Classifications

• • 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
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1678—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes intracorporal
• • 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0127—Magnetic means; Magnetic markers
• • 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
• • 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
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1698—Blood oxygenators with or without heat-exchangers
• • 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
  • A61M2202/00—Special media to be introduced, removed or treated
  • A61M2202/02—Gases
  • A61M2202/0208—Oxygen
• • 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
  • A61M2202/00—Special media to be introduced, removed or treated
  • A61M2202/02—Gases
  • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
• • 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
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/10—Trunk
  • A61M2210/1042—Alimentary tract
  • A61M2210/106—Small intestine

Definitions

• This invention relates to medical treatment appa ⁇ ratus and methods and more specifically is concerned with an intraluminal membrane oxygenator for use in sustaining vitality of an organ in the gastrointestinal tract .
• each indi ⁇ vidual organ' s vitality is sustained by the circulation of blood through the organ' s vascular system.
• Each organ ' s vascular system is of course a part of the body' s larger car dio -vascular system.
• the circulation, and hence oxygen delivery, to any given organ may become insufficient to sustain the full vitality of that organ.
• partial occlusion of an artery may reduce blood flow to a point where the oxygen supply is insufficient.
• An occlusion, whether full or partial may be due entirely to naturally occurring phenom ⁇ enon or it may be in consequence of certain procedures.
• reduced oxygen delivery can have potentially devastating effects on a patient.
• surgical procedures possibly not even directly related to a particular organ, may have an effect on the organ. For instance, in the case of certain vascular sur ⁇ gery procedures, it may be necessary to interrupt the blood flow to a given organ or organs during the course of procedures.
• the present invention is directed to a novel apparatus and procedure for sustaining vitality of an internal organ in situations such as these, particularly with reference to gastro ⁇ intestinal organs. With the present invention it is unnecessary to utilize external devices, such as blood pumps, in association with the vascular system.
• the present invention offers a proce ⁇ dure and apparatus which can be used at any desired time, for
• SUBSTITUTE SHEET example pre-operatively, during an operation, or postopera ⁇ tively.
• the invention does not directly involve the cardio-vascular system. Rather, the invention contemplates the introduction of a catheter into an organ of interest with vitality-sustaining oxygen being introduced through the cathe ⁇ ter.
• the catheter comprises a tube having a walled chamber at one end. The catheter is introduced to dispose the chamber against the lumen of the organ of interest.
• the material of the chamber is one which is freely permeable -to gas but poorly permeable to liquid.
• the tube contains a conduit for deliver ⁇ ing fluid to the chamber. Oxygen is perfused through the cham ⁇ ber via the tube from an external source.
• the external source may comprise any suitable means to create an oxygen partial pressure gradient between the interior of the chamber and the lumen of the organ whereby oxygen can diffuse through the wall of the chamber and into the organ.
• Carbon dioxide gas gener ⁇ ated by the organ can also diffuse through the wall of the cham- ber to be conveyed back through the tube for removal.
• the cham ⁇ ber and tube are so constructed and arranged as to create an axial flow along the interior of the wall of the chamber along substantially the full length of the chamber. This promotes the maximum area availability for delivering oxygen to an organ, particularly in the case where the organ is in the gastrointes- ⁇ tinal tract.
• the diameter of the chamber is less than that of the organ so that the catheter does not block passage through the organ.
• the invention also contemplates the use of agents such as the use of blood and/or blood substitutes for oxygen- bearing purposes.
• Fig. 1 is a view, partly schematic, illustrating appa- ratus for practice of the present invention.
