MULTI-PURPOSE BLOOD MONITORING CATHETER ASSEMBLY

Abstract

A catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal and proximal ends of the catheter adapter. The catheter assembly may include a septum disposed within the lumen, a septum actuator fixed within the lumen, and a spring disposed within the lumen distal to the septum. The septum may include a distal end, a proximal end, and a barrier that may divide the interior of the septum into a distal and a proximal cavity. In response to the insertion of a medical device into the proximal end of the catheter adapter, the septum may move from a proximal to a distal position, and the septum actuator may penetrate the septum. The spring may return the septum from the distal to the proximal position in response to the removal of the medical device.

Description

MULTI-PURPOSE BLOOD MONITORING CATHETER ASSEMBLY Background of the Invention Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to draw blood from the patient. A common type of catheter is a peripheral intravenous catheter over the needle (PIVC). As the name suggests, the PIVC over the needle can be mounted on an introducer needle with a sharp distal tip. The PIVC and introducer needle are 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 upward, away from the patient's skin. The PIVC and introducer needle are typically inserted at a shallow angle through the skin into the patient's vasculature. To verify proper placement of the introducer needle and / or the PIVC in the vein, a user typically confirms that there is blood backflow in a backflow chamber of a PIVC assembly. Once needle placement has been confirmed, the user can occlude CHORUS Ln / ίZΖΠΖ / Β / YΙΛΙ Ref. 326314 Temporarily stop the flow in the vein and remove the introducer needle, leaving the PIVC in place within the vein. The PIVC can then be used for fluid infusion and / or blood collection. The subject matter addressed in this document is not limited to methods that resolve any disadvantages or that operate solely in environments such as those described above. Rather, this background information is provided only to illustrate an example technology area in which some of the implementations described herein can be practiced. Brief Description of the Invention This description generally refers to vascular access devices and related systems and methods. More specifically, this description refers to catheter assemblies. In some modalities, a catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some designs, the catheter assembly may include a septum, which may be positioned within the lumen. In some designs, the septum may include a distal end, a proximal end, and a barrier. CHORUS Ln / įZРZ / B / YILI between the distal end of the septum and the proximal end of the septum. In some modalities, the barrier may divide an inner portion of the septum into a distal cavity and a proximal cavity. In some modalities, the barrier may include a slit. In some modalities, the septum may be configured to move from a proximal to a distal position in response to the insertion of a medical device into the proximal end of the catheter adapter. In some models, the catheter assembly may include a septum actuator, which can be fixed within the lumen. In some models, the septum actuator can be configured to penetrate the slit in response to the septum's movement from the proximal to the distal position. In some models, the catheter assembly may include a spring, which may be positioned within the lumen distal to the septum. In some models, the spring may be configured to return the septum from the distal to the proximal position in response to withdrawal of the medical device from the proximal end of the catheter adapter. In some models, the spring may surround the septum actuator. In some models, the spring and / or the septum can be made of an elastomeric material. For example, the The spring and / or septum may be constructed of silicon or another suitable material. In some embodiments, the spring and septum may be formed monolithically as a single unit. In some embodiments, the spring may include a coil, which may surround the septum actuator. In some embodiments, the coil may be constructed of metal or another suitable material. In some embodiments, the coil may include a helical shape or multiple waves. In some embodiments, the partition actuator may include a tubular body. In some embodiments, an outer surface of the tubular body may be smooth. In some embodiments, the tubular body may be generally cylindrical or tapered. In some models, the septum actuator may include an annular flange extending outward from an outer surface of the tubular body. In some models, the annular flange may extend distally from the outer surface of the tubular body. In some models, the annular flange may be located at a proximal end of the septum actuator. In some models, the annular flange may include a generally truncated cone shape. In some forms, an inner surface of the septum forming the distal cavity may include one or more protuberances. In some forms, one or more CHORUS Ln / įZРZ / B / YILI protuberances can be annular. In some modalities, the annular rim can be configured to pass one or more protuberances in response to the movement of the septum from the proximal