WO2022240594A1 - Annular valve securement within a catheter assembly - Google Patents
Annular valve securement within a catheter assembly Download PDFInfo
- Publication number
- WO2022240594A1 WO2022240594A1 PCT/US2022/026813 US2022026813W WO2022240594A1 WO 2022240594 A1 WO2022240594 A1 WO 2022240594A1 US 2022026813 W US2022026813 W US 2022026813W WO 2022240594 A1 WO2022240594 A1 WO 2022240594A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- annular valve
- catheter
- proximal
- catheter system
- disposed
- Prior art date
Links
- 239000012530 fluid Substances 0.000 claims abstract description 54
- 230000037361 pathway Effects 0.000 claims abstract description 8
- 238000001802 infusion Methods 0.000 claims description 63
- 230000007704 transition Effects 0.000 claims description 34
- 230000004044 response Effects 0.000 claims description 29
- 230000007423 decrease Effects 0.000 claims description 8
- 238000000465 moulding Methods 0.000 claims description 5
- 238000003486 chemical etching Methods 0.000 claims description 3
- 238000005488 sandblasting Methods 0.000 claims description 3
- 230000003213 activating effect Effects 0.000 description 11
- 238000000034 method Methods 0.000 description 7
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- 238000011010 flushing procedure Methods 0.000 description 3
- 229910052710 silicon Inorganic materials 0.000 description 3
- 239000010703 silicon Substances 0.000 description 3
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 230000000881 depressing effect Effects 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 230000002093 peripheral effect Effects 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
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 238000004519 manufacturing 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
- A61M25/01—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
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
-
- 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
- A61M25/0693—Flashback chambers
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 or a bump 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 undercut may correspond to a proximal undercut, and the inner surface of the catheter adapter may further include a distal undercut.
- the annular valve may be disposed between the proximal undercut and the distal undercut.
- the annular valve may include silicon. In some embodiments, the annular valve may be cylindrical. In some embodiments, the retainer ring may be formed by molding. In some embodiments, 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 2 retainer ring or the bump are 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. In some embodiments, the method may include activating the infusion device. In some embodiments, 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. In some embodiments, 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. In some embodiments, in response to activating the infusion device, a proximal end of the annular valve may be forced against the bump.
- 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.
- the inner surface of the catheter adapter may include a stepped surface.
- the stepped surface may include a distal surface, a proximal surface, and a transition surface disposed between the distal surface and the proximal surface.
- the annular valve disposed within the lumen may seal the fluid pathway from the side port to the lumen.
- the annular valve may contact the distal surface.
- the catheter assembly may include a cavity disposed between an outer surface of the annular valve and the proximal surface.
- the transition surface may form a distal end of the cavity.
- the transition surface may be disposed between the distal end of the annular valve and the proximal end of the annular valve.
- the annular valve may contact the distal surface and a portion of the proximal surface.
- the annular valve may contact the portion of the proximal surface to form a proximal end of the cavity.
- a depth of the cavity may decrease in a proximal direction.
- the transition surface and the distal surface may meet at a sharp edge.
- the stepped surface and the cavity may be semi-annular.
- the annular valve in response to infusion through the side port, the annular valve may decrease a size of the cavity.
- the catheter assembly may include radial vertical ribs extending distally from the transition surface.
- the proximal surface may include sand blasting or chemical etching.
- the stepped surface may correspond to a first stepped surface.
- the inner surface of the catheter adapter may include a second stepped surface proximal to the first stepped surface.
- the catheter assembly may include another cavity disposed between an outer surface of the annular valve.
- another transition surface of the second stepped surface may form a distal end of the other cavity.
