Insertion and removal catheters and intestinal tubes for restricting absorption

• US 4,315,509 A
• Filed: 10/16/1978
• Issued: 02/16/1982
• Est. Priority Date: 01/10/1977
• Status: Expired due to Term

• Current Assignee: Julie A. Smit
• Original Assignee: Julie A. Smit
• Inventors: Smit, Julie A.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Rose, Arthur S.
• Application Number:
  US05/951,864
• Time in Patent Office: 1,219 Days
• Field of Search: 128/1 R, 128/1.3, 128/1.4, 128/6, 128/8, 128/303 R, 128/132 R, 128/348, 128/349 R, 128/349 B, 128/349 BV, 128/350 R, 128/350 V, 128/356, 128/DIG. 9, 3/1, 417/474
• US Class Current: 606/108
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers

Abstract

A first part of the inventive instrument comprises an insertion and removal device in the form of a maneuverable catheter which may be inserted through the mouth or nostril, pharynx, and esophagus into the stomach. In one form, the catheter includes an outer sheath which protects the human body while a tool extending coaxially through an inner sheath is being manipulated. The tool includes a remotely operated pair of tweezers for holding or releasing a loop on insertion or seizing and holding the loop on removal of the second part of the inventive instrument. An alternate device for capturing and holding the second part of the inventive instrument uses an electromagnet. The second part of the inventive instrument comprises a self-compressing, open-ended, balloon-like tube for implantation in and lining of the digestive tract, especially in the intestine, to prevent food from being absorbed into the villi. The balloon-like tube expands outwardly when filled with food chemicals, enabling peristalsis to squeeze the food chyme through the tube. An alternate embodiment intermittently lines only desired areas of the alimentary canal. The tube may also be used to treat obesity or alcoholism, or to cover an ulcer and give it an opportunity to heal with minimum exposure to digesting food and gastric juices.

Claims

1. A method of inserting an instrument including a thin wall tube which is open on both ends and is implanted while completely empty and collapsed in radial dimension, said tube comprising means for restricting absorption of food chemicals within at least the intestinal portion of the alimentary canal of an animal body while said food chemicals are being squeezed by bodily peristaltic action, said method comprising the steps of (a) inserting a thin wall tube while in a state which is flexible enough to be passed completely through the throat and be implanted entirely within said portion of said alimentary canal which is below the stomach at a position wherein said tube does not extend out of the intestinal portion of the alimentary canal of said body while it is so implanted, said tube lacking substantially all radial rigidity and being completely collapsible at least in parts when empty and at the time of implanting, (b) locating said tube with its open ends positioned to enable digesting food chemicals to enter and expand said tube only to the extent that food is within said tube and to pass under peristaltic action completely through said tube while digestion continues whereby said tube may be used to control absorption of food chemicals in that portion of the alimentary canal which is lined by said tube, said digesting food chemicals which pass through said tube being the normally consumed food which enters the body in whole, non-digested form through the mouth of a patient, said non-digested food solids becoming partially digested in the stomach before coming into contact with and entering said implanted tube, and (c) anchoring said implant tube at a point which is below the intake to the stomach so that said implanted tube and its entire anchoring remain in place entirely within a selected part of the alimentary canal, below said intake point.

2. The method of claim 1 wherein said implant tube is an extruded tube.

3. The method of claim 1 wherein said implant tube is a molded casting.

4. The method of claim 1 wherein said tube means has longitudinal folds which reduce its effective diameter when empty of said food chemicals, said longitudinal folds opening outwardly to increase the effective diameter of said tube when said tube is filled with food chemicals.

5. The method of claim 1 wherein said tube is formed to billow and constrict generally following the naturally-occurring shape of the interior of a small intestine.

6. The method of claim 1 wherein said anchoring of said implant tube includes an impervious, airtight float which is capable of floating in the stomach.

7. The method of claim 1 wherein interrupted portions of said walls of said open-ended tube are formed by a porous mesh-type material.

8. The method of claim 1 wherein extended longitudinal portions of the wall of said tube are open.

9. The method of claim 1 wherein said open-ended tube is a balloon-like tube which has an elongated semi-flexible support means running lengthwise within said tube to prevent it from twisting responsive to peristaltic movements acting upon said tube when implanted within said alimentary canal, and semi-flexible ring means around the circumference of one of said open ends to hold open said one end so that digesting food chemicals enter into said tube.

