Abstract:
Surgical apparatus for providing extracorporeal pneumoperitoneum. One embodiment provides a reversely turned fluid and gas impermeable fingerless sleeve ( 14 ) with a quick connect and disconnect assembly around the cuff of the sleeve ( 14 ) for sealing around an abdominal incision to allow hand-assisted minimally invasive surgery under conditions of pneumoperitoneum. A dome shaped enclosure ( 62 ) is provided for use with the quick connect and disconnect assembly to seal around an abdominal incision and maintain pneumoperitoneum during interruptions in a surgical procedure. Another embodiment incorporates a fingerless sleeve ( 14 ) which is adhesively secured directly to a patient&#39;s skin around an incision. The sleeve is applied over a pre-gloved surgeon&#39;s hand, and an outer surgical glove ( 18 ) is applied over the sleeve ( 14 ) in the region where the fingers and thumb protrude before the sleeve ( 14 ) is reversely turned on itself for connection to a patient.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is a 371 of PCT/US97/18168, filed Oct. 8, 1997, which claims the benefit of the priority of U.S. patent application Ser. No. 08/801,752, filed Feb. 18, 1997. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to an apparatus and method suitable for maintaining extracorporeal pneumoperitoneum at an abdominal fenestration during surgery, and more particularly to a quick connect and disconnect enclosure and method for insertion of instruments or a surgeon&#39;s hand into the body cavity through a fenestration for access to organs and instruments within the cavity without loss of insufflation pressure. 
     BACKGROUND OF THE INVENTION 
     Laparoscopy and endoscopy have become a preferred surgical procedure because it is minimally invasive of the patient&#39;s body and, in many instances, can be performed in short-procedure facilities with minimal trauma and significantly reduced recuperation time. In some cases, a new procedure referred to as hand-assisted laparoscopy, or endoscopy, has been employed in which a small muscle splitting incision is made just large enough for admitting the surgeon&#39;s hand into the abdominal cavity to enable palpation of organs and manipulation of surgical instruments, and to provide bio-physical feedback. Visual feedback is usually provided as well through an endoscope and TV monitor. 
     Several medical devices have been developed which make it possible for hand-assisted laparoscopy to be carried out in the abdominal cavity while under conditions of pneumoperitoneum. One device, for instance, by Patrick F. Leahy et al. disclosed in U.S. patent application Ser. No. 08/300,346 filed Mar. 29, 1995 (International Application PCT/US95/04202 published Oct. 29, 1995) provides a gas-tight sleeve which communicates with the abdominal cavity through an incision allowing the surgeon&#39;s hand access through entry and exit openings at opposite ends of the sleeve. The exit opening is sealed around the incision by a flange adhesively attached to the external surface of the abdomen. After the hand is passed through the entry opening, the sleeve is sealed around the surgeon&#39;s forearm by an adjustable cuff. A duckbill check valve disposed between the entry and exit openings forms with the exit opening a substantially gas-tight chamber which allows the surgeon to withdraw his hand from the insufflated cavity with only a slight drop in gas pressure which can be quickly restored. 
     Another device disclosed in U.S. Pat. No. 5,480,410 to Cuschieri et al. provides a gas-tight enclosure in which a resilient ring at an exit opening is squeezed by hand into an oblong shape for insertion through the abdominal incision, then allowed to expand to its original shape under the edge of the incision to seal the peritoneum and enclosure for sufflation. At least one entry opening is provided for passing an instrument or a surgeon&#39;s hand into the enclosure. The enclosure may also include a surgical glove integrally sealed to the entry opening in a glove-box manner for allowing the surgeon&#39;s hand sterile access through the exit opening to organs and instruments within the abdominal cavity. 
     None of these devices, however, satisfies the need for such a gas-tight enclosure which can be quickly disconnected and reconnected as often as necessary during hand-assisted laparoscopic or endoscopic surgery while the enclosure remains sealed in place around the surgeon&#39;s hand, and which can maintain abdominal pneumoperitoneum during extended interruptions in an operation for other medical procedures. 
     OBJECTS OF THE INVENTION 
     Accordingly, it is an object of the present invention to provide a gas-tight extracorporeal pneumoperitoneum enclosure which is worn by the surgeon during hand-assisted laparoscopic or endoscopic surgery, which can be quickly disconnected from a patient as often as necessary in the course of an operation and reconnected while still sealed around the surgeon&#39;s hand, which allows the surgeon to manipulate or palpate organs and instruments from within the abdominal cavity, and which provides bio-physical feedback from the surgeon&#39;s hand under conditions of pneumoperitoneum. 
