surgical marker shown in  FIG. 2 . 
           [0043]      FIG. 4  is a diagrammatic, exploded, perspective view of a second embodiment of a cap. 
           [0044]      FIG. 5  is a diagrammatic, exploded, partial, perspective view of the surgical marker shown in  FIG. 1 . 
           [0045]      FIG. 6  is a diagrammatic sectional view of the second embodiment of the cap shown in  FIG. 4  that includes a marker. 
           [0046]      FIG. 7  is a side view of a third embodiment of the cap according to the invention. 
           [0047]      FIG. 8  is a side sectional view of the second embodiment of the marker shown in  FIG. 1  that inserted in the second embodiment of the cap shown in  FIG. 7 . 
           [0048]      FIG. 9  is an exploded, partial, side-sectional view of the marker and cap shown in  FIG. 8 . 
           [0049]      FIG. 10  is an exploded, side view of the marker and cap shown in  FIG. 8 . 
           [0050]      FIG. 11  is an exploded, side sectional view of the marker and cap shown in  FIG. 8 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0051]      FIG. 1  shows an embodiment of a surgical marker  30 . The surgical marker  30  may be referred to as a “marker”. While the preferred embodiment of a method of using the surgical marker  30  is for surgery, other procedures than need to mark a target at a distance from the user might use the surgical marker  30 . The surgical marker  30  is particularly useful in procedures in which the user needs to mark a target via conduit or cannula. A rod assembly  10  is used to deliver the surgical marker  30  via a cannula. The cannula is not shown. Examples of compatible cannulas are those that are sold under the trade name COVIDIEN. 
         [0052]    The rod assembly  10  includes a rod  20 . The rod  20  is cylindrical. The rod  20  is made of a flexible resilient material. The rod  20  has a diameter that is less than an inner diameter of the cannula. The rod  20  is configured to be pushed through the cannula to a targeted tissue within a patient&#39;s body. A preferred embodiment of the rod  20  has a diameter of five millimeters (5 mm); other widths are possible for different uses. In the drawings, the rod  10  is not necessarily drawn to scale. In particular, the length in proportion to the width could be different. A particularly, preferred embodiment of the rod  20  is a rod that is similar to a blunt dissector with the dissector removed such as the dissectors sold under the trade name ENDO PEANUT by Covidien. The rod  20  has a proximal end  25  and a distal end  21 . The proximal end  25  is handled by the surgeon and is used to push the rod assembly  10  through the cannula. The distal end  21  ends in a peg  22 . The peg  22  is a cylinder with smaller diameter than the rod  20 . 
         [0053]    The marker  30  includes a connector  33 , a holder  32 , and a nib  31 . The connector  33  is used to connect the marker  30  to the rod assembly  10 . The holder  32  encloses part of the nib  31 . The holder  32  fastens to the connector  33  and secures the nib  31  to the connector  33 . The holder  32  has an opening  153  formed in a distal end of the holder  32 . The distal tip  37  of the nib  31  extends beyond the holder  32 . The tip  37  of the nib  31  is used to write on a target, for example, targeted tissue. 
         [0054]      FIG. 2  shows the surgical marker  30  and rod assembly  10  with a first embodiment of a cap  40 . The cap  40  is an enclosure with a proximal opening for receiving the tip  37  of the marker  30 . The cap  40  has a proximal cylindrical portion  49  and a distal frustoconical portion  48 . The distal end  43  of the cap  40  is closed. The cap  40  has an inner tube wall  44 . The rod diameter d 1  is approximately equal to a diameter of the opening  42 . The diameter d 1  of the opening in relation to the diameter of the marker should be close enough to allow the cap  40  to receive the surgical mark  30  and form an airtight connection when inserted but still allow the cap  40  to be removed by hand from the surgical marker  30 . 
