Apparatus and method for abdomino-pelvic chemotherapy perfusion and lavage

• US 6,383,162 B1
• Filed: 11/12/1999
• Issued: 05/07/2002
• Est. Priority Date: 11/12/1999
• Status: Expired due to Fees

• Current Assignee: Paul H. Sugarbaker
• Original Assignee: Paul H. Sugarbaker
• Inventors: Sugarbaker, Paul H.
• Primary Examiner(s): Dawson, Glenn K.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/438,479
• Time in Patent Office: 907 Days
• Field of Search: 606/1, 606/130, 606/213, 604/26, 604/28, 128/849-852, 128/868, 128/870, 128/874, 128/887, 128/888, 600/201
• US Class Current: 604/28
• CPC Class Codes: A61B 2218/008 for smoke evacuation
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• CPC Class Codes: A61F 2007/0069 with return means
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61H 2201/105 with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 2203/0456 Supine
• CPC Class Codes: A61H 33/14 Devices for gas baths with ozone, hydrogen, or the like production of ozone or hydrogen C01B, C25B1/02
• CPC Class Codes: A61H 35/00 Baths for specific parts of the body electric circuits therefor A61H33/005; specific components therefor A61H33/60
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2210/1017 Peritoneal cavity
• CPC Class Codes: A61M 3/0258 by means of electric pumps
• CPC Class Codes: A61M 35/30 Gas therapy for therapeutic treatment of the skin

Abstract

An abdomino-pelvic perfusion and lavage apparatus is disclosed to which skin surrounding an incision formed through an abdominal wall of a patient can be attached and suspended. The apparatus includes a containment vessel impermeable to water and air, having a wall having a base, wherein the wall has an upper end with a perimeter which defines an upper opening, a lower end with a perimeter which defines a base opening, a cranial end with a perimeter edge which defines an opening, and a caudal end with a perimeter edge which defines an opening. The containment vessel can be carried by a table on which a patient is positioned. Scaffolding carried by the containment vessel supports and elevates the skin surrounding the incision made through the abdominal wall of the patient and thereby forms a well above, and extending into, an abdomino-pelvic cavity. A plurality of fluid ports communicate through the wall of the containment vessel. The cranial opening and the caudal opening can be sealed around the patient'"'"'s torso. A base seal can seal the base of the containment vessel to the table. Perfusion fluid can be supplied from a reservoir to one of the fluid ports communicating through the wall of the containment vessel and delivered to the well and can be withdrawn from the well and returned to the reservoir. A removable cover can be sealed over the upper opening of the containment vessel. The cover can be removed for visual inspection and manual manipulation of the lavage fluid and the patient'"'"'s viscera. An air evacuation system can be connected to the fluid port and can evacuate aerosols and gasses from within the containment vessel. A heater can be used to heat the perfusion fluid when carrying out hyperthermic perfusion. The apparatus can be left in place on a patient for up to 5-10 days particularly when using cell-cycle specific chemotherapy agents which require long-term contact with tissues in order to achieve their optimal effect. Similarly, the apparatus can be used for repeated access to the abdomino-pelvic space in patients with peritonitis or pancreatitis.

Claims

1. An abdomino-pelvic perfusion and lavage apparatus to which a skin surrounding an incision made through an abdominal wall of a patient can be attached and suspended, comprising:

a containment vessel impermeable to water and air, having a wall having a base, wherein said wall has an upper end with a perimeter edge which defines an upper opening, a lower end with a perimeter edge which defines a base opening, a cranial end with a perimeter edge which defines an opening, a caudal end with a perimeter edge which defines an opening;

a plurality of fluid ports capable of providing fluid communication through said wall of said containment vessel;

a scaffolding carried by said containment vessel adapted for supporting and elevating the skin surrounding the incision made through the abdominal wall of the patient, an elevated skin forming a well above, and extending into, an abdomino-pelvic cavity;

said containment vessel being capable of being carried by a table on which the patient is positioned.

2. The abdomino-pelvic perfusion and lavage apparatus of claim 1, wherein said scaffolding comprises:

a support ring for connecting to the skin surrounding the incision made through the abdominal wall of the patient;

at least one connector for connectively disposing between the skin surrounding the incision made through the abdominal wall of the patient and said support ring;

a suspension for carrying said support ring adapted to be disposed superior to the patient'"'"'s abdominal wall and carried by said wall of said containment vessel;

wherein said support ring defines a shape of an open upper end of the well formed by said elevated skin when said support ring is suspended from said suspension.

3. The abdomino-pelvic perfusion and lavage apparatus of claim 2, wherein said suspension is carried by an inner surface of said wall of said containment vessel.

4. The abdomino-pelvic perfusion and lavage apparatus of claim 2, wherein said suspension is carried by said perimeter edge of said upper end of said wall of said containment vessel.

