Abstract:
A puncture assistance device for use in connection with an ultrasound probe to guide a Veress needle through the layers of the wall into a bodily cavity is provided. The puncture assistance device comprises a tenaculum-like forceps, a needle guide body provided with a slot for guiding the Veress needle within the scan plane of the ultrasound probe, attachment means to the ultrasound probe, and attachment means of the needle guide to the tenaculum-like forceps. Also provided is a balloon catheter for use as a retractor in gaining access into the abdominal cavity, presenting at its distal end an inflatable balloon membrane and an framework of non-distendable flexible fibers disposed in a specific arrangement. A method access the abdominal cavity with the aid of said devices under ultrasound guidance is also provided.

Description:
PRIORITY CLAIM 
       [0001]    This invention claims priority to U.S. Provisional patent application Ser. No. 13/619,14997, filed on 12 Dec. 2013, and is incorporated by reference herein. 
       BACKGROUND OF THE INVENTION 
       [0002]    Over the past 50 years, developments in electronic and optical technologies have meant that it has become possible to perform many operations laparoscopically. The unique feature distinguishing laparoscopic from open abdominal or vaginal surgery is the need to insert needles, trocars and cannulas for initial entry into the abdomen, the insertion of the primary trocar being made blindly in most cases. This may result in inadvertent bowel or vascular injury which can be responsible for major morbidity and mortality. In the last 25 years great efforts have been made for the prevention of these injuries by developing so called safe entry techniques especially because almost 50% of the complications of laparoscopic surgery occur at the time of primary entry site into the abdomen, before even surgery has begun. 
         [0003]    The classic site for gaining access into the abdominal cavity by insertion of the first trocar is the umbilicus, this being the thinnest part of the abdominal wall, with abdominal fasciae fused into the umbilical ring. 
         [0004]    The problem resides in the proximity of the large retroperitoneal vessels and the frequency of infraumbilical adhesions by the bowel and omentum found in almost 10% of cases, which can lead to injury of the aforementioned structures, especially in the case of a previous laparotomy or obese or too thin patients. 
         [0005]    The closed entry technique comprises the Veress needle technique and the direct entry technique. The technique used by most gynecologic surgeons implies inserting a hollow needle called the Veress needle into the abdomen through the abdominal wall, after lifting the latter, performing a series of tests that whiteness the probable location of the tip inside the abdomen, insufflation of the abdomen with CO 2  to a predetermined set pressure and insertion of a trocar cannula after the removal of the needle. Note that there are three blind steps in performing this procedure: insertion of the Veress needle, insufflation and insertion of the cannula. The direct trocar entry implies insertion of the primary trocar through the umbilicus, followed by insertion of the optics and the insufflation of the abdominal cavity. Although it takes less time to perform than the Veress needle technique, and is associated with less minor insufflation-related side effects, the possible complications associated with insertion of a large sharp instrument blindly could prove to be severe. 
         [0006]    The open Hasson technique (U.S. Pat. No. 3,817,251) implies the visualization and cutting of the abdominal layers upon entry by using blunt and sharp dissection, and insertion of the primary trocar under sight. This technique has not lowered the rate of bowel complications however in large population studies, just the recognition of them. 
         [0007]    The radially expanding access system (U.S. Pat. No. 5,827,319), was developed to minimize tissue trauma. This system uses a pneumoperitoneum needle with a polymeric sleeve. Following routine insufflation the needle is removed leaving the outer sleeve in situ, followed by direct dilatation of the sleeve into creation of a port. Complications are similar to the ones of the closed technique. 
         [0008]    Visual trocars imply the use of optics through the cannulas upon insertion through the abdominal layers (U.S. Pat. No. 6,638,265, States Surgical Corps Visiport™ trocar and the Ethicon Endosurgery&#39;s Optiview™). Studies have not shown a reduction of entry complication by using these techniques, but only the rate of recognition. 
         [0009]    However, the incidence of first entry complications remains the same in the last 25 years, whichever technique is performed, in spite of the technical progress, studies not showing the superiority of either technique into lowering the complication rate. 
         [0010]    Attempts to use ultrasound as a recognition tool for umbilical adhesions have been made. The “Visceral slide” technique developed by F. Tu et al. uses an abdominal probe placed over the umbilicus and the patient is asked to take very quick and large breaths. The underlying viscera (bowel) move freely relative to the abdominal wall for 3-5 in normal cases. In the event of underlying adhesions, there is no or little movement. 
         [0011]    The PUGSI technique (Peroperative periumbilical ultrasound-guided saline infusion) developed by C. Nezhat et al. implies performing visceral slide followed by infraumbilical injection of 6-10 cc of sterile saline through a spinal needle under direct ultrasound guidance. Formation of fluid pocket and non-dispersion suggest subumbilical adhesions. 
         [0012]    U.S. Pat. No. 5,209,721 uses a Veress needle with an ultrasonic wave generator and a sensor mounted thereon, monitoring ultrasonic pressure waves reflected from internal organs or tissues located along the insertion path of the needle. 
         [0013]    Various designs of percutaneous needle guides for attachment to non-invasive medical scanning devices, for example hand-held transducer probes, are known in the art. These guides may be used to direct a percutaneous needle to a needle entry site, which is located alongside the scanning device on an epidermis of a scanned body, and which corresponds to a subcutaneous target located by the device. 
