WO1998030268A1 - Catheter apparatus having valved catheter hub and needle protector - Google Patents
Catheter apparatus having valved catheter hub and needle protector Download PDFInfo
- Publication number
- WO1998030268A1 WO1998030268A1 PCT/US1998/000160 US9800160W WO9830268A1 WO 1998030268 A1 WO1998030268 A1 WO 1998030268A1 US 9800160 W US9800160 W US 9800160W WO 9830268 A1 WO9830268 A1 WO 9830268A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- needle
- hub
- valve
- catheter
- valve chamber
- Prior art date
Links
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
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
-
- 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
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- 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
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
Definitions
- the present invention relates to a catheter apparatus. More specifically, the invention is directed to a catheter apparatus having a catheter hub and a needle protector.
- the catheter apparatus is used to, among other things, insert a catheter in a blood vessel of a patient.
- Catheter insertion apparatus is known in the art.
- This prior art apparatus has many problems.
- the catheter hub does not include a valve for controlling or regulating fluid flow through the catheter hub.
- the apparatus does not include a needle protector with dual handles that allows the needle to be accurately positioned during insertion of the catheter in the blood vessel and retraction of the needle into the needle protector.
- the apparatus does not include a shape that provides ease in handling during use. Therefore, there is a need for a "bloodless" catheter apparatus that includes an internal valve in the catheter hub to regulate fluid flow, a needle protector that includes dual handles for accurate manipulation of the needle, and an apparatus that is shaped for easy handling during use.
- the present invention satisfies the above-identified needs.
- the catheter apparatus of the present invention has a needle protector including a body having a first end and a second end.
- the body includes a plurality of side walls extending between the first and second ends in a first geometric configuration.
- the side walls define an interior space.
- the side walls define a first slot and a second slot.
- a needle hub having a front end, a back end, a first side and a second side is positioned in the internal space.
- the front end is adapted to receive a needle.
- the first and second sides each includes a handle. The handles extend through the slots to positions outside of the body.
- a needle is in communication with the front end of the needle hub.
- the catheter apparatus further has a catheter hub including a housing having a connection end defining a first fluid passageway and a catheter end defining a second fluid passageway.
- the housing includes a plurality of hub walls arrange din a second geometric configuration.
- a valve is positioned in the valve chamber for regulating fluid flow through the chamber between the first and second fluid passageways.
- An actuator actuates the valve.
- the primary object of the present invention is to provide a catheter apparatus that includes a valve for regulating fluid flow in the catheter hub.
- An important object of the present invention is to provide a needle protector that includes dual handles for accurate manipulation of the needle.
- Another important object of the present invention is to provide a catheter apparatus having a unique profile that aids in the insertion of a catheter in a blood vessel.
- FIG. 1 is a perspective view of a catheter apparatus according to the present invention
- Fig. 2 is a perspective view of the body of the needle protector
- Fig. 3 is a top view of the body of the needle protector
- Fig. 4 is a cross-sectional view taken along line 4-4 of Fig. 3;
- Fig. 5 is an elevational view of the second end of the body of the needle protector;
- Fig. 6 is an elevational view of the first end of the body of the needle protector;
- Fig. 7 is a cross-sectional view taken along line 7-7 of Fig. 3;
- Fig. 8 is a perspective view of the end cap according to the present invention.
- Fig. 9 is a side elevational view of the end cap shown in Fig. 8.
- Fig. 10 is a cross-sectional view taken along line 10-10 of Fig. 9;
- Fig. 11 is a view similar to the view of Fig. 1 in which the needle hub according to the present invention has been moved from the first end of the body to the second end of the body;
- Fig. 12 is a perspective view of the needle hub and needle according to the present invention.
- Fig. 13 is a top view of the needle hub according to the present invention.
