Abstract:
The present invention provide for improved optical entry systems and methods for minimally invasive surgery. According to some aspects of the disclosure, an obturator and trocar are merged to provide a device that can be used with an integrated visualization means (e.g. laparoscope) to provide optical entry into a patient&#39;s body cavity. Further, a reconfigurable tip is configured to be in an entry state and a visualization state. Said aspects and associated method steps can significantly reduce the complexity of the entry process and do not require removal and reinsertion of surgical instruments which eliminates the need for valves in the trocar and reduces the possibility of contamination of the visualization means&#39; objective lens.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a non-provisional application of U.S. Provisional Application No. 61/780,281, filed on Mar. 13, 2013. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to the field of minimally invasive surgical instruments involving optical visualization systems. More specifically, the minimally invasive surgical instruments and procedures comprising trocars and/or cannulas that can be used to create a minimally invasive punctures into the body and which may retain optical properties of the optical components. 
       BACKGROUND OF THE INVENTION 
       [0003]    Minimally invasive surgery (MIS) is the technique of performing surgery through small incisions (less than two centimeters) or punctures in the body. During these surgical procedures visualization can be achieved using optical devices such as endoscopes, laparoscopes, arthroscopes, boroscopes and the like; this is contrasted to open surgery performed through large incisions with direct visualization. Two surgical instruments typically used to introduce the visualization device into the body is a trocar and obturator. The obturator can be used to create the incision or puncture through tissue and the trocar to maintain tissue or an opening in an open position. Once the trocar is in place, the visualization device can be inserted in to the body cavity. In some embodiments, trocars can also be used to facilitate the introduction of other surgical instruments as well as other functions such as providing a means for gases to pass through for insufflation purposes. 
         [0004]    Typically the trocar can fit over the obturator during insertion. In the case of laparoscopic surgery, the surgeon can push the trocar and obturator through the abdominal wall until the distal end of the trocar has been introduced into the body cavity and is proximal to the surgery site. The obturator is then removed while the trocar holds the incision open, allowing the laparoscope to be introduced in to the abdominal cavity. 
         [0005]    A preferred procedure for entry using a trocar and obturator is known as visual entry. In the visual entry procedure, the tip of the obturator is transparent, and a laparoscope is placed inside the obturator during entry. From this location the laparoscope may be used to image the tissue visible through the transparent obturator tip. The standard visual entry procedure includes the following six steps: 1) The obturator is inserted into the trocar; 2) The endoscope is inserted into the obturator; 3) The three instruments are pushed through the abdominal wall by the surgeon who may simultaneously monitors the progress on a video screen; 4) The laparoscope is then removed; 5) The obturator is then removed; and finally, 6) the endoscope can be reinserted for visualization during surgery. 
         [0006]    This standard procedure for visual entry is cumbersome as it requires many steps to remove and reinsert various surgical instruments as described above. For example, valve systems are required to seal the surgical site during removal and reinsertion. Furthermore, biological contaminants can be introduced into the trocar during removal of the obturator which can contaminate the lens of the laparoscope upon reinsertion impairing the vision of the surgeon or exposing the surgical site to biological contaminants. 
         [0007]    It is desirable therefore to have novel devices, systems, and/or tools that can facilitate procedures by eliminating one or more of the steps, and thereby various associated risks, that occur during surgical procedures. 
       SUMMARY OF THE INVENTION 
       [0008]    The foregoing needs are met, to a great extent, by the present invention, in which a system for use in minimally invasive surgery for introducing a visualization device into a body cavity is disclosed. 
         [0009]    According to some aspects of the disclosure, a system for use in minimally invasive surgery for introducing a visualization device into a body cavity is provided. The system can include a tube, a visualization device disposed inside the tube; and a distal tip configured of being in either an entry state or a visualization state and adapted for the tube. The entry state can be characterized by a rigid tip geometry capable of puncturing through a body wall into an anatomical cavity and the visualization state by a tip geometry that has substantially articulated away from an optical axis of the visualization device disposed in the tube. 