       SUMMARY OF THE INVENTION 
       [0014]    In accordance with the present invention, a puncture assistance device for use in connection with an ultrasound probe to guide a Veress needle through the layers of the wall into a bodily cavity is provided. The puncture assistance device comprises a tenaculum-like forceps provided with ratchet fixation and sharp incurving, needle like pointed blades, a needle guide body provided with a slot for guiding the Veress needle within the scan plane of the ultrasound probe, attachment means to the ultrasound probe, and attachment means of the needle guide to the tenaculum-like forceps. The improvement consists in the possibility of maneuvering the cavity wall layers by the tenaculum-like forceps, into spacing them apart for better ultrasound view and to create access space for preventing entry injuries. 
         [0015]    Pursuant to another feature of the present invention, a balloon catheter for use as a retractor in gaining access into the abdominal cavity, is comprising an elongated shaft with a balloon retractor at the distal end of the elongated shaft, providing an inner balloon membrane that is inflatable to a maximum volume and an attached outer framework of non-distendable flexible fibers disposed in a specific arrangement on the different faces of the balloon, providing a mesh-like structure on a side of the balloon. A pilot balloon is connected to the balloon retractor. The balloon retractor is inserted guided by the Veress needle through the layers of the abdomen with balloon in a collapsed state, followed by its inflation, leading to the expansion of the fiber net, and upon piercing by a sharp trocar through the layers of the abdomen and balloon, the burst of said balloon is followed by the entanglement of the tip of the trocar in the mesh, preventing thereby puncturing wounds to the internal organs made by the sharp tip of the trocar upon insertion. 
         [0016]    Another aspect of the current invention is represented by a method to develop pneumoperitoneum with the aid of an ultrasound device. This is comprising making an incision in the skin of the abdominal wall, attaching the puncturing assistance device that is operatively connected to an ultrasound transducer to the abdominal fascia, inserting a Veress needle through the said puncturing device, observing the path of the Veress needle through the layers of the abdomen by means of the ultrasound transducer that sends an image to a ultrasound monitor, interpreting the image by the operator and redirecting the needle according to the information until entering the peritoneum, insufflating the abdominal cavity while observing with the ultrasound transducer. A safety alternative is represented by the use of the balloon retractor that is inserted by guidance from the Veress needle, and by inflation protects the content of the abdomen from piercing injuries made by the tip of the trocar. 
         [0017]    Another aspect of the current invention is represented by a method to develop pneumoperitoneum with the aid of an ultrasound device by access through the vagina. This is comprising, attaching the puncturing assistance device that is operatively connected to an ultrasound transducer to the cervix of the uterus, inserting a Veress needle through the said puncturing device, observing the path of the Veress needle through the posterior fornix of the vagina by means of the ultrasound transducer that sends an image to a ultrasound monitor, interpreting the image by the operator and redirecting the needle according to the information until entering the abdominal cavity, insufflating the abdominal cavity while observing with the ultrasound transducer. A safety alternative is represented by the use of the balloon retractor that is inserted by guidance from the Veress needle, and by inflation protects the content of the abdomen from injuries made by the tip of the trocar. 
         [0018]    Another aspect of the current invention is represented by a method to access a hollow inner organ with the aid of an ultrasound device. This is comprising applying the puncturing assistance device that is operatively connected to an ultrasound transducer to the abdominal wall, inserting a needle through the puncturing device, observing the path of the needle through the layers of the abdomen and inner organ by means of the ultrasound transducer that sends an image to a ultrasound monitor, interpreting the image by the operator and redirecting the needle according to the information until entering the organ cavity. A safety alternative is represented by the use of the balloon retractor that is inserted by guidance from the Veress needle, and by inflation protects other organs from injuries made by the tip of the trocar. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIG. 1  Perspective view illustrating an embodiment of the puncture assistance device, clamp, Veress needle and the ultrasound probe; 
           [0020]      FIG. 2  Exploded view illustrating an embodiment of the puncture assistance device, clamp, Veress needle and the ultrasound probe; 
           [0021]      FIG. 3  Perspective bottom view of the puncture assistance device in this embodiment; 
           [0022]      FIG. 4  Perspective top view of the puncture assistance device in this embodiment; 
           [0023]      FIG. 5  Sectional transverse view of the puncture assistance device in this embodiment at the level of its joints to the clamp; 
           [0024]      FIG. 6  Sectional transverse view of the puncture assistance device in this embodiment at the level of its clamping member for the ultrasound probe with clamping member in closed position; 
           [0025]      FIG. 7  Sectional transverse view of the puncture assistance device in this embodiment at the level of its clamping member for the ultrasound probe with clamping member in open position; 
           [0026]      FIG. 8  Sectional longitudinal view of the puncture assistance device in this embodiment; 
           [0027]      FIG. 9  Perspective bottom view of an embodiment of the balloon retractor and Veress needle; 
           [0028]      FIG. 10  Sectional longitudinal view of the pilot balloon; 
           [0029]      FIG. 11  Perspective top view of this embodiment of the balloon retractor and Veress needle; 
           [0030]      FIG. 12  Detailed top perspective view of this embodiment of the balloon retractor; 
           [0031]      FIG. 13-17  Perspective sectional views of the abdominal wall illustrating successive steps of the method of use of the device in this embodiment; 
           [0032]      FIG. 18  Perspective view of an alternate embodiment of the puncture assistance device; 
           [0033]      FIG. 19  Exploded view of the puncture assistance device in a preferred embodiment; 
           [0034]      FIG. 20  Perspective view of a preferred embodiment of the balloon retractor 
           [0035]      FIGS. 21-23  Perspective sectional views of the female pelvis illustrating successive steps of the method of use of the device in this embodiment; 
           [0036]      FIG. 24  Perspective view of the puncture assistance device and an alternate embodiment of the ultrasound device; 
           [0037]      FIG. 25  Perspective view of an alternate embodiment of the balloon retractor; 
           [0038]      FIG. 26  Perspective view of an embodiment of the device illustrating a method of gaining access into a hollow organ. 
