EP0591192A1 - Tube ameliore d'alimentation enterale - Google Patents

Tube ameliore d'alimentation enterale

Info

Publication number
EP0591192A1
EP0591192A1 EP91914067A EP91914067A EP0591192A1 EP 0591192 A1 EP0591192 A1 EP 0591192A1 EP 91914067 A EP91914067 A EP 91914067A EP 91914067 A EP91914067 A EP 91914067A EP 0591192 A1 EP0591192 A1 EP 0591192A1
Authority
EP
European Patent Office
Prior art keywords
stylet
lumen
tube
fluid
adjacent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP91914067A
Other languages
German (de)
English (en)
Inventor
Eugene Francis Schrader
Eugene Elmer Weilbacher
Raymond Otto Bodicky
James Gerard Schneider
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sherwood Medical Co
Original Assignee
Sherwood Medical Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sherwood Medical Co filed Critical Sherwood Medical Co
Publication of EP0591192A1 publication Critical patent/EP0591192A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A61J15/0007—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth inserted by using a guide-wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0073—Multi-lumen tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/008—Sensor means, e.g. for sensing reflux, acidity or pressure
    • A61J15/0088—Sensor means, e.g. for sensing reflux, acidity or pressure for sensing parameters related to the device

Definitions

  • the present invention relates to an improved enteral feeding tube for delivering nutritional, irrigational, or medicinal fluids or the like to the intestinal tract of a patient.
  • Enteral feeding tubes are conventionally used for introducing nutritional, irrigational, or medicinal fluids, or all of these, through a patient's mouth or nose and esophagus into the patient's intestinal tract and sometimes for aspiration of fluids therefrom.
  • Such enteral feeding tubes are typically constructed of soft, flexible material to minimize patient discomfort and trauma during insertion and extended placement.
  • a relatively stiff but narrow metal stylet is conventionally inserted into a relatively large feeding lumen of the tube to stiffen the same to facilitate forcing the tube through the restricted, tortuous path required for movement through the patient's mouth or nose and esophagus for insertion into the patient's stomach or intestines.
  • Such a stylet placement is disclosed in the U.S. Patent Nos. 4,659,328 to Potter et al and 4,874,365 to Frederick et al.
  • the present invention provides a relatively flexible, dual-lumen enteral feeding tube for delivering fluids through a patient's esophagus to the patient's intestinal tract, the enteral feeding tube having proximal and distal ends and comprising a primary or enteral feeding lumen having a feeding lumen inlet opening adjacent the proximal end of the tube and at least one feeding lumen outlet opening adjacent the distal end of the tube.
  • a secondary or stylet lumen separate from the entera feeding lumen is additionally provided, the stylet lumen having a stylet lumen opening adjacent the proximal end of the tube and being longitudinally co-extensive with a sub ⁇ stantial length of the enteral feeding lumen and closed on its distal end.
  • a relatively stiff wire stylet is removably positioned in the stylet lumen and extends from the stylet lumen opening to adjacent the feeding lumen outlet opening.
  • the wire stylet is positioned in a separate stylet lumen instead of in the enteral feeding lumen, it cannot interfere with fluid flow and the stylet is not contaminated by bodily fluids, as would be the case if the wire stylet were positioned in the enteral feeding lumen as in some prior art devices.
  • this arrangement assists in stiffening the enteral feeding tube to a more appropriate degree than would be the case if the stylet were loosely positioned in the substantially larger enteral feeding lumen.
  • TEFLON ® polymer polytetrafluorethylene
  • Figure 1 is a plan view of an improved enteral feedin tube according to the present invention, with portions thereof broken away for illustrative purposes;
  • Figure 2 is a cross-sectional view of the enteral feeding tube shown in Figure 1 and taken along lines 2-2 therein;
  • Figure 3 is a left side view of the enteral feeding tube shown in Figure 1; and Figure 4 is plan view, on an enlarged scale, of a distal tip portion of a wire stylet of the enteral feeding tube shown in Figure 1; and
  • Figure 5 is a schematic illustration on an enlarged scale of the distal tip portion of the wire stylet shown i Figure 4 but shown with TEFLON ® and silicone coatings sche matically represented on the stylet according to the prese invention.
  • an improved enteral feeding tube JLO . for nasogastric or nasointestinal feeding which basically comprises a relatively flexible, dual-lumen tube assembly 12 . , to the distal end of which is fixed a conven ⁇ tional bolus weight assembly 14..
  • Fixed to the proximal en of the tube assembly 12 is a Y-site connector, adaptor and closure assembly .16., to the right of which, as shown in Figure 1, is fixedly positioned a laterally projecting stylet opening saddle 18. having a wire stylet assembly 20 removably positioned therein.