     Another object of the invention is to provide a surgical apparatus which can be continuously sealed around the surgeon&#39;s hand and forearm and selectively connected around an open wound while maintaining pneumoperitoneum in the course of a hand-assisted laparoscopic or endoscopic operation, and which will maintain pneumoperitoneum within the body cavity during any interruptions for any other medical procedure in the course of an operation. 
     A still further object of the invention is to enable minimally invasive surgery with minimal risk of damage to the immune system, and with shorter healing time and less time needed for recuperation in a hospital. 
     A further object is to provide a disposable surgical device which is relatively simple in design and easy to use. 
     SUMMARY OF THE INVENTION 
     More specifically, in one embodiment, the extracorporeal pneumoperitoneum enclosure is a fluid and gas impermeable elongate fingerless sleeve having an open proximal end and a distal end with holes arranged to seal gas-tightly around the base of the surgeon&#39;s thumb and each of the fingers. The sleeve section intermediate its ends is reversely-turned on itself before its proximal end is fastened either directly, or indirectly, onto a patient&#39;s skin around an incision. Preferably, a quick connect and disconnect assembly at the proximal end of the sleeve gas-tightly seals to the skin around an incision allowing the surgeon to interrupt and resume a hand-assisted laparoscopic surgical procedure under conditions of pneumoperitoneum as often as needed without removing the sleeve from his/her hand. Integral with the quick connect and disconnect assembly is a pressure relief valve for preventing over-sufflation. At least one instrument port is provided in the cuff for admitting, without loss of gas pressure, surgical instruments. 
     In another embodiment of the extracorporeal pneumoperitoneum enclosure, a fluid and gas impermeable hemispheric envelope is sealed gas-tightly around the incision. A quick connect and disconnect assembly with integral pressure relief valve is secured around an open base for maintaining the abdominal cavity sufflated during interruptions in an operation. This embodiment also includes a sealable instrument port. 
     Upper and lower seal rings in both embodiments of the quick connect and disconnect assembly have respectively mating interfaces enabling the sleeve and envelope to be interchangeable without removing the lower seal ring previously attached to a patient. 
     The method for using the apparatus in a hand-assisted laparoscopic operation is as follows. A lower seal ring of the quick connect and disconnect assembly is adhesively sealed to the skin of the patient around the site where a small muscle-splitting incision is made through the abdomen wall and peritoneum. A wound liner and retractor may be inserted into the incision to protect the wound from contamination and to spread it apart for easier access. Wearing an inner surgical glove, the surgeon inserts his/her hand into the fingerless sleeve until the fingers extend completely through the holes and become tightly sealed around their bases. For extra precaution against leakage, an outer surgical glove is then placed over both the inner glove and the fingerless sleeve. The sleeve is then reversely turned on itself. An upper seal ring of the quick connect and disconnect assembly around the cuff of the glove is then sealingly interconnected with the lower seal ring and the abdomen and glove insufflated to the desired pressure either through a separate cannula or a port in the glove. The surgeon&#39;s hand may then be inserted into the abdominal cavity and removed as often as necessary during a laparoscopic procedure. The port in the sleeve permits instruments to be inserted as often as needed. Any increase in sufflating gas pressure, caused by a sudden reduction in volume when inserting the hand, is prevented by the pressure relief valve in the quick connect and disconnect assembly. 
     Whenever the surgeon wishes to interrupt a surgical procedure while still maintaining pneumoperitoneum, the sleeve is disconnected from the lower seal ring, and in its place the dome-like envelope with upper seal ring are connected to the lower seal ring left on the abdomen and sufflation restored. 