       
    
    
     DETAILED DESCRIPTION 
       [0039]    In the following specification I shall nominate as proximal a part of the assembly that is located relatively close to the operator, and as distal a part of the assembly that is located further away from the operator and hence close to the operating field. 
         [0040]      FIG. 1  presents an perspective right top view of the assembly  1 , formed by the ultrasound probe  5  in combination with the puncture assistance device  10  to which the Veress needle  60  is added, and  FIG. 2  presents an exploded view of the same. They depict an elongated ultrasound probe  5  that is otherwise known to be used for transvaginal or transrectal diagnostic procedures, with a flattened upper surface, formed of an elongated handle part  6  that serves to be gripped by the operator, an elongated shaft  7  that presents an elongated niche  8  on its flattened upper side ( FIG. 2 ), and a rounded distal scanning part  9  that sends and receives ultrasound signals to/from the area to be examined that are converted to an image on the desktop of the ultrasound scanning device, this image serving to be interpreted by the examiner. 
         [0041]    The Veress needle  60  depicted in the following is represented by a tubular needle shaft with a needle tip  61  and a tubular obturator that is slidably located inside the needle shaft and has an open front end  62 . The obturator has an extended position with its front end in front of the needle tip of the needle shaft and a retracted position with its front end behind the needle tip. The obturator forms a channel there trough to pass an article out the open front end. 
         [0042]    The puncture assistance device  10  comprises a tenaculum-like clamp  50 , that is removably attached to the elongated body of the needle guide  15 , this being also removably attached to the upper body of the ultrasound probe  5  by means of clamping fasteners  30  and  40  that fit closely around the handle part  6 , respectively the elongated shaft  7  of the ultrasound probe and an elongated ridge  16  ( FIG. 3 ) that fits within the elongated niche  8  of the ultrasound probe. The distal part of the body of the needle guide  15  presents a prominent part  20 , which includes an inner slot for the insertion of the Veress needle  60 . 
         [0043]    The tenaculum clamp  50  is made of two opposing mirroring handles  51  and  52  with proximal finger loops, and two half-toroid segments  53  and  54  each one corresponding to a handle, that serve as pivot point, these being internally circumscribed by a circular ring  55  that is C-shaped on section and is holding segments  53  and  54  in contact to each other ( FIG. 8 ). The handles  51 ,  52  are provided with ratchet fixation  56  at the level of the finger loops, represented by a series of interlocking teeth, a few on each handle, and the clamp also provides sharp incurving, needle-like inward pointing, sharp pointed curved blades  58  at the distal end. 
         [0044]    Part  20  of the elongated body of the needle guide  15  also presents attachment means to the aforementioned clamp  50 , which are represented by self-locking snap fit joints  17  and  17 ′, that address the clamp&#39;s handles  51 ,  52  of round shape on section, as well as snap fit coupling assembly  23 , which fits within the circular ring  55  of the clamp  50  when attached. Snap-fit coupling assembly  23  is located at the distal part of needle guide  15  on its upper face, and comprises two symmetrical solid prominences  24 ,  25  having the shape of a frustum of a cone segment located on top of a corresponding cylinder segment, together forming a base of rounded shape for inserting the circular ring  55  of clamp  50 . The two segments  24 ,  25  are separated by a latching device represented by a non-permanent releasing cantilever snap  26  having knobs  27  of triangular shape on section that are attached to the base by flexible lamellas. The attachment of the clamp  50  to the needle guide  15  is made by pressing the clamp at the level of the circular ring  55  against the coupling assembly  23 , thereby causing the knobs  27  to be pressed against each other in order to allow ring  55  to enter and be latched. The height of the coupling assembly  23  is slightly higher than the one of the pivot part of clamp  50 , allowing thereby a slight tilting freedom of motion. Supplemental stability to the attachment is given by the following insertion of the clamp handles  51 ,  52  inside the snap fit joints  17  and  17 ′, this step being optional. The detachment of the clamp  50  from the needle guide  15  is made by exerting angular traction on the handles  51 ,  52  at the level of their finger loops, which allows them to exit snap fit joints  17 ,  17 ′, followed by manually squeezing together the knobs  27  this allowing ring  55  to exit the snap fit  23 . 
         [0045]      FIG. 3-8  illustrate the puncture assistance device  10  depicting several supplemental aspects thereof. 
         [0046]      FIG. 5  depicts a cross section front view of the puncture assistance device made at the level of snap fit joints  17 ,  17 ′. 
         [0047]      FIGS. 6 and 7  illustrate a cross section rear view of the puncture assistance device made at the level of clamping member  40  that addresses the elongated shaft  7  of the ultrasound probe. 
         [0048]    The snap-fit joints  17 ,  17 ′ ( FIG. 5 ) are located on lateral protrusions  18 ,  18 ′ of the prominent part  20  of the needle guide  15 . Thereon arciform flexible lamellas  19 ,  19 ′ partially include handles  51 ,  52 , latching them in position when inserted. 