- Figure l 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 2A, 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 of Figure 2A following infusion through the side port, according to some embodiments;
- Figure 3 A is a cross-sectional view of a catheter system, illustrating an example annular valve removed for illustrative purposes, according to some embodiments;
- Figure 3B is a cross-sectional view of the catheter system of Figure 3 A, illustrating the annular valve prior to fluid infusion through the side port, according to some embodiments;
- Figure 3C is a cross-sectional view of the catheter system of Figure 3A, illustrating the annular valve opened in response to fluid infusion, according to some embodiments; 5 [0027] Figure 3D is a transverse cross-sectional view of the catheter system of Figure 3 A cut proximal to an example transition surface and the annular valve removed for illustrative purposes, according to some embodiments;
- Figure 3E is a cross-sectional view of the catheter system of Figure 3A, illustrating two example stepped surfaces and the annular valve removed for illustrative purposes, according to some embodiments;
- Figure 3F is an enlarged cross-sectional view of the catheter system of Figure 3A, illustrating the two example stepped surfaces and the annular valve removed for illustrative purposes;
- Figure 3G is a cross-sectional view of the catheter system of Figure 3 A, illustrating the two stepped surfaces prior to fluid infusion through the side port, according to some embodiments;
- Figure 3H is a cross-sectional view of the catheter system of Figure 3 A, illustrating the two stepped surfaces and the annular valve opened in response to fluid infusion, according to some embodiments;
- Figure 31 is a cross-sectional view of the catheter system of Figure 3A, illustrating multiple example ribs, according to some embodiments;
- Figure 3J is an enlarged cross-sectional view of the catheter system of Figure 3A, illustrating the multiple example ribs, according to some embodiments;
- Figure 3K is another cross-sectional view of the catheter system of Figure 3 A, according to some embodiments.
- Figure 4A is a cross-sectional view of a catheter system, illustrating multiple example bumps, according to some embodiments; 6
- Figure 4B is a cross-sectional view of the catheter system of Figure 4A, illustrating the multiple bumps, and the annular valve removed for illustrative purposes, according to some embodiments;
- Figure 4C is a transverse cross-sectional view of the catheter system of Figure 4A cut immediately distal to the multiple bumps, according to some embodiments;
- Figure 5A is a cross-sectional view of a catheter system, illustrating an example proximal undercut and an example distal undercut and the annular valve removed for illustrative purposes, according to some embodiments;
- Figure 5B is a cross-sectional view of the catheter system of Figure 5 A, according to some embodiments.
- 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.
- 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.
- the catheter assembly 20 may include the lumen 30 extending through the distal end 24 and the proximal end 26.
- the catheter assembly 20 may include a side 7 port 32 disposed between the distal end 24 and the proximal end 26.
- 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.
- 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.
- the septum 40 may include silicon or another suitable material.
- 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 8 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 into which the liquid or malleable raw material may be poured. In some embodiments, 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 9 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 or similar 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.
- 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 22 of the catheter assembly 20.
- 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 10 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.
- a catheter assembly 68 is illustrated, according to some embodiments.
- the catheter assembly 68 may be similar or identical to the catheter assembly 20 described with respect to Figure 2 in terms of one or more features and/or operation.
- the inner surface 28 of the catheter adapter 22 may include a stepped surface 70.
- the stepped surface 70 may include a proximal surface 72, a distal surface 74, and a transition surface 76 disposed between the proximal surface 72 and the distal surface 74.
- the annular valve 34 disposed within the lumen 30 may seal the fluid pathway from the side port 16 to the lumen 30, as illustrated, for example, in Figures 3B. 11 [0055] In some embodiments, the annular valve 34 may contact or rest on the distal surface 74.
- the catheter assembly 20 may include a cavity 78 disposed between an outer surface 80 of the annular valve 12 and the proximal surface 72. In some embodiments, the outer surface of the annular valve 12 may be generally cylindrical. In some embodiments, the transition surface 76 may form a distal end of the cavity 78.
- the transition surface 76 may be disposed between the distal end 64 of the annular valve 12 and the proximal end 62 of the annular valve 34.
- the annular valve 34 may contact the distal surface 74 and a portion 80 of the proximal surface 72, which may be spaced apart from the transition surface 76.
- the annular valve 34 may contact the proximal surface 72 to form a proximal end of the cavity 78.
- a depth of the cavity 78 may decrease in the proximal direction, as illustrated, for example, in Figure 3B.
- the transition surface 76 and the distal surface 74 may meet at a sharp edge 82, which may reduce slipping and movement of the annular valve 34.
- the stepped surface 70 and/or the cavity 78 may be semi-annular or arc-shaped, which may facilitate ejection during de-molding. In some embodiments, the stepped surface 70 and/or the cavity 78 may be semi-circular.