         [0055]      FIG. 3  shows an exploded view of the rod assembly  10 , surgical marker  30 , and cap  40  that is shown in  FIG. 2 . In  FIG. 3 , the nib  31  is not shown. A peg  22  is disposed on a distal face  23  of the rod  30 . In the preferred embodiment, the peg  22  is cylindrical. The peg  22  has a length l 1  and a diameter d 2 . The connector  33  of the marker  30  has a proximal abutment  39 . A socket  34  is formed in the connector  33 . The socket  34  has a diameter d 2  and a length l 2 . The length l 2  of the socket  34  is at least as the length l 1  of the peg  22 . The peg  22  inserts in the socket  34  to connect the rod assembly  10  and the marker  30 . The diameters d 2  of the socket  34  and the peg  22  should be substantially equal such that a snug connection is formed such that more force than can be applied by hand is required to separate the rod assembly  10  from the marker  30 . 
         [0056]      FIG. 5  shows a view of the embodiment in  FIGS. 1-3  and details how the holder  32  secures the nib  31 . The nib  31  is a block of absorbent fiber material. Synthetic fiber materials are preferred for sanitary reasons over natural fibers such as felt. The nib  31  holds and dispenses ink. The ink is preferably a highly visible color that contrasts the color of the tissue to be marked. Blue is typically a preferred color of ink. The nib  31  includes distal frustoconical portion  36  that has a distal tip  37 . The nib  31  includes a proximal cylindrical portion  38  that has a proximal abutment  39 . 
         [0057]      FIG. 5  shows details of the connector  33 . The connector includes a proximal wide cylindrical portion  158  and a distal narrow cylindrical portion  156 . The wide cylindrical portion  158  has a diameter d 3 . The narrow cylindrical portion  156  has a diameter d 4 . An abutment  159  is defined between the wide cylindrical portion  158  and the distal narrow cylindrical portion  156 . A frustoconical portion  157  is at the distal-most location of the connector  33  and provides a surface on which the nib  31  can rest. 
         [0058]      FIG. 5  shows details of the holder  32 . The holder  32  includes a distal frustoconical portion  131  and a proximal cylindrical portion  132 . The holder  32  has an inner wall  133 . Both ends of the holder  32  are open. A proximal face  134  is located on the cylindrical portion  132 . A hole  135  is formed at the distal end of the frustoconical portion  131 . The cylindrical portion  132 , which is hollow has an outside diameter d 3  and an inside diameter d 4 . 
         [0059]    As shown in  FIGS. 1 ,  2 , and  5 , when the holder  32  is fitted over the nib  31  and seated on the narrow cylindrical portion  156 , the nib  31  is secured and the tip  37  of the nib  31  extends beyond the hole  135 . The holder  32  should form a snug connection, which requires more torque to unscrew than can be applied by hand, when the holder is seated on the narrow cylindrical portion  156  because the inner diameter of the holder  32  and the outer diameter of the narrow cylindrical portion are equal d 4 . The holder  32  and the wide cylindrical wall provide a smooth outer surface when the holder  32  is seated on the narrow cylindrical portion  156  because the outer diameter of the holder  32  and the outer diameter of the wide cylindrical wall  158  are equal d 3 . The proximal face  134  of the holder  32  abuts the abutment  159  of the connector  33  when the holder  32  is seated on the connector  33 . 
         [0060]      FIGS. 4 and 6  show a second embodiment of a cap  200  according to the invention.  FIGS. 7-11  show a third embodiment of a cap. The cap  200  has an ink reservoir for wetting the nib of markers. 
         [0061]      FIG. 6  shows the second embodiment of the cap  200  according to the invention. An enclosure for a marker  30  is formed by a generally cylindrical body that is capped at a distal end and open at a proximal end. A cylindrical, narrow wall  202  is provided at a proximal end of the cap  200 . An inner diameter of the narrow wall  202  is sized to fit over an outer diameter of the marker  30 . The narrow wall  202  has an opening  205  for receiving the distal end of the marker  30  as shown in  FIG. 4 . A flange  201  is provided to form an air-right fit when the marker  30  is inserted in the opening  205  of the cap. 