10. The method of claim 9 and the step wherein said semi-flexible ring is surgically bound in place within the body of a patient so that said balloon-like tube does not pass from that portion of the alimentary canal in which it is anchored.

11. The method of claim 9 wherein said open-ended, balloon-like tube is supported by a hollow, elongated, semi-flexible, tubular means running lengthwise within said balloon-like tube, whereby an elongated semi-rigid rod or wire may be inserted through said hollow, semi-flexible, tubular means to give a more rigid support to said semi-flexible means.

12. The method of claim 1 and the step of punching holes along said tube implant means, said punching being made by a two-member, scissor-like instrument which has a protruding punch on one member and a mating die on the other member.

13. The method of claim 12 wherein said punch and die are oval.

14. The method of claim 1 wherein the walls of said tube means are reinforced by strips of material attached to and running lengthwise within the walls of said tube.

15. The method of claim 14 wherein said reinforcing means are strands of catgut.

16. The method of claim 1 and said step (a) using means for inserting and removing said implant means in a patient'"'"'s body, said insertion means comprising a catheter having means for capturing and holding at least an end of said tube while it is being inserted or removed and for releasing said tube after it is implanted, whereby said catheter may be removed while the tube remains in place, said catheter having means for curling its end in order to approach the end of said tube, the ends of said tube and of said catheters having complementary coupling means for seizing the tube and pulling it into the catheter.

17. The method of claim 16 wherein said capturing and holding means includes a grasping device which begins at handles at one end of said catheter, runs through the lumen of said catheter, and ends in opposing jaws at the other end of said catheter, whereby the jaws of said grasping device may be opened and closed by manipulating the handle end of said grasping means.

18. The method of claim 16 wherein said capturing and holding means is a magnetic means positioned on the end of said catheter.

19. The method of claim 16 wherein said capturing and holding means comprises both a grasping means and a magnetic means for capturing and holding an end of said tube.

20. The method of claim 16 wherein said catheter has light means on the lower end of said catheter to aid in visually locating objects in the patient.

21. A process for controlling the transfer of food chemicals and body fluids with an implanted tube means in a part of a gastrointestinal tract, said implanted tube being contained in its entirety within the gastrointestinal tract while it is implanted, said tube further having physical characteristics by which food chyme within the tube is transported by normal body peristalsis, said process comprising:

a. implanting a thin-walled, open-ended tube totally within at least a part of a gastrointestinal tract for passing digesting food solids through said tube responsive to normal bodily peristaltic contractions, said food solids being the food normally consumed through the mouth of the person with the tube implant, said food further becoming partially digested before coming into contact with and entering into said implanted tube, said implanted tube lining the adjacent intestinal wall to receive the chyme discharged from the tract and into the tube and to control a transfer of said digesting food chemicals and the walls of said gastrointestinal tract; and

b. using the implant over an extended period of time while it is totally contained within said gastrointestinal tract for controlling an amount of such chemical transfer.

22. The process of reducing the size of the villi in a gastrointestinal tract by reducing the use of said villi for absorption of food chemicals, said process comprising the steps of:

a. forming a thin-walled, balloon-like tube with a relatively smaller outer diameter when empty of food chemicals

b. forming holes in said tube for passing digesting food chemicals to a desired portion of said gastrointestinal villi, whereby said tube reduces the food chemical absorption of said gastrointestinal villi, thereby reducing the size of the villi; and

c. implanting said thin-walled, open-ended, balloon-like tube into at least a part of a gastrointestinal tract of a person while said tube is empty and has said small diameter, said balloon-like tube being implanted totally within the gastrointestinal tract with said holes adjacent said desired portion of said villi, whereby no portion of said tube extends away from the body of the person, said balloon-like tube expanding to have a wider effective outer diameter when filled with food chemicals, whereby normal bodily peristaltic motion transports digesting food chemicals through said tube.