- Fig 14 is a cross-sectional view taken along line 14-14 of Fig. 13;
- Fig 15 is a cross-sectional view taken along line 15-15 of Fig. 13;
- Fig 16 is an elevational view of the back end of the needle hub;
- Fig 17 is a cross-sectional view taken along line 17-17 of Fig. 11;
- Fig 18 is a perspective view of the catheter hub according to the present invention connected to a standard luer fitting;
- Fig. 19 is a cross-sectional view taken through the center of the catheter hub with the valve in a closed position;
- Fig. 19A is a cross-sectional view taken along line 19A-19A of Fig. 19;
- Fig. 20 is a view similar to the view of Fig. 19 showing the valve in an open position;
- Fig. 21 is a cross-sectional view taken through the center of the catheter hub according to the present invention attached to the first end of the needle protector with the needle extending from the needle protector through the catheter hub;
- Fig. 22 is a cross-sectional side elevational view taken through the center of the catheter apparatus according to the present invention with the needle hub of the needle protector positioned at the first end of the needle protector;
- Fig. 23 is a view similar to the view of Fig. 22 with the needle hub positioned at the second end of the needle protector;
- Fig. 24 is a cross-sectional top view of the catheter apparatus according to the present invention with the needle hub of the needle protector positioned at the first end of the needle protector;
- Fig. 25 is a view similar to the view of Fig. 24 with the needle hub positioned at the second end of the needle protector.
- the catheter apparatus of the present invention is indicated generally in the drawings by the reference number "1 ".
- the catheter apparatus includes a needle protector 10 and a catheter hub 110.
- the needle protector 10 includes a body 12 having a first end 14 and a second end 16. As shown in Figs. 1, 2, 4 and 6, the first end 14 is attached to receive a catheter hub 110.
- the first end 14 includes a plurality of threads 20, as shown in Figs. 4 and 6, for receiving mating threads on the catheter hub 110, as described below, for attaching the needle protector 10 to the catheter hub.
- the first end 14 and the threads 20 are usually constructed to conform with American National Standard Institute No. ANSI/HIMA MD70. 1-1 983 relating to luer lock fittings, which is incorporated herein by reference.
- the second end 16 of the body 12 is adapted to receive an end cap 24.
- the cap 24 includes a head
- each of the first and second legs 32 and 34 includes a locking recess 36 having a locking surface 38.
- the first and second legs 32 and 34 are inserted in the second end 16 of the body 12 to attach the cap 24 to the body.
- the body 12 includes a plurality of side walls extending between the first end 14 and the second end 16 in a first geometric configuration.
- the body 12 includes a first side wall 40, a second side wall 42, a third side wall 44, a fourth side wall 46, a fifth side wall 48 and a sixth side wall 50.
- the side walls 40-50 are arranged to form a hexagonal configuration. It should be understood that the number of side walls of the body 12 can be varied to form other polygonal configurations, with a hexagonal configuration being preferred. As described below, the hexagonal configuration allows the needle protector 10 to be easily handled during use.
- the fourth side wall 46 provides a flat, smooth surface for contact with, for example, the skin of a patient.
- the first side wall 40 provides a surface upon which, for example, the thumb of a person using the needle protector 10 can engage during handling.
- a plurality of spaced upwardly extending projections 52 are positioned on the first side wall 40. The projections 52 may be engaged by a thumb to more accurately and easily handle the catheter apparatus 1.
- the side walls of the body 12 define at least two slots.
- second and third side walls 42 and 44 define a first slot 54
- the fifth and sixth side walls 48 and 50 define a second slot 56.
- the first and second slots 54 and 56 extend longitudinally between the first end 14 and the second end 16 of the body 12 in an opposed relationship to one another.
- the first and second slots 54 and 56 define first and second locking portions 58 and 60, respectively, adjacent the second end 16 of the body 12 in opposed relationship to one another.
- the first and second locking portions 58 and 60 are positioned adjacent the locking recesses 36 of the first and second legs 32 and 34 of the end cap 24. Referring to Figs.
- the side walls 40-50 define an interior space 62 extending between the first and second ends 14 and 16 of the body 12.
- a needle opening 64 is defined by the body 12 at the first end 14.
