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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
  • A61M25/09016—Guide wires with mandrils
  • A61M25/09025—Guide wires with mandrils with sliding mandrils
• • 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
  • A61M25/0043—Catheters; Hollow probes characterised by structural features
  • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• • 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
• • 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
  • A61M2210/1053—Stomach
• • 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
• • 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
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• • 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
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
  • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• • 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
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/008—Strength or flexibility characteristics of the catheter tip

Definitions

• This invention relates generally to catheters and catheter insertion methods. It relates particularly to a catheter and stylet assembly for introducing the catheter into a patient's body cavity, and to a method of doing so.
• Stylets rather than guidewires are used in medical practice in situations where the clinician desires to push the catheter into a body cavity or vessel.
• Naso-enteral feeding tubes are inserted with stylets, as are Groshong intravenous catheters.
• Stylets have constant stiffness over their entire length, however. This can be a disadvantage when the catheter must travel around acute angle bends or through valves or sphincters. Having the stylet constructed with a softer leading portion can be a disadvantage because in its course of travel the catheter may encounter obstructions that will not readily permit the entry of the leading softer portion of the stylet.
• An object of the invention is to provide a new and improved catheter and stylet assembly for inserting a feeding tube into a body cavity.
• Another object is to provide a catheter and stylet assembly affording almost infinite varying stiffness adjustability over its leading distal portion. Another object is to provide a catheter and stylet assembly with variable stiffness over much of the entire length.
• Another object is to prevent coiling of the tube in the stomach during attempts to insert it through the pylorus.
• Another objective is to provide a tube that has minimal friction along its entire outside surface from the nares to its tip in the jejunum. Another object is to prevent necrosis in the nasopharynx, pylorus and the Ligament of Trietz by allowing the use of a small flexible ⁇ Frtube.
• Another object is to incorporate a stylet tip configuration that provides maximum protection against the inadvertent pushing of the stylet through the tube wall.
• Another object is to provide a catheter with very lubricious water activated internal and external coating to assure both easy insertion and free movement of the stylets within the tube.
• Still another object is to provide a catheter and stylet assembly of the aforedescribed character which includes a multi-lumen tube containing a gastric suction lumen.
• the catheter and stylet assembly of the present invention can be used for any medical catheter insertion where a stylet is required.
• One embodiment described in the present application is used for naso-enteral insertion of a feeding tube into and through the stomach, the duodenum and finally into the jejunum.
• This use presents some unique requirements for adjustable variability of stylet stiffness.
• Moderate stiffness is provided for initial insertion through the nasopharynx, the esophagus and into the stomach.
• more stiffness is provided to transmit pushing force from outside the patient to the catheter tip as it is pushed through the pylorus into the duodenum and to the Ligament of Trietz.
• conventional feeding tubes resist entry through the pylorus and tend to coil in the stomach. After the stiffer distal tube reaches the Ligament of Treitz, the leading portion of the stylet and catheter is converted to a softer mode so that they can navigate around the acute curve formed by the Ligament of Trietz and into the
• the catheter and stylet assembly of the invention provides moderate stiffness over a long, 25-35" distal length during gastric insertion. Much greater stiffness is provided over the entire length of the catheter during duodenal insertion. Finally, moderate to soft stiffness is provided over 10" to 15" of the distal end as it enters the jejunum.
• the assembly has two stylets and allows the stylet wire of one to pass through the proximal connector of the other. The assembly also allows irrigation of the inside of the tube through the stylet connection of the assembly to activate a lubricious coating inside the tube lumen (which allows stylet wire manipulation and removal).
• the coating is also on the exterior surface of approximately the first 35" of the distal tube and tip to minimize friction along the surface of the tube from the insertion point at the nares along its entire length to the tip in the jejunum.
• the coating adheres to the urethane surface and is activated by contact with water.
• the stylet that seats itself in the feeding tube "Y" connector contains a stylet wire whose tip end position is most distal. This stylet is referred to as the primary stylet.
• a secondary stylet connects to the luer lock of the primary stylet and its tip is normally immediately adjacent the primary stylet tip.
• the overall tube is approximately 60" long. This compares to a conventional feeding tube length of approximately 45". The extra length tube provides for entry into the jejunum.
• the method of insertion of a catheter tube using the aforedescribed assembly of the invention comprises the following steps:
• a multi-lumen tube containing a suction lumen in addition to the feeding lumen accesses both the stomach and the jejunum.
• the stylet system invention can also be used in this multi- lumen configuration and provides for both jejunal feeding and gastric suction.
• FIG. 1 is a side elevational view of a common flow-through stylet connector
• FIG. 2 is an end view of the connector
• FIG. 3 is a sectional view of the connector showing the flow-through lumen and the socket for the wire stylet;
• FIG. 4 is a sectional view of the connector with a stylet in place
• FIG. 5 is a side elevational view of the assembled primary stylet
• FIG. 6 is a side elevational view of a short segment of vinyl tubing
• FIG. 7 is a side elevational view of a male luer lock connector designed to fit over a delivery tube