5. The abdomino-pelvic perfusion and lavage apparatus of claim 2, wherein said support ring forms a closed loop.

6. The abdomino-pelvic perfusion and lavage apparatus of claim 2, wherein said support ring forms an open loop.

7. The abdomino-pelvic perfusion and lavage apparatus of claim 3, wherein said support ring can be connected to the skin surrounding the incision made through the abdominal wall of the patient before said support ring is suspended from said suspension.

8. The abdomino-pelvic perfusion and lavage apparatus of claim 2, wherein said support ring can be connected to the skin surrounding the incision made through the abdominal wall of the patient after said support ring is suspended from said suspension.

9. The abdomino-pelvic perfusion and lavage apparatus of claim 2, wherein:

said support ring can be fully or partially connected to the skin surrounding the incision made through the abdominal wall of the patient before said support ring is suspended from said suspension; and

said support ring can be fully or partially connected to the skin surrounding the incision made through the abdominal wall of the patient after said support ring is suspended from said suspension.

10. The abdomino-pelvic perfusion and lavage apparatus of claim 1, wherein said scaffolding comprises:

a support structure disposed around an interior perimeter of said wall of said containment vessel adapted to be superior to the patient'"'"'s abdominal wall; and

at least one connector for connectively disposing between the skin surrounding the incision made through the abdominal wall of the patient and said support structure.

11. The abdomino-pelvic perfusion and lavage apparatus of claim 10, wherein said support structure is adapted to frame the incision made through the abdominal wall of the patient.

12. The abdomino-pelvic perfusion and lavage apparatus of claim 10, wherein said support structure is comprised of rods inserted through a plurality of sealable openings communicating through said wall of said containment vessel.

13. The abdomino-pelvic perfusion and lavage apparatus of claim 12, further comprising a plurality of opening-seals for forming air and watertight seals in said plurality of sealable openings thereby forming a barrier to aerosols so that chemotherapy can be used without exposing personnel to chemotherapy aerosols, and so that the containment vessel can be left in place on the patient who can then be returned to a surgical intensive care unit for follow-up examinations and repeated lavage procedures without necessitating use of an operating room except for closure of the incision made through the abdominal wall of the patient.

14. The abdomino-pelvic perfusion and lavage apparatus of claim 10, wherein said support structure is comprised of rods carried by an inner surface of said wall of said containment vessel.

15. The abdomino-pelvic perfusion and lavage apparatus of claim 10, wherein said support structure is integral with an inner surface of said wall of said containment vessel.

16. The abdomino-pelvic perfusion and lavage apparatus of claim 1, further comprising at least one seal for forming an air and watertight seal between said containment vessel and a torso of the patient, thereby forming a barrier to aerosols so that chemotherapy can be used without exposing personnel to chemotherapy aerosols, and so that said containment vessel can be left in place on the patient who can then be returned to an intensive care unit for follow-up examinations and repeated lavage procedures without introducing bacterial pathogens and without necessitating use of an operating room except to close the incision made through the abdominal wall of the patient.

17. The abdomino-pelvic perfusion and lavage apparatus of claim 16, wherein said at least one seal further comprises:

a first seal disposed proximate to said perimeter edge of said cranial end; and

a second seal disposed proximate to said perimeter edge of said caudal end.

18. The abdomino-pelvic perfusion and lavage apparatus of claim 1, further comprising:

a base seal disposed proximate to said base of said containment vessel, said base seal for forming an air and watertight seal between said containment vessel and the table, thereby forming a barrier to aerosols so that chemotherapy can be used without exposing personnel to chemotherapy aerosols, and so that said containment vessel can be left in place on the patient who can then be returned to a surgical intensive care unit for follow-up examinations and repeated lavage procedures without introducing bacterial pathogens and without necessitating use of an operating room except to close the incision made through the abdominal wall of the patient.

19. The abdomino-pelvic perfusion and lavage apparatus of claim 1, wherein pneumatic communication can be established through at least one of said plurality of fluid ports.

20. The abdomino-pelvic perfusion and lavage apparatus of claim 19, further comprising an air evacuation means, in pneumatic communication with said at least one of said plurality of fluid ports, for removing chemotherapy aerosols from within said containment vessel.

21. The abdomino-pelvic perfusion and lavage apparatus of claim 20, wherein said air evacuation means is a smoke evacuator system.

22. The abdomino-pelvic perfusion and lavage apparatus of claim 1 wherein said plurality of fluid ports are sealable.

23. The abdomino-pelvic perfusion and lavage apparatus of claim 22 further comprising a plurality of port-seals for selectively sealing said plurality of fluid ports thereby forming a barrier to aerosols so that chemotherapy can be used without exposing personnel to chemotherapy aerosols, and said containment vessel can be left in place on the patient who can then be returned to an intensive care unit for follow-up examinations and repeated lavage procedures without introducing bacterial pathogens and without necessitating use of an operating room except to close the incision made through the abdominal wall of the patient.