to the distal position. In some modalities, the annular rim can be configured to contact one or more protuberances when the septum moves from the proximal to the distal position. In some designs, a portion of the inner surface of the septum forming the distal cavity may be smooth. In these and other designs, the inner surface of the septum forming the distal cavity may not include one or more protrusions. In some designs, the portion of the inner surface may be distal to the barrier. In some designs, the portion of the inner surface may be aligned with or near the annular rim when the septum is in the proximal position. In some designs, the annular rim may be spaced from the portion of the inner surface of the septum so that the annular rim does not contact the portion of the inner surface when the septum is moved from the proximal to the distal position. In some designs, the portion of the inner surface may be near and / or proximal to an opening at the distal end of the septum. CHORUS Ln / ίZΖΠΖ / Β / YΙΛΙ It should be understood that both the preceding general description and the following detailed description are illustrative and explanatory and are not restrictive of the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and instruments shown in the figures. It should also be understood that the embodiments may be combined, or that other embodiments may be used, and that structural changes may be made, unless so claimed, without departing from the scope of the various embodiments of the present invention. The following detailed description should therefore not be taken in a limiting sense. Brief Description of the Figures Examples of modalities will be described and explained with additional specificity and detail through the use of the attached figures, in which: Figure 1 is a top perspective view of an example catheter system, according to some modalities; Figure 2A is a partial cutaway view of an example catheter assembly, illustrating an example spring and example septum arranged in a proximal position, according to some modalities; Figure 2B is a cross-sectional view of the catheter assembly of Figure 2A, illustrating the spring and septum arranged in the proximal position, according to CHORUS Ln / ίΖΠΖ / Β / ΥΙΛΙ some modalities; Figure 2C is a cross-sectional view of the catheter assembly of Figure 2A, illustrating the spring and septum arranged in a distal position, according to some modalities; Figure 3A is a partial cross-sectional view of the catheter assembly, illustrating another example spring and septum arranged in a proximal position, according to some modalities; Figure 3B is a cross-sectional view of the catheter assembly, illustrating the other spring and septum arranged in the proximal position, according to some modalities; Figure 3C is a cross-sectional view of the catheter assembly, illustrating the other spring and septum arranged in a distal position, according to some modalities; Figure 4A is a partial cross-sectional view of the catheter assembly, which illustrates another example septum arranged in a proximal position, according to some modalities; Figure 4B is a cross-sectional view of the catheter assembly, illustrating the other septum arranged in a distal position, according to some modalities; Figure 5A is a partial cross-sectional view of the catheter assembly, illustrating the other septum arranged in a CHORUS Ln / Lznz / E / YILI proximal position and an example septum actuator, according to some modalities; Figure 5B is a cross-sectional view of the catheter assembly, illustrating the other septum arranged in the proximal position and the septum actuator, according to some modalities; Figure 5C is a cross-sectional view of the catheter assembly, illustrating the other septum arranged in a distal position and the septum actuator, according to some modalities; and Figure 6 is a top perspective view of the partition or the other partition, according to some modalities. Detailed Description of the Invention With reference to Figure 1, a catheter system 10 is illustrated, according to some modalities. In some modalities, the catheter system 10 may include a needle protection device 12 and a catheter assembly 14. In some modalities, the catheter assembly 14 may include a catheter adapter 16, which may include a distal end 18, a proximal end 20, and a lumen extending through the distal end 18 and the proximal end 20. In some modalities, the catheter assembly 14 may include a catheter 22, which may include a distal end 24 and a proximal end 26. In some modalities, the catheter 22 may include a peripheral intravenous catheter (PIVC). CORO Ln / įZРZ / В / YΙЛΙ a midline catheter, a peripherally inserted central catheter (PICC), or another suitable catheter. In some modalities, the proximal end 26 of the catheter 22 may be secured within the catheter adapter 16. In some embodiments, the Catheter System 10 may include one or more features of the safety catheter assembly described in U.S. Patent Application No. 15 / 012,013, filed February 1, 2016, entitled "Releasable Catheter Hub Retainer," which is incorporated herein by reference in its entirety. In some embodiments, the Catheter System 10 may include one or more features of the safety catheter assembly described in U.S. Patent