IMPROVED INTRAVENOUS INFUSION SET
20210128822 · 2021-05-06
Assignee
Inventors
Cpc classification
A61M2039/1077
HUMAN NECESSITIES
A61M2205/7536
HUMAN NECESSITIES
A61M39/285
HUMAN NECESSITIES
A61M2005/1657
HUMAN NECESSITIES
A61M5/165
HUMAN NECESSITIES
International classification
A61M5/14
HUMAN NECESSITIES
A61M39/28
HUMAN NECESSITIES
Abstract
An improved intravenous infusion set (10) to administer delivery of intravenous fluid to a patient, said intravenous infusion set (10) comprising: a drip chamber (12), a flexible infusion line (30) of sufficient length for fluid delivery to the patient and connected the drip chamber (12); a roller clamp (34) arranged movably along the length of the flexible infusion line (30), an air vent (18) with a cap arranged at the distal end (54) of the drip chamber (12) for management of air in the infusion system, said drip chamber (12) has a spike (14) on a distal end (54) and an infusion fluid outlet (20) at a proximal end (52) of the drip chamber (12), a fluid flow regulating member (36) sealed within the drip chamber (12) over said infusion fluid outlet (20) and wherein said infusion fluid outlet (20) configured to house a flow path adapter (22) which facilitates in administering continuous air free delivery of intravenous fluid to patients under gravitational pull.
Claims
1. An intravenous infusion set (10) to administer delivery of intravenous fluid to a patient, said intravenous infusion set (10) comprising: a drip chamber (12), a flexible infusion line (30) of sufficient length for fluid delivery to the patient and connected the drip chamber (12); a roller clamp (34) arranged movably along the length of the flexible infusion line (30), an air vent (18) with a cap arranged at the distal end (54) of the drip chamber (12) for management of air in the infusion system, said drip chamber (12) has a spike (14) on a distal end (54) and an infusion fluid outlet (20) at a proximal end (52) of the drip chamber (12), a fluid flow regulating member (36) sealed within the drip chamber (12) over said infusion fluid outlet (20) and wherein said infusion fluid outlet (20) configured to house a flow path adapter (22) which facilitates in administering continuous air free delivery of intravenous fluid to patients under gravitational pull.
2. The improved intravenous infusion set (10) as claimed in claim 1, wherein the flow path adapter (22) comprises an upper portion (24), a lower portion (26) and a through hole (28) therethrough forming a passage for fluid flow.
3. The improved intravenous infusion set (10) as claimed in claim 2, wherein the lower portion (26) of the flow path adapter (22) connected to the flexible infusion line (30) in a leak proof of arrangement and the upper portion (24) of the flow path adapter (22) received in the infusion fluid outlet (20) in a leak proof arrangement.
4. The improved intravenous infusion set (10) as claimed in claim 1, wherein the drip chamber (12) comprising an upper part (12a) and a lower part (12b) connected by a joining member (16) in a leak proof arrangement.
5. The improved intravenous infusion set (10) as claimed in claim 1, wherein said fluid flow regulating member (36) is a hydrophilic membrane being permeable to fluid and impermeable to air.
6. The improved intravenous infusion set (10) as claimed in claim 1, wherein the fluid flow regulating member (36) sealed on a sealing leg or ring (38) which extends within the circumference of an inner wall (40) adjacent to the infusion fluid outlet (20) in the lower part (12b) of the drip chamber (12).
7. The improved intravenous infusion set (10) as claimed in claim 6, wherein the sealing leg or ring (38) circularly arranged being distanced from the inner wall (40) of the lower part (12b) of the drip chamber (12).
8. The improved intravenous infusion set (10) as claimed in claim 6, a circular rim (44) adjoining circumferentially the inner wall (42) provided below the sealing leg or ring (38) in an inner area (42).
9. The improved intravenous infusion set (10) as claimed in claim 6, wherein the fluid flow regulating member (36) has a proximal face (46) and a distal face (48) and the proximal face (46) of the member (36) includes a sealing area.
10. The improved intravenous infusion set (10) as claimed in any one of claims 1 to 9, wherein the flow regulating member (36) can be sealed to said sealing leg or ring (38) by heat sealing, adhesive sealing, ultrasonic welding, heated die, radio frequency, mechanical seal, insert molding, laser welding, press/snap fit, and annular ring with groove fitment.
