Abstract:
A natural orifice transluminal endoscopic surgery (NOTES) device is provided with a puncture needle including a puncture end, an intermediate protruding safety stud, and a positioning projection on an outer surface; dilator sheaths each including tapered first diameters, an insert member at one end, a limiting shoulder at the other end, a positioning protrusion on an outer surface, and a groove on an inner surface; working sheaths each having a plurality of tapered second diameters and including a positioning protuberance on an outer surface and a trough on an inner surface; and a tool member including a shaft having a graduation on an outer surface, and an operating head threadedly secured to the shaft.

Description:
CROSS-REFERENCED TO RELATED APPLICATIONS 
       [0001]    This application is a Continuation-In-Part of application Ser. No. 12/649,669, filed Dec. 30, 2009, and this application claims priority from that application which is also deemed incorporated by reference in its entirety in this application. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable 
       FIELD OF THE INVENTION 
       [0003]    The present invention generally relates to a technical field of surgical device, in particular, to a natural orifice transluminal endoscopic surgery (NOTES) device. 
       BACKGROUND OF THE INVENTION 
       [0004]    At early stage, a surgical operation such as a thoracic surgery generally leaves a large wound and causes a serious postoperative pain to patients. As modern medicine and medical instruments have been advanced, minimal invasive surgery (MIS) has become a trend of current medical treatments. Along with the development of medical imaging equipments, endoscopic surgery has become a representative of minimal invasive surgery. The endoscopic surgery not only brings a revolutionary change to medical treatments only, but also reduces the post-operation pain to patients. Even so, the endoscopic surgery still needs to create several minor wounds on a patient&#39;s body in order to let an endoscopic device enter into the patient&#39;s body for the surgical operation. Therefore, the patient still has to bear with an acute postoperative pain and requires a follow-up treatment of possible wound scars. Obviously, such surgery has an adverse impact on the quality of life of the patients. 
         [0005]    However, many imaging systems are used for entering the natural orifices of a patient&#39;s body for different medical treatments as the medical imaging equipments have been advanced. With the limitations of surgical devices and technologies, scarless surgical operations through natural orifices are still immature. In recent years, the technology of natural orifice transluminal endoscopic surgery (NOTES) has been developed rapidly, and different surgical operations can be performed with an endoscope passed through a natural orifice (such as an oral cavity, a colon cavity, and a birth channel) then through an internal incision into the body. The postoperative wound is reduced significantly, and a scarless operation can be achieved without affecting the patient&#39;s appearance and, thus, NOTES has many advantages over laparoscopy and thoracoscopy. However, NOTES requires more sophisticated surgical skills and only an experienced endoscopic surgery doctor to achieve a high success rate and safety. 
         [0006]    The concept of the natural orifice transluminal endoscopic surgery was proposed in 2004. Current literatures related to the successful experience of animal experiments include abdominal and laparoscopic explorations plus liver section surgery, ovary and partial hysterectomy, gastrojejunostomy, tubal ligation, cholecysto-jejunostomy, cholecystectomy, abdominal lymphadenectomy, hernioplasty and proctocolectomy, etc. In 2005, surgical doctors first adopted the NOTES technology on human surgery for appendectomy, and then other NOTES surgeries taken place are laparoscopic exploration and cholecystectomy. 
         [0007]    Popular subjects of the NOTES include: how to select an endoscopic entry, prevention of a postoperative infection, sewing-up a postoperative endoscopic entry, and design of endoscopic equipments. Among them, the design and development of the endoscope are the first step of the development of NOTES. Only the best design and user-friendly surgical machinery can provide a good foundation for the surgery and, thus, it is necessary to design appropriate surgical machinery for a specific natural orifice to achieve the effects of NOTES. 
         [0008]    In view of the aforementioned shortcomings of the prior art, the inventor of the present invention based on years of experience in the related industry to conduct extensive researches and experiments, and finally developed a NOTES device in accordance with the present invention to overcome the shortcomings of the prior art. 
       SUMMARY OF THE INVENTION 
       [0009]    It is a primary objective of the present invention to overcome the shortcomings of the prior art by providing a natural orifice transluminal endoscopic surgery (NOTES) device which comprises a puncture needle comprising a puncture end, a protruding safety stud disposed at a position substantially at a middle section of the puncture needle, and a positioning projection on an outer surface wherein the puncture needle is provided for puncturing into an internal wall of a nature lumen at the beginning of a surgical procedure; a plurality of dilator sheaths each comprising a plurality of tapered first diameters, an insert member at one end, and a limiting shoulder at the other end, each dilator sheath being sheathed sequentially onto the puncture needle and each dilator sheath further comprising an elongated positioning protrusion on an outer surface and an elongated groove on an inner surface, the groove being disposed correspondingly to the positioning protrusion wherein the positioning projection is complementarily received in the groove when the puncture needle is disposed in the dilator sheath, and the protruding safety stud of the puncture needle is stopped by the limiting shoulder such that such that the insert member is not allowed to pass through the puncture end; a plurality of working sheaths each having a plurality of tapered second diameters, and each of the tapered second diameters of the working sheaths being slightly greater than each of the tapered first diameters of the dilator sheaths wherein each of the working sheaths comprises an elongated positioning protuberance on an outer surface and an elongated trough on an inner surface, the trough being disposed correspondingly to the positioning protuberance, the positioning protrusion being complementarily received in the trough when the dilator sheath is disposed in the working sheath, and the working sheath being used for inserting and retracting the dilator sheaths and the puncture needle after the dilator sheaths have expanded a natural orifice; and a tool member comprising a cylindrical shaft including a graduation on an outer surface, and an operating head threadedly secured to one end of the cylindrical shaft. 