- the transition surface 76 may include a shoulder or an undercut. In some embodiments, the transition surface 76 may be disposed at about 90 degrees with respect to a longitudinal axis 83 of the catheter assembly 68, which may facilitate creation of the cavity 78. In some embodiments, the transition surface 76 may be disposed at an angle other than 90 degrees with respect to the longitudinal axis of the catheter assembly 10. In some embodiments, the transition surface 76 may be smooth and/or planar. In some embodiments, the transition surface 12 76 may be uneven, rough, or irregular. In some embodiments, the first transition surface 36 may be curved.
- infusion of the fluid 84 may include flushing the catheter system 18 or injecting the bolus by activating the infusion device 60 (see, for example, Figure 2D).
- 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, as illustrated, for example, in Figure 3C.
- the annular valve 34 in response to infusion of fluid 84 through the side port 32, may decrease a size or volume of the cavity 78, as illustrated, for example, in Figure 3C. In these embodiments, the annular valve 34 may be forced against the proximal surface 72. In some embodiments, in response to infusion of fluid 84 through the side port 32, the annular valve 34 may conform and clinch to the sharp edge 82 reducing slip of the annular valve 34. In some embodiments, the stepped surface 70 and the sharp edge 82 may reduce movement of the annular valve 34 in the distal direction and/or the proximal direction, such that the annular valve 34 continues to seal the side port 32 after the infusion of fluid 84 is complete.
- the cavity 78 may be empty and not include fluid prior to infusion of the fluid 84 through the side port 32.
- the annular valve 34 in response to infusion of fluid 84 through the side port 32, the annular valve 34 may be forced against the proximal surface 72 and may not allow fluid to enter the cavity 78 during infusion of the fluid 84, such that the cavity 78 is a dead space.
- the transition surface 76 may be disposed towards the distal end 64 and/or the transition surface 76 may be disposed distal to an opening of the side port 32 proximate the lumen 30 and the inner surface 28, which may facilitate securement of the annular 13 valve 34 and opening or depression of the proximal end 62 in response to infusion of fluid 84 through the side port 32.
- at least the proximal surface 72 of the stepped surface 70 may include a rough surface, which may include sand blasting or chemical etching.
- the rough surface is speckled in the drawings for illustration purposes.
- the rough surface may increase friction between the annular valve 34 and the proximal surface 72 to decrease movement of the annular valve 34.
- the stepped surface 70 may correspond to a first stepped surface.
- the inner surface 28 of the catheter adapter 22 may include a second stepped surface 86 proximal to the first stepped surface.
- the second stepped surface 86 may include a distal surface that may correspond to the proximal surface 72 of the stepped surface 70.
- the second stepped surface 86 may include a proximal surface 90 and a transition surface 92 disposed between the proximal surface 72 and the distal surface 74.
- the second stepped surface 86 may be similar or identical to the stepped surface 70 in terms of one or more features and/or operation. As illustrated in Figures 3E-3F compared to Figures 3G-3H, in some embodiments, a location of the first stepped surface and/or the second stepped surface 86 may vary along the inner surface 28.
- the transition surface 92 and the distal surface of the second stepped surface 86 may meet at a sharp edge 94, which may reduce slipping and movement of the annular valve 34.
- a cavity 96 may be disposed between an outer surface of the annular valve 34.
- the transition surface 92 of the second stepped surface 86 may form a distal end of the other cavity 94.
- the sharp edge 94 may 14 contact the annular valve 34.
- the sharp edge 94 may not contact the annular valve 34 prior to infusion, and a single semi-annular cavity may extend between the outer surface of the annular valve 34 and the inner surface 28.
- the second stepped surface 86 and/or the cavity 96 may be semi- annular. In some embodiments, the second stepped surface 86 and/or the cavity 78 may be semi circular. In some embodiments, in response to infusion of fluid 84 through the side port 32, the annular valve 34 may decrease a size or volume of the cavity 96. In these embodiments, the annular valve 34 may be forced against the proximal surface 90 and the proximal surface 72. In some embodiments, in response to infusion of fluid 84 through the side port 32, the annular valve 34 may conform and clinch to the sharp edge 94 in addition to the sharp edge 82 reducing slip of the annular valve 34.
- the cavity 96 may be empty and not include fluid prior to infusion of the fluid 84 through the side port 32.