- the needle opening 64 extends from the exterior of the body 12 to the interior space 62.
- the needle protector 10 includes a needle hub 66 having a front end 68, a back end 70, a first side 72 and second side 74.
- the needle hub 66 is movably positioned in the interior space 62 of the body 12.
- the front end 68 of the needle hub 66 is adapted to receive a hollow needle 76 defining a needle fluid passageway 78.
- the front end 68 includes a front end opening 80 for receiving the needle 76.
- the needle hub 66 defines a hub fluid passageway 82 extending between the front and back ends 68 and 70.
- the needle 76 is positioned in the front end opening 80 so that the needle fluid passageway 78 is in communication with the hub fluid passageway 82.
- the back end 70 of the needle hub 66 includes absorbent material 84.
- the absorbent material 84 absorbs any fluid, such as blood, contained in the hub fluid passageway 82.
- the first and second sides 72 and 74 of the needle hub 66 include first and second handles 86 and 88, respectively.
- the first and second handles 86 and 88 include first and second wings 90 and 92, respectively.
- the first and second wings 90 and 92 extend from the needle hub 66 through the first and second slots 54 and 56, respectively, to the exterior of the body 12.
- the first and second handles 86 and 88 include first and second handle members 94 and 96, respectively, attached to the first and second wings 90 and 92, respectively.
- Each of the first and second handle members 94 and 96 includes an interior surface 98 and an exterior surface 100.
- each exterior surface 100 includes a plurality of spaced grips 102.
- the grips 102 allow the first and second handles 86 and 88 to be firmly gripped during actuation of the needle hub 66.
- the first and second handle members 94 and 96 each includes a locking projection 104 extending inwardly from the interior surface 98.
- each locking projection 104 includes a ramp surface 106 and a locking surface 108.
- the locking projections 104 are received by the locking recesses 36 of the first and second legs 32 and 34.
- the locking surfaces 108 of the locking projections 104 engage the recess surfaces 38 of the locking recesses 36 to lock the needle hub 66 to the second end 16 of the body 12.
- the catheter hub 110 of the catheter apparatus 1 includes a housing 112 having a connection end 114 defining a first fluid passageway 116 and a catheter end 118 defining a second fluid passageway 120.
- the catheter end 118 includes a catheter 122 consisting of a polymeric material positioned in the second fluid passageway 120.
- the connection end 114 includes a plurality of threads 124.
- the connection end 114 and the threads 124 are usually constructed to conform with American National Standard Institute No. ANS1/HIMA MD70.1-1983 relating to luer lock fittings.
- the catheter hub 110 is attached to the needle protector 10.
- the plurality of threads 20 of the first end 14 of the needle protector 10 mates with the plurality of threads 124 of the housing 112. As shown in
- the needle protector 10 includes a needle protector projection 132 that extends into the first fluid passageway 116.
- the needle 76 of the needle protector 10 extends through the catheter hub 110.
- the housing 112 includes a plurality of hub walls arranged in a second geometric configuration.
- the housing 112 includes a first hub wall 136, a second hub wall 138, a third hub wall 140, a fourth hub wall 142, a fifth hub wall 144 and a sixth hub wall 146.
- the housing 112 includes a top 148 and a bottom 150.
- the fourth hub wall 142 is positioned at the bottom 150 of the housing 112. When so positioned, the fourth hub wall 142 is planar.
- the planar surface provided by the fourth hub wall 142 provides a flat, smooth surface that can rest against the skin of a patient during use of the catheter hub 110. As described below, this allows the catheter hub 110 to be easily positioned at the site of the blood vessel into which the catheter 122 is to be inserted.
- the geometric configuration formed by the hub walls 136-146 is a hexagon. However, it should be understood that a variety of polygonal configurations may be used as long as there is a planar surface adjacent the bottom 148 of the housing 112. Still referring to Figs. 19 and 19A, the hub walls 136-146 define a valve chamber 152 having a shoulder end 154 and a passageway end 156. As shown in Fig.