11. An intravenous infusion set (110) to administer delivery of intravenous fluid to a patient comprising: a drip chamber (112), a flexible infusion line (130) of sufficient length for fluid delivery to the patient and connected to the drip chamber (112); a roller clamp (134) arranged movably along the length of the flexible infusion line (130), an air vent (118) with a cap arranged at the distal end (154) of the drip chamber (112) for management of air in the infusion system, said drip chamber (112) has a spike (114) on a distal end (154) and an infusion fluid outlet (120) at a proximal end (152) of the drip chamber (112), a fluid flow regulating member (136) sealed within the drip chamber (112) over said infusion fluid outlet (120) and wherein said infusion fluid outlet (120) configured to house a flow path adapter (122) which facilitates in administering continuous air free delivery of intravenous fluid without bubbles or air trap to patients under gravitational pull.
12. The intravenous infusion set (110) as claimed in claim 11, the flow path adapter (122) has an upper portion (124) having a distal extension (160), a middle portion (168) and a lower portion (126) and a through hole (128) therethrough for fluid flow.
13. The intravenous infusion set (110) as claimed in claim 11, the flow path adapter (122) so adjusted and housed in the infusion fluid outlet (120) of the drip chamber (112) that the fluid flow regulating member (136) rests over the flow path adapter (122).
14. The intravenous infusion set (110) as claimed in any preceding claim, the flow path adapter (122) in its upper portion (124) in particularly, in the distal extension (160) comprises one or more slits (158) periodically placed in an axial direction.
15. The intravenous infusion set (110) as claimed in claim 12, the through hole (128) i.e. opening at the top in the flow path adapter sealed with a knob (162) in a leak proof arrangement.
16. The intravenous infusion set (110) as claimed in claim 12, the distal extension (160) has one or more projections (164) and one or more ridges/depression (170).
17. The intravenous infusion set (110) as claimed in claim 16, the distal extension (160) of the flow path adapter (122) at its proximal end has a circular fitment (166) which acts as a reservoir for the fluid to pass smoothly through the slits (158) and further into the through hole (128) and into the infusion line (130).
Description
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0040] The foregoing and other objects, features, and advantages of the invention will be apparent from the following detailed description taken in conjunction with the accompanying drawings, wherein:
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
DETAILED DESCRIPTION OF THE INVENTION
[0049] Generally speaking, the term “proximal” refers to a region of the device or parts thereof or a location on the device, which is closest to, for example, a user using the device. In contrast to this, the term “distal” refers to a region of the device, which is farthest from the user, for example, the distal region of a needle will be the region of a needle containing the needle tip which is to be inserted e.g. into a patient's vein.
[0050] Referring to
[0051] The drip chamber 12 is provided with a spike 14 at a distal end of the upper part 12a. The spike 14 has a pointed tip which is used to pierce a fluid bag/bottle (not shown) so that the infusion fluid will be pulled by gravity into the drip chamber 12. The spike 14 is provided with slits or holes for fluid to flow into the drip chamber 12 from the fluid bag/bottle to the patient.
[0052] The proximal end 52 of the lower part 12b of drip chamber 12 as illustrated in
[0053] The outer diameter of the upper portion 24 has a close-fit ratio with the inner diameter of infusion fluid outlet 20.
[0054] A fluid flow adjustment device, such as a roller clamp 34, is arranged being movable along the length of the flexible infusion line 30. The roller clamp 34 can be gradually adjusted so that the infusion line 30 could be squeezed proportionally to change the infusion rate and can also help in changing the fluid source, i.e. bottle or bag for multiple infusion procedures.
[0055] A clip (not shown) can also be arranged between the drip chamber 12 and the roller clamp 34 along the length of the flexible infusion line 22. The clip is configured to stop the flow of infusion fluid instantly by a clipping action.
[0056] Referring now to
[0057] A circular rim 44 adjoining circumferentially the inner wall 42 is provided below the said sealing leg or ring 38 in the inner area 42. The circular rim 44 supports the fluid flow regulating member 36. The circular rim 44 may touch or may not touch when the fluid flow regulating member 36 is sealed over the sealing ring 38 and wetted by the fluid in operation.