         [0010]    The above and other objects, features and advantages of the invention will become apparent from the following detailed description taken with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a perspective view of a puncture needle in accordance with a preferred embodiment of the present invention; 
           [0012]      FIG. 1A  is a sectional view taken along line A-A of  FIG. 1 ; 
           [0013]      FIG. 2  is a perspective view of a dilator sheath in accordance with a preferred embodiment of the present invention; 
           [0014]      FIG. 2A  is a sectional view taken along line B-B of  FIG. 2 ; 
           [0015]      FIG. 3  is a perspective view of a working sheath in accordance with a preferred embodiment of the present invention; 
           [0016]      FIG. 3A  is a sectional view taken along line C-C of  FIG. 3 ; 
           [0017]      FIG. 4A  is an exploded view of a tool member in accordance with a first configuration of the present invention; 
           [0018]      FIG. 4B  is an exploded view of a tool member in accordance with a second configuration of the present invention; 
           [0019]      FIG. 4C  is an exploded view of a tool member in accordance with a third configuration of the present invention; 
           [0020]      FIG. 5  is a side view of a puncture needle coupled to a dilator sheath in accordance with a preferred embodiment of the present invention; 
           [0021]      FIG. 5A  is a sectional view taken along line D-D of  FIG. 5 ; and 
           [0022]      FIG. 6  is a perspective view showing the tool member passing through the working sheath in a surgical procedure. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0023]    With reference to  FIGS. 1 to 6 , a NOTES device of the present invention is shown. The device comprises a puncture needle  10 , a plurality of dilator sheaths  20 , a plurality of working sheaths  30 , and a tool member  40 . The puncture needle  10  comprises a puncture end  11 , a protruding safety stud  12  disposed substantially at a position of a middle section of the puncture needle  10 . The puncture needle  10  includes an elongated positioning projection  13  on an outer surface ( FIG. 1 ). The puncture needle  10  is provided for puncturing into an internal wall of nature lumen at the beginning of the surgical procedure. The nature lumen wall can be a tracheal wall, or an internal wall of other natural orifices. In the present invention, an embodiment of the tracheal wall is used for the illustration. The dilator sheath  20  comprises a plurality of tapered first diameters (or a series of different successively increasing diameters), an insert member  21  at one end, and a limiting shoulder  22  at the other end opposite to the insert member  21 . Each dilator sheath  20  is sheathed sequentially onto the puncture needle  10 . Each dilator sheath  20  further includes an elongated positioning projection  23  on an outer surface and an elongated groove  24  on an inner surface, the groove  24  being disposed correspondingly to the positioning projection  23  ( FIG. 2 ). The positioning projection  13  is partially, complementarily received in the groove  24  for guiding and positioning purposes when the puncture needle  10  is disposed in the dilator sheath  20  ( FIG. 5 ). Thus, the dilator sheath  20  and the puncture needle  10  can be sequentially slid in place. Otherwise, tissues adjacent the bronchus may be damaged. The protruding safety stud  12  of the puncture needle  10  is stopped by the limiting shoulder  22  such that the insert member  21  will not exceed the puncture end  11  and will form a safety interval from the puncture end. The working sheaths  30  have a plurality of tapered second diameters (or a series of different successively increasing diameters), and each of the second diameters of the working sheaths  30  is slightly greater than each of the first diameters of the dilator sheaths  20 . 
         [0024]    The working sheath  30  comprises an elongated positioning projection  31  on an outer surface and an elongated groove  32  on an inner surface, the groove  32  being disposed correspondingly to the positioning projection  31  ( FIG. 3 ). The positioning projection  23  is complementarily received in the groove  32  for guiding and positioning purposes when the dilator sheath  20  is disposed in the working sheath  30 . The working sheath  30  is used for inserting and retracting the dilator sheaths  20  and the puncture needle  10  after the dilator sheaths  20  have expanded a natural orifice. Only the working sheath  30  is remained to form a space required for the surgical operation. Thus, the working sheath  30  can be correctly guided along the dilator sheath  20 . In addition, a breathing apparatus can be connected when the working sheath  30  is used. 
         [0025]    As shown in  FIG. 4A , a first configuration of the tool member  40  comprises an elongated, cylindrical shaft  41  and a steel cutting needle  42  releasably secured to the shaft  41 . The steel cutting needle  42  has an inclined surface with a V-shaped sharp end  421 . 
