Arterial blood collection system and arterial blood module
阅读说明:本技术 动脉血液采集系统和动脉血液模块 (Arterial blood collection system and arterial blood module ) 是由 M·伊沃塞维克 A·J·布莱克 A·V·托里斯 M·奎因 R·A·克罗嫩贝格 于 2019-09-06 设计创作,主要内容包括:一种动脉血液采集系统,包括限定采集室的动脉血液采集元件以及能够可移除地连接到所述动脉血液采集元件的一部分的动脉血液模块,动脉血液模块包括:具有第一端部和第二端部的壳体;从第一端部伸出的针;能够可移除地固定在针上的帽;邻近第二端部的混合室;和与壳体的一部分接合的安全护罩,安全护罩能够从第一护罩位置转换至第二护罩位置,在第一护罩位置,针的一部分暴露出来,在第二护罩位置,针被安全护罩的一部分屏蔽。本公开还包括一种动脉血液模块。本公开简化和减少了工作流程步骤的数量,并且实现了单手设备操作,这允许更有效的动脉血液气体采集程序。(An arterial blood collection system comprising an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element, the arterial blood module comprising: a housing having a first end and a second end; a needle extending from the first end; a cap removably securable over the needle; a mixing chamber adjacent the second end; and a safety shield engaged with a portion of the housing, the safety shield being transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield. The present disclosure also includes an arterial blood module. The present disclosure simplifies and reduces the number of workflow steps and enables one-handed device operation, which allows for more efficient arterial blood gas collection procedures.)
1. An arterial blood collection system comprising:
an arterial blood collection element defining a collection chamber; and
an arterial blood module removably connectable to a portion of the arterial blood collection element, the arterial blood module comprising:
a housing having a first end and a second end;
a needle extending from the first end;
a cap removably securable over the needle;
a mixing chamber adjacent the second end; and
a safety shield engaged with a portion of the housing, the safety shield transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield.
2. The arterial blood collection system of claim 1, wherein the safety shield comprises:
a shroud assembly; and
an actuator transitionable from a first actuator position in which the actuator engages a portion of the shield assembly to lock the shield assembly in the first shield position to a second actuator position in which the actuator releases the shield assembly and the safety shield automatically moves to the second shield position.
3. The arterial blood collection system of claim 2, wherein the actuator comprises a push button.
4. The arterial blood collection system of claim 2, wherein the shield assembly comprises a telescoping shield.
5. The arterial blood collection system of claim 2, wherein the shield assembly comprises:
fixing the outer protective cover;
a movable intermediate shield in communication with the fixed outer shield, wherein the movable intermediate shield moves relative to the fixed outer shield; and
a movable inner shield in communication with the movable intermediate shield, wherein the movable inner shield moves relative to the movable intermediate shield.
6. The arterial blood collection system according to claim 5, wherein with the safety shield in the first shield position, the movable inner shield is nested inside the movable intermediate shield and the movable intermediate shield is nested inside the fixed outer shield.
7. The arterial blood collection system according to claim 5, wherein with the safety shield in the second shield position, the movable inner shield extends from the movable intermediate shield and the movable intermediate shield extends from the fixed outer shield.
8. The arterial blood collection system of claim 1, wherein the housing of the arterial blood module defines a flow passage from the first end to the second end.
9. The arterial blood collection system of claim 8, wherein the arterial blood module further comprises a sample stabilizer disposed within the flow channel between the first end of the housing and the mixing chamber.
10. The arterial blood collection system according to claim 9, further comprising:
a material comprising pores, the material disposed within the flow channel between the first end of the housing and the mixing chamber; and
a dry anticoagulant powder located within pores of the material.
11. The arterial blood collection system of claim 10, wherein a blood sample dissolves and mixes with the dry anticoagulant powder as it passes through the material.
12. The arterial blood collection system according to claim 10, wherein said material is an open cell foam.
13. The arterial blood collection system according to claim 10, wherein said sample stabilizer is a dry anticoagulant powder.
14. The arterial blood collection system of claim 1, wherein the housing of the arterial blood module defines a vent lumen.
15. The arterial blood collection system of claim 14, wherein the arterial blood module further comprises a vent plug that allows air to pass therethrough but prevents a blood sample from passing therethrough, wherein a portion of the vent plug is in communication with the vent lumen.
16. The arterial blood collection system according to claim 15, wherein the arterial blood module further comprises a first valve, and with the arterial blood module connected to the arterial blood collection element, a blood sample enters the collection chamber of the arterial blood collection element via the needle and the first valve.
17. The arterial blood collection system according to claim 16, wherein said first valve allows a blood sample to flow from said arterial blood module to said collection chamber of said arterial blood collection element.
18. The arterial blood collection system according to claim 17, wherein the first valve prevents a blood sample from returning from the collection chamber of the arterial blood collection element to the arterial blood module.
