Abstract:
A tissue perforation device and method. The device preferably includes a housing having a housing pass-through, a penetrator device securely and sealably positioned so that the penetrator device passes through the housing pass-through, and a vacuum system comprising a vacuum source securely and sealably attached through the housing for advancing a patient&#39;s tissue onto the penetrator device.

Description:
CROSS REFERENCE  
       [0001]     This is a divisional application of U.S. Ser. No. 10/238,113, which was filed on Sep. 10, 2002. 
     
    
     BACKGROUND OF THE INVENTION  
     Field of the Invention  
       [0002]     Significant morbidity and mortality occurs each year by iatrogenic injuries during establishment of pneumoperitoneum prior to laparoscopic surgical procedures. The main source of these injuries is inadvertent perforation of blood vessels or organ structures within the abdominal cavity when the penetration device (needle, trocar or punch biopsy cutting tool) is advanced too far through the abdominal wall piercing the underlying organs that are located adjacent thereto. These injuries are more common with inexperienced surgeons, but can occur even in the most experienced hands. Built-in safety devices exist in the perforation devices themselves, but injuries still occur because of the close proximity of the structures that are intended to be perforated and those to be avoided.  
         [0003]     Vacuum has been used to fix or distort the body and body cavities. In addition, techniques exist for insufflation, or mechanical or vacuum elevation of the abdominal wall during surgical procedures.  
         [0004]     In U.S. Pat. No. 6,042,539, a vacuum-actuated tissue-lifting device and method for performing a surgical procedure in an operative space of a patient are disclosed. The preferred device has a shell with a profile configured to surround a tissue surface of the patient, a vacuum port located on the shell for applying a vacuum between the shell and the tissue surface, and an air conduit extending through the shell to permit air to pass into the operative space of the patient when vacuum is applied. However, the technology described in the above-mentioned patent requires that the incision is made prior to the vacuum system being activated.  
         [0005]     In U.S. Pat. No. 6,340,358, a trocar is disclosed having a safety shield control mechanism that prevents the inner cannula from rotating and from moving axially when in the locked position. The safety shield control mechanism applies consistent pressure on the safety shield and has an open architecture for ease of sterilization. The trocar provides holding levels for different sizes of hands.  
         [0006]     In U.S. Pat. No. 6,197,041, a pneumatically powered trocar assembly is disclosed that includes a source of compressed gas which releases a metered amount of gas to a chamber. A piston slidably positioned within the chamber is driven forward by the compressed gas introduced therein, and an obturator with a tissue piercing tip are advanced thereby. Optionally, a sensor detects the presence of body tissue within the cutting path of the tip and blocks the passage of compressed gas to the chamber, or alternatively, opens an escape vent to release compressed gas therefrom if insufficient body tissue resistance is encountered.  
         [0007]     In U.S. Pat. No. 5,669,883, a Veress needle and cannula assembly is disclosed that includes a stainless steel cannula assembly with a cannula having an outer diameter of approximately 4 mm and a Veress needle assembly having a Veress needle with an outer diameter of approximately 3 mm. The cannula assembly includes a proximal valve assembly and the Veress needle is insertable through the valve assembly.  
         [0008]     In U.S. Pat. No. 5,690,607, an apparatus is disclosed for allowing two retractors to be used to lift the abdominal wall to provide improved visualization and working space in the abdomen of obese patients, and in the lateral regions of the abdomen of normal patients. The apparatus connects a first retractor and a second retractor to a mechanical lifting arm, and comprises a bar, and first, second, and third connecting devices. The apparatus is used by making a first incision and a second incision in the abdominal wall at separated locations. The first retractor is inserted into the first incision, and the second retractor is inserted into the second incision. The first retractor and the second retractor are attached to the crossbar, anal a lifting force is applied to the crossbar.  
         [0009]     In U.S. Pat. No. 5,575,759, an apparatus for retracting an organ to gain access to treat a tissue is disclosed. The apparatus has a main envelope, a second envelope, a first inflation device and a second inflation device. The main envelope encloses a main chamber, and includes a window and a removable window. The second envelope covers substantially all the main envelope, except the window and the removable window. The second envelope and the main envelope enclose a second chamber outside the main chamber. The first inflation device passes a fluid into the main chamber to expand the main chamber and the second chamber from a compacted state to retract the organ. The second inflation device passes a fluid into the second chamber to further expand the second chamber to maintain the organ in its retracted state after fluid has been released from the main chamber.  