         [0010]    In some embodiments, the tube can include auxiliary channels and/or integrated lighting means. The auxiliary channels may be used for the introduction of gases or liquids during one or more of the visualization steps and/or for the surgery. For example, the gases may be used for insufflation of a surgical area. The liquids may be active agents and/or liquids used to rinse clean an objective lens of the visualization device. 
         [0011]    In additional aspects of the disclosure, a method for use of a visualization device in minimally invasive surgery is disclosed. The method can include: (1) puncturing a body wall with a transparent reconfigurable arranged with a tube to include a visualization device, wherein the transparent reconfigurable tip includes a distal end and a proximal end and the distal end is configured in an entry state during the puncturing; (2) monitoring the puncturing progress as imaged by the visualization device; (3) actuating the reconfigurable tip to transition from the entry state to a visualization state once the reconfigurable tip is the body cavity; and (4) adjusting the visualization device to image a surgical site. In some embodiments the method can additionally include: actuating an integrated lighting means contained in the transparent reconfigurable tip during one or more of the puncturing step, the actuating of the reconfigurable tip, and the adjusting of the visualization device; and/or the introduction of a liquid or a gas through one or more auxiliary channels of the tube. Further, the steps of monitoring and adjusting may be performed without having to replace or temporarily remove the imaging device arranged inside of the tube. Similarly, the steps of puncturing, monitoring, actuating, and adjusting can be performed without using valve systems for the removal and reinserting of additional surgical instruments utilized for the viewing of the surgical site. 
         [0012]    There has thus been outlined, rather broadly, certain aspects of the invention in order that the detailed description thereof herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional aspects of the invention that will be described below and which will also form the subject matter of the claims appended hereto. 
         [0013]    In this respect, before explaining at least one aspects of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of aspects in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting. 
         [0014]    As such those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    The above mentioned features and aspects of the disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which: 
           [0016]      FIG. 1   a  is a side view of an exemplary embodiment of the merged trocar-obturator device in the entry state according to various aspects of the present disclosure; 
           [0017]      FIG. 1   b  is a side view of the merged trocar-obturator device of  FIG. 1   a  in the visualization state according to various aspects of the present disclosure; 
           [0018]      FIG. 2   a  is a cross section of an exemplary embodiment of a reconfigurable tip in the entry state; 
           [0019]      FIG. 2   b  is a cross section of the exemplary embodiment of  FIG. 2   a  with the reconfigurable tip in the visualization state according to various aspects of the present disclosure; 
           [0020]      FIG. 3  is an isometric view of the reconfigurable tip in the entry state according to various aspects of the present disclosure; 
           [0021]      FIG. 4  is a view of the proximal end of a reconfigurable tip of  FIG. 3  in the entry state according to various aspects of the present disclosure; 
           [0022]      FIG. 5  is an isometric view of an alternative exemplary embodiment of the reconfigurable tip in the visualization state with integrated illumination means according to various aspects of the present disclosure; 
           [0023]      FIG. 6  is a side view of the exemplary merged trocar-obturator device of  FIG. 5  disposed through a body wall and introducing the visualization device into the body cavity according to various aspects of the present disclosure; and 
           [0024]      FIG. 7  is a flowchart with exemplary method steps that may be used according to aspects of the systems of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0025]    The present disclosure provides for a system in which, in some embodiments, one or more of these problems can be addressed by the merging of the obturator and the trocar into a single surgical device. According to some aspects, this can be accomplished by a reconfigurable tip, preferably transparent, with at least two states—an entry state and visualization state. In the entry state the tip can be closed and/or sealed, and form a tip geometry that can allow the instrument to puncture patient&#39;s tissue, e.g., the patient&#39;s outer tissue. In this configuration, the image capturing end of a visualization device can be placed proximal to or touching the closed and/or sealed tip. 
         [0026]    In the visualization state, the tip can be substantially displaced or articulated into the body cavity to provide a relatively unobstructed view of the surgical field as it may be imaged by the visualization device. In one embodiment, for example, the tip can include at least one transparent component that allows light to enter the visualization device allowing tissue to be imaged through the tip providing visual entry. 
         [0027]    The tip may be able to substantially rotate about the approximately outside diameter of the trocar as to not interfere with the optical path of the visualization device and providing an unobstructed view of the surgical site, for example. This rotation can be facilitated by a standard hinge, a compliant flexure, or the like. The tip may be an integral component of the trocar, attached, or a separate component that is movably attached to the trocar. 