     Other objects, advantages and novel features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a view in elevation and partial cross section of an extracorporeal pneumoperitoneum enclosure, or sleeve, according to one embodiment of the invention as applied in hand-assisted laparoscopic surgery in the abdomen; 
     FIG. 2 is perspective view of various components of the sleeve, or enclosure, of FIG. 1 spatially arranged in order of assembly; 
     FIG. 3 is a more detailed view, partially in cross section, of a segment of a connect and disconnect assembly shown connected in the enclosure of FIG. 1; 
     FIG. 4 is a cross sectional view like FIG. 3 but with the assembly shown partially disconnected; 
     FIG. 5 is a view in cross section of an upper seal ring of the sleeve, or enclosure, taken along the line  5 — 5  of FIG. 2; 
     FIG. 6 is a plan view of a lower seal ring with an integral relief valve; 
     FIG. 7 is a view in cross section of an instrument port shown in the enclosure of FIG. 1; 
     FIG. 8 is a view of the instrument port of FIG. 7 view from within the enclosure of FIG. 1; 
     FIG. 9 is a view in elevation and partial cross section of an extracorporeal pneumoperitoneum enclosure according to another embodiment of the invention as applied during an interruption of a surgical procedure; 
     FIG. 10 is a perspective view of an enclosure, or sleeve, similar to the embodiment of FIG. 1, but utilizing a simplified connect and disconnect assembly; and 
     FIG. 11 is a partially-sectioned elevational view showing the enclosure, or sleeve, of FIG. 10 reversely turned and in use in an operating position. 
    
    
     DETAILED DESCRIPTION 
     Referring now to the drawings, FIG. 1 illustrates an extracorporeal pneumoperitoneum enclosure  10  according to the invention applied to a patient&#39;s anterior abdominal wall W. A surgeon&#39;s hand extends into the abdominal cavity through a small muscle splitting incision which is protected from wound contamination by a wound protector/retractor  12  such as disclosed in U.S. Pat. No. 5,524,644 to Berwyn M. Crook. 
     In one preferred embodiment, enclosure  10  includes an elongate gas impermeable flexible sleeve  14  of sufficient length to receive the hand and forearm of the surgeon. Sleeve  14  has an intermediate section that extends from a proximal end cuff section  14   a  to a “fingerless,” distal, hand section  14   b  where it terminates with holes  15  positioned to receive the full length of the surgeon&#39;s thumb and fingers and to seal the sleeve snugly around the root of each as shown in FIG.  2 . 
     As best seen in FIG. 2, sleeve  14  has an inner side  14   c  which faces outward in FIG. 1 because, in use, the intermediate cuff section is inverted, or reversely-turned on itself, so that the inside faces out. An inner surgical glove  16 , worn in direct contact with the hand, is contiguous with inner side  14   c,  and an outer surgical glove  18 , worn to ensure against leakage at holes  15 , covers an outer side  14   d.  Thus, the distal end portion  14   b  of the sleeve  14  is sandwiched between the inner and outer surgical gloves  16  and  18 , respectively and thereby secured in place. 
     Sleeve  14  is made of surgical grade supple transparent material in one size designed to seal around the fingers of a small hand but which will also stretch slightly under plastic deformation with residual elasticity to accommodate larger hands without constricting circulation to the fingers. A suitable material is 2 mil thick polyethylene film such as X-2000 by Pierson Industries. The preferred diameters of the holes  15 , in inches, are as follows: thumb 0.98, index finger 0.79, middle finger 0.87, ring finger 0.75, and pinky 0.63. 
     In the embodiments of FIGS. 1-9, an annular quick connect and disconnect coupling means assembly  20  is permanently sealed around the proximal end of cuff section  14   a  and removably sealed with an adhesive  22  to the abdominal skin around the protector/retractor  12 . 
     Referring to FIGS. 3-6, coupling assembly  20  includes interconnecting upper and lower seal rings  20   a  and  20   b,  preferably molded of a medical grade flexible, slightly resilient thermoplastic rubber of Shore  80 A hardness such as Santoprene® made by Advanced Elastomer Systems. Upper ring  20   a  defines an annular collar  24  permanently sealed around the periphery of cuff section  14   a  with an upwardly facing annular bead  26  concentrically disposed around collar  24 . 
     Lower ring  20   b  includes an annular flange  28  having adhesive  22  for securing ring  20   b  to the skin of a patient during surgery. A peel strip  30  (FIG. 2) covers the adhesive until the ring is to be applied to the skin of the abdomen. A preferred adhesive is IT8-59-A by Tolas Health Care Packaging of Feasterville, Pa. An annular member  32  sealed around its bottom to flange  28  extends upward and terminates in a downwardly facing annular groove  33  formed to interface in a tight seal with bead  26  of upper ring  20   a.  An annular detent  34  extending radially from bead  26  snaps into an annular groove  36  on the inner surface of member  32  when bead  26  and groove  33  are positively engaged as shown in FIG.  3 . Pull tabs  38  extending inward from cylinder  24  enable the surgeon&#39;s fingers to pull detent  34  inward and disengage it from groove  36 , thereby releasing upper ring  16   a  from lower ring  20   b  as shown in FIG.  4 . 