19. The arterial blood collection system according to claim 16, wherein the arterial blood module further comprises a second valve, and with the arterial blood module connected to the arterial blood collection element, air contained in the collection chamber of the arterial blood collection element and a portion of the blood sample enter the vent lumen via the second valve.
20. The arterial blood collection system according to claim 19, wherein air exits the arterial blood module via the vent plug.
21. The arterial blood collection system of claim 1, wherein the arterial blood module comprises a first finger grip portion.
22. The arterial blood collection system according to claim 21, wherein the arterial blood module comprises a second finger grip portion, wherein the first finger grip portion is opposite the second finger grip portion.
23. The arterial blood collection system of claim 1, wherein the needle comprises a thin walled needle technology.
24. The arterial blood collection system of claim 1, wherein the arterial blood collection element comprises a plunger rod assembly comprising a stopper and a plunger rod.
25. An arterial blood module comprising:
a housing having a first end and a second end;
a needle extending from the first end;
a cap removably securable over the needle;
a mixing chamber adjacent the second end; and
a safety shield engaged with a portion of the housing, the safety shield transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield.
26. The arterial blood module according to claim 25 wherein the arterial blood module is removably connectable to a portion of an arterial blood collection element.
27. The arterial blood module according to claim 26 wherein the arterial blood collection element defines a collection chamber.
28. An arterial blood collection system comprising:
an arterial blood collection element defining a collection chamber; and
an arterial blood module removably connectable to a portion of an arterial blood collection element, the arterial blood module comprising:
a housing having a first end and a second end;
a needle extending from the first end;
a cap removably securable over the needle;
a vent lumen;
a mixing chamber adjacent the second end; and
a safety shield engaged with a portion of the housing, the safety shield transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield.
29. The arterial blood collection system according to claim 28, wherein said safety shield comprises:
a shroud assembly; and
an actuator transitionable from a first actuator position in which the actuator engages a portion of the shield assembly to lock the shield assembly in the first shield position to a second actuator position in which the actuator releases the shield assembly and the safety shield automatically moves to the second shield position.
30. The arterial blood collection system according to claim 29, wherein said actuator comprises a push button.
Technical Field
The present disclosure relates generally to arterial blood collection systems.
More particularly, the present disclosure relates to an arterial blood collection system including an arterial blood collection element and an arterial blood module adapted for radial artery access.
Background
Arterial blood collection syringes are used to draw and collect arterial blood samples from a patient. Once a blood sample is collected, it is subjected to diagnostic analysis, primarily blood gases, and often electrolytes, metabolites, and other components indicative of the patient's condition. Various types of syringes have been designed for the collection of arterial blood samples, primarily including elements from hypodermic syringes (i.e., plastic or glass syringe barrels), sealed elastomeric stoppers with or without vents, and plunger rods.
Conventional arterial blood collection syringes typically use a conventional hypodermic needle with a safety shield that needs to be snapped or slid over the needle after the blood collection procedure. During blood collection procedures, such safety shields are typically in line of sight, thereby obscuring the view of the physician during such delicate procedures.
Conventional arterial blood collection syringes also have a separate vent cap that requires removal of the needle to expel trapped air bubbles from the collected sample prior to attaching the cap to the syringe.
Conventional arterial blood collection syringes that include an anticoagulant typically contain the anticoagulant within the syringe, thus requiring the user to roll or shake the collected sample to ensure adequate mixing with the anticoagulant.
Disclosure of Invention
The present disclosure provides an arterial blood module removably connectable to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap removably securable over the needle, a mixing chamber, and a safety shield engaged with a portion of the housing and transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system including an arterial blood collection element defining a collection chamber and an arterial blood module removably connected to a portion of the arterial blood collection element.
In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood collection device for collecting arterial blood samples using a radial puncture technique. The system of the present disclosure provides an effective system that simplifies and reduces the number of workflow steps and enables one-handed device operation, which allows for more efficient Arterial Blood Gas (ABG) acquisition procedures. The arterial blood module of the present disclosure includes ergonomic contact points, push button safety shields, automatic anticoagulant mixing, and an integrated vent cap for dislodging air bubbles after the collection procedure if necessary.
According to an embodiment of the invention, an arterial blood collection system comprises: an arterial blood collection element defining a collection chamber; and an arterial blood module removably connected to a portion of the arterial blood collection element, the arterial blood module comprising: a housing having a first end and a second end; a needle extending from the first end; a cap removably securable over the needle; a mixing chamber adjacent the second end; and a safety shield engaged with a portion of the housing, the safety shield being transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield.