[0058] The sealing ring 38 and circular rim 44 ensure that applying a force to the drip chamber 12 in a direction perpendicular to the main extension direction of the lower part will not affect the fluid flow regulating member 36. This ensures that fluid flow regulating member 36 maintains its shape and ensure that the exerted force is not transferred to the fluid flow regulating member 36. In other words, the fluid flow regulating member 36 remains tightly sealed on the sealing ring or leg 38 without any deformity or malfunction.
[0059] As shown in
[0060] Alternatively, the fluid flow regulating member 36, i.e. the hydrophilic membrane, can be sealed on the distal face 48. Further alternatively, the fluid flow regulating member 36 can be sealed on both the proximal face 46 and distal face 48.
[0061] The act of sealing referred above, for example sealing of fluid flow regulating member 36 with the drip chamber 12 in particularly with sealing leg or sealing ring 38, takes place by heat sealing, adhesive sealing, ultrasonic welding, heated die, radio frequency, mechanical seal, insert molding, laser welding, press/snap fit, annular ring with groove fitment, clamping, gluing or by the like processes etc.
[0062] The fluid flow regulating member 36 which is a hydrophilic membrane of the present invention has a strong affinity for fluid/liquid while restricting air from attaching to its surface. As a result, the membrane is permeable to fluid/liquid and impermeable to air. A fully wetted hydrophilic membrane will allow fluid/liquid to flow through while acting like a barrier to air bubbles passing across it. Under normal conditions, flow of fluid/liquid from a fully wetted membrane is expected to start under gravity pull more readily. Hence with the present membrane setup, the fluid in the drip chamber will be ready to flow once it is filled up. No milking of the roller clamp is required to initiate the flow.
[0063] In the present invention, said hydrophilic membrane will automatically stop the fluid flow once the fluid in the drip chamber 12 is empty and as long as the membrane is still totally wet. As such, no air will get into the flexible infusion line 30 during and at the end of the infusion procedure. Furthermore, because the same intravenous infusion set 10 can be used for multiple infusions, the material cost and clinical waste is greatly reduced. This is one of the advantages of the present invention.
[0064] Referring to
[0065] The drip chamber 112 is provided with a spike 114 at a distal end of the upper part 112a. The spike 114 has a pointed tip which is used to pierce a fluid bag/bottle (not shown) so that the infusion fluid will be pulled by gravity into the drip chamber 112. The spike 114 is provided with slits or holes for fluid to flow into the drip chamber 112 from the fluid bag/bottle to the patient.
[0066] Referring now to
[0067] The lower portion 24 of the flow path adapter 122 is connected to a flexible infusion line 130 in a leak proof arrangement. The upper portion 124 of the flow path adapter 122 is received in the outlet 120 in a leak proof arrangement. One end of the flexible infusion line 130 of sufficient length as shown in
[0068] The proximal end of drip chamber 112 in particularly lower part thereof ends in an infusion fluid outlet 120 which is tubular and configured to house a flow path adapter 122. Said infusion fluid outlet 120 is covered with a fluid flow regulating member 136. The flow path adapter 122 is so adjusted and housed in the infusion fluid outlet 120 of the drip chamber 112 that the fluid flow regulating member 136 rests over the flow path adapter 122 impeccably once said fluid flow regulating member 136 is sealed by the means and methods such as energy director for ultrasonic welding or the like. The flow path adapter 122 is so housed that the gap between the fluid flow regulating member 136 and the distal extension 160 having a knob is minimal to ensure that the fluid passes through member 136 smoothly. Consideration is taken into account to take care for any damage to the fluid flow regulating member 136 due to interference between a distal end of flow path adapter 122 and the fluid flow regulating member 136 to avoid any functional failure.