         [0062]    The cap  200  includes an absorbent fiber block  225 . The absorbent fiber block  225  is soaked with ink. The absorbent fiber block  225  contacts the nib  31  of the marker  30  when the marker  30  is inserted in the cap  200 . Ink diffuses from the absorbent fiber block  225  into the nib  31  to keep the nip  31  moist and inked. As shown in  FIG. 11 , the absorbent fiber block  225  has a dimple  228  formed in the absorbent fiber block  225 . The dimple  228  is shaped to complement the shape of the tip  37  of the nib  31 . As shown in  FIG. 6 , the tip  37  of the nib seats in the dimple  228  when the marker  30  is fully inserted in the cap  200 . 
         [0063]      FIG. 6  shows that the narrow wall  202  has a frustoconical portion  238 . The frustoconical portion  131  of the holder  32  complements the frustoconical portion  238  of the narrow wall  202  and abuts the frustoconical portion  238  when the marker  30  is fully inserted in the cap  200 . 
         [0064]      FIG. 6  shows the wide outer wall  203  and the inner wall  209 . A proximal abutment  204  is defined between where the cap reduces inner diameter between the wide outer wall  203  and the narrow wall  202 . A proximal face  227  of the absorbent fiber block  225  abuts the proximal abutment  204 . The proximal abutment  204  prevents the absorbent fiber block  225  from dislodging from the cap  200 . 
         [0065]      FIG. 6  shows a plug  220 . The plug  220  has a distal end  220  that is wider than an inner diameter of the distal portion of the cap. The plug  220  has a proximal portion  222  that is approximately the same diameter as an inner diameter of the distal portion of the cap  200 . The proximal portion forms a snug fit when inserted in the cap  200 . A proximal abutment  221  contacts a distal end of the wide portion  220  when the plug is fully inserted. The plug  240  includes a narrow wall  223  and conical portion  224  to urge the absorbent fiber block  225  toward the proximal abutment  204  when the plug  240  is inserted. 
         [0066]    To assemble the cap  200 , the cylindrical portion including the narrow wall  202  and wide outer wall  203  is fabricated, for example, by molding. Next, the absorbent fiber block  2225  is inserted from the distal end of the cylindrical portion. Then, the cap  240  is seated within the distal end of the cylindrical portion. 
         [0067]      FIGS. 7-8  show a rod assembly  10 , connected to a marker  30 , inserted in a cap  200 .  FIG. 9  shows a rod assembly  10 , a marker  30 , and a cap  200  aligned axially for connection with each other.  FIGS. 10 and 11  show the rod assembly, the marker  30 , and the cap in exploded and exploded sectional views. 
         [0068]    A preferred method of using the marker  30  shown in  FIGS. 7-9  includes a method marking tissue in a laparoscopic surgical procedure. In a first step of the method, a peg  22  of a rod assembly  10  is inserted into the socket  34  of the connector  33 . When the marker  30  is ready to be inserted, the surgeon removes the cap  200  from the marker  30 . Next, the surgeon delivers the marker  30  to the targeted tissue by pushing the marker  30  through a cannula to the targeted area. The surgeon then manipulates and maneuvers the marker  30  to the targeted tissue by operating the proximal end  25  of the rod  20 . The tip  37  of the marker  30  is pressed against the targeted tissue to leave an inked mark on the targeted tissue. 
         [0069]    In a further embodiment of method of using the marker  30 , the marker  30  can be used during the installation of a diaphragmatic pacemaker. The surgeon begins by making an incision and inserting a cannula and an endoscope. The surgeon inserts the marker by pushing the marker  30  through the cannula with the rod  20 . The surgeon examines an inferior surface of the diaphragm and locates the phrenic nerve. Portions of the phrenic nerve will respond to electric stimuli better than other portions. When a responsive portion is found, the surgeon marks that portion with the tip  37  of the marker  30 . After marking the nerve, the marker  30  is removed by retracting the rod  20  from the cannula. The surgeon then connects the lead of the pacemaker to the marked portion of the phrenic nerve. 
         [0070]    While the embodiments show preferred devices and methods, the scope of the invention may be broader than those examples.

Technology Category: 1