  • the dual-lumen tube assembly 12 is constructed of a soft, flexible material, such as polyurethane or the like, in relatively small diameters, such as from 8 to 12 French (0.1048 to 0.1572 inch) (.2662 cm to .3993 cm). As best seen in Figure 2, the tube assembly 12 is hollow and com- prises a relatively large diameter primary or enteral feed ⁇ ing lumen 22 . adjacent a relatively small diameter, separate secondary or stylet lumen 2 ⁇ , approximately 0.04 inch (.10 cm) in diameter the distal end 2_6 of which is closed as by dead-ending within the tube assembly 12 by a plug or the like. The proximal end 23.
  • a soft, flexible material such as polyurethane or the like
  • stylet lumen is in commu ⁇ nication with an angularly oriented saddle lumen 30 of a like small diameter extending from the proximal end 28 of the stylet lumen to a stylet lumen inlet opening or port 3_1 provided in a laterally offset face 3_3 in the stylet opening saddle 18.
  • the enteral feeding lumen 22 extends from its proximal end 32. to its distal end 34. adjacent a bolus weight assembly junction 3J5 fixed between the tube assembly 12 and the bolus weight assembly 14 and through which are provided two longi ⁇ tudinally-spaced enteral feeding lumen outlets 38. and 4j) spaced at 180" about the tube periphery in fluid communica ⁇ tion with the distal end 34 of the enteral feeding lumen 22.
  • the exterior surface of the tube assembly 12 is provided with a plurality of depth gauge or reference marks 4_1 to assist in properly positioning the enteral feeding tube 10.
  • the bolus weight assembly 14 includes a cavity 4 in which are positioned a plurality of conventional cylindrical bolus weights 44. constructed of tungsten and of approximate- ly 0.75 gram each, the function of which is to assist in positioning the enteral feeding tube in the patient's diges ⁇ tive system and maintaining such positioning over an extended period.
  • a radiopaque line 4J5 may be provided on the surface of the bolus weight assembly 14 to assist in locating the position of the distal end 4J5 of the enteral feeding tube 10 in a patient by conventional x-ray means or this line 46 may be eliminated because the weights 44 are by their nature radiopaque and therefore make the line 46 unnecessary.
  • the tube assembly 12 and bolus weight assembly 14 may be constructed of a plastic material such as DOW PELLETHANE ® thermoplastic with Barium Sulfate (BaS0 4 ) mixed throughout such material to provide a radi ⁇ opaque construction of the entire tube and bolus assemblie
  • the distal end 48 of the bolus weight assembly 14 is provided with a cushion of soft, flexible material such as polyurethane, and is rounded to avoid trauma to the patien induced by tube insertion or extended placement.
  • the Y-site connector, adaptor and closure assembly 16 is con- structed of a plastic material such as polyvinyl chloride, or the like and is fixed .to the proximal end of the tube assembly 12.
  • the Y-site connector comprises a hollow feed ing tube portion 5() including a feeding port lumen 5_2. in fluid communication with the proximal end 32 of the entera feeding lumen 22 and an angularly disposed, hollow irriga ⁇ tion tube portion .54. including an irrigation port or lumen 56. the distal end of which is in fluid communication with the distal end of the feeding port lumen 52 and thereby in fluid communication with the proximal end 32 of the entera feeding lumen 22.
  • the feeding port lumen 52 and irrigatio port lumen 56 include larger and adjacent smaller diameter portions which are shaped, sized and adapted to receive a conventional catheter tip syringe and the feeding port lum is also shaped and sized to receive a standard stepped feeding tube connector of a conventional enteral administr tion tubing set.
  • the irrigation port lumen 56 is also adapted to receive an adaptor, as will be hereinafter dis ⁇ cussed, to facilitate reception of a conventional luer tip syringe, and is adapted to be used for delivery of any irrigational, medicinal, or other prescribed fluids to the patient's intestinal tract or aspiration of fluids there ⁇ from.
  • a cup-shaped closure 60 Connected to the proximal end of the feeding tube portion 50 by a flexible arm 58 is a cup-shaped closure 60 as best seen in Figure 3, the closed end j52 . of which is adapted to be inserted in the feeding port or lumen 52 with the cup-shaped recess 6__%_ on the exterior side of the closure 60 when seated in the feeding port or lumen 52. It should be noted that by providing the cup-shaped recess 64 on the exterior side of the closure 60, the closure 60 may be conveniently compressed for insertion into the feeding port lumen 52 and withdrawal therefrom.
  • the distal end of flexible arm 58 further includes a web j66 extending beyond the closure 60, the web being provided with a finger-grip projection ___ to facili- tate insertion and withdrawal of the closure 60 in or from the feeding port lumen 52.
  • a flexible arm 2_l Connected to the proximal end of the irrigation tube portion 54 is a flexible arm 2_l and a hollow tubular adaptor 72. having a bore 7.3. therein, the adaptor being shaped and sized to be positioned in the irrigation port lumen 56 to reduce the size thereof to facilitate sealing engagement with a luer slip or luer lock tip of a syringe.
  • a web 7__ Connected to the arm 70 and the adaptor 72 is a web 7__ having a finger-grip projection 7_6 to facilitate insertion and with- drawal of the adaptor 72 in or from the irrigation port lumen 56.