23. A method of implanting an instrument for controlling and restricting absorption of food chemicals within a specific intestinal portion of an alimentary canal beginning below the intake to the stomach while enabling other portions of the same intestinal canal to have an unrestricted absorption of food chemicals, said specific portion of said intestine being removed to a point below the exit of the stomach by a predetermined length of said intestine, said method comprising the steps of (a) implanting an open-ended flexible tube which completely collapses at least in part owing to its lack of rigidity, (b) anchoring said tube at a point below the intake to the stomach, said entire instrument including anchoring means completely contained within said stomach and the intestine attached thereto, an end of said tube nearest said stomach being held by said anchor means totally within the intestinal part of the alimentary canal and at a point located said predetermined distance away from the beginning of said intestine, means for joining one end of the tube to said anchor means, said joining means comprising a narrow, elongated device which is impervious to chemicals likely to appear in said intestinal portion of the alimentary canal, whereby said tube restricts absorption in the areas of said alimentary canal which begins at the tube end of said joining means and said tube does not restrict absorption in the area of said alimentary canal between said anchor means and said one end of the tube, said food chemicals being consumed in a solid, non-digested form through the mouth of the person having the implant and becoming partially digested in the stomach before coming into contact with said anchor means and thereafter being squeezed by peristalsis through said tube, and (c) positioning said anchor means to enable said food chemicals to pass from the stomach and into the intestine where they will enter said tube after peristalsis has transported them said predetermined distance beyond said anchor means.

24. The method of claim 23 wherein the anchoring means is a bar-shaped device having a midpoint attached to said elongated device, said bar being generally perpendicular to said device when anchored in place, whereby food chemicals pass over and around said bar before leaving the stomach and entering the intestine.

25. The method of claim 23 wherein the anchoring means is a ring.

26. The method of claim 23 and slow-dissolving means for streamlining an end of said tube which first enters said canal to enable an insertion thereof without snagging, said slow-dissolving means later dissolving in the stomach or intestine.

27. The method of claim 23 wherein said joining means is longitudinally flexible to elongate and contract in response to the gastrointestinal movements, thereby reducing erosion on the portion of said alimentary canal which is used to anchor said implant instrument.

28. The method of claim 27 wherein said means for anchoring said tube includes a float which is supported by the fluid in the stomach.

29. The method of claim 23 wherein said joining means includes as part thereof a spring which elongates and contracts said joining means in response to said gastrointestinal movements.

30. The method of claim 23 wherein said joining means has a spring-tensioned reel means which pays out a cable or reels in a cable to add or reduce length of said joining means in response to the expanding and contracting gastrointestinal tract.

31. The method of claim 23 wherein said tube is a thin, balloon-like tube which begins a predetermined distance from said anchor means which distance is fixed by said joining means, and semi-flexible ring means attached around its circumference to said one end of said tube for holding open said tube to receive digesting food chemicals which enter said tube through said ring.

32. The method of claim 31 wherein said ring is covered with a sponge material passing around the outer circumference of said semi-flexible ring, said sponge material being supple enough to mold itself to the surrounding area of said alimentary canal.

33. The method of claim 23 wherein said tube is a balloon-like tube including a hollow tubular means for receiving an elongated semi-rigid rod or wire which may be inserted through said tubular means to give a more rigid support to said balloon-like tube.

34. The method of claim 23 wherein at least some of the open-ended tube is formed into a porous mesh-type material, with interrupted sections of said mesh-type material impregnated with a material for restricting said absorption.

35. The method of claim 23 wherein large portions of the walls of said tube are open.

36. An implant instrument for controlling and restricting absorption of food chemicals within a specific intestinal portion of an alimentary canal while enabling other portions of the same intestinal canal to have an unrestricted absorption of food chemicals, said specific portion of said intestine beginning at a point which is a predetermined distance below the stomach, said implant instrument comprising an open-ended tube, means for anchoring said tube totally within the intestinal part of the alimentary canal and at a point located said predetermined distance away from the stomach, means for joining one end of the tube to said anchor means, said joining means comprising a narrow, elongated device which is impervious to chemicals likely to appear in said intestinal portion of the alimentary canal, whereby said tube restricts absorption in the areas of said alimentary canal which begins at the tube end of said joining means and said tube does not restrict absorption in the area of said alimentary canal between said anchor means and said one end of the tube, said food chemicals being consumed in a solid, non-digested form through the mouth of the person having the implant and becoming partially digested in the stomach before coming into contact with said anchor means and thereafter being squeezed by peristalsis through said tube, said anchor means having a design which enables said food chemicals to pass from the stomach and into the intestine where they will enter said tube after peristalsis has transported them said predetermined distance, means for inserting and removing said implant instrument in said body, said insert means comprising a catheter having means for capturing and holding an end of said implant instrument while it is being inserted into or removed from said canal and for releasing said implant instrument means after it is implanted, whereby said catheter may be removed while the implant instrument is in place, said catheter having means for curling its end in order to approach the end of said tube, and the ends of said tube and of said catheters having complementary coupling means for seizing the tube and pulling it into the catheter.