         [0049]    The prominent part  20  of the needle guide  15  presents a sloped part  21  proximally from snap fit coupling assembly  23 , that is including an inner slot  14  for the insertion of the Veress needle  60 , this slot presenting an entry orifice  11  on the proximal face  22  of part  21 , and an exit orifice  12  located at the distal tip of guide  15 . The axis of slot  14  presents an angle in relation to the axis of the body of the needle guide, this angle allowing proper and easy manipulation of the Veress needle. 
         [0050]    Clamping fastener  40  of needle guide  15  ( FIG. 6 ,  7 ) is having an overall rounded shape that is correspondent to the shape on transversal section of the elongated shaft  7  that is flat on its upper side, comprising two symmetrical arciform lamellas  41 ,  42  that present an inferior opening in between that allows the insertion of shaft  7 . Arciform lamellas  41 ,  42  thicken towards their ending into a cuboid shape with parallel inner and outer faces. At this point, the lamellas present orifice  45  on lamella  41  and  45 ′ on lamella  42 , through which a bolted screw  46  is inserted, this comprising an outer knob  47 , that can be manually rotated, located outside orifice  45 , from which a pin extension enters through slot  45  and ends into a threaded bolt  48 , that enters the nut  49 , located in orifice  45 ′ of lamella  42 . The bolt  48  presents a slight bigger diameter than the pin segment. Orifice  45  of lamella  41  presents an inner flange  44 , which prevents bolt  48  from exiting the orifice when in retracted position. 
         [0051]    The attachment of the ultrasound probe  5  to the needle guide  15  at this level is made by inserting the elongated shaft  7  through the opening between lamellas  41  and  42  with bolted screws in retracted position ( FIG. 7 ), followed by pushing the bolt  46  towards orifice  45 ′ of lamella  42 , and screwing it into nut  49 , thereby causing lamellas  41 ,  42  to approach each other, pressing within clamp  40  the shaft  7  of the ultrasound probe, hence resulting a solid grip at this level. The detachment of the ultrasound probe follows the same pathway in reverse order. Clamp fastener  30 , located proximally presents a similar construction manner to clamp  40 , the only difference being represented by the overall ovoid shape that addresses the handle section  6  of the ultrasound probe. 
         [0052]    The attachment of the ultrasound probe  5  to the needle guide  15  is made by aligning them against each other, inserting handle  6  into clamp  30 , elongated shaft  7  into clamp  40 , and elongated ridge of needle guide  15  into corresponding niche  8 , verifying the alignment, followed by the fastening of clamping members  30  and  40  until obtaining a solid grip. 
         [0053]      FIG. 9-12  display a balloon retractor catheter  80  that serves as an external sheath of the Veress needle  60  upon entry. The balloon retractor catheter  80  comprises an elongated double lumen shaft  85 , the length of which being inferior to that of the Veress needle shaft. Shaft  85  consists of two lumens, one being designated for the insertion of the Veress needle, the tip  61  surpassing the tip  87  of shaft  85  distally. The tip  87  is also sharpened in form of a needle tip, thereby easing the insertion of the balloon retractor catheter through the layers of the abdominal wall on the path created by the Veress needle  60 . At the proximal end, the shaft  85  presents a neck  81  followed by a thickened adaptor  82  for the insertion of the Veress needle  60 . The second lumen of the shaft  85  having a smaller diameter is represented by a channel there trough to pass a fluid between pilot balloon  70  and balloon retractor  90 . The inflatable pilot balloon  70  presents a rounded shape, being made of resilient material, being included within a rigid frame  72 , that comprises distally a protrusion  73  for the exit of tube  71 , and proximally a female syringe connector  75 , that presents a single direction flow valve  77 , which doesn&#39;t allow the fluid entering the pilot balloon to exit it, except through tube  71 , which connects the pilot balloon to the aforementioned second lumen of the elongated shaft  85 . Tube  71  is surrounded by a flexible reinforcing, strengthened outer tube  74 , which is inserted at the level of the neck  81  of the elongated shaft  85 , surrounding it, assuring thereby that a strong pull may be exerted by hand by the operator. 
         [0054]    Balloon retractor  90  is having an overall cylindrical shape, surrounding symmetrically the elongated shaft  85  to which it is attached on its inner side, and being surpassed distally by tip  87 , being comprised of a balloon  91  represented by an inner layer of thin material, that when inflated recreates the aforementioned cylindrical shape, and is not inflatable beyond its maximum volume capacity. An outer mesh of reinforced, non-distendable thin fibers is attached to the outer surface of balloon  91 , presenting different patterns on the different faces of cylinder. On its lower distal face, there is represented a single reinforced non-pierceable layer  92 , that is attached on the outer surface of balloon  91 . The lateral aspect of the fibers is represented by longitudinally oriented fibers  93 , displayed in a circular pattern around balloon  90 , connecting the lower, distal part  92  to the mesh  95  of the upper face. On the upper proximal side of the balloon  91 , and attached to it, a cobweb-like net  95  of intersecting, interconnected fibers displayed in a crisscross pattern, creating non-distendable reinforced mesh spaces, with diameter significantly smaller than that of a trocar, but large enough for the sharp tip of the trocar to pass through. A trocar ( FIG. 17 ) is a sharp pointed surgical instrument, which is used inside a hollow cannula to introduce it inside the abdomen in laparoscopic surgery. It is displayed as a means for introduction of cameras or other laparoscopic instruments. Net  95  is attached to and surrounded by circular fibers  96 , which are being attached to longitudinal fibers  93 , previously described, and also to radially ascending fibers  98  displayed in a circular pattern around shaft  85 . Fibers  98  are connected to circular fibers  96 , and ascend freely towards shaft  85 , where they attach at a more proximal level than the level of mesh  95 . The length of fibers  98  is equal or greater than the sum of the radius of cylinder  90  plus the distance between the upper face of cylinder  90  and the attachment level of fibers  98  onto shaft  85 . 