• Fig. 2 is an enlarged transverse cross sectional view taken in the direction of arrows 2-2 in Fig. 1 and enlarged.
• Fig. 3 is a transverse cross sectional view taken in the direction of arrows 3-3 in Fig. 1.
• Fig. 4 is a transverse cross sectional view taken in the direction of arrows 4-4 in Fig. 1 and enlarged.
• FIG. 1 illustrates a presently preferred exemplary embodiment of apparatus 10 for practice of the invention.
• Apparatus 10 comprises a catheter designated by the general reference numeral 12.
• catheter 12 Associated with catheter 12 is any suitable oxygen source designated by the general reference numeral 14.
• Catheter 12 comprises a tube 16 on the distal end of which is disposed a walled chamber 18. The opposite proxi ⁇ mal end of tube 12 is adapted for connection with apparatus 14.
• Chamber 18 is provided by a tubular element having a nominal diameter greater than that of tube 16.
• Fig. 1 illus ⁇ trates a representative shape but the invention is not limited to the particular shape or proportions illustrated.
• the tubular element 20 constitutes a membrane which forms chamber 18 and is fitted over the distal end of tube 16.
• the opposite axial ends of element 20 are closed onto the outside of tube 16 as at 22 and 24. In this way the chamber 18 defines an annular space 26 around the outside of tube 16.
• Tube 16 is a soft pliable material, silicone for example, which has a circular cross sectional shape. Tube 16 is provided with a pair of axially extending conduits, or pas ⁇ sages, 28 and 30 respectively. These extend the full length of the tube and the catheter includes any suitable closure means,
• SUBSTITUTE SHEET for example an end closure element 32 to close off the distal end of the tube for the purpose of closing conduits 28 and 30 at that end.
• Conduits 28 and 30 are communicated with the interior chamber space 26 by means of respective apertures 34 and 36 as shown in Figs. 4 and 3 respectively.
• Each aperture is pro ⁇ vided as a transversely extending hole from the exterior of the wall of tube 16 to intercept the corresponding conduit as shown in the drawing figures.
• oxygen is introduced into one of the two con ⁇ duits and conveyed through tube 16 to exit the tube at the corresponding aperture into chamber space 26.
• the interior of the chamber space is thereby perfused with oxygen.
• the oppo ⁇ site aperture provides for return conveyance of gasses via the other conduit through tube 16.
• conduit 28 if oxygen is introduced into conduit 28, it will flow through that conduit, exit via aperture 34 and pass into the far distal end of chamber space 26. The flow will continue axially through the annular chamber space 26 toward the proximal end of the chamber to enter aperture 36 and sub ⁇ sequently pass via conduit 30 back through tube 16.
• the material of tube 20 is one which is freely permeable to gas but poorly permeable to liquid, so that tube 20 is a membrane.
• a suitable material is pol dimeth Isiloxane which is freely per- meable to oxygen and carbon dioxide gasea.
• the oxygen in the catheter chamber has a partial pressure so that oxygen can dif ⁇ fuse through the wall of the chamber 18.
• catheter 12 is introduced into a patient such that chamber 18 is placed against the lumen of a hollow internal organ of interest.
• the elongate shape illustrated in Fig. 1 is
• SUBSTITUTE SHEET intended for placement in the gastrointestinal tract, parti ⁇ cularly the intestines. The placement may be made pfeopera- tively or intraoperatively, and the catheter may remain in place even into a postoperative period.
• Apparatus 14 is of any suitable configuration which is capable of perfusing oxygen through tube 16 and chamber 18 at a suitable partial pressure.
• the apparatus may comprise a standard hospital oxygen supply giving a pres ⁇ sure of 760 mm.Hg. It could also alternately comprise a pump which delivers oxyge -enriched fluid.
• the fluid may be a saline solution which is pumped by the pump through the catheter with provisions being made for oxygenating the saline solution prior to introduction into the catheter so that the fluid bears a dissolved oxygen gas at suitable partial pressure.
• the flow of oxygen axially along the interior of the wall of tube 20 creates a condition whereby oxygen can diffuse through the wall of tube 20 and into the lumen of the organ so that the catheter does not block flow through the tract.
• oxygen may continue to be supplied to the organ so as to sustain its vitality under con ⁇ ditions which otherwise might render the organ moribund.