  • a second flexible arm 7_8 Connected to the outer end of the web 74 is a second flexible arm 7_8, as shown in Figure 1, which is connected to a solid cylindrical closure or plug .80., shaped and sized for insertion into and sealing engagement with the bore 73 of the hollow tubular adaptor 72.
  • the plug 80 is supported on a web _2_, the outer end of which is provided with a finger-grip projection .84 . to facilitate insertion o withdrawal of the plug 80 from the bore 73 of the hollow tubular adaptor 72.
  • the wir stylet assembly 20 comprises a stainless steel wire .85_ of appropriate strength (290,000 to 300,000 P.S.I, tensile strength) (20,407 ⁇ 9 /cm 2 to 21,111 K9 /cm 2 ) and rigidity to appropriately stiffen the enteral feeding tube 10 for inse tion through the nose or mouth, the esophagus and into the stomach or small intestines.
  • the wire 85 is fully hardene along the full length thereof except adjacent the distal e thereof which will be subsequently discussed.
  • the proximal free end of the wire 85 is looped back o itself to form a finger pull or wire loop j$6_ by fixing the free end to the shaft j$8. of the wire 85 by positioning the free end and the adjacent portion of the shaft 88. in an appropriately sized section of heat shrink tubing j39. havin an adhesive-coating on the inner surface thereof and heati the same to shrink the tubing 89 and thereby fix the free end to the shaft 88.
  • heat shrink tubing may be like FIT ® 321 shrinkable polyolefin tubing sold by Alpha Wire Corporation, or equivalent.
  • the wire loop 86 is positioned on the proximal exteri side of the stylet opening saddle 18 when the stylet is in serted in the stylet lumen inlet opening 30 and bottomed i the stylet lumen 24. It should be noted that the stylet opening saddle is longitudinally spaced and laterally offs from the Y-site connector for convenience on stylet inser- tion. Additionally, this positioning, as opposed to a location in the Y-site connector, avoids obstructing or interference with use of the Y-site or primary lumen for other, more usual, purposes.
  • the distal end ⁇ K) of the wire 85 is tapered in a converging manner commencing at a point about three inches (7.62 cm) from the distal end to enhance the flexibility thereof to meet the requirement of the tortuous path of tube insertion and is fixedly connected at its distal end, as by plasma welding, to a spherical stylet globe ⁇ 32..
  • the diameter of the wire shaft 88 at point "A” as indicated in Figure 4, is about 0.02 inch (.05 cm), at point "B” is about 0.01 inch (.025 cm), and the diameter of the globe 92 is about 0.022 inch (.056 cm).
  • the globe 92 is shaped and sized to make piercing of the tube assembly 12 unlikely.
  • the globe 92 provides a relatively snug fit for the distal end (90) of the stylet (85) in the distal end 26 of the stylet lumen 24 (as compared to positioning of the stylet in the relatively larger enteral feeding lumen) to enhance the stiffening effect of the stylet.
  • approximately the last two (2) inches (5.1 cm) of the distal end 90 of the wire 85 is fully an ⁇ nealed to completely soften the stainless steel to induce stylet deformation rather than tube piercing.
  • the tensile strength of the annealed portion is reduced to 60,000 to 100,000 P.S.I. (4,222 Kg /cm 2 to 7,037 K9 /cm 2 ) .
  • TEFLON ® polymer polytetrafluorethylene
  • silicone medical fluid or the like to pro ⁇ vide a lubricant to facilitate insertion and withdrawal of the wire stylet assembly 20 into or from the relatively small stylet lumen 24. It is believed that such lubrication is enhanced because, as schematically illustrated in Figure 4, the TEFLON ® particles £4 schematically illustrated as small circles in Figure 4, are unevenly deposited along the metal wire stylet assembly 20 so that some particles of TEFLON ® are elevated relative to the remainder thereof.
  • a continuous layer of a silicone medical fluid 6. (such as Dow Corning 360 silicone medical fluid, or equivalent) is deposited to provide a lubricous coating on the stylet.
  • a silicone medical fluid 6. such as Dow Corning 360 silicone medical fluid, or equivalent
  • the wire stylet assembly 20 is substantially shorter than the distance between the Y-site feeding and irrigation ports 52 and 56 and the outlet openings 38 and 40, so that even if the stylet assembly 20 was erroneously or accidentally inserted in the feeding lumen 22, the dista end globe 92 would not reach the feeding lumen outlet open ⁇ ings 38 and 40, so that no danger exists that the stylet ti could project through the openings 38 and 48 and thereby possibly injure a patient.
  • the metal wire stylet of the present invention is coated with a silicone medical fluid for lubrication purposes, because the wire stylet is advantageously segregated in a separate stylet lumen and not positioned in the enteral feeding lumen, any danger of enteral feeding or irrigation fluids washing such silicone into the patient's intestinal tract is eliminated, as might be the case if the silicone-coated stylet were positioned in the feeding lumen. While the invention has been described in connection with one embodiment, one skilled in the art should appreci ⁇ ate that the invention is not necessarily so limited and that other embodiments or modifications thereof may be provided without departing from the inventive concept of th present invention, which is to be determined by reference to the following claims.