         [0055]    Upon insertion into the abdominal cavity, the balloon retractor  90  is inserted in deflated state, adjacent to the elongated shaft  85 , to which the inner part of the balloon  91  is closely attached, with reinforced layer  92  on the outer side of the deflated complex of the balloon retractor. 
         [0056]      FIG. 13-17  illustrate an abdominal entry technique in patients at risk for abdominal wall adhesion with the use of the aforementioned device. 
         [0057]      FIG. 13 : A segment of the abdominal wall from the central area is depicted, the umbilicus being known to be the site of choice for primary entry in the abdomen by Veress needle or trocar. The following layers of the abdominal wall are represented: skin  101 , subcutaneous fat tissue  102 , anterior rectus fascia  103 , body of the left  104  and right  104 ′ rectus muscle,  transversalis  fascia  105 , properitoneal fat  106 , parietal peritoneum  107 . 
         [0058]    The first step is to create a small intra- or periumbilical incision of the skin  101  by scalpel, followed by the instrumental sharp and blunt dissection and retraction of the subcutaneous fatty tissue  102  to expose the fascia  103 . After visualization of the fascia  103 , this is grasped with tenaculum-like clamp  50  by piercing it with its sharp pointed hooks  58 , and by securing the ratchet  56 , resulting a solid grip at this level. 
         [0059]      FIG. 14 : The next step is to attach the ultrasound probe  5  to the needle guide  15  by fixing it with clamp fasteners  30  and  40 , to align the resulted combination to clamp  50 , and to attach the clamp  50  to the needle guide  15  by fastening coupling assembly  23  to the circular ring  55  and clamps handles to snap-fit joints  17 ,  17 ′. The scanning part  9  of the ultrasound probe and the tip of the needle guide are hereby in perpendicular contact to the fascia and attached to it by means of the clamp  50 . The operator can hereby visualize on the desktop (not shown) of the ultrasound device the different layers of the abdominal wall, measure them, and apply pressure and traction on it, viewing the way that the layers are distended or compressed and especially the mobility of the inner organs, represented in this area by intestines and omentum in relation to the parietal peritoneum identifying thereby possible adhesions if the mobility is very limited. 
         [0060]    A Doppler ultrasound of the abdominal wall helps identifying blood vessels that lay on the path of the instruments, and could be damaged. The path can therefore be changed by tilting or repositioning assembly  1 . 
         [0061]    At this point a visceral slide test and a peroperative periumbilical ultrasound-guided saline infusion test with a spinal needle through the slot of the needle guide  15  can be made by the aforementioned technique in order to identify possible occluding adhesions to the abdominal wall. 
         [0062]    If these are identified, the operator can choose either:
       to continue at this site and perform the safety tests and procedures that are to be described,   to tilt the complex formed by the puncture assistance device  10  and the ultrasound probe  5  for attempting entry at a different angle,   reposition the puncture assistance device—detach the needle guide  15  together with ultrasound probe  5  from tenaculum  50  and tenaculum from fascia  103 , and to apply the same steps previously described at another level in the same incision   to leave this surgical site and continue at another site.       
 
         [0067]    In thin patients it is possible to perform the aforementioned procedure and tests without performing an incision, by applying the tenaculum clamp  50  directly on the skin. 
         [0068]      FIG. 15  illustrates the next step of using the assembly  1  that is applied on the rectus fascia  103 , with the Veress needle  60  inserted through the needle guide  15  and pushed through the layers of the abdominal wall. One hand of the surgeon is gripping assembly  1 , applying traction, while the other hand is inserting the Veress needle through the needle guide  15 . The first assistant is holding a syringe with isotone solution that is coupled to the Veress needle by means, of a connector (not seen). By applying traction on the rectus fascia by pulling assembly  1 , the abdominal wall is pulled away from the inner organs and great retroperitoneal vessels, creating a space in between, and the different layers of the abdominal wall are spaced apart for a better differentiation on ultrasound. The path of insertion of the Veress needle  60  is displayed on the screen of the ultrasound device, until the perforation of the parietal peritoneum  107  and entrance into the abdominal cavity. 
         [0069]    A clearer picture on the ultrasound can be obtained by infiltrating saline solution through the Veress needle while inserting it, hereby creating by hydro-dissection fluid pockets  110 ,  110 ′ between the different layers of the wall that are separating them. 
         [0070]    Of utmost importance is the fluid pocket  110 ′ located in the properitoneal layer  106 , as this allows the precise measurement of the peritoneal membrane  107 , whose thickness differs with age and associated pathology, and the relation between inner organs (represented at this level by intestine and omentum) and the peritoneal membrane depicting either mobility or immobility of the underlying structures. 
         [0071]    A measurement corresponding to the normal thickness of the peritoneum  107  according to age and pathology associated with normal motion of the underlying structures when mobilizing the abdominal wall by pushing/pulling it with assembly  1  should exclude the presence of occluding parietal adhesions and ensure a safe entry at the site, followed by piercing the peritoneal membrane with the Veress needle. 