• Be ⁇ cause the organ will also generate carbon dioxide gas as a waste product, that waste gas can diffuse from the lumen through the wall of tube 20 and into the fluid which is being conveyed through chamber space 26.
• the carbon dioxide gas is conveyed from chamber space 26 with the exiting fluid flow which passes proximally through tube 16 to the proximal end. In this way not only is oxygen made available to the organ but a waste product from the organ is also removed.
• the carbon dioxide may be removed from the fluid and the fluid recirculated so as to form a closed system or other-
• the apparatus may be an. open system in which the fluid which returns from tube 16 is discarded.
• the P0 « of the oxygen introduced into chamber 26 must be high enough to create a certain gradient across the wall of the chamber and the lumen of the organ.
• the PO2 is about 100 mm.Hg. If the organ becomes ischemie, this figure drops to about 60 mm.Hg. Therefore, the PO2 of the fluid delivered to the catheter should certain- ly exceed 100 mm.Hg.
• the use of 760 mm.Hg. oxygen gas as the sole fluid introduced into the catheter ap ⁇ pears to be very effective. The return flow is merely exhausted.
• the invention is also preferably practiced such that the material of tube 20 is not significantly stretched, or ex ⁇ panded, when in use, so that blockage of the passage through the tract may be avoided.
• the material of tube 20 will be permeable to mole ⁇ cules having molecular weights of less than about 3000. There- fore, it is also possible to use the catheter to introduce drugs, nutrients, and/or other agents having molecular weights of less than about 3000.
• Certain agents enhance the effectiveness of the pro ⁇ cedure. For example it is possible to introduce a vasodia- lator via the catheter to enhance the local oxygenation. It is also contemplated that blood or blood substitutes could be used in an oxygen-bearing fluid to enhance the oxygen carrying capacity.
• a significant advantage of the invention is that it is unnecessary to directly involve the circulatory system for practice of the invention.
• the invention is different in principle from prior vascular oxygenation procedures which merely oxygenate the blood.
• oxygen is made available directly at the lumen of the organ.
• the oxygen so delivered may be assistive of the current vascular flow, or
• SUBSTITUTE SHEET it may be the sole source of oxygen.
• the present disclosure illustrates one preferred em ⁇ bodiment of the invention in a form which is especially useful for the intestine.
• Other embodiments and forms are contem- plated within the scope of the invention.
• the catheter could be constructed with a full nasoanal extent through the tract with oxygen being introduced at one end and the flow being discharged at the opposite end.
• the invention has been shown to provide for perfusion of oxygen through a hollow internal organ of the gastrointesti ⁇ nal tract independently of the vascular system.
• the oxygen so delivered may be assistive of current blood flow to the organ or it may be the sole source. While the invention may be prac ⁇ ticed alone, it may also be practiced in conjunction with other procedures.
• the perfusion is accomplished with direct oxygen delivery to the lumen of the organ in a controlled manner without blockage of the tract.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• Pulmonology (AREA)
• Biophysics (AREA)
• Urology & Nephrology (AREA)
• Child & Adolescent Psychology (AREA)
• Emergency Medicine (AREA)
• Vascular Medicine (AREA)
• External Artificial Organs (AREA)
• Agricultural Chemicals And Associated Chemicals (AREA)
• Materials For Medical Uses (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• General Induction Heating (AREA)
• Separation Using Semi-Permeable Membranes (AREA)

Priority Applications (1)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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Cited By (3)

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Citations (7)

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• 1983
  • 1983-12-29 US US06/566,649 patent/US4576590A/en not_active Expired - Lifetime
• 1984
  • 1984-12-28 JP JP60500404A patent/JPS61500832A/ja active Granted
  • 1984-12-28 AU AU38311/85A patent/AU581421B2/en not_active Ceased
  • 1984-12-28 DE DE8585900567T patent/DE3481274D1/de not_active Expired - Lifetime
  • 1984-12-28 WO PCT/US1984/002126 patent/WO1985003005A1/en not_active Ceased
  • 1984-12-28 EP EP85900567A patent/EP0168439B1/en not_active Expired

Patent Citations (7)

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