In one arrangement, the safety shield includes a shield assembly and an actuator transitionable from a first actuator position in which the actuator engages a portion of the shield assembly to lock the shield assembly in a first shield position to a second actuator position in which the actuator releases the shield assembly and the safety shield automatically moves to a second shield position. In another configuration, the actuator includes a push button. In yet another configuration, the shroud assembly includes a telescoping shroud. In one arrangement, the shroud assembly comprises: fixing the outer protective cover; a movable intermediate shield in communication with the fixed outer shield, wherein the movable intermediate shield moves relative to the fixed outer shield; and a movable inner shield in communication with the movable intermediate shield, wherein the movable inner shield moves relative to the movable intermediate shield. In another configuration, with the safety shield in the first shield position, the movable inner shield is nested inside the movable intermediate shield and the movable intermediate shield is nested inside the fixed outer shield. In yet another arrangement, the movable inner shield extends from the movable intermediate shield and the movable intermediate shield extends from the fixed outer shield with the safety shield in the second shield position. In one configuration, the housing of the arterial blood module defines a flow channel from the first end to the second end. In another configuration, the arterial blood module further comprises a sample stabilizer disposed within the flow channel between the first end of the housing and the mixing chamber. In yet another configuration, an arterial blood collection system includes: a material containing pores (pores) disposed within the flow channel between the first end of the housing and the mixing chamber; and a dry anticoagulant powder located within the pores of the material. In one configuration, the blood sample is dissolved and mixed with the dry anticoagulant powder while passing through the material. In another configuration, the material is an open cell foam. In another configuration, the sample stabilizer is a dry anticoagulant powder. In one configuration, the housing of the arterial blood module defines a vent lumen. In another configuration, the arterial blood module further comprises a vent plug that allows air to pass therethrough but prevents a blood sample from passing therethrough, wherein a portion of the vent plug is in communication with the vent lumen. In yet another configuration, the arterial blood module further comprises a first valve, and wherein with the arterial blood module connected to the arterial blood collection element, the blood sample enters the collection chamber of the arterial blood collection element via the needle and the first valve. In one configuration, the first valve allows a blood sample to flow from the arterial blood module to the collection chamber of the arterial blood collection element. In another configuration, the first valve prevents a blood sample from returning from the collection chamber of the arterial blood collection element to the arterial blood module. In yet another configuration, the arterial blood module further comprises a second valve, and wherein, with the arterial blood module connected to the arterial blood collection element, air and a portion of the blood sample contained in the collection chamber of the arterial blood collection element enters the vent lumen via the second valve. In one configuration, air exits the arterial blood module via a vent plug. In another configuration, the arterial blood module includes a first finger grip portion. In yet another configuration, the arterial blood module includes a second finger grip portion, wherein the first finger grip portion is opposite the second finger grip portion. In one configuration, the needle comprises thin-walled needle technology. In another configuration, the arterial blood collection element comprises a plunger rod assembly comprising a stopper and a plunger rod.
According to another embodiment of the invention, an arterial blood module comprises: a housing having a first end and a second end; a needle extending from the first end; a cap removably securable over the needle; a mixing chamber adjacent the second end; and a safety shield engaged with a portion of the housing, the safety shield being transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield.
In one configuration, the arterial blood module is removably connectable to a portion of the arterial blood collection element. In another configuration, the arterial blood collection element defines a collection chamber.
Drawings
The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:
FIG. 1 is a perspective view of an arterial blood collection system according to an embodiment of the present invention.
Fig. 2 is a perspective view of an arterial blood module with a cap secured to a needle according to an embodiment of the present invention.
Fig. 3 is a perspective view of an arterial blood module with the cap removed from the needle according to an embodiment of the invention.
Fig. 4 is a perspective view of an arterial blood collection system according to an embodiment of the present invention with air bubbles being expelled from the system.
Fig. 5 is a perspective view of a first step in using the system of the present disclosure, according to an embodiment of the present invention.
Fig. 6 is a perspective view of a second step in using the system of the present disclosure, according to an embodiment of the present invention.
Fig. 7 is a perspective view of a third step in using the system of the present disclosure, according to an embodiment of the present invention.
Fig. 8 is a perspective view of a fourth step in using the system of the present disclosure, according to an embodiment of the present invention.
Fig. 9 is a perspective view of a fifth step in using the system of the present disclosure, according to an embodiment of the present invention.
FIG. 10 is a first schematic view of an arterial blood collection system according to an embodiment of the present invention.
FIG. 11 is a second schematic view of an arterial blood collection system according to an embodiment of the present invention.
FIG. 12 is a third schematic view of an arterial blood collection system according to an embodiment of the present invention.
Fig. 13 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a first shield position according to an embodiment of the invention.
Fig. 14 is a cross-sectional view of a portion of an arterial blood module with a safety shield in a second shield position according to an embodiment of the invention.
Fig. 15 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the invention with the safety shield in the first shield position.
Fig. 16 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the invention with the safety shield in the second shield position.