37. The instrument of claim 36 wherein said means for curling the end of said catheter includes a series of V-slots and a cord for closing said slots.

38. The instrument of claim 36 wherein said means for curling the end of said catheter is a spring guide.

39. An implant instrument for controlling and restricting absorption of food chemicals within a specific intestinal portion of an alimentary canal while enabling other portions of the same intestinal canal to have an unrestricted absorption of food chemicals, said specific portion of said intestine beginning at a point which is a predetermined distance below the stomach, said implant instrument comprising an open-ended tube, semi-flexible ring means attached around its circumference to said one end of said tube for holding open said tube to receive digesting food chemicals which enter said tube through said ring, said ring being mounted in a track for expanding and contracting relative to the expanding and contracting dimensions of the surrounding area, means for anchoring said tube totally within the intestinal part of the alimentary canal and at a point located said predetermined distance away from the beginning of said intestine, means for joining one end of the tube to said anchor means, said joining means comprising a narrow, elongated device which is impervious to chemicals likely to appear in said intestinal portion of the alimentary canal, said tube being a thin, balloon-like tube which begins said predetermined distance from said stomach, which distance is fixed by said joining means, whereby said tube restricts absorption in the areas of said alimentary canal which begins at the tube end of said joining means and said tube does not restrict absorption in the area of said alimentary canal between said anchor means and said one end of the tube, said food chemicals being consumed in a solid, non-digested form through the mouth of the person having the implant and becoming partially digested in the stomach before coming into contact with said anchor means and thereafter being squeezed by peristalsis through said tube, said anchor means having a design which enables said food chemicals to pass from the stomach and into the intestine where they will enter said tube after peristalsis has transported them said predetermined distance beyond said anchor means.

40. An artificial peristalsis-producing implant instrument for passing digesting food chemicals through the intestine, said digesting food chemicals being consumed in a non-digested form through the mouth of a person having the implanted instrument, the food solids becoming partially digested in the stomach before entering said implant instrument, said implant instrument including an elongated open-ended tube for implantion in the intestine, said tube having passageway for transporting digesting food solids within a smooth and unobstructed surface to enable said digesting food solids to be artificially squeezed through said tube, a plurality of controllable magnetic means integral with and incorporated into a side of the walls of said tube, said opposite wall integrally containing magnetic material which is attracted to said magnetic means when said magnetic means is energized, said plurality of magnetic means being distributed along the entire length of said tube for alternately and periodically attracting the opposite wall of said tube, whereby said walls of the tube are periodically drawn together to reduce the effective cross section of the lumen within said tube, means for selectively energizing said controllable magnetic means for periodically reducing the lumen of said tube, and means for periodically interrupting said energization to eliminate the attraction of said controllable magnetic means to enable the walls of said tube to relax and open the effective cross section of said lumen, and means for causing said attraction and relaxing to occur in a sequence simulating natural peristalsis, whereby said implant instrument artificially squeezes the digesting food solids through said tube in a gradual manner, similar to normal peristalsis, so as not to cause an unnecessary buildup of pressure in the alimentary canal of the person having the implant.

41. An artificial peristalsis-producing implant instrument for passing digesting food chemicals, said digesting food chemicals being consumed in a non-digested form through the mouth of a person having the implanted instrument, the food solids becoming partially digested before entering said implant instrument, said implant instrument including an elongated open-ended tube, said tube having a passageway for transporting digesting food solids within a smooth and unobstructed surface to enable said digesting food solids to be artificially squeezed through said tube, a plurality of controllable magnetic means integral with and incorporated into a side of the walls of said tube, said opposite wall integrally containing magnetic material which is attracted to said magnetic means when said magnetic means is energized, said plurality of magnetic means being distributed along the entire length of said tube for alternately and periodically attracting the opposite wall of said tube, whereby said walls of the tube are periodically drawn together to reduce the effective cross section of the lumen within said tube, means for selectively energizing said controllable magnetic means for periodically reducing the lumen of said tube, means for periodically interrupting said energization to eliminate the attraction of said controllable magnetic means to enable the walls of said tube to relax and open the effective cross section of said lumen, and means for causing said attraction and relaxing to occur in a sequence simulating natural peristalsis, whereby said implant instrument artificially squeezes the digesting food solids through said tube in a gradual manner, similar to normal peristalsis, so as not to cause an unnecessary buildup of pressure in the alimentary canal of the person having the implant.