- connection end 114 of the housing 112 defines an annular shoulder 158 adjacent the shoulder end 154 of the valve chamber 152.
- the housing 112 defines a plurality of inwardly extending valve ribs 159 in the valve chamber 152.
- a valve seat 160 is positioned in the valve chamber 152 adjacent the passageway end 156.
- the valve seat 160 defines a plurality of fluid openings 162 that allows for fluid flow between the second fluid passageway 120 defined by the catheter end 1 18 of the housing 112 and the valve chamber 152.
- the catheter hub 110 includes a valve 164 positioned in the valve chamber 152 adjacent the valve ribs 159.
- the valve 164 is comprised of a resilient material having a substantially cylindrical configuration.
- the valve 164 has an actuator end 166 and a housing end 168.
- the actuator end 166 is engaged with the annular shoulder 158 of the connection end 114. This engagement acts to seal the valve chamber 152 from the first fluid passageway 116 defined by the connection end 114 of the housing 112.
- the housing end 168 of the valve 164 engages the valve seat 160.
- the valve 164 can consist of a variety of resilient materials, with rubber, silicon and polyisoprene being preferred.
- the catheter hub 110 includes an actuator 170 that is positioned in the first fluid passageway 116.
- the actuator 170 includes a luer end 172 and a valve end 174.
- the actuator 170 is free to move within the first fluid passageway 116 and the valve chamber 152.
- the actuator 170 defines a needle passageway 176 that extends longitudinally between the luer and valve ends 172 and 174. As shown in
- valve end 174 of the actuator 170 includes an annular flange 178 that is received by a recess 180 defined by the valve 164 at the actuator end 166. This allows a portion of the valve 164 to be positioned between the annular shoulder 158 and the annular flange 178.
- the annular flange 178 provides structural support for the valve 164 at the actuator end 166 so that a superior seal is formed.
- the catheter hub 110 is attached to the needle protector 10 by insertion of the projection 132 into the first fluid passageway 116 and the mating of the threads 20 and 130.
- the projection 132 is adapted so that it does not move the actuator 170 to actuate the valve 164 regardless of the travel of the projection into the first fluid passageway 116.
- the needle 76 of the needle protector 10 extends through the needle opening 64 of projection 132, into the needle passageway 176 of the actuator 170, the valve 164, the valve seat 160, the catheter 122 to the exterior of the catheter hub 110. When so positioned, the pointed end 182 of the needle 76 can be inserted in the blood vessel of the patient (not shown).
- the fourth wall 142 of the housing 112, which provides a planar surface, and the fourth side wall 46 of the needle protector 10 are positioned on the skin of the patient adjacent the injection site. This allows the catheter apparatus 1 to be easily moved along the skin during insertion of the needle 76 into the blood vessel.
- the user of the catheter apparatus 1 grips the body 12 of the needle protector 10 and places his or her index finger on the first side wall 40. The finger engages the projections 52 so that the body 12 can be accurately positioned with respect to the blood vessel.
- the pointed end 182 of the needle 76 is properly positioned, the user pushes the pointed end into the blood vessel.
- Blood from the blood vessel "flashes” or enters the needle fluid passageway 78 of the needle 76 and then proceeds to the hub fluid passageway 82.
- the absorbent material 84 absorbs the blood to prevent leakage from the needle hub 66. Insertion of the needle 76 into the blood vessel results in the insertion of the catheter 122 into the blood vessel.
- the user of the catheter apparatus 1 causes his or her thumb and forefinger to engage the first and second handles 86 and 88 of the needle hub 66.
- the grips 102 prevent slippage by the user.
- the user pulls back on the first and second handles 86 and 88 thereby causing the needle hub 66 to move from the first end 14 to the second end 16 of the body 12.
- the first and second wings 90 and 92 travel along the first and second slots 54 and 56, respectively, to guide the needle hub 66 along its predetermined path.