         [0028]    According to additional aspects, one or more tips may be included. One or more of the tips, each preferably being transparent, may include a plurality of partial tips with independent hinges. When in the entry state, the various tips can connect to create a substantially rigid tip with a geometry capable of piercing an abdominal wall, i.e., a sharp or pointed structure. When in the visualization state, the partial tip components can disengage and articulate away from the visualization device independently. In some embodiments, the transition from entry state to visualization state can be achieved by actuating the tip using the visualization device itself. For example, using forces from the dissection which can tend to keep the tip in the entry state, while forces from the visualization device can push on the proximal end of the tip causing a transition to the visualization state. 
         [0029]    In this specification and claims it is to be understood that reference to a “trocar” or “trocar device” is intended to encompass a cannula or tube that may be inserted through an incision or tissue to maintain it open, for example, to allow surgical instruments and/or visualization devices to be inserted into a body cavity. 
         [0030]    The term “obturator” or “obturator device” is intended to encompass any device that can be placed into, distally attached or integrated, into a trocar to prevent the trocar from being blocked by any tissue during insertion. Furthermore, an obturator can include a tip or sharp geometry that substantially dissects the tissue and can allow for easier insertion of the trocar. By definition, the obturator must be removed or substantially disposed away from the trocar to allow for a considerably/completely unobstructed view of the surgical area. The obstructed view means any occlusion or aberration of light prior to image capture by the visualization device. 
         [0031]    Referring now to  FIG. 1   a  and  FIG. 1   b , side views of an exemplary embodiment of a merged trocar-obturator device  100  are depicted. In particular,  FIG. 1   a  depicts the exemplary merged trocar-obturator device  100  with a reconfigurable tip  102  in the entry state  102   a . Regardless of the reconfigurable geometry of the reconfigurable tip  102 , the entry state  102   a  can be characterized by a rigid tip geometry capable of dissecting or puncturing tissue. This geometry can be the result of a single movable tip (e.g. reconfigurable tip  102 ), or in additional embodiments, a rigid structural interaction between or combination of multiple tip components. This reconfigurable tip  102  geometry during the entry state  102   a  could be a sharp point, blade, or cutter as well as blunt. By blunt it is meant that small force interaction with human tissue does not cause cutting or dissection; there is also some force threshold above which interaction with human tissue does cause cutting or dissection. 
         [0032]    Disposed inside of the trocar  104  can be a visualization device  101 , as depicted in  FIG. 1   a  when the reconfigurable tip  102  is in the entry state  102   a . The visualization device  101  can be an endoscope, laparoscope, arthroscope, borescope or the like. In the entry state  102   a , the distal end of the visualization device  101  can be directed at the back portion of the reconfigurable tip  102 . In some embodiments, the reconfigurable tip  102  can be clear allowing the visualization device  101  to image tissue (not shown) during insertion, allowing for visual entry. 
         [0033]    In particular,  FIG. 1   b  depicts the exemplary merged trocar-obturator device  100  with the reconfigurable tip  102  in the visualization state  102   b . According to some aspects, the reconfigurable tip  102  can include a plurality of components that are configured to provide an unobstructed view of the surgical area in the visualization state  102   b . In some embodiments, the reconfigurable tip  102  may be disposed such that the distal end of the visualization device  103  can move axially in the direction denoted by  104  such that it enters the body cavity for wide angle visualization that is unobstructed by the trocar  104  or reconfigurable tip  102  during the visualization state  102   b.    
         [0034]    Referring now to  FIGS. 2   a  and  2   b , cross sections of an exemplary combined trocar/obturator device  250  including an at least two piece reconfigurable tip  200  are shown. In particular,  FIG. 2   a  is a cross section representation of an exemplary reconfigurable tip  210  at an entry state  210   a . In the entry state  210   a  the at least two components of the reconfigurable tip  210  may be substantially connected by a cap  206  attached to one of the at least two tip components  200  forming a blunt or sharp point that can be suitable for tissue dissection. The distal end of the visualization device  205  can be positioned behind the reconfigurable tip  210 . Since the reconfigurable tip  210  can generally be clear/transparent it can be possible for the visualization device  205  to image objects and tissue that is beyond the reconfigurable tip  210  before, during and after insertion into a body cavity. 