         [0026]    As shown in  FIG. 4B , a second configuration of the tool member  40  comprises an elongated, cylindrical shaft  41  and a steel cutting needle  43  releasably secured to the shaft  41 . The steel cutting needle  43  has a trapezoidal end  431   
         [0027]    As shown in  FIG. 4C , a third configuration of the tool member  40  comprises an elongated, cylindrical shaft  41  and a steel cutting needle  44  releasably secured to the shaft  41 . The steel cutting needle  44  has a pointed end  441 . 
         [0028]    In each of the first to third configurations, an externally threaded extension is formed at one end of the shaft  41  and the other end of each of the steel cutting needles  42 ,  43  and  44  is provided with an externally threaded hole for threadedly securing to the externally threaded extension of the shaft  41 . Moreover, the tool member  40  further comprises a graduation  410  on an outer surface for measuring the location of damaged tissues and allowing an appropriate surgical instrument to perform a surgical procedure. 
         [0029]    The V-shaped sharp end  421  of the steel cutting needle  42  can be complimentarily disposed on an inclined surface for embedding and cutting a surgical thread at the end of the surgical procedure. Further, the trapezoidal end  431  of another steel cutting needle  43  is used for outward deflecting the tissues in a surgical procedure. It is a physician&#39;s choice of using one of the three steel cutting needles  42 ,  43  and  44  in surgical procedure. 
         [0030]    The puncture needle  10  has a first length substantially equal to 70 cm. 
         [0031]    The dilator sheath  20  has a second length substantially equal to 33 cm. The safety interval is substantially equal to 2 cm. 
         [0032]    The plurality of first diameters can be equal to 5 mm, 7 mm, 9 mm and 11 mm respectively. In other words, the dilator sheaths  20  have diameters equal to 5 mm, 7 mm, 9 mm, and 11 mm sequentially for expanding an orifice. 
         [0033]    The plurality of second diameters can be equal to 7 mm, 9 mm, 11 mm, and 13 mm respectively. In other words, the plurality of working sheaths  30  can have diameters of 7 mm, 9 mm, 11 mm, and 13 mm respectively for maintaining the smoothness of the orifice during the operation. 
         [0034]    In general, the endoscope is entered from a trachea during a surgical operation, and a rigid (or soft) bronchoscopy is used for the surgical operation, and then the puncture needle  10  is inserted into the trachea, and the plurality of dilator sheaths  20  expand an orifice, and a working sheath  30  is used for maintaining the smoothness of the orifice during the surgical operation, and then a rigid bronchoscopy machinery (a rigid one has been used clinically) is used for a surgical operation, and the tool member also is disposed in the working sheath  30  in the surgical operation ( FIG. 6 ). 
         [0035]    In addition, a method or procedure of the present invention comprises the steps of (a) creating a stable airway by a rigid bronchoscopy; (b) selecting an appropriate puncture position; (c) passing a surgical sheath from a tracheal sidewall situated at a position substantially 3 cm from the top of a tracheal carina and out of a trachea through a natural orifice; (c1) passing a puncture needle  10  out of the tracheal sidewall; (c2) passing a series of dilator sheaths  20  with tapered diameters along the puncture needle  10  sequentially to create an opening; (c3) preventing unnecessary damages by a design of a safety stud  12  which latches the dilator sheath  20  at a position substantially 2 cm from the tip of the puncture needle  10 ; (c4) expanding the opening sequentially, and then retracting the dilator sheath  20  to a position of a sheath with one size smaller than the desired working sheath  30 ; (c5) passing the working sheath  30  through the puncture needle  10  and the opening into a pleural space; (d) using the rigid bronchoscopy machinery for the surgical operation after creating a working channel; (d1) exchanging air by the working sheath  30  of the rigid bronchoscopy during the surgical operation; (d2) prohibiting a removal of the sheath during the surgical operation; (e) making sure that the oxygen level of an experimental animal or a patient reaches 100% before removing the working sheath  30 ; (f) removing the working sheath  30  after the air exchange is terminated; (g) immediately installing a tracheal stent after the working sheath  30  is removed; (g1) selecting the tracheal stent primarily by using a silicone stent (which can be removed easily), and evaluating the tracheal stent by a 3D CT before the surgical operation takes place; (g2) covering the opening of the trachea to avoid a pneumothorax; (g3) performing the endoscopic examination to confirm the position of the stent after the tracheal stent is disposed, wherein if the wound is smaller than one-third of the external circumference of the trachea, then the trachea will be healed automatically; and (h) performing a rigid bronchoscopic examination after the surgical operation takes place, and performing a stent removal operation if the incision healing condition is good. In general, the tracheal stent is covered onto a wound orifice, and the tracheal stent can be removed after two weeks when the wound has been recovered naturally. 
         [0036]    In brief, the present invention provides a NOTES device that is disposed in a trachea to achieve the advantages of the NOTES, and the design of the device provides a user-friendly and easy operation for a scarless surgical operation without affecting a patient&#39;s appearance. In addition, the present invention further includes a protruding safety stud disposed at a position substantially at a middle section of the puncture needle, such that the dilator sheath can be latched at a position substantially 2 cm from the tip of the puncture needle to prevent unnecessary damages. 
         [0037]    While the invention has been described in terms of preferred embodiments, those skilled in the art will recognize that the invention can be practiced with modifications within the spirit and scope of the appended claims.