         [0010]     In U.S. Pat. No. 5,562,603, an apparatus is described for laparoscopically retracting an organ inside the body to provide surgical access to adjacent tissue. The apparatus includes a thin, flexible envelope, which encloses a chamber. The envelope is laparoscopically insertable in a collapsed state into a body cavity, and the chamber is inflatable to an expanded state following introduction of the envelope into the body. Inflation of the chamber causes retraction of adjacent tissue. An elastomeric seal is insertable into the chamber following inflation and is attachable to part of the envelope inside the chamber following inflation of the chamber. The seal provides a gas-tight seal to maintain the chamber in the expanded state, and to maintain the organ in the retracted state, notwithstanding the piercing of an aperture in the part of the envelope covered by the seal.  
         [0011]     In U.S. Pat. No. 5,531,856, an inflatable apparatus for organ retraction includes a main envelope that forms a main chamber is disclosed. An additional chamber is formed by attaching the periphery of an additional envelope to the outside or the inside of the main envelope. The part of the surface of the main envelope that is not covered by the additional envelope provides a plurality of windows, which, after the additional chamber is inflated, may be at least partially removed to provide apertures through, which treatment or observation can be carried out.  
         [0012]     In U.S. Pat. No. 5,527,264, a method is disclosed for retracting an organ inside the body to provide access for treating a tissue, a retractor having a main envelope, which defines a main chamber is positioned in a collapsed state adjacent to the organ to be retracted. The main chamber is subsequently inflated to retract the adjacent organ. A surgical instrument is passed through the main envelope into the main chamber to contact the tissue for treatment.  
         [0013]     In U.S. Pat. No. 5,522,790, a first inflatable retraction device is disclosed having a first inflatable chamber and a non-pressurized chamber inside the main chamber. The non-pressurized chamber is expanded by inflating a second inflatable chamber. The non-pressurized chamber enables the main chamber to remain inflated when an aperture is cut in the envelope of the main chamber, through which treatment is carried out. A second inflatable retraction device has an inflatable retractor and a maintainer. The inflatable retractor retracts the organ and the maintainer maintains the organ in its retracted condition after the inflatable retractor is deflated. The maintainer can be inflatable, and can be inside or outside the inflatable retractor. A self-retracting endoscope has an optical assembly with an expandable retractor fitted to its distal end. The distal end of the endoscope is inserted into the body with the retractor in a collapsed condition. The retractor is then expanded to retract organs that would otherwise obstruct the view from the distal end of the optical assembly. After observations are complete, the retractor is returned to its collapsed condition. An insertion tube enables cylindrical objects, such as packaged inflatable retraction devices, to be pulled, instead of pushed, into the body. The additional chamber of an inflatable retraction device having two inflatable chambers is filled with a slurry of a particulate solid in a liquid. The liquid is removed and the additional chamber evacuated to consolidate the particulate solid. This increases the retracting strength of the additional chamber.  
         [0014]     In U.S. Pat. No. 5,505,689, a fan retractor is disclosed for laparoscopic surgery which has a pair of angle-shaped elements with first legs disposed in parallel relationship to one another and second legs extending laterally from the first legs for movement between a juxtaposed collapsed condition and a fanned-out expanded condition responsive to rotation of the first legs about their longitudinal axes. Actuators are provided on the first legs to move the second legs between the collapsed and extended conditions. A first lock engages the actuators to lock the second legs in the extended condition and against movement toward or away from one another. A second lock in the form of a block slidably received on the first legs is selectively engageable between the second legs when in the extended condition. When engaged, the second lock serves both to block the second legs from movement toward one another and to restrain the first legs against movement away from one another.  
         [0015]     In U.S. Pat. No. 5,465,711, an organ or tissue plane to be retracted is performed to gain access for a surgical instrument to treat an organ or tissue plane to be treated. An inflatable retractor, including a main envelope enclosing a main chamber, is provided with the main envelope in a collapsed state. The main envelope of the retractor is placed adjacent the organ or tissue plane to be retracted. The main chamber is inflated to an expanded state to retract the organ or tissue plane to be retracted. An aperture is pierced in the main envelope to provide access for the surgical instrument passed into the main chamber to contact an organ or tissue plane to be treated while the main chamber is maintained in the expanded state, notwithstanding the aperture pierced in the main envelope.  
