EP4281157A1 - Bague de retenue de valve et systèmes et procédés associés - Google Patents
Bague de retenue de valve et systèmes et procédés associésInfo
- Publication number
- EP4281157A1 EP4281157A1 EP21851762.1A EP21851762A EP4281157A1 EP 4281157 A1 EP4281157 A1 EP 4281157A1 EP 21851762 A EP21851762 A EP 21851762A EP 4281157 A1 EP4281157 A1 EP 4281157A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- catheter
- annular valve
- retainer ring
- side port
- lumen
- 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.)
- Pending
Links
- 238000000034 method Methods 0.000 title claims description 20
- 239000012530 fluid Substances 0.000 claims abstract description 25
- 230000037361 pathway Effects 0.000 claims abstract description 6
- 238000001802 infusion Methods 0.000 claims description 40
- 230000004044 response Effects 0.000 claims description 13
- 230000003213 activating effect Effects 0.000 claims description 12
- 229910052710 silicon Inorganic materials 0.000 claims description 5
- 239000010703 silicon Substances 0.000 claims description 5
- 238000000465 moulding Methods 0.000 claims description 4
- 230000008878 coupling Effects 0.000 claims description 3
- 238000010168 coupling process Methods 0.000 claims description 3
- 238000005859 coupling reaction Methods 0.000 claims description 3
- 230000000881 depressing effect Effects 0.000 claims description 3
- 238000011010 flushing procedure Methods 0.000 claims description 3
- 238000001990 intravenous administration Methods 0.000 claims description 3
- 230000002093 peripheral effect Effects 0.000 claims description 3
- 239000007788 liquid Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 239000002184 metal Substances 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 210000005166 vasculature Anatomy 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 235000021476 total parenteral nutrition Nutrition 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
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
- A61M25/0097—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
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M2005/1401—Functional features
- A61M2005/1403—Flushing or purging
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
Definitions
- Catheters are commonly used for a variety of infusion therapies. Catheters may be used for infusing normal saline solution, various medicaments, total parenteral nutrition, or other fluids into a patient. Catheters may also be used to withdraw blood from the patient for diagnostic or other purposes.
- a common type of catheter is a peripheral intravenous catheter (“PIVC”) that is “over- the-needle.”
- PIVC peripheral intravenous catheter
- the PIVC that is over-the-needle may be mounted over an introducer needle having a sharp distal tip.
- the PIVC and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up away from skin of the patient.
- the PIVC and introducer needle are generally inserted at a shallow angle through the skin into the vasculature of the patient.
- a clinician In order to verify proper placement of the introducer needle and/or the PIVC in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may remove the introducer needle, leaving the PIVC in place for future fluid infusion.
- a catheter system may include the catheter assembly.
- the catheter assembly may include the catheter adapter, which may include a distal end, a proximal end, an inner surface forming a lumen, the lumen extending through the distal end and the proximal end, and a side port disposed between the distal end and the proximal end.
- the catheter assembly may include an annular valve, which may be disposed within the lumen and aligned with the side port.
- the annular valve may seal a fluid pathway from the side port to the lumen.
- the catheter assembly may include a retainer ring disposed proximal and/or proximate the annular valve within the lumen.
- the catheter assembly may include a catheter extending distally from the distal end of the catheter adapter.
- the inner surface of the catheter adapter may include an undercut.
- the retainer ring may be disposed within the undercut.
- the annular valve may include silicon.
- the annular valve may be cylindrical.
- the retainer ring may be formed by molding.
- the retainer ring may be plastic.
- the catheter system may include a needle assembly.
- the needle assembly may include a needle hub and an introducer needle extending distally from the needle hub and through the retainer ring, the annular valve, and the catheter.
- the side port may extend from a top of the catheter adapter.
- the side port may be configured to receive a syringe.
- the retainer ring is configured to reduce proximal movement of the annular valve in response to fluid infusion through the side port that opens the annular valve.
- a method of flushing the catheter assembly may include coupling an infusion device to the side port of the catheter adapter of the catheter assembly.
- the method may include activating the infusion device.
- the annular valve in response to activating the infusion device, the annular valve may be opened to allow fluid to flow from the side port into the lumen.
- a proximal end of the annular valve in response to activating the infusion device, a proximal end of the annular valve may be forced against the retainer ring and the retainer ring may remain in place.
- the infusion device may include a syringe.
- activating the infusion device may include depressing a plunger of the syringe.
- the method may include uncoupling and removing the needle assembly from the catheter adapter.
- the infusion device may be activated after the needle assembly is uncoupled and removed from the catheter adapter.
- Figure 1 is a cross-sectional view of a prior art catheter system
- Figure 2A is a cross-sectional view of a catheter system, illustrating an example retainer ring, according to some embodiments
- Figure 2B is an upper perspective view of the retainer ring, according to some embodiments.