         [0072]    An abnormally thickened peritoneal membrane with an inhomogeneous structure that cannot be distinguished from the underlying structures, which are relative immobile to the abdominal wall, raises the suspicion for occluding adhesions. In this case, the operator can choose either:
       to tilt the complex formed by the assembly  1  for attempting entry at a different angle, continuing with hydro-dissection until normal peritoneum and underlying mobility are depicted,   to reposition the puncture assistance device—detach the needle guide  15  together with ultrasound probe  5  from tenaculum  50  and tenaculum from fascia  103 , and to apply the same steps previously described at another level in the same incision,   to leave this surgical site and continue at another site.       
 
         [0076]    After piercing the peritoneum and entering the abdominal cavity, one should continue the instillation of fluid. Normally the fluid disappears as instilled as it flows in the cavity. If fluid pockets are depicted that do not disappear, occlusive adhesions are to be suspected. 
         [0077]    After ensuring the safe entry into the abdominal cavity, the Veress needle is connected to the insufflation tubing and the abdomen is inflated with CO 2 . 
         [0078]    Assembly  1  should not be discarded while insufflating the pneumoperitoneum, as occult adhesions may become obvious at this time, interfering and creating supplemental risk when inserting the trocar. Normally with insufflation the intraabdominal structures underlying the peritoneum disappear from the screen of the ultrasound device, as gas is non-conductive to ultrasound waves. When observing intraabdominal structures that remain adherent to the abdominal wall and elevate together with it when insufflating, occlusive adhesions are present that may be damaged upon first trocar insertion. 
         [0079]      FIG. 16  illustrates an alternative way of entry by using the balloon retractor catheter  80  in conjunction and as an external sheath to the Veress needle  60 . Insertion steps and safety tests are the same as previously described, with balloon  90  in deflated state, applied to the body of the elongated shaft (not shown). After ensuring safe entry into the abdominal cavity, the Veress needle  60  and the balloon catheter  80  are pushed through until the neck  81  engages the slot of the puncture assistance device  10  at the level of orifice  11 . A fluid filled syringe is then adapted to the female syringe connector  75  of the pilot balloon  70  and liquid is instilled hereby. The balloon  90  is filled with fluid until its maximum volume capacity where it assumes the cylindrical shape previously described, and any loose adhesions are pushed aside. The filling of the balloon  90  is witnessed by the inflation of the pilot balloon  70 , without being followed by deflation as the latter is manufactured of elastic material, the connector  75  presenting a unidirectional valve, which allows only filling. By pulling on the pilot balloon  70 , the upper face of the balloon  90  is applied on the inner surface of the peritoneum  107 . This can be visually confirmed by identifying the fluid filled balloon in position on the screen of the ultrasound device. At this time, any thickening between the peritoneum and the upper face of the balloon retractor can be considered an adhesion, and that path should be avoided when inserting the primary trocar, except for when it disappears when the balloon is pushed inward and retracted afterwards. 
         [0080]      FIG. 17  illustrates the entry of the primary trocar by using this technique. After ensuring the safety of entry by the aforementioned methods, the ultrasound probe  5  is uncoupled from puncture assistance device  10  and removed, and a trocar  130  is inserted through the skin incision to impact the fascia  103 , at a small distance to the level where Veress needle  60  and balloon catheter  80  pierce the fascia and with a similar orientation. Rotating advancing movement are exerted on the trocar with one hand while the other provides counter-traction on the pilot balloon  70 , lifting thereby the abdominal wall and ensuring close contact between the upper face of the cylindrical balloon  90  and the parietal peritoneum  107 . As the sharp tip  135  of the trocar enters the abdominal cavity through the peritoneum, it will come in contact with the balloon retractor  90 . It will enter through the mesh  95 , and pierce the thin wall of balloon  91 , creating a hole in it and causing it to burst, followed by the collapse of the mesh  95  around the tip of the trocar. This is witnessed by the rapid deflation of the elastic pilot balloon  70 , which empties its content into the abdominal cavity through the burst balloon. As mentioned, tip  135  of the trocar enters in one of the non-distendable mesh holes of  95 , of smaller diameter than the trocar, being entangled in it, and contacts the inferior reinforced layer  92  that it cannot pierce. The previously described radially ascending fibers  98  ( FIG. 12 ) prevent the lateral misplacement of the mesh  95  after the collapse of the balloon  91 , by keeping the surrounding circular fibers  96  in a steady position, creating a hammock-like stable structure that induces a centralized path to the trocar towards layer  92 , and does not allow it to slip sideways. After the deflation of the pilot balloon  70 , one should exert a lower amount of counter-traction at its level and let the balloon slide together with the trocar for a small distance until the insertion of the cannula, as layer  92  will prevent possible damage made by the sharp tip of the trocar. After the insertion of the cannula through the abdominal wall, the sharp trocar is removed, releasing thereby the collapsed balloon  90 . The removal of the balloon  90  is made by pulling it reversely through its path after removing clamp  50  from the fascia, and disassembling it from needle guide  15 , by traction exerted on the needle guide  15 , which impacts at the level of slot orifice  11  of face  22  the neck  81  of the balloon trocar  85 . 
         [0081]      FIG. 18  introduces an alternate embodiment of the invention, namely assembly  110 , which comprises ultrasound probe  5 , attached to needle guide assembly  115  that contains tenaculum  150  and needle guide  120 . Through a slot in the prominent part  125  of the needle guide  120 , a Veress needle  60  is inserted. Attachment of the puncturing assistance device to the ultrasound probe is made by similar means as in the former embodiment by clamps  30 ,  40 . Attachment of the tenaculum  150  to the needle guide  120  is made by lever  130  that rotates around pivot  135 , inserted at the level of the elongated base of needle guide  120 . Lever  130 , is presenting an L-shape that allows it to be elevated from the base by pulling on the shorter segment, and insert it between the handles of the tenaculum  150 , securing it thereby to the needle guide  120 . 