         [0035]    According to aspects of the present disclosure, after insertion the reconfigurable tip  210  can be articulated by moving the distal end of the visualization system  205  towards the distal end of the reconfigurable tip  210 , triggering an actuation means that can cause the tip to articulate out of the way about hinge  203 . The actuation could be from the distal end of the visualization system  205  by physically pushing on the proximal surfaces of the tip  201 ,  202 ; actuated automatically via spring loading; or by any other exogenous force such as other electromagnetic, pneumatic, hydraulic, cable, pushrod actuation and the like. Hinge  203  could be a standard hinge, a compliant flexure, a flexible tether, a compliant wire or the like. The component of the at least two component reconfigurable tip  210  which the cap  206  can be attached to could be actuated first to free the other components to articulate freely. The cap  206  may serve at least two purposes including substantially holding the components of the reconfigurable tip in the entry state and maintaining the correct tip geometry for entry. The reconfigurable tip  210  may be readily changed from entry state  210   a , depicted in  FIG. 2   a , to visualization state  210   b , depicted in  FIG. 2   b , by articulating the tip component attached to the cap  206  first to free the remaining tip components. 
         [0036]    Accordingly, in some embodiments the distal end of the visualization device  205  may actuate the reconfigurable tip  210  so as to move it from the entry state  210   a  to the visualization state  210   b . Component(s) attached to the cap  206  can be actuated first by extending the proximal surface  201  further than the proximal surfaces of the component(s) with no cap  202  such that the distal end of the visualization system comes in contact with proximal surface  201  before proximal surface  202 . After the reconfigurable tip  210  is configured in the visualization state  210   b , the reconfigurable tip  210  can be maintained as such by physical interference between the visualization device  205  and the tip&#39;s proximal surfaces  201  and  202  as shown by  204 . 
         [0037]    In some embodiments, an auxiliary channel  207  may be integrated in the reconfigurable tip  210  of the trocar/obturator device  250 . The auxiliary channel  207  may be curved to direct liquid or gas at the distal end of the visualization device  205 , the purpose of cleaning the objective lens from debris that may have contaminated it, for defogging purposes, and/or for administration of an active agent such as an analgesic. 
         [0038]    Referring now to  FIG. 3 , an isometric view of the reconfigurable tip in the entry state is depicted. In particular, the isometric view shows the reconfigurable tip  300  being transparent so as to allow the visualization device  303  to image body wall tissue during entry into a body cavity using the cap  302  having a blunt geometry for entry through body wall tissue into a body cavity. To seal the mating surfaces of a plurality of tip components, a flange  301  substantially attached to one tip component or integrally part of the component&#39;s structure may extend to partially cover an adjacent component sealing the interface from tissue introduction. The flange structure  301  may also provide beneficial surface geometry to further enhance tissue dissection or puncture during entry. Accordingly, depending on the flange structure, it may be necessary to actuate the plurality of tip components in sequence to transition from the entry state to the visualization state avoiding binding of components. 
         [0039]    Referring now to  FIG. 4 , a view of the proximal end of the reconfigurable tip as seen through the trocar or tube is depicted. The transparent spaces  400  denote areas of the reconfigurable tip where light can be imaged by the visualization device without being obstructed by reconfigurable the tip geometry. As previously mentioned, the sealing flanges  401  may extend from one component to cover an adjacent component to seal the interfacing surfaces from tissue introduction during entry. The proximal geometry of the cap  402  may readily cover the adjacent components maintaining the entry state during entry. 