- Figure 2C is an enlarged cross-sectional view of a portion of the catheter system of Figure 2 A, according to some embodiments;
- Figure 2D is a cross-sectional view of the catheter system of Figure 2A, illustrating an example infusion device coupled to an example side port and activated, according to some embodiments;
- Figure 2E is a top view of the catheter system following infusion through the side port, according to some embodiments.
- FIG. 1 a prior art catheter system 10 is illustrated.
- the prior art catheter system includes an annular valve 12 disposed in a catheter adapter lumen 14.
- the annular valve 12 is often moved proximally in response to fluid infusion through a side port 16 of the prior art catheter system 10. Proximal movement of the annular valve 12 may prevent the annular valve 12 from sealing the side port 16, and thus may result in leakage from the catheter adapter lumen 14 through the side port 16 following fluid infusion.
- FIGs 2A-2C a catheter system 18 is illustrated, according to some embodiments.
- the catheter system 18 may include a catheter assembly 20.
- the catheter assembly 20 may include a catheter adapter 22, which may include a distal end 24, a proximal end 26, an inner surface 28 forming a lumen 30. In some embodiments, the catheter assembly 20 may include the lumen 30 extending through the distal end 24 and the proximal end 26. In some embodiments, the catheter assembly 20 may include a side port 32 disposed between the distal end 24 and the proximal end 26. In some embodiments, the catheter assembly 20 may include a cap 33 removably coupled to the side port 32.
- the catheter assembly 20 may include an annular valve 34, which may be disposed within the lumen 30 and aligned with the side port 32.
- the annular valve 34 may seal a fluid pathway from the side port 32 to the lumen 30.
- the annular valve 34 may include silicon or another suitable material that allows an edge of the annular valve 34 to depress and open the fluid pathway from the side port 32 to the lumen 30 in response to fluid infusion through the side port 32.
- the annular valve 34 may be cylindrical.
- the catheter assembly 20 may include a retainer ring 36 disposed proximal and/or proximate the annular valve 34 within the lumen 30. In some embodiments, the retainer ring 36 may be contacting the annular valve 34. In some embodiments, the catheter assembly 20 may include a catheter 38 extending distally from the distal end 24 of the catheter adapter 22. In some embodiments, the catheter 38 may include a peripheral intravenous catheter (PIVC), a midline catheter, a peripherally-inserted central catheter, or another suitable type of catheter. [0022] In some embodiments, the catheter assembly 20 may include a septum 40, which may be disposed proximal to the retainer ring 36 and the annular valve 34. In some embodiments, the septum 40 may include silicon or another suitable material.
- PIVC peripheral intravenous catheter
- the catheter assembly 20 may include a septum 40, which may be disposed proximal to the retainer ring 36 and the annular valve 34. In some embodiments, the septum 40 may include silicon
- the inner surface 28 of the catheter adapter 22 may include an undercut 42, which may be annular.
- the retainer ring 36 may be disposed within the undercut 42.
- a width 44 of the retainer ring 36 may be approximately equal to a length 46 of the undercut 42 such that a distal edge 48 of the retainer ring 36 and a proximal edge 50 of the retainer ring 36 may abut edges of the undercut 42.
- the distal edge 48 and the proximal edge 50 may be annular.
- the retainer ring 36 may fit snugly within the undercut 42.
- an outer diameter may be slightly larger than a diameter of the undercut 42 such that the retainer ring 36 snaps into the undercut 42.
- the retainer ring 36 may be plastic, metal, or another suitable material. In some embodiments, the retainer ring 36 may be rigid or semi-rigid. In some embodiments, a durometer of the retainer ring 36 may be greater than a durometer of the annular valve 12. In some embodiments, the retainer ring 36 may be formed by molding. In further detail, in some embodiments, the retainer ring 36 may be formed by shaping a liquid or malleable raw material by using a fixed frame, such as a mold or a matrix. In some embodiments, the mold may include a hollow cavity receptacle, wherein the liquid or malleable raw material may be poured.
- the liquid or malleable raw material may include plastic, metal, or another suitable material. As the liquid or malleable raw material hardens inside the mold, forming the retainer ring 36.
- the catheter system 18 may include a needle assembly 52.
- the needle assembly 52 may include a needle hub 54 and an introducer needle 56 extending distally from the needle hub 54 and through the retainer ring 36, the annular valve 34, and the catheter 38.
- the introducer needle 56 may include a sharp distal tip, which may facilitate placement of the catheter 38 within vasculature of a patient.
- the side port 32 may extend from a top of the catheter adapter 22 or a portion of the catheter adapter 22 opposite skin of the patient, which may be placed below the catheter adapter 22 and/or beneath one or more wings 58 extending outwardly from the catheter adapter 22.
- the side port 32 may be configured to receive an infusion device 60, which may include a syringe or another suitable infusion device configured to infuse fluid from the side port 32 into the lumen 30.
- the retainer ring 36 is configured keep the annular valve 34 in a same position in response to fluid infusion through the side port 32 that opens the annular valve 34.