• FIG. 8 is a side elevational view of the flow-through connector shown in FIG. 5, assembled to the male luer lock in FIG. 7 by means of both parts being inserted and glued into the short segment of vinyl tubing;
• FIG. 9 is a cross sectional view of the assembly in FIG. 8.
• FIG. 10 is a side elevational view of the primary and secondary stylets connected, the tip of the secondary stylet being slightly behind the tip of the primary stylet;
• FIG. 11 is a cross sectional view of the primary and secondary stylets unconnected, but with the secondary stylet wire inserted through the flow- through lumen of the primary stylet;
• FIG. 12 shows both stylets' distal ends as they would be positioned in a feeding tube with both stylet connectors attached;
• FIG. 13 is a cross sectional view through the tube in FIG. 12, at line 13-13, the main body of the primary stylet and through the tip of the secondary stylet, the tube being 8Fr with an 0.080" internal lumen and the stylet wire having a 0.014" OD;
• FIG. 14 is a cross section of the tube in FIG. 12 and the main bodies of both stylets, at line 14-14;
• FIG. 15 is a side elevational view of the invention assembly with the stylet connectors assembled, but not seated, in the feeding tube "Y" connector with a cross sectional view of the tube and tip showing the position of the stylets;
• FIG. 16 shows the connected two stylet assembly seated in the "Y" connector with the distal tip of the primary stylet positioned just behind the tube tip;
• FIG. 17 shows the two stylet assembly with the secondary stylet retracted
• FIG. 18 shows both stylets disconnected from each other and from the "Y";
• FIG. 19 shows the secondary stylet removed and the primary stylet seated in the "Y" as it would be in a normal feeding tube insertion procedure;
• FIG. 20 illustrates the almost infinite stiffness adjustability of the catheter, i.e., there are three potential stiffness zones in the tube, all adjustable;
• FIG. 21 shows the secondary stylet retracted approximately 35" so that gastric insertion can be carried out with normal stylet stiffness
• FIG. 22 shows the secondary stylet re-seated in the "Y" connector
• FIG. 23 shows both stylets remaining in place for maximum stiffness, the catheter having been pushed through the pylorus and into the duodenum up to the Ligament of Trietz;
• FIG. 24 shows the secondary stylet retracted approximately 12", the primary stylet remaining in place, so as to provide reduced but adequate stiffness so that the tube can be pushed around the Ligament of Trietz into the jejunum;
• FIG. 25 shows the secondary stylet removed after final placement of the tip in the jejunum
• FIG. 26 illustrates the tube ready for infusion of nutrients after careful removal of the secondary stylet
• FIG. 27 is a side elevational view of a mid-port bolus in a feeding tube wherein the dual stylet features of the invention are employed;
• FIG. 28 is a top plan view of the bolus of FIG. 27.
• FIG. 29 is a longitudinal sectional view taken along line 29-29 of FIG. 28.
• the assembly 10 comprises a catheter tube sub-assembly 12, a first stylet sub-assembly 14 and a second stylet sub-assembly 16. Referring now also to FIGURES 1-14, the catheter tube sub-assembly
• the 12 comprises an 8 French (Fr) tube 20 having a bolus tip 22 on its distal end.
• a conventional Y-connector 24 is mounted on its proximal end.
• the Y-connector has a conventional inlet port 26 at its proximal end.
• the first stylet sub-assembly 14 comprises a molded acrylic connector sleeve 28 and a primary twisted wire stylet 30.
• the proximal end 32 of the stylet 30 is force fit into a slot 34 formed within, and on the side, of a lumen 36 extending longitudinally through the connector sleeve 28.
• the distal end 37 of the stylet extends approximately 48 inches from the nose of the sleeve 28.
• the connector sleeve 28 can be threaded into the proximal end port 26 of the Y-connector 24. Its stylet 30 then extends through the tube 20 as illustrated in FIGURE 19.
• the second stylet sub-assembly 16 comprises a molded acrylic connector sleeve 38 identical to the sleeve 28.
• a secondary twisted wire stylet 40 has a proximal end 42 which is force fit into a slot 44 formed inside, and on one side of, a lumen 46 extending longitudinally through the connector sleeve 38.
• the distal end 47 of the secondary stylet 40 extends approximately 52 inches from the nose of the sleeve 38.
• the second stylet sub-assembly 16 also comprises an acrylic male luer lock fitting 50 and a vinyl sleeve 52.
• the vinyl sleeve 52 connects the luer lock fitting 50 to the connector sleeve 38.
• the catheter tube sub-assembly 12, first stylet sub-assembly 14 and second stylet sub-assembly 16 are joined together to form the assembly 10 in the manner illustrated in FIGURE 16. In this assembly 10, the relationship of the stylets 30 and 40 are shown in FIGURES 12-14.
• FIGURE 21 shows stylet sub- assembly 16 disconnected from stylet sub-assembly 14 and its stylet 28 withdrawn approximately 35 inches. In this configuration, the assembly provides a more flexible tube 20 for insertion through a patient's nose.
• the first and second stylet sub-assemblies 14 and 16 are connected. In this configuration both stylet tips are positioned just behind tube tip 22. This facilitates passage of the tube 20 through the Pyloric valve to the position shown in FIG. 23.
• the second stylet sub-assembly 16 is disconnected from the first stylet subassembly 14 using the luer lock fitting. The secondary stylet can then be withdrawn a short distance (12" as seen in FIGURE 24). This permits easy passage into the duodenum, for example.
• FIGS. 27-29 a modified application of the invention is illustrated in the form of a catheter and stylet assembly 110 (with parts removed).
• the primary and secondary stylets 30 and 40 extend through a dual lumen catheter tube sub-assembly 112.
• the catheter tube sub-assembly 112 includes an 8 Fr dual lumen tube 120, a mid-port bolus 124 and a 5 Fr single lumen tube 128.
• the stylets 30 and 40 extend through the lumens and the bolus in the manner illustrated.
• the lubricant is a combination of methyl cellulose and polyvinylpyrolidone.
• the lubricaniad heres to the tube surface and becomes extremely slippery when contacted by water.

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Citations (5)

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• 2003
  • 2003-01-24 EP EP03707545A patent/EP1409061A4/de not_active Withdrawn
  • 2003-01-24 WO PCT/US2003/002347 patent/WO2003061752A1/en not_active Application Discontinuation

Patent Citations (5)

Non-Patent Citations (1)

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