         [0016]     In U.S. Pat. No. 5,454,367, an inflatable retractor including a main envelope enclosing a main chamber is provided. The main envelope is provided in a collapsed state. An elastomeric window is also provided. The main envelope of the inflatable retractor is placed adjacent the organ inside the body, and the main chamber is expanded to an expanded state to retract the organ. Following inflation of the main chamber to the expanded state, the elastomeric window is attached to the main envelope inside the main chamber to cover part of the main envelope. The surgical instrument is passed into the main chamber. An aperture is pierced in the pan of the main envelope covered by the elastomeric window to provide access for the surgical instrument to contact the tissue. The elastomeric window provides a gas-tight seal to maintain the main chamber in the expanded state.  
         [0017]     In contrast to known techniques and methods, the preferred device of the present invention advances tissue to be perforated onto a stationary perforation device and away from the underlying structures. The simplicity of technique leads to a short learning curve and virtually eliminates the possibility of iatrogenic injuries.  
       SUMMARY OF THE INVENTION  
       [0018]     The preferred embodiment of the invention advances tissue to be perforated onto a perforation device or piercing instrument. Presently, the primary intended use of the preferred embodiment is for pulling the abdominal wall onto a perforation device, such as a Veress needle, trocar or punch biopsy cutting tool, and away from abdominal viscera and great vessels for the initial establishment of pneumoperiotoneum pneumoperitoneum. Another intended application for the preferred embodiment is for implanting a device below the skin surface for diagnostic or therapeutic purposes. The present invention is not limited to these applications and may be extended into other diagnostic and therapeutic applications.  
         [0019]     The limitations imposed on the invention are expressly set out in the appended claims only. The invention itself, however, both as to its construction and its method of operation, together with additional objects and advantages thereof, will be best understood from the following description of the specific embodiments when read and understood in connection with the accompanying drawings.  
       LIST OF REFERENCE NUMERALS UTILIZED IN THE DRAWINGS  
       [0000]    
       
           10 —tissue perforation and inflation device ( 10 )  
           12 —housing ( 12 )  
           12 A—housing seal ( 12 A)  
           12 C—housing pass-through ( 12 C)  
           14 —penetrator device ( 14 )  
           14 A—penetrator tube device tip ( 14 A)  
           14 B—penetrator device valve ( 14 B)  
           14 C—hollow shaft of penetrator device ( 14 C)  
           14 D—pentrator tube ( 14 D)  
           16 —vacuum system ( 16 )  
           16 A—vacuum attachment tube ( 16 A)  
           16 B—vacuum valve ( 16 B)  
           18 —abdominal wall ( 18 )  
           18 A—abdominal wall bubble ( 18 A)  
           20 —top center housing ( 20 )  
           22 —O-ring or elastomeric seal ( 22 )  
           24 —optical device or camera ( 24 )  
           30 —“clamshell” housing ( 30 )  
           32 —collar or adapter plate ( 32 )  
           34 —left half section ( 34 ) of housing ( 30 )  
           36 —right half section ( 36 ) of housing ( 30 )  
           38 —left sealing edge ( 38 )  
           40 —right sealing edge ( 40 )  
           42 —left half seal ( 42 )  
           44 —right half seal ( 44 )  
           46 —“clamshell” housing pass through ( 16 )  
           50 —bell housing ( 50 )  
           52 —opening ( 52 )  
           54 —bell housing pass-through ( 54 ) 
       
     
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0049]      FIG. 1  is a side view of a tissue perforation device ( 10 ) positioned over a non-extended abdominal wall ( 18 ).  
         [0050]      FIG. 2  is a bottom view of the perforation device ( 10 ).  
         [0051]      FIG. 3  is a side view of the perforation device ( 10 ) exhibiting an extended abdominal wall ( 18 ) forming an abdominal wall bubble ( 18 A).  
         [0052]      FIG. 4  is an exploded perspective view of a “clamshell” housing ( 30 ).  
         [0053]      FIG. 4   a  is a view of the clamshell housing ( 30 ) being removed after penetration with penetration penetrator device ( 14 ) ( 14 C).  
         [0054]      FIG. 5  is a side view of a bell housing ( 50 ).  
         [0055]      FIG. 5   a  is a perspective view of the bell housing ( 50 ) being removed after penetration with penetration penetrator device ( 14 ) ( 14 C). 
     
    
     DETAILED DESCRIPTION  
     Embodiments of the Mounting Assembly  
       [0056]     The following is a detailed description of the preferred embodiment of the invention.  