24. An abdomino-pelvic perfusion and lavage apparatus to which a skin surrounding an incision made through an abdominal wall of a patient can be attached and suspended, comprising:

a containment vessel impermeable to water and air, having a wall having a base, wherein said wall has an upper end with a perimeter edge which defines an upper opening, a lower end with a perimeter edge which defines a base opening, a cranial end with a perimeter edge which defines an opening, a caudal end with a perimeter edge which defines an opening;

a plurality of fluid ports capable of providing fluid communication through said wall of said containment vessel;

a scaffolding carried by said containment vessel adapted for supporting and elevating the skin surrounding the incision made through the abdominal wall of the patient, an elevated skin forming a well above, and extending into, an abdomino-pelvic cavity;

wherein hydraulic communication can be established through at least one of said plurality of fluid ports.

25. The abdomino-pelvic perfusion and lavage apparatus of claim 24, wherein:

at least one of said plurality of fluid ports further comprises at least one inflow port; and

at least one of said plurality of fluid ports further comprises at least one outflow port.

26. The abdomino-pelvic perfusion and lavage apparatus of claim 25, further comprising:

a fluid supply reservoir;

a f first pump in hydraulic communication with the fluid supply reservoir and said at least one inflow port to provide a perfusion fluid from said supply reservoir to said containment vessel;

a second pump in hydraulic communication with the fluid supply reservoir and said at least one outflow port to provide the perfusion fluid from said containment vessel back to the supply reservoir; and

a heater in thermal communication with a fluid containing means to heat the perfusion fluid to a temperature of about 30°

C. to about 50°

C. during use of said containment vessel in hyperthermic peritoneal perfusion.

27. The abdomino-pelvic perfusion and lavage apparatus of claim 26, further comprising:

at least one inflow tube connected to said at least one inflow port for providing the perfusion fluid to the well in the abdomino-pelvic cavity; and

at least one drain tube connected to said at least one outflow port having a distal intake end for extending into the abdomino-pelvic cavity of the patient for providing the perfusion fluid from the well.

28. The abdomino-pelvic perfusion and lavage apparatus of claim 27, further comprising:

at least one temperature sensor positioned in proximity with the distal intake end of the at least one drain tube, said at least one temperature sensor being in communication with a thermostatic control; and

said thermostatic control being in communication with said heater.

29. An abdomino-pelvic perfusion and lavage apparatus to which a skin surrounding an incision made through an abdominal wall of a patient can be attached and suspended, comprising:

a containment vessel impermeable to water and air, having a wall having a base, wherein said wall has an upper end with a perimeter edge which defines an upper opening, a lower end with a perimeter edge which defines a base opening, a cranial end with a perimeter edge which defines an opening, a caudal end with a perimeter edge which defines an opening;

a plurality of fluid ports capable of providing fluid communication through said wall of said containment vessel;

a scaffolding carried by said containment vessel adapted for supporting and elevating the skin surrounding the incision made through the abdominal wall of the patient, an elevated skin forming a well above, and extending into, an abdomino-pelvic cavity;

at least one removable cover capable of being secured and sealed over said upper opening of said containment vessel to enclose the well therein, thereby forming a barrier to aerosols so that chemotherapy can be used without exposing personnel to chemotherapy aerosols, and so that said containment vessel can be left in place on the patient who can then be returned to an intensive care unit for follow-up examinations and repeated lavage procedures without introducing bacterial pathogens and without necessitating use of an operating room except for closure of the incision made through the abdominal wall of the patient.

30. An abdomino-pelvic perfusion and lavage apparatus to which a skin surrounding an incision made through an abdominal wall of a patient can be attached and suspended, comprising:

a containment vessel impermeable to water and air, having a wall having a base, wherein said wall has an upper end with a perimeter edge which defines an upper opening, a lower end with a perimeter edge which defines a base opening, a cranial end with a perimeter edge which defines an opening, a caudal end with a perimeter edge which defines an opening;

a plurality of fluid ports capable of providing fluid communication through said wall of said containment vessel, said containment vessel being capable of being carried by a table on which the patient is positioned;

a scaffolding carried by said containment vessel adapted for supporting and elevating the skin surrounding the incision made through the abdominal wall of the patient whereby said elevated skin forms a well above, and extending into, an abdomino-pelvic cavity;

at least one removable cover capable of being secured and sealed over said upper opening of said containment vessel to enclose the well therein, thereby forming a barrier to aerosols so that chemotherapy can be used without exposing personnel to chemotherapy aerosols, and said containment vessel can be left in place on the patient who can then be returned to an intensive care unit for follow-up examinations and repeated lavage procedures without introducing bacterial pathogens and without necessitating use of an operating room except to close the incision made through the abdominal wall of the patient;

a plurality of port-seals for sealing said plurality of fluid ports;

a first seal disposed proximate to said perimeter edge of said cranial end to seal fluid communication between said containment vessel and a torso of the patient;

a second seal disposed proximate to said perimeter edge of said caudal end to seal fluid communication between said containment vessel and a torso of the patient; and

a base seal disposed proximate to said base of said containment vessel to seal fluid communication between said containment vessel and the table.