     Lower ring  2   b  further includes a normally closed gas pressure relief valve  40  for limiting increases in pressure in the abdominal cavity as may be caused when the surgeon inserts his/her hand and displaces the sleeve  14 . The valve  40  comprises a seat  42  integrally molded in the periphery of lower ring  20   b,  a cap  44 , a poppet valve  46 , and a helical spring  48 . Cap  44  is secured to ring  16   b  by turning it about its cylindrical axis until tabs  43   a  on the bottom edge mate with slots  43   b  around seat  42 . An aperture  44   a  in the top of cap  44  guides a stem  46   a  of plunger  46  onto seat  42  as well as serves as a vent for sufflation gas released through valve  40 . Spring  48 , around stem  46   a  between the top of cap  44  and a head  46   b  of plunger  46 , biases valve  40  to a normally closed position. A recess  43  in the surface beneath seat  42   b  forms a channel  47  with flange  28  for continuously communicating between valve  40  and the abdominal cavity when lower seal ring  20   b  is adhered to the surface of the abdomen. If the cavity pressure exceeds a safe limit for pneumoperitoneum, e.g. 30 mm Hg, plunger  46  lifts off of seal  42  against the force of spring  48  to release the gas to ambient atmosphere. The materials of construction for cap  44  and plunger  46  are preferably a rigid thermoplastic polycarbonate of Shore  80 C hardness. 
     FIGS. 10 and 11 illustrate a simplified annular assembly means  70  for securing sleeve  14  directly to a patient. The assembly  70  includes a annular flange  72  of flexible plastic permanently heat-sealed or bonded around the proximal end of sleeve cuff section  14   a.  An adhesive  74  is coated on the bottom side of flange  72  for applying either directly to the patient&#39;s skin, or to a surgical drape, around the site of the incision. Complementary peelable strips  76  around respective halves of the flange cover the adhesive until the glove is ready for attachment to the skin or drape. A boss, that may mount either a pressure relief valve  40 , as previously discussed, or provide a sealed instrument port  50 , as will be discussed, may be provided in the sleeve  14  adjacent its proximal end as shown in FIG. 10. A preferred material for flange  72  is a 4 mil plastic laminate of EVA/Surlyn®/EA, and a preferred adhesive is IT8-59-A supra. 
     Sleeve  14  includes an instrument port  50  located close to the proximal end of cuff section  14   a  to provide an optional entry into the abdominal cavity for instruments such as graspers, staplers, clip appliers, scopes, etc. Referring to FIGS. 7 and 8, port  50  includes a generally cylindrical housing  52  with a first flanged base  52   a  at one end secured to the inner side  14   c  of cuff section  14   a.  The other end defines a cone-shaped wall  52   b  tapering along its conical axis into the housing to a circular hole  54  at the small end which is sized for slidably receiving an instrument without leakage. A duckbill check valve  56  prevents pressure loss when no instrument is present in port  50 . The duckbill check valve  56  comprises a second flanged base  56   a  at one end secured to the inside of the housing  52  adjacent to wall  52   b.  The other end tapers to a normally closed slit  56   b  spaced below hole  54  in a plane transverse to the conical axis of wall  52   b.  Housing  52  and insert  56  have sufficient resilience for wall  52   b  to form a gas-tight seal around the instrument&#39;s surface and to ensure that slit  56   b  closes tightly after the instrument is withdrawn. A suitable material found for this purpose is a molded thermoplastic rubber such as Santoprene® by Advanced Elastomer Systems. 
     FIG. 9 illustrates an alternate embodiment of an extended pneumoperitoneum enclosure  60  according to the invention for use in place of the glove enclosure  10  during interruptions in surgery conducted under pneumoperitoneum conditions. It comprises a hemispheric dome-shaped envelope  62  of thin transparent flexible polyethylene film and an upper seal ring  64  of like construction as upper seal ring  20   a.  The perimeter at the open base is sealed around upper seal ring  64  and interconnects with lower seal ring  20   b  of assembly  20 . Of course, enclosure  60  may also include its own lower seal ring such as utilized in the FIGS. 10 and 11 embodiment. Access by surgical instruments is provided by an instrument port  66 , like port  50 , secured to envelope  62 . 