[0069] The flow path adapter 122 has a unique design in that it eliminates collapsing of flexible infusion line 130 affecting flow of liquid. This unique design of the flow path adapter 122 also eliminates the chances of trapped air or bubbles going into the infusion line 130. The working principle behind such elimination of the trapped air or bubbles going into the infusion line 130 is that once the bubble or trapped air hits the upper part 124 having a distal extension 160 of the flow path adapter 122 i.e. one or more projections 164 and ridges/depression 170 provided therein, the bubble or trapped air breaks down. The area or passage provided is so less that any chances of trapped air or bubbles passing through one or more slits 158 provided in the flow path adapter 122 and into its passage 128 and in turn into the infusion line 130 is eliminated. Thus, the improved design of the flow path adapter 122 deals effectively with the most common yet serious issue of travelling of the bubble or trapped air into the infusion line 130 which is eliminated providing safety to the end user.
[0070] A fluid flow adjustment device, such as a roller clamp 134, is arranged being movable along the length of the flexible infusion line 130. The roller clamp 134 can be gradually adjusted so that the infusion line 130 could be squeezed proportionally to change the infusion rate and can also help in changing the fluid source, i.e. bottle or bag for multiple infusion procedures.
[0071] Referring to
[0072] The slits 158 are periodically placed in an axial direction on the distal extension 160 having a flow communication with the through hole 128 of flow path adapter 122. Alternatively, the slits 158 can be arranged in a direction opposite to the Axial direction or combination or in other fashion. The dimension of the slits 158 is so designed so that it only allows the flow of fluid from the slits 158 and stop bubble or trapped air to get into the through hole 128 and further into the infusion line 130. The slits can be designed in any shape and size.
[0073] The slits 158 are dimensioned such that air bubbles or trap do not pass through the slit 158. In another embodiment, the edge of the slits 158 may be serrated/rough to improve the desired bubble bursting or bubble breaking feature as part of a further improved bubble bursting mechanism.
[0074] Referring now to
[0075] Referring now to
[0076] Alternatively, or in addition to the slits, one or more holes, perforations, openings (not shown) or the combination thereof can be provided in the flow path adapter. Such holes, perforations, openings, improves the bubble bursting mechanism and ensure that any errant air bubble that may have entered through the fluid flow regulating member popped and does enter into the infusion line. The positions of such slits, perforations, opening can vary, for example in addition to keeping the slits in the distal extension such slit can be provided anywhere in between the proximal to distal end of the flow path adapter.
[0077] In a still further embodiment, the drip chamber 112 and its components are unitarily constructed and manufactured.
[0078] In yet another embodiment, the drip chamber 112 and its components are constructed and manufactured separately and assembled as one device.
[0079] In yet another embodiment, the lower portion of the drip chamber 112 can be made into two parts with the bubble bursting mechanism.
[0080] Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, from the foregoing description, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the scope of the invention as set forth in the claims.
[0081] Accordingly, it is not intended that the scope of the foregoing description be limited to the exact description set forth above, but rather that such description be construed as encompassing such features that reside in the present invention, including all the features and embodiments that would be treated as equivalents thereof by those skilled in the relevant art.
[0082] Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above but should be determined only by a fair reading of the appended claims.
LIST OF REFERENCE NUMERALS
[0083] 10, 110 intravenous infusion set
[0084] 12, 112 drip chamber
[0085] 12a, 112a upper part
[0086] 12b, 112b lower part
[0087] 14, 114 spike
[0088] 16, 116 joining member
[0089] 18, 118 air vent
[0090] 20, 120 infusion fluid outlet
[0091] 22, 122 flow path adapter
[0092] 24, 124 upper portion
[0093] 26, 126 lower portion
[0094] 28, 128 through hole
[0095] 30, 130 flexible infusion line
[0096] 32, 132 standard connector
[0097] 34, 134 roller clamp
[0098] 36, 136 fluid flow regulating member
[0099] 38 sealing leg or sealing ring
[0100] 40, 140 inner wall
[0101] 42, 142 inner area
[0102] 44, 142 circular rim
[0103] 46 proximal face
[0104] 48 distal face
[0105] 50 outer area
[0106] 52, 152 proximal end
[0107] 54, 154 distal end
[0108] 56 rim
[0109] 158 slit
[0110] 160 distal extension of the flow path adapter
[0111] 162 knob
[0112] 164 projections
[0113] 166 fitment
[0114] 168 middle portion
[0115] 170 ridges/depression
[0116] A Axial direction