Landscapes

  • Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un tube d'alimentation entérale relativement flexible et à double orifice (10) pour l'apport d'un fluide au travers de l'oesophage d'un patient jusqu'au conduit intestinal du patient possède un orifice d'alimentation entérale (22) et un orifice (24) de stylet relativement petit séparé de l'orifice (22) d'alimentation entérale et s'étendant dans le même plan et sur une certaine longueur que l'orifice d'alimentation entérale (22). L'orifice pour stylet (24) possède un stylet métallique amovible relativement rigide (85) présentant une partie distale conique recuite. Le stylet (85) possède un revêtement en polytétrafluoroéthylène et un revêtement de silicone sur le polytétrafluoroéthylène. Le tube (10) possède également un adaptateur de site en Y (16) fixé sur l'extrémité proximale du tube (10). L'adaptateur en Y (16) possède des ouvertures en Y permettant l'accès à l'orifice d'alimentation entérale (22).
EP91914067A 1990-07-19 1991-07-16 Tube ameliore d'alimentation enterale Withdrawn EP0591192A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US555969 1983-11-29
US55596990A 1990-07-19 1990-07-19
PCT/US1991/004848 WO1992001436A1 (fr) 1990-07-19 1991-07-16 Tube ameliore d'alimentation enterale

Publications (1)

Publication Number Publication Date
EP0591192A1 true EP0591192A1 (fr) 1994-04-13

Family

ID=24219357

Family Applications (1)

Application Number Title Priority Date Filing Date
EP91914067A Withdrawn EP0591192A1 (fr) 1990-07-19 1991-07-16 Tube ameliore d'alimentation enterale

Country Status (4)

Country Link
EP (1) EP0591192A1 (fr)
AU (1) AU656143B2 (fr)
CA (1) CA2087335C (fr)
WO (1) WO1992001436A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5674209A (en) * 1996-01-22 1997-10-07 Yarger; Richard J. Connector for attachment to a drain tube
GB9717024D0 (en) * 1997-08-13 1997-10-15 Geo L White Limited Animal feeding apparatus

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4033331A (en) * 1975-07-17 1977-07-05 Guss Stephen B Cardiac catheter and method of using same
JPS617684Y2 (fr) * 1979-12-13 1986-03-10
US4874365A (en) * 1984-10-11 1989-10-17 Baxter International Inc. Feeding tube facilitating improved placement and permitting subsequent delivery of a second prescribed product and method therefor
US4867173A (en) * 1986-06-30 1989-09-19 Meadox Surgimed A/S Steerable guidewire

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9201436A1 *

Also Published As

Publication number Publication date
CA2087335C (fr) 1997-09-16
AU8308491A (en) 1992-02-18
AU656143B2 (en) 1995-01-27
WO1992001436A1 (fr) 1992-02-06
CA2087335A1 (fr) 1992-01-20

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