         [0040]    Referring now to  FIG. 5 , an isometric view of an alternative exemplary embodiment of the reconfigurable tip with integrated illumination means is depicted. In particular, the reconfigurable tip  550  can include, for example, six tip components  500 . The reconfigurable tip could also include one, two, three or any plurality of tip components depending on design aspects, such as overall size, precision needed and the like. According to aspects of the disclosure, illumination components  501  can be integrated into the reconfigurable tip  550 , for example, into the tip components  500  forming part of the reconfigurable tip  550 . The illumination components  501  may include, for example, light emitting diodes (LED). Other illumination components  501  may alternatively or additionally include optical fibers in the walls of the trocar or the trocar being one large optical fiber, UV light sources, lasers, phototherapy light sources, and the like. As shown the illumination can be directed parallel to the optical axis of the visualization device  502  as denoted by  504 . However, some illumination components may be oriented perpendicular to  504  as denoted by  505 . These perpendicularly oriented illumination components may function to illuminate, in the entry state, the tissue during entry. Alternately, the remaining illumination components may be used to illuminate, in the visualization state, the surgical area. 
         [0041]    Referring now to  FIG. 6 , a side view of the exemplary merged trocar-obturator device of  FIG. 5  disposed through a body wall is shown. In particular, the trocar/obturator device  600  and visualization device  603  being disposed through a patient&#39;s tissue  601  with the reconfigurable tip  602  being in the visualization state. Accordingly, the components of the reconfigurable tip  602  can be articulated away from the visualization device  603  which can offer beneficial purposes beyond providing an unobstructed view of the surgical site  604 . For example, the articulated components may be used and designed to hold tissue away from the visualization device  603  as well as to prevent the assembly  600  from being expelled from the incision or puncture. This expulsion from the incision or puncture could happen due to pressure from insufflation, mechanical pulling from the proximal end of the trocar and the like. 
         [0042]    Referring now to  FIG. 7 , a flowchart with exemplary method steps that may be used according to aspects of the present disclosure is shown. In particular, the exemplary method steps are associated with various embodiments and can be used to simplify the insertion procedure by minimizing risk, provide additional visualization capabilities for improved control by the practitioner, and/or reducing the number of steps that are needed. Before providing further description regarding the steps that may take place, it must be understood that the order of steps may vary, additional steps may take place in between steps, and the order of the exemplary steps presented may occur more than once throughout different stages or omitted depending on the procedure and as it will be apparent to those skilled in the art from the contents of the present disclosure. 
         [0043]    At step  701 , puncturing of a body wall/tissue can occur. According to aspects of the disclosure, puncturing of the body wall can be done with a transparent reconfigurable tip being at an entry state and arranged with a tube to include a visualization device. At step  705 , the puncturing progress may be monitored using the visualization device to image the tissue being punctured. Step  706  may occur during or after the puncturing step  701 . In particular, step  706  includes the introduction of one or more liquids and/or one or more gases through at least one auxiliary channel of the tube. Liquid(s) can include, for example, an active agent such as an analgesic, an antibiotic, an enzyme, a defogger, or a non-active agent used to rinse the tip, tissue, the illumination source, and/or the visualization device. One or more gases may also be introduced, for example, to assist in the displacement of debris arising from surgical activity, for insufflation purposes, and the like. For example, gas such as carbon dioxide can flow out of the trocar to aerate the lens of the visualization device to thereby prevent debris/smoke, from the pulverization of tissue that may take place during a surgery, from blocking the field of view of the imaging device. 
         [0044]    At step  710 , actuation of the reconfigurable tip to transition from the entry state to a visualization state once the reconfigurable tip is the body cavity can occur. This may be done for both visualization purposes or to use the tip components to lock the device onto the tissue. According to some aspects, the visualization device does not need to be removed from the trocar, eliminating the need for valves and sealing means in the proximal end. However, fittings such as luer locks may still be included in the proximal end to introduce liquids or gasses to the auxiliary channels when step  701  takes place. At step  715 , the visualization device may be adjusted to image the surgical site. Adjustment may include, for example, adjusting zoom magnification, moving the trocar device itself, focusing an image or changing contrast of an image, and the such. In some embodiments, actuation one or more integrated illuminating means at step  720  may also take place before, during, or after any of the aforementioned steps. 
         [0045]    In view of the teachings herein, many further embodiments, alternatives in design and uses of the embodiments of the instant invention will be apparent to those of skill in the art. As such, it is not intended that the invention be limited to the particular illustrative embodiments, alternatives, and uses described above but instead by the claims presented hereafter.