- the retainer ring 36 may be configured to reduce proximal movement of the annular valve 34 in response to fluid infusion through the side port 32 that opens the annular valve 34.
- a proximal end 62 of the annular valve 34 may not move in a proximal direction and/or a distal direction but may stay in place.
- the retainer ring 36 may prevent fluid, such as blood and/or another fluid, from leaking through the annular valve 34 and out the side port 32.
- the infusion device 60 may be activated in order to flush the catheter system 18 or inject a bolus.
- a method of flushing the catheter assembly 20 may include coupling the infusion device 60 to the side port 32 of the catheter adapter
- the side port 32 may include a luer, such as, for example, a female luer, which may be configured to couple to a corresponding luer of the infusion device 60.
- the method may include activating the infusion device 60.
- the annular valve 34 in response to activating the infusion device 60, the annular valve 34 may be opened to allow fluid to flow from the side port 32 into the lumen 30.
- the proximal end 62 of the annular valve 34 opposite a distal end 64 of the annular valve 34 may be forced against the retainer ring 36 and the retainer ring 36 may remain in place.
- the proximal end 62 of the annular valve 34 may not move in a proximal direction and/or a distal direction but may stay in place.
- the infusion device 60 may include the syringe, as illustrated, for example, in Figure 2D.
- activating the infusion device 60 may include depressing a plunger 66 of the syringe or otherwise causing fluid to be expelled from the infusion device into the catheter assembly 20.
- the method may include uncoupling and removing the needle assembly 52 from the catheter adapter 22, as illustrated, for example, in Figure 2D.
- the infusion device 60 may be activated after the needle assembly 52 is uncoupled and removed from the catheter adapter 22.
- FIG. 2E the catheter assembly 20 is illustrated with the cap 33 open after fluid infusion through the side port 32. As illustrated, the annular valve 34 is still in place and sealing the side port 32 after the fluid infusion.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Vascular Medicine (AREA)
- Biophysics (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Prostheses (AREA)
- Float Valves (AREA)
- Check Valves (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
La présente invention concerne un système de cathéter qui peut comprendre un ensemble cathéter. L'ensemble cathéter peut comprendre un adaptateur de cathéter, qui peut comprendre une extrémité distale, une extrémité proximale, une surface interne formant une lumière, la lumière s'étendant à travers l'extrémité distale et l'extrémité proximale, et un orifice latéral disposé entre l'extrémité distale et l'extrémité proximale. L'ensemble cathéter peut comprendre une valve annulaire, qui peut être disposée à l'intérieur de la lumière et alignée avec l'orifice latéral. La valve annulaire peut fermer hermétiquement un trajet de fluide de l'orifice latéral à la lumière. L'ensemble cathéter peut comprendre une bague de retenue disposée de manière proximale et/ou adjacente à la valve annulaire à l'intérieur de la lumière. L'ensemble cathéter peut comprendre un cathéter s'étendant de manière distale à partir de l'extrémité distale de l'adaptateur de cathéter.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202163139640P | 2021-01-20 | 2021-01-20 | |
US17/565,189 US11992647B2 (en) | 2021-01-20 | 2021-12-29 | Valve retainer ring and related systems and methods |
PCT/US2021/065643 WO2022159238A1 (fr) | 2021-01-20 | 2021-12-30 | Bague de retenue de valve et systèmes et procédés associés |
Publications (1)
Publication Number | Publication Date |
---|---|
EP4281157A1 true EP4281157A1 (fr) | 2023-11-29 |
Family
ID=80122523
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21851762.1A Pending EP4281157A1 (fr) | 2021-01-20 | 2021-12-30 | Bague de retenue de valve et systèmes et procédés associés |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP4281157A1 (fr) |
AU (1) | AU2021422317A1 (fr) |
CA (1) | CA3204132A1 (fr) |
WO (1) | WO2022159238A1 (fr) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP4346978A1 (fr) * | 2021-05-27 | 2024-04-10 | Becton, Dickinson and Company | Élément de retenue pour fixer une valve d'adaptateur de cathéter |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE202007006190U1 (de) * | 2006-07-31 | 2007-08-23 | B. Braun Melsungen Ag | Kathetervorrichtung |
US10500376B2 (en) * | 2013-06-07 | 2019-12-10 | Becton, Dickinson And Company | IV catheter having external needle shield and internal blood control septum |
-
2021
- 2021-12-30 AU AU2021422317A patent/AU2021422317A1/en active Pending
- 2021-12-30 WO PCT/US2021/065643 patent/WO2022159238A1/fr active Application Filing
- 2021-12-30 CA CA3204132A patent/CA3204132A1/fr active Pending
- 2021-12-30 EP EP21851762.1A patent/EP4281157A1/fr active Pending
Also Published As
Publication number | Publication date |
---|---|
CA3204132A1 (fr) | 2022-07-28 |
WO2022159238A1 (fr) | 2022-07-28 |
AU2021422317A1 (en) | 2023-07-20 |
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