Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K38/00—Medicinal preparations containing peptides
  • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
  • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
  • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
  • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
  • A61K38/1725—Complement proteins, e.g. anaphylatoxin, C3a or C5a
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
  • A61M1/287—Dialysates therefor
• • C—CHEMISTRY; METALLURGY
  • C07—ORGANIC CHEMISTRY
  • C07K—PEPTIDES
  • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
  • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria

Definitions

• Dialysis solution is passed into the peritoneal cavity and allowed to dwell for a period of hours while it engages in dialysis across the membranes of the peritoneal cavity for removal of metabolic waste products. The dialysis solution is then removed from the peritoneal cavity, and, in the case of continuous ambulatory peritoneal dialysis, promptly replaced with another quantity of fresh dialysis solution.
• an opsonin for microorganisms is administered to the peritoneal cavity of a patient in sufficient dose to suppress the symptoms of peritonitis.
• the peritoneal cavity contains white cells, particularly those known as peritoneal macrophages.
• an opsonin for example mixed with the peritoneal dialysis solution, potentiates the white cell activity in the peritoneal cavity, causing them to destroy greater numbers of bacteria and thus to suppress peritonitis symptoms.
• opsonins may naturally be found in the peritoneal cavity, it has been noted that some patients appear to lack sufficient opsonin concentrations to effectively suppress peritonitis when exposed to it.
• the artificial addition of opsonins to the peritoneal cavity can be a valuable tool in suppressing the symptoms of peritonitis, and particularly to prevent its occurrence.
• opsonin relates to any agent that modifies microorganisms to promote white cells to phagocytize the microorganisms, including bacteria, fungi, and the like. It is believed that a typical opsonin coats or otherwise- attaches itself to the microorganism, and facilitates the action of the white cell in phagocytizing and typically destroying it.
• gamma globulin a known therapeutic blood fraction, is a known opsonin, which is particularly effective against gram positive bacteria.
• Complement which is also a therapeutic blood fraction, may also be used, being a known opsonin for gram negative bacteria.
• Separated components of gamma globulin and complement may also be used, i.e., specific IgG antibodies (e.g., peptidoglycan antibodies) or a C3B-containing component of complement.
• the opsonin may be administered to the peritoneal cavity in any desired way, for example by injection, but in the case of peritoneal dialysis patients it is preferable to make use of the peritoneal catheter, which provides communication between the peritoneal cavity and the exterior, to administer the opsonin.
• the opsonin may be added to the peritoneal dialysis solution prior to its administration to the peritoneal cavity by mixing with the solution just prior to such administration.
• the opsonin may be placed in the solution as it is manufactured so that it is unnecessary for the user to have to administer extra opsonin, above and beyond that which is provided by the peritoneal dialysis solution itself.
• the peritoneal dialysis solution which contains an opsonin such as gamma globulin or complement may have the opsonin present in any desired, safe and effective
• gamma globulin or components thereof may be present in the peritoneal dialysis solution in a concentration of 0.05 to 10 mg. of dialysis solution, preferably no more than 5 mg. per ml.
• the C3 portion of tne complement may be present in the solution in a
• opsonins may also be provided to the peritoneal dialysis solution or otherwise administered as may be desired, for example C-reactive protein or fibronectin.
• the peritoneal dialysis solution into which the opsonins are added may be otherwise of conventional formulation, being of physiologically tolerable pH and having physiological salts and an osmotic agent, each in safe and effective concentrations to effect peritoneal 0 dialysis when placed in the peritoneal cavity of a patient.
• glucose may be pres'ent as the osmotic agent
• the ions of the physiological salts may include sodium, calcium, magnesium, chloride, acetate, and lactate, for example, in conventional concentrations. Potassium ion as well as other physiologically compatible ions may also be present if appropriate.
• Figure 1 is a perspective view showing a container of peritoneal dialysis solution in communication with the peritoneal cavity of a patient, using conventional equipment.
• container 10 of peritoneal dialysis solution may be of a design which is commercially available from Travenol Laboratories, Inc. of Deerfield, Illinois.
• Container 10 communicates with a transfer set 12, which is also commercially available from the same company, and communicates with a conventional Tenckhoff catheter 14 which is permanently implanted in the peritoneal cavity of a patient 15.
• the solution contents of container 10 typically 2 liters
• the patient can then fold or roll up the flexible container 10 into a small package and wear it under his clothes in compact form for a period of about four hours.
• the patient unfolds container 10, opens catheter 14, and allows the spent dialysis solution to drain back into container 10. Thereafter he closes container 10 with a clamp, disconnects it from set 12, and replaces the connection with a new container of fresh dialysis solution.
• a typical peritoneal dialysis solution which may be utilized in this invention may contain, per 100 ml., 1.5 to 4.25 grams of dextrose hydrous U.S.P., 500 mg. of sodium chloride ⁇ .S.P, 448 mg. of sodium lactate, 25.7 gm. of calcium chloride ⁇ .S.P., and 5.08 mg. of magnesium chloride U.S.P.
• the pH may preferably be about 5.5, broadly ranging from about pH 5 to 7.
• 100 mg. of gamma globulin per liter of dialysis solution present may be added to the container 10 by injection syringe 20 through auxiliary medication port 18, which may be of conventional design, to mix with the peritoneal dialysis solution present in container 10.
• 100 mg. per liter of dialysis solution of the C-3 component of complement may be added, either as part of whole complement or a purified fraction thereof.
• 100 mg. per liter of the same C-3 component may be added as a further additive to the solution along with the gamma globulin.
• peritoneal dialysis causes peritoneal dialysis to proceed in ordinary manner, but with the symptoms of peritonitis being effectively suppressed, since the presence of opsonins causes greater white- cell phagocytosis and subsequent destruction of any bacteria or other microorganisms present.

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• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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• External Artificial Organs (AREA)

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• 1983
  • 1983-09-02 WO PCT/US1983/001373 patent/WO1984001505A1/fr not_active Ceased
  • 1983-09-02 EP EP19830903133 patent/EP0122267A4/fr not_active Withdrawn
  • 1983-10-06 CA CA000438565A patent/CA1219212A/fr not_active Expired
  • 1983-10-20 IT IT23375/83A patent/IT1169596B/it active

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