         [0057]     Referring to  FIG. 1  and  FIG. 2 , which are a side and bottom view, respectively, of a perforation device ( 10 ) positioned over a non-extended abdominal wall ( 18 ). The perforation device ( 10 ) comprises a housing ( 12 ) having a housing pass-through ( 12 C) and a housing seal ( 12 A) along a perimeter functioning to form a tight seal between the housing ( 12 ) and an abdominal wall ( 18 ). The housing ( 12 ) is manufactured from a strong non-collapsible material to withstand the internal negative pressure in the range of about 50 to 250 mm Hg exerted therein. Suitable materials are specifically designed for medical use and capable of sterilization. The materials include plastic, plastic composite, rubber, rubber composite, fiberglass, epoxy, glass, glass composite, and the like. Plastic, such as polycarbonate, and plastic composites are particularly well suited due to its superior strength, transparency, rapid manufacturing and low cost. The housing ( 12 ) is usually translucent or transparent. Transparency is preferable to allow the physician to monitor the perforation. Housing ( 12 ) is sized to accommodate adults and children of different sizes and/or body mass indexes. The diameter of the circumference of housing ( 12 ) in contact with the abdomen for adults ranges from about 3 inches to 8 inches and for pediatric patients from 1½ to 3 inches.  
         [0058]     A penetrator device ( 14 ) is can be securely and sealably positioned through a top center housing ( 20 ) of the housing ( 12 ). The seal and fixation of the penetrator device ( 14 ) can be done by means of the O ring ( 22 )[[.]] or any other elastomeric member known in the art for such sealing purposes. The seal and fixation of the penetrator device ( 14 ) can also be accomplished by other means, e.g., by pressing the operator&#39;s fingers on penetrator device ( 14 ) and braced against the housing pass-through ( 12 C). The penetrator device ( 14 ) comprises a penetrator device ( 14 C) penetrator device tip ( 14 A), such as a Veress needle, trocar, or other suitable device, designed to penetrate or cut tissue. The penetrator device ( 14 C) ( 14 ) has a penetrator device valve ( 14 B) for allowing the penetrator tube ( 14 D) hollow shaft of the penetrator device ( 14 C) either to introduce ambient room air, or for connection to a pressurized source of a gas, e.g., carbon dioxide, helium, nitrogen, air and mixtures thereof, for insufflation. The tissue perforation device ( 10 ) further comprises a standard operating room vacuum system ( 16 ). A vacuum tube ( 16 A) is securely and sealably attached to the housing ( 12 ) through a valve or pressure regulator ( 16 B), which functions to regulate the amount of negative pressure exerted within the housing ( 12 ).  
         [0059]     Referring now to  FIG. 3 , an extended abdominal wall ( 18 ) is shown with an abdominal wall bubble ( 18 A). In the preferred embodiment, abdominal wall bubble ( 18 A) is formed by applying negative pressure at vacuum attachment tube ( 16 A), which extends into and is sealed against housing ( 12 ). Internal negative pressure within the housing ( 12 ) creates an abdominal wall bubble ( 18 A) within the housing ( 10 ) ( 2 ) and elevates the abdominal wall ( 18 ) away from the underlying organs and vascular structures. As the abdominal wall bubble ( 18 A) enlarges, the abdominal wall ( 18 ) is advanced onto the stationary penetrator device ( 14 C) tip ( 14 A). Room air or inert gas introduced through penetrator device valve ( 14 B) into the peritoneal cavity to further facilitates the separation between the abdominal wall ( 18 ) and the underlying organs and vessels. Preferably, the penetrator device ( 14 C)  14 ) contains an optical device or integral camera ( 24 ) at its tip to direct visualization of the passage of penetrator device ( 14 C) ( 14 ) through tissue.  
         [0060]     The distance of tissue movement is controlled directly by the operator through regulation of the vacuum. This may be controlled by periodic opening of a vacuum valve, or through a regulator ( 16 B). Optimal vacuum will be a function of the tissue characteristics, and will be regulated by the operator to achieve the desired tissue displacement.  
         [0061]     Following penetration and insufflation, the applied vacuum may be released and the housing ( 12 ) removed by means of a “clamshell” housing ( 30 ) shown in  FIGS. 4 and 4 A or by means of an adaptor plate or collar ( 32 ) shown in  FIG. 5  while leaving the perforation penetrator device ( 14 ) ( 14 C) in place through the abdominal wall ( 18 ).  