31. A method for perfusing, lavaging and irrigating an abdomino-pelvic cavity, comprising:

placing a containment vessel impermeable to water and air over a patient, said containment vessel having a wall having a base, said wall having an upper end with a perimeter edge which defines an upper opening, a lower end with a perimeter edge which defines a base opening, a cranial end with a perimeter edge which defines an opening, a caudal end with a perimeter edge which defines an opening, and a plurality of fluid ports capable of providing fluid communication through said wall, and a scaffolding carried by said containment vessel adapted for supporting and elevating a skin surrounding an incision made through an abdominal wall of the patient;

upwardly extending skin edges surrounding the incision made through the abdominal wall of the patient and connecting the skin edges to said scaffolding to form a well above and extending into the abdomino-pelvic cavity of the patient;

introducing a perfusion fluid through said wall of said containment vessel into the well for treatment of intra-abdominal tissues;

draining the perfusion fluid from the abdomino-pelvic cavity to flush fibrinous debris and other intra-abdominal contaminants from the abdomino-pelvic cavity.

32. The method of claim 31, including the steps of:

inserting a surgeon'"'"'s hands through said upper opening in said containment vessel into the abdomino-pelvic cavity;

manipulating the perfusion fluid and the intra-abdominal tissues;

debriding narrow margins of excisions;

removing fibrinous accumulations; and

visually inspecting all bowel surfaces.

33. The method of claim 31, including the step of adding drugs to a lavage fluid for treatment of diseases, infection, conditions, and other disorders in the abdomino-pelvic cavity.

34. The method of claim 33, including the step of sealing a cover over said containment vessel and performing a lavage for up to 5-10 days.

35. The method of claim 34, including the steps of:

selectively opening said cover; and

inserting a surgeon'"'"'s hands through said upper opening in said containment vessel into the abdomino-pelvic cavity;

manipulating the perfusion fluid and the intra-abdominal tissues;

debriding narrow margins of excisions;

removing fibrinous accumulations; and

visually inspecting all bowel surfaces.

36. The method as claimed in claim 35, including the step of evacuating aerosols and gasses from an interior space within said containment vessel.

37. The method as claimed in claim 36, including the step of activating a means for evacuating the aerosols and gasses when said cover is opened.

38. The method of claim 33, including the step of heating the perfusion fluid to a desired temperature before it is introduced into the abdomino-pelvic cavity to increase a toxicity of the drugs to a disease being treated.

39. The method of claim 38, including the step of sealing a cover over said containment vessel and performing a lavage for up to 5-10 days.

40. The method of claim 39, including the steps of:

selectively opening said cover;

inserting a surgeon'"'"'s hands through said upper opening in said containment vessel into the abdomino-pelvic cavity;

manipulating the perfusion fluid and the intra-abdominal tissues;

debriding narrow margins of excisions;

removing fibrinous accumulations; and

visually inspecting all bowel surfaces.

41. The method as claimed in claim 40, including the step of evacuating aerosols and gasses from an interior space within said containment vessel.

42. The method as claimed in claim 41, including the step of activating a means for evacuating the aerosols and gasses when said cover is opened.

43. The method as claimed in claim 35 further comprising the step of performing or continuing a surgical procedure in the patient'"'"'s abdominal cavity through said upper opening.

44. The method as claimed in claim 43 wherein the surgical procedure is conducted while chemotherapy or drugs are being administered in the well.

45. A method for perfusing an abdomino-pelvic cavity, comprising:

placing a containment vessel impermeable to water and air over a patient, said containment vessel having a wall having a base, said wall having an upper end with a perimeter edge which defines an upper opening, a lower end with a perimeter edge which defines a base opening, a cranial end with a perimeter edge which defines an opening, a caudal end with a perimeter edge which defines an opening, and a plurality of fluid ports capable of providing fluid communication through said wall, and a scaffolding carried by said containment vessel adapted for supporting and elevating a skin surrounding an incision made through an abdominal wall of the patient;

upwardly extending skin edges surrounding the incision made through the abdominal wall of the patient and connecting the skin edges to said scaffolding to form a well above and extending into the abdomino-pelvic cavity of the patient;

introducing a perfusate through said wall of said containment vessel into the well for perfusing intra-abdominal tissues;

draining the perfusate from the abdomino-pelvic cavity to remove fibrinous debris and other intra-abdominal contaminants from the abdomino-pelvic cavity.