         [0082]      FIG. 19  presents a preferred embodiment of the invention, namely assembly  200  comprised of an ultrasound probe  5 , previously described, together with a puncture adapter  210  that is comprised of an elongated part  215 , which presents on its upper side a recess  220  of trapezoid shape, with a ratcheted lower face segment  225 . The elongated part  210  presents attachment means to the ultrasound probe  5  through snap-fits  216 ,  217  which enter into corresponding recesses (not seen) of the ultrasound probe, securing thereby part  215  to probe  5 . 
         [0083]    A needle guide insert  230  is illustrated presenting a distal prominent part  235  with a slot  237  for the insertion of the Veress needle (not illustrated) through it, and an insertable part  240 , of corresponding shape to the recess  220  of the elongated part  21 . It also presents the pin  245 , attached by a lever  246  to the needle guide insert  230 . Pin  245  is designed to enter into the ratcheted lower face segment  225  of the elongated part  215 , and thereby to axially lock the needle guide  230  from distal displacement. 
         [0084]    Insert  250  is composed of an insertable part  255  of corresponding shape to the recess  220 , with a hook  252  on its upper face with proximal convexity for securing tenaculum  150  ( FIG. 21 ). Part  255  presents a distal sloped surface  257  and a proximal lever  259 , ending in a handle part  260 , which presents on its inferior surface a pin  262  meant for engaging the ratcheted segment  225  of the elongated part  215 , thereby axially locking part  250  from distal displacement. 
         [0085]    Inserts  230  and  250  are to be introduced by their insertable parts from distal towards proximal into recess  220 , while pin  262  of part  250  and pin  245  of part  230  allow for proximal axial movement but prevent distal displacement of the inserts. Axial distal displacement of the insert  250  is made by elevating handle  260 , thereby disconnecting pin  262  from ratchet  225 . The sloped part  257  engages and elevates pin  245  of the insert  230  from the ratchet, thereby allowing it to be distally displaced and disconnected from the elongated part  215 . 
         [0086]      FIG. 20  discloses a preferred embodiment of a balloon retractor  270  composed of a single lumen elongated shaft  272  with a proximal handle part  274  and a Luer adaptor  275 . In the distal part of the elongated shaft a balloon  280  is provided. The balloon is filled with fluid through the lumen of the elongated shaft  272  by attaching a syringe (not shown) to the Luer adaptor. Around the balloon and distended by it, a net  282  of reinforced fibers is provided. These are composed of longitudinal fibers  285 , which are attached on both ends to the elongated shaft  272  by inserts  287  and  289 , located proximal and respectively distal to the balloon  280 . Circular fibers  290  are provided within the proximal half of the net  282 , that intersect and are attached to the longitudinal fibers  285  creating thereby a cobweb-like mesh  292  with non-distendable holes. 
         [0087]      FIGS. 21-23  present a method for transvaginal access for laparoscopy. A sagittal section of the pelvic viscera is illustrated for a patient in lithotomy position with the urinary bladder  300  located superiorly, the rectum  320  inferiorly, and the vagina  315  and uterus  310  in between. Device  200  is inserted into the vagina  315 . Prior steps comprise exposure of the cervix  312  by means of specula (not illustrated), followed by grasping of the cervix  312  with tenaculum  150 . Afterwards the assembled device  210 , comprising ultrasound probe  5  with the elongated part  215  of the puncture adapter attached to it, and with inserts  250  and  230  introduced into recess  220  ( FIG. 19 ) is introduced into the vagina  315  and a Veress needle  60  is inserted through the slot  237  ( FIG. 19 ) of the needle guide insert  230 . The puncture adapter  210  is previously secured to the tenaculum forceps  150  by hook  252  which enters between the jaws of the tenaculum, while insert  250  is pulled proximally and locked into position by traction applied on handle  260  causing pin  262  to enter ratchet  225  ( FIG. 19 ). The tenaculum  150  pulls the uterus  310  and aligns it so that the trajectory of the Veress needle  60  through the posterior fornix  317  of the vagina does not cause injury. The piercing of the posterior fornix is made under ultrasound guidance with images provided by the probe  5  within a fluid environment on an ultrasound screen (not illustrated). After piercing through the posterior vaginal fornix, fluid is injected into the abdominal cavity in order to obtain an image that could show abnormal findings that contraindicate the continuation of the procedure. The obturator  62  of the Veress needle  60  protects the rectum or other viscera from injuries. 
         [0088]    The next steps of the procedure are illustrated in  FIGS. 22 and 23 . Through the Veress needle approximately 200 cc of fluid is introduced into the abdominal cavity, while observing on the screen (not shown) of the ultrasound device the distension of the space between the rectum  320  and the uterus  310 , called the pouch of Douglas, observing thereby conditions like adhesions or endometriosis that contraindicate the continuation of the procedure. 