Fig. 17 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the invention with the safety shield in the first shield position.
Fig. 18 is a cross-sectional view of a portion of an arterial blood module according to another embodiment of the invention with the safety shield in the second shield position.
FIG. 19 is a perspective view of an open cell foam material according to an embodiment of the present invention.
Fig. 20 is a microscopic view of the microstructure of an open-cell foam material having dry anticoagulant powder distributed throughout its microstructure, according to an embodiment of the present invention.
Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein illustrate exemplary embodiments of the disclosure, and these examples should not be construed as limiting the scope of the disclosure in any way.
Detailed Description
The following description is presented to enable any person skilled in the art to make and use the embodiments contemplated for carrying out this invention. Various modifications, equivalents, changes, and substitutions will now occur to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "side," "longitudinal," and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. It is to be understood, however, that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.
The present disclosure provides an arterial blood module removably connectable to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap removably securable over the needle, a mixing chamber, and a safety shield engaged with a portion of the housing and transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system including an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element.
In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood collection device for collecting arterial blood samples using a radial puncture technique. The system of the present disclosure provides an effective system that simplifies and reduces the number of workflow steps and enables one-handed device operation, which allows for more efficient Arterial Blood Gas (ABG) acquisition procedures. The arterial blood module of the present disclosure includes ergonomic contact points, push button safety shields, automatic anticoagulant mixing, and an integrated vent cap for dislodging air bubbles after the collection procedure if necessary.
Fig. 1-20 illustrate an exemplary embodiment of an arterial
Referring to fig. 1 and 4-12, in one embodiment, arterial
When arterial blood is removed using the
As shown in fig. 1-20, in one embodiment, the
In an exemplary embodiment,
Advantageously, the
In one embodiment, a
The sample stabilizing agent may be an anticoagulant, or a substance designed to preserve a particular component of the blood, such as RNA, protein analyte, or other component. In one embodiment, a
Referring to fig. 19-20, in one embodiment, the
In one embodiment, the open-cell foam may be treated with an anticoagulant to form a dry anticoagulant powder that is finely distributed throughout the pores of the open-cell foam. When the
The open-cell foam may be a soft deformable open-cell foam inert to blood, e.g., a melamine foam such as commercially available from BASF
The foam, or open-cell foam, may be comprised of a formaldehyde-melamine-sodium bisulfite copolymer. The open cell foam may also be a flexible, hydrophilic open cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the open-cell foam may comprise a sponge material.Anticoagulants or other additives may be introduced into the open-cell foam by soaking the open-cell foam in a liquid solution of the additive and water and then evaporating the water to form a dry additive powder that is finely distributed within the internal structure of the foam.
The
The interior portion of the mixing
The mixing
Referring to fig. 1-20, in one embodiment, the
Referring to fig. 1-20, in one embodiment, the
Referring to fig. 1-20, in one embodiment, the
Advantageously, the
Referring to fig. 13-18, in an exemplary embodiment, the
Referring to fig. 13, in one embodiment, with the
Referring to fig. 14, in one embodiment, with the
In one exemplary embodiment, upon activation of the
Other exemplary embodiments are shown in fig. 15-18. The embodiment shown in fig. 15-16 includes similar components to the embodiment shown in fig. 13-14, and like components are indicated by reference numerals followed by the letter a. The embodiment shown in fig. 17-18 also includes similar components to the embodiment shown in fig. 13-14, and like components are indicated by reference numerals followed by the letter B. For the sake of brevity, these similar components and similar steps of using
Advantageously, the
In one embodiment, the
Referring to fig. 10-12, in one embodiment, the
In one embodiment, the
Advantageously, the
Referring to fig. 5-9, the use of the arterial
Referring to fig. 5, a
Referring to fig. 6, the
Referring to fig. 7, the
Referring to fig. 8, arterial
Referring to fig. 9,
The present disclosure provides an arterial blood module removably connectable to an arterial blood collection element. The arterial blood module includes a housing, a needle, a cap removably securable over the needle, a mixing chamber, and a safety shield engaged with a portion of the housing, the safety shield transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system including an arterial blood collection element defining a collection chamber and an arterial blood module removably connectable to a portion of the arterial blood collection element.
In an exemplary embodiment, the arterial blood collection system of the present disclosure provides a novel blood collection device for collecting arterial blood samples using a radial puncture technique. The system of the present disclosure provides an effective system that simplifies and reduces the number of workflow steps and enables one-handed device operation, which allows for more efficient Arterial Blood Gas (ABG) acquisition procedures. The arterial blood module of the present disclosure includes ergonomic contact points, push button safety shields, automatic anticoagulant mixing, and an integrated vent cap for dislodging air bubbles after the collection procedure if necessary.
In an exemplary embodiment, the
While this disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.
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