Application No. 62 / 808,133, filed February 20, 2019, entitled "Improved Coupling Between a Telescoping Needle Shield and a Catheter Adapter," which is incorporated herein by reference in its entirety. In some embodiments, the needle protection device 12 may include a needle housing 30, which can be detachably attached to the catheter adapter 16. In some embodiments, the needle housing 30 may include an elongated body 32. In some embodiments, the needle protection device 12 may include a needle assembly 34, which can be slidably attached to the needle housing 30. CHORUS Ln / ίZΖΠΖ / Β / YΙΛΙ In some modalities, the needle assembly 34 may include an introducer needle 36, which may include a sharp distal tip 38. In some modalities, the introducer needle 36 may be extended through the catheter 22 when the catheter system 10 is in an insertion position, ready for insertion into a patient's vasculature, as illustrated, for example, in Figure 1. In some modalities, the needle assembly 34 may include a needle handle 40, which the user can grasp and move proximally to withdraw the introducer needle 36 from the vasculature once placement of the catheter 22 within the vasculature is confirmed. In some modalities, placement of the catheter 22 within the vasculature can be confirmed by blood backflow. In some modalities, in response to the insertion of the introducer needle 36 into the patient's vasculature, blood backflow may flow through the sharpened distal tip 38 of the introducer needle 36 and out of a distal notch of the introducer needle 36 into a portion of the catheter system 10. For example, blood backflow may flow through the sharpened distal tip 38 and out of the distal notch in a space between an outer surface of the introducer needle 36 and an inner surface of the catheter 22. In some modalities, after the clinician observes blood backflow, the introducer needle 36 may be CORO Ln / Lznz / E / YILI removal, and the needle assembly 34 and needle housing 30 can be removed from the catheter adapter 16. With reference now to Figures 2A-2C, in some modalities, the catheter assembly 14 may include the catheter adapter 16, which may include the distal end 18, the proximal end 20, and a lumen 42 extending through the distal end 18 of the catheter adapter 16 and the proximal end 20 of the catheter adapter 16. In some configurations, the catheter assembly 14 may include a septum 44, which may be disposed within the lumen 42. In some configurations, the septum 44 may include a distal end 46, a proximal end 48, and a barrier 50 disposed between the distal end 46 of the septum 44 and the proximal end 48 of the septum 44. In some configurations, the barrier 50 may divide the interior of the septum 44 into a distal cavity 52 and a proximal cavity 54. In some configurations, the barrier 50 may prevent fluid flow between the distal cavity 52 and the proximal cavity 54 when the barrier 50 is closed. In some configurations, the barrier 50 may include a slit 56. In some configurations, the septum 44 may be configured to move from a proximal to a distal position in response to the insertion of a medical device 55 into the proximal end 20 of the catheter adapter 16. In some modalities, catheter assembly 14 The CORO Ln / įZРZ / B / YILI may include a septum actuator 58, which can be fixed within the lumen 42. In some modalities, the septum actuator 58 may be configured to penetrate the slit 56 in response to the movement of the septum 44 from the proximal to the distal position. In some modalities, the septum 44 may include a substantially H-shaped cross-section. In some modalities, the catheter assembly 14 may include a spring 60, which may be disposed within the lumen 42 distal to the septum 44. In some modalities, the spring 60 may be configured to return the septum 44 from the distal to the proximal position in response to the withdrawal of the medical device 55 from the proximal end 20 of the catheter adapter 16. Thus, in some modalities, the spring 60 may facilitate multiple uses of the catheter assembly 14 and septum 44, including multiple infusions and / or blood draws through multiple connections of the medical device 55 to the catheter adapter 16. In some modalities, the spring 60 may be compressed in response to the movement of the septum 44 to the distal position. In some modalities, the spring 60 may be decompressed in response to the movement of the septum 44 to the proximal position. In some embodiments, the spring 60 may surround the partition actuator 58, as illustrated, for example, in Figure 2A. In some embodiments, the spring 60 may CORO Ln / įZРZ / B / YILI include a coil, as illustrated, for example, in Figure 2A, which may surround the septum actuator 58. In some embodiments, the coil may be helical. In some embodiments, the coil may be constructed of metal or another suitable material. In some embodiments, the coil may be constructed of an elastomer. For example, the coil and / or the septum 44 may be constructed of silicon, which may provide improved mechanical properties, or another suitable material. In some embodiments, the coil and the septum 44 may be formed monolithically as a single unit. In some embodiments, a proximal end of the spring 60 may be coupled to the septum 44 and / or a distal end of the