         [0062]     Referring now to  FIGS. 4 and 4 A, a perspective view of “clamshell” housing ( 30 ) is shown, which is another embodiment of the housing ( 12 ) shown in  FIGS. 1 and 3 . In this embodiment, the housing ( 30 ) comprises left half section ( 34 ) and right half section ( 36 ) having male left sealing edge ( 38 ) and female right sealing edge ( 40 ), respectively, which cooperate to form a tight seal when vacuum is applied to “clamshell” housing ( 30 ). Left half seal ( 42 ) and right half seal ( 44 ) are respectively molded in the top of left half ( 34 ) and right half ( 36 ) of “clamshell” housing ( 30 ) forming housing pass-through ( 12 C) ( 46 ) in “clamshell” housing ( 30 ) that is sized to accommodate various sizes of penetrator tubes ( 14 A) of hollow shafts ( 14 C) for different sizes of penetrator devices ( 14 ).  
         [0063]      FIG. 4A  shows “clamshell” housing ( 30 ) being removed after the abdominal wall ( 18 ) has been penetrated with the penetrator device ( 14 C) ( 14 ) and the vacuum has been released to leave penetrator device ( 14 ) in place without its disturbance.  
         [0064]      FIGS. 5 and 5 A shows another alternative embodiment of housing ( 12 ). In this embodiment, a perspective view of a bell housing ( 50 ) having opening ( 52 ) to accommodate the adaptor plate or collar ( 32 ) is shown. In this embodiment, a needle or trocar is sealed within pass-through ( 54 ) in an adapter plate or collar ( 32 ), which is sealingly mounted in opening ( 52 ) of housing ( 50 ). Adapter plate ( 32 ) has a ¼ turn bayonet or thread on its edge. When the surgeon makes a V4 (90 degrees) turn of the penetrator ( 14 ), adapter plate ( 32 ) relative to the bell housing ( 50 ), adapter plate ( 32 ) is released from opening ( 52 ).  
         [0065]      FIG. 5A  shows the bell housing ( 50 ) being removed after the abdominal wall ( 18 ) has been penetrated with the penetrator ( 14 C) penetrator device tip ( 14 A), the vacuum has been released, and the penetrator device ( 14 ) has been rotated to leave both the adaptor plate ( 32 ) and penetrator device tip ( 14 ) ( 14 A) in place.  
         [0066]     As this device may be adapted to work with any current or future commercially available trocar or Veress needle devices simply by changing the size of the pass-through ( 54 ) in the adaptor plate ( 32 ), the techniques for establishment of pneumoperitoneum, and the testing for adequate penetration past the peritoneum during establishment of pneumoperitoneum will be device dependant and are not described herein as they are well known to those skilled in the medical arts.  
       EXAMPLE  
       [0067]     This example illustrates the one embodiment of the present invention shown in  FIGS. 1 and 3  in which housing ( 12 ) was a Tupperware TUPPERWARE® bowl having O-ring ( 22 ) inserted in the center of the bottom of the bowl. The example is for illustrative purposes only and are is not meant to limit the scope of the claims in any way.  
         [0068]     In experimentation with a post mortem female pig, a standard hospital 300 mm Hg vacuum source was used to elevate the external abdominal surface 24 inches, depending on the amount of vacuum applied by vacuum system ( 16 ). The stationary Veress needle penetrated the pig&#39;s abdomen without difficulty and water was observed to drain upon penetration. CO2 was attached and the abdomen insufflated to 12 mm Hg. Following insufflation, a 10 mm Ethicon Endo-Surgery trocar was installed at the midline 1″ caudal to the xiphoid and a 30° Stortz camera ( 24 ) was inserted to verify uninjured tissue below the needle entry site, and to observe the inside abdominal wall. The experimental needle was removed and the experiment repeated at 2 mm Hg insufflation under direct observation from inside the abdomen. After external application of vacuum, from inside the abdomen, the abdominal wall could be seen arching up and away from the internal contents, and the needle tip was seen penetrating the displaced tissue.  
         [0069]     It will be understood that each of the elements described above, or two or more together, may also find a useful application in other types of constructions differing from the type described above. An example of another application of the apparatus of the present invention is the performance of a surface skin biopsy where the stationary penetrator device ( 14 ) is designed to only penetrate a certain distance into tissue of the abdominal wall ( 18 ).  
         [0070]     While the invention has been illustrated and described as embodied in an abdomen perforation and inflation device, it is not intended to be limited to the details shown, since it will be understood that various omissions, modifications, substitutions and changes in the forms and details of the device illustrated and in its operation can be made by those skilled in the art without departing in any way from the spirit of the present invention. What is claimed as new and desired to be protected by Letters Patent is set forth in the appended claims.