         [0089]    After ensuring the correct placement of the Veress needle, its obturator is unscrewed and removed, leaving only the outer shaft in place, and through it the balloon retractor  270  with balloon  280  ( FIG. 20 ) and net  282  in collapsed state. The balloon (not shown) is afterwards filled with fluid, leading thereby to the expansion of the net  282 . Yet again, by means of the ultrasound device, several contraindications for the procedure are accounted for. The balloon also creates a safe entry site with no interposed structures between the rectum and the uterus, minimizing the risk of injury when the trocar is inserted ( FIG. 23 ). The next steps comprise the disposal of the tenaculum  150 , elevation of the handle  260  of the insert  250 , which leads to the disengagement of pin  262  from ratchet  225  ( FIG. 19 ), thus allowing the axial translation towards distal of the insert  250 . When the sloped part  257  ( FIG. 19 ) of insert  250  engages the pin  245  ( FIG. 19 ) of the needle guide insert  230 , it also leads to the disengagement from the ratchet  225  ( FIG. 19 ). This allows by pushing towards distal the disengagement of the needle guide insert  230  from the recess  220  ( FIG. 19 ) of the puncture adapter. Afterwards, the device  210  is extracted from the surgical site, leaving behind only the balloon retractor  270  located within the outer shaft of the Veress needle  60  and the needle guide insert  230 , as illustrated in  FIG. 23 . After obtaining the described configuration, the balloon retractor is pulled by its handle  274 , causing the balloon (not shown) and net  282  to be pressed against the vaginal wall at the level of the posterior vaginal fornix  317  and to create a bulging at the level of the inner part of the vagina, thereby indicating a safe place for the insertion of the trocar  130 . 
         [0090]    Trocar  130  is inserted while pulling the balloon retractor  270  against the abdominal side of the vaginal wall. When the sharp tip of the trocar obturator  135  pierces through the vagina, it causes the burst of the balloon  280  (not seen in this figure), and the collapse of the cob-web like mesh  292  around it, leading to its entanglement and thus not allowing the trocar to be pushed further towards distal, as not to cause any nearby organ injury. The progression of the trocar  130  is felt through the handle  274  of the balloon retractor, and the process is timely stopped. Of utter importance is the fact that the circumference of the holes of the mesh  292  is smaller than the circumference of the trocar obturator  135 , leading to its entanglement. 
         [0091]    After entry, the obturator is removed from the trocar  130 , and an optic telescope (not shown) is inserted. After an inspection, the collapsed balloon retractor is extracted from the vagina and surgery is continued. 
         [0092]    As the steps are similar with the technique illustrated in the first described embodiment, it is understood that this preferred embodiment ca also be used for first entry into the abdomen by its surface, as well as for other hollow organ access. 
         [0093]    Although the previous embodiments illustrate a vaginal probe  5 , it is to be understood that this method of treatment is not limited to this type of ultrasound transducer—which can be of different shapes. 
         [0094]      FIG. 24  illustrates an alternate embodiment of an ultrasound device  350 , which comprises a screen and control part  355 , connected by a handle  360  to an elongated ultrasound probe  370 , of considerable smaller diameter than the vaginal probe previously depicted. The puncture assistance device  210  is attached to the probe  370  either by clamp rings, or by snap fits (not illustrated). The tenaculum  150  grips the fascia  103  of the abdominal wall, securing the device to it and allowing thereby the procedure to be made by following the steps previously described. The screen and control part  355  of the ultrasound device  350  provides control buttons  356  to be operated on by the surgeon, batteries (not seen), hardware and software components (not seen) that translate the signals from the probe into an image projected on the screen  357 . The advantage of this embodiment would be its easier handling, by providing a sterile wrap (not shown) for the device. 
         [0095]    Also the software component of the device can be programmed to detect an area of safe entry where the surgeon can pierce the wall without the risk of injury to the underlying organs. The software component recognizes safe entry sites and directs the surgeon by different color codes displayed of the screen  357 , or by sonic signals. 
         [0096]      FIG. 25  illustrates an alternate embodiment of the balloon retractor  400 , where the net  405  is composed of elastic memory shape fibers with longitudinal  410  and circular 402 orientations, creating thereby in the proximal half where the fibers are interconnected, a non-distendable mesh meant to catch the tip of the trocar (not illustrated). Fibers  410  are attached to ring inserts  420 ,  421 , which are themselves connected to the elongated shaft  425  of the balloon catheter. Insert  421  is immobile in relation to the elongated shaft, while insert  420  is slidably movable along elongated shaft  425 . In order to insert the balloon retractor  400  through the hollow shaft of a Veress needle (not illustrated here), insert  420  has to be pulled proximally so as to keep the net  405  taut around the elongated shaft. After passing through the needle, insert is released so that the fibers regain their ellipsoid shape. This can be done either by a latching mechanism of the insert or a wrap around the fibers (not shown). 
         [0097]      FIG. 26  illustrates the use of the apparatus into gaining minimally invasive access in other hollow organs like in the stomach  440  for a gastrostomy or the urinary bladder for a cystostomy. The ultrasound device  350  is placed with the ultrasound probe  370  on the patient&#39;s skin  101  or within a small incision. The puncture assistance device  210  is attached thereto. The natural cavity is filled with fluid either by pathological causes (bladder) or by means of and endoscope  450  or gastric tube (stomach). By guidance of the ultrasound device, a hollow needle  460  is used to pierce the layers of the abdominal wall, until its tip is inside the organ cavity and fluid is aspirated through the needle. There is no need for a tenaculum clamp or any other fastening devices, as there should only be applied pressure on the devices so that no other organs are within the path of the needle. The balloon retractor  270  is afterwards inserted through the needle  460  and the balloon  280  is filled with fluid. After ensuring the intracavitary situs of the balloon retractor, devices  210  and  350  are discarded from the surgical site and a trocar for the stoma is inserted while applying traction on the balloon retractor.