     A method according to the invention for performing hand-assisted abdominal laparoscopic surgery utilizing the extended pneumoperitoneum enclosures as above-described will now be described. 
     The site for making the incision is precisely traced on the abdomen of the patient. In the embodiment of FIGS. 1-8, seal ring  20   b  and sleeve  14  are preferably separated from upper seal ring  20   a  and placed on the surgeon&#39;s hand before ring  20   a  is attached to the abdomen in order to afford a more clear unobstructed view of the tracing. Peel strip  30  covering adhesive  22  on lower ring  20   b  is removed and the ring adhered to the abdomen around the tracing. 
     Guided by the tracing, a small muscle-splitting incision is made through the abdomen wall sufficient in size to allow the surgeon&#39;s hand to pass through. The peritoneum is incised roughly the same amount. Wound liner and retractor  12  is installed in the incision to protect the wound from contamination and to spread it apart for easier access by the hand. The abdomen wall and peritoneum may also be punctured at other locations for receiving an insufflator, a laparoscope and other instruments. 
     Wearing an inner surgical glove  16 , the surgeon dons sleeve  14  by placing his/her hand into fingerless hand section  14   b  until the thumb and fingers extend completely through holes  15  and become snugly sealed thereby. Cuff section  14   a  and upper ring  20   a  (or assembly  70  of FIG. 10) are drawn up over the forearm exposing the outer side  14   d  of fingerless section  14   a.  For added protection against leakage around holes  15 , an outer surgical glove  18  is preferably placed over the exposed finger portions of inner glove  16  and hand section  14   a.  If preferred, the surgeon may don the sleeve  14  and attach it to the lower ring  20   b  before incising the abdomen. 
     The sleeve  14  is then reversely turned on itself with the cuff section  14   a  inverted and upper ring  20   a  is sealed in lower ring  16   b  by pressing bead  26  into recess  33  until detent  36  of upper ring  20   a  snaps into groove  36  of lower ring  20   b.  The abdominal cavity and the annular envelope formed by sleeve  14  may now be insufflated to the desired pressure either through a separate cannula or through port  50  in sleeve  14 . The thus-covered surgeon&#39;s hand may thereafter enter and re-enter the abdominal cavity as often as necessary during the surgery without losing pneumoperitoneum. Any increase in insufflating gas pressure, such as caused by a reduction in volume inside the sleeve-formed chamber surrounding the surgeon&#39;s forearm when inserting the hand, is relieved by pressure relief valve  40 . 
     Should an extended interruption in a surgical procedure be needed while still maintaining pneumoperitoneum, sleeve  14 , attached to upper seal ring  20   a,  may be disconnected leaving in place lower seal ring  20   b.  Dome-shaped envelope  62 , attached to upper seal ring  64 , may then be connected to lower seal ring  20   b  and insufflation restored. 
     Of course, when using the embodiment of FIGS. 10 and 11, the surgeon would don the sleeve  14 , as described above, peel strips  76  from the adhesive  74  and place the flange directly on the skin or surgical drape around the incision site after the wound liner and retractor  12  has been installed. 
     Some of the many advantages and novel features of the invention should now be readily apparent. For example, an extracorporeal pneumoperitoneum enclosure is provided which can be continually worn by the surgeon during hand-assisted laparoscopic surgery under conditions of pneumoperitoneum without loss of free hand and finger movement. It allows the surgeon to quickly disconnect and reconnect the enclosure from the patient while still retaining it on his/her hand. An alternate embodiment provides a dome-like enclosure which can be substituted for the sleeve whenever a protracted interruption in a surgical procedure is necessary. It enables minimal invasive surgery and risk of damage to a patient&#39;s immune system. Due to the smaller incisions, shorter healing time and less time for recuperation in the hospital is possible. The enclosures are also relatively simple in design and easy to use. 
     It will be understood, of course, that various changes in the details, materials, steps and arrangement of parts which have been herein described and illustrated in order to explain the nature of the invention may be made by those skilled in the art within the principle and scope of the invention as expressed in the appended claims.