- the annular valve 34 in response to infusion of fluid 84 through the side port 32, the annular valve 34 may be forced against the proximal surface 90 and may not allow fluid to enter the cavity 96 during infusion of the fluid 84, such that the cavity 96 is a dead space.
- the catheter assembly 68 may include multiple ribs 98 extending distally from a particular transition surface, such as the transition surface 76 and/or the second transition surface 92.
- the ribs 98 may be radial and/or spaced along the particular transition surface.
- the ribs 98 may be evenly spaced along the particular transition surface.
- the ribs 98 may extend along a portion of a length of the proximal surface 72.
- the ribs 98 may extend along less than half of an entire length of the proximal surface 72.
- the ribs 98 may be aligned with the longitudinal axis 83 and/or in a direction of de molding.
- the proximal surface 72 is illustrated from an upper perspective, according to some embodiments.
- the proximal surface 72 and/or the distal surface 74 may be partial cylindrical surfaces.
- the proximal surface 72 and not the distal surface 74 may include the rough surface, which may facilitate insertion of the annular valve 34 during manufacture and securement of the annular valve 34 during infusion through the side port 16.
- the proximal surface 72 and the distal surface 74 may include the rough surface, which may facilitate securement of the annular valve 34 during infusion through the side port 16.
- the catheter assembly 100 may be similar or identical to the catheter assembly 20 described with respect to Figure 2 and/or the catheter assembly 68 described with respect to Figure 3 in terms of one or more features and/or operation.
- the inner surface 28 of the catheter adapter 22 may include one or more bumps 102, which may be disposed in a ring around a circumference of the inner surface 28.
- the inner surface 28 may include four of the bumps 102 or three of the bumps 102.
- the inner surface 28 may include more than four of the bumps 102.
- the bumps 102 may include lengths, heights, and/or angles that are different from each other, which may increase securement of the annular valve 32 in response to infusion through the side port 16. In some embodiments, the bumps 102 may include same lengths, heights and/or angles as each other. In some embodiments, the inner surface 28 may include no more than one of the bumps 102, which may include an annular ring. 16 [0070] In some embodiments, the bumps 102 may be disposed proximal and/or proximate the annular valve 34 within the lumen 30. In some embodiments, the bumps 102 may be contacting the annular valve 34. In some embodiments, the bumps 102 may be rigid or semi-rigid. In some embodiments, a durometer of the bumps 102 may be greater than a durometer of the annular valve 34. In some embodiments, the bumps 102 may be monolithically formed with the inner surface 28 as a single unit.
- the bumps 102 may be configured to keep the annular valve 34 in a same or similar position in response to fluid infusion through the side port 32 that opens the annular valve 34.
- the bumps 102 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.
- the proximal end 62 of the annular valve 34 may not move in the proximal direction.
- movement of the annular valve 34 in the proximal direction may be reduced.
- the bumps 102 may prevent fluid, such as blood and/or another fluid, from leaking through the annular valve 34 and out the side port 32.
- fluid such as blood and/or another fluid
- the catheter assembly may be similar or identical to one or more of the following in terms of one or more features and/or operation: the catheter assembly 20 described with respect to Figure 2, the catheter assembly 68 described with respect to Figure 3, and the catheter assembly 100 described with respect to Figure 4.
- the inner surface 28 may include a proximal undercut 104 and a distal undercut 106, and the annular valve 34 may be disposed between the proximal undercut 104 17 and the distal undercut 106.
- the proximal undercut 104 and/or the distal undercut 106 may be annular.
- a length of the annular valve 34 may be approximately equal to a distance between the proximal undercut 104 and the distal undercut 106 such that the annular valve 34 abuts the proximal undercut 104 and the distal undercut 106.
- the distal edge 48 and the proximal edge 50 may be annular.