- the first and second wings 90 and 92 maintain the needle hub 66 in proper axial alignment with respect to the body 12. Movement of the needle hub 66 causes corresponding movement of the needle 76.
- the engagement of the locking surfaces 108 with the recess surfaces 38 provides a positive lock so that the needle 76 cannot exit through the needle opening 64. After the needle 76 has been locked in place, the user of the catheter apparatus 1 disengages the needle protector 10 from the catheter hub 110.
- the luer 184 is in communication with, for example, intravenous tubing (not shown) that is connected to a supply of intravenous fluid (not shown).
- the luer 184 includes a luer projection 186 that extends into the first fluid passageway 116 of the housing 112.
- the luer projection 186 includes an actuator surface 188 that engages the luer end 172 of the actuator 170.
- Movement of the luer 184 with respect to the connection end 114 of the housing 112 results in corresponding movement of the actuator 170. This movement causes the actuator
- valve 164 is comprised of a resilient material. Therefore, the valve can be compressed, as shown in Fig. 20, to allow the actuator end 166 of the valve 164 to become disengaged from the annular shoulder 158.
- Intravenous fluid is allowed to flow in the direction indicated by the arrows in Fig. 20 when the valve 164 is in the open position. This allows the intravenous fluid in communication with the luer 184 to pass through the catheter hub 110 into the blood vessel of the patient. It should also be understood that blood or some other bodily fluid can be drawn from the patient through the catheter hub 110 with the valve 164 controlling the flow of the fluid between the first and second fluid passageways 116 and 120, respectively.
- the actuator end 166 of the valve 164 engages the annular shoulder 156 to reseal the valve chamber 152 as shown in Fig. 19.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP53104098A JP4044621B2 (en) | 1997-01-08 | 1998-01-08 | Catheter apparatus provided with valve-equipped catheter receiving part and needle protector |
DE69831317T DE69831317T2 (en) | 1997-01-08 | 1998-01-08 | CATHETER DEVICE WITH VALVE CATHETER HUB AND NEEDLE PROTECTION |
EP98901701A EP0964716B1 (en) | 1997-01-08 | 1998-01-08 | Catheter apparatus having valved catheter hub and needle protector |
HK00103806A HK1026856A1 (en) | 1998-01-08 | 2000-06-22 | Catheter apparatus having valved catheter hub and needle protector |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/778,234 | 1997-01-08 | ||
US08/778,234 US5954698A (en) | 1997-01-08 | 1997-01-08 | Catheter apparatus having valved catheter hub and needle protector |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998030268A1 true WO1998030268A1 (en) | 1998-07-16 |
Family
ID=25112699
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/000160 WO1998030268A1 (en) | 1997-01-08 | 1998-01-08 | Catheter apparatus having valved catheter hub and needle protector |
Country Status (6)
Country | Link |
---|---|
US (1) | US5954698A (en) |
EP (1) | EP0964716B1 (en) |
JP (1) | JP4044621B2 (en) |
DE (1) | DE69831317T2 (en) |
ES (1) | ES2244044T3 (en) |
WO (1) | WO1998030268A1 (en) |
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- 1997-01-08 US US08/778,234 patent/US5954698A/en not_active Expired - Lifetime
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- 1998-01-08 DE DE69831317T patent/DE69831317T2/en not_active Expired - Lifetime
- 1998-01-08 JP JP53104098A patent/JP4044621B2/en not_active Expired - Fee Related
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- 1998-01-08 ES ES98901701T patent/ES2244044T3/en not_active Expired - Lifetime
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Also Published As
Publication number | Publication date |
---|---|
EP0964716B1 (en) | 2005-08-24 |
ES2244044T3 (en) | 2005-12-01 |
JP4044621B2 (en) | 2008-02-06 |
DE69831317D1 (en) | 2005-09-29 |
US5954698A (en) | 1999-09-21 |
DE69831317T2 (en) | 2006-06-22 |
JP2001508678A (en) | 2001-07-03 |
EP0964716A1 (en) | 1999-12-22 |
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