- the annular valve 34 may fit snugly within the proximal undercut 104 and the distal undercut 106. In some embodiments, the proximal undercut 104 and the distal undercut 106 may form a cavity in which the annular valve 34 may be seated.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP22723930.8A EP4337292A1 (en) | 2021-05-10 | 2022-04-28 | Annular valve securement within a catheter assembly |
AU2022274531A AU2022274531A1 (en) | 2021-05-10 | 2022-04-28 | Annular valve securement within a catheter assembly |
KR1020237042103A KR20240006607A (en) | 2021-05-10 | 2022-04-28 | Secure annular valve within catheter assembly |
JP2023568011A JP2024516999A (en) | 2021-05-10 | 2022-04-28 | Fixation of an annular valve within a catheter assembly |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202163186668P | 2021-05-10 | 2021-05-10 | |
US63/186,668 | 2021-05-10 | ||
US17/731,082 US20220355093A1 (en) | 2021-05-10 | 2022-04-27 | Annular valve securement within a catheter assembly |
US17/731,082 | 2022-04-27 |
Publications (1)
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WO2022240594A1 true WO2022240594A1 (en) | 2022-11-17 |
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ID=81654931
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2022/026813 WO2022240594A1 (en) | 2021-05-10 | 2022-04-28 | Annular valve securement within a catheter assembly |
Country Status (5)
Country | Link |
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EP (1) | EP4337292A1 (en) |
JP (1) | JP2024516999A (en) |
KR (1) | KR20240006607A (en) |
AU (1) | AU2022274531A1 (en) |
WO (1) | WO2022240594A1 (en) |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5098405A (en) * | 1991-01-31 | 1992-03-24 | Becton, Dickinson And Company | Apparatus and method for a side port cathether adapter with a one piece integral combination valve |
EP1197242A1 (en) * | 2000-10-13 | 2002-04-17 | Arrabona Medical KFT. | Indwelling venous cannula |
DE202007006190U1 (en) * | 2006-07-31 | 2007-08-23 | B. Braun Melsungen Ag | catheter device |
AU2012318631A1 (en) * | 2011-10-06 | 2014-04-24 | Becton, Dickinson And Company | Port valve of a blood control catheter |
US20140364809A1 (en) * | 2013-06-07 | 2014-12-11 | Becton, Dickinson And Company | Ported iv catheter having external needle shield and internal blood control septum |
US20170348518A1 (en) * | 2014-01-21 | 2017-12-07 | Becton, Dickinson And Company | Ported catheter adapter having combined port and blood control valve with venting |
WO2018217781A1 (en) * | 2017-05-25 | 2018-11-29 | Timothy Joseph Erskine | Catheter hub with injection port and valve |
WO2020242878A1 (en) * | 2019-05-29 | 2020-12-03 | Becton, Dickinson And Company | Catheter assembly having an injection port and related methods |
-
2022
- 2022-04-28 WO PCT/US2022/026813 patent/WO2022240594A1/en active Application Filing
- 2022-04-28 EP EP22723930.8A patent/EP4337292A1/en active Pending
- 2022-04-28 KR KR1020237042103A patent/KR20240006607A/en unknown
- 2022-04-28 JP JP2023568011A patent/JP2024516999A/en active Pending
- 2022-04-28 AU AU2022274531A patent/AU2022274531A1/en active Pending
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5098405A (en) * | 1991-01-31 | 1992-03-24 | Becton, Dickinson And Company | Apparatus and method for a side port cathether adapter with a one piece integral combination valve |
EP1197242A1 (en) * | 2000-10-13 | 2002-04-17 | Arrabona Medical KFT. | Indwelling venous cannula |
DE202007006190U1 (en) * | 2006-07-31 | 2007-08-23 | B. Braun Melsungen Ag | catheter device |
AU2012318631A1 (en) * | 2011-10-06 | 2014-04-24 | Becton, Dickinson And Company | Port valve of a blood control catheter |
US20140364809A1 (en) * | 2013-06-07 | 2014-12-11 | Becton, Dickinson And Company | Ported iv catheter having external needle shield and internal blood control septum |
US20170348518A1 (en) * | 2014-01-21 | 2017-12-07 | Becton, Dickinson And Company | Ported catheter adapter having combined port and blood control valve with venting |
WO2018217781A1 (en) * | 2017-05-25 | 2018-11-29 | Timothy Joseph Erskine | Catheter hub with injection port and valve |
WO2020242878A1 (en) * | 2019-05-29 | 2020-12-03 | Becton, Dickinson And Company | Catheter assembly having an injection port and related methods |
Also Published As
Publication number | Publication date |
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AU2022274531A1 (en) | 2023-11-02 |
KR20240006607A (en) | 2024-01-15 |
EP4337292A1 (en) | 2024-03-20 |
JP2024516999A (en) | 2024-04-18 |
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