spring 60 may be coupled to the catheter adapter 16. In some embodiments, spring 60 may include a wave spring, which may be coiled and / or surround the septum actuator 58. In some embodiments, the wave spring may be made of coiled wire that includes waves to give the coiled wire a spring effect. In some embodiments, the wave spring may be constructed of metal or another suitable material. In some embodiments, the wave spring may be constructed of an elastomer. For example, the wave spring and / or the septum 44 may be constructed of silicon, which may provide enhanced mechanical properties, or another suitable material. In some embodiments, the wave spring and the septum 44 may be formed monolithically as a single unit. In some embodiments, a proximal end of spring 60 may be coupled to the septum 44 and / or a distal end of spring 60 may be coupled to the catheter adapter 16. In some embodiments, the septum actuator 58 may include a tubular body 62. In some embodiments, the tubular body 62 may be generally cylindrical or tapered. In some embodiments, the septum actuator 58 may include an annular flange 64 extending outward from an outer surface 66 of the tubular body 62. In some embodiments, the annular flange 64 may extend distally from the outer surface 66 of the tubular body 62. In some embodiments, the annular flange 64 may be disposed at a proximal end of the septum actuator 58. In some embodiments, the annular flange 64 may include a generally truncated cone shape, as illustrated, for example, in Figure 2A.In some modalities, the annular rim 64 or the generally truncated cone shape can facilitate fixation of the septum 44 in the proximal position prior to insertion of the medical device 55 into the proximal end 20 of the catheter adapter 16, providing resistance to distal movement of the septum 44. In some modalities, an inner surface of the septum 44 that forms the distal cavity 52 may include one or more protuberances 68. In some modalities, one or more CHORUS Ln / Lznz / E / YILI protrusions 68 may be annular. In some modalities, the annular rim 64 may be configured to pass one or more protrusions 68 in response to the septum moving from the proximal to the distal position. In some modalities, the annular rim 64 may be configured to contact one or more protrusions 68 when the septum 44 moves from the proximal to the distal position. In some modalities, one or more protrusions 68 may contact the tubular body 62, or one or more protrusions 68 may not contact the tubular body 62. In some modalities, one or more protrusions 68 and / or the annular flange 64 may provide resistance to the septum 44 returning from the distal to the proximal position in response to the removal of the medical device 55. More specifically, one or more protrusions 68 may contact or engage the annular flange 64 when the septum 44 moves to the proximal position from the distal position, and / or the annular flange 64 may contact or engage the barrier 50 when the septum 44 moves to the proximal position from the distal position. However, the spring 60 can overcome this resistance to facilitate the movement of the septum 44 from the distal to the proximal position. In this way, in some modalities, the spring 60 can facilitate multiple uses of the catheter assembly 14 and the septum 44. CHORUS Ln / ίZΖΠΖ / Β / YΙΛΙ With reference to Figures 3A-3C, in some embodiments, the spring 60 and / or the partition 44 may be constructed of an elastomer. For example, the spring 60 and / or the partition 44 may be constructed of silicon, which can provide improved mechanical properties, or another suitable material. In some embodiments, the spring 60 and the partition 44 may be formed monolithically as a single unit. In some embodiments, the spring 60 may surround the partition actuator 58. With reference now to Figures 4A-4B, in some modalities, a portion 70 of the inner surface of the septum 44 forming the distal cavity 52 may be smooth. In these and other modalities, the inner surface of the septum 44 forming the distal cavity 52 may not include one or more protrusions 68. In some modalities, the portion 70 of the inner surface may be distal to the barrier 50. In some modalities, the removal of one or more protrusions 68 may facilitate the return of the septum 44 from the proximal to the distal position, and multiple uses of the septum 44. In some models, portion 70 of the inner surface may be aligned with or close to the annular rim 64 when the septum 44 is positioned proximally. In some models, the annular rim 64 may be separated from portion 70 of the inner surface of the CHORUS Ln / ίZРZ / Β / YΙΛΙ septum 44, so that the annular rim 64 does not make contact with portion 70 of the inner surface when septum 44 moves from the proximal to the distal position. In some modalities, portion 70 of the inner surface may be close to and / or proximal to an opening 72 at the distal end of septum 44. With reference now to Figures 5A-5C, in some embodiments, an outer surface of a proximal end 74 of the septum actuator 58 may be smooth and may not include the annular rim 64. More specifically, in some embodiments, an outer surface of the tubular body 62 may be smooth and may not include the annular rim 64. In some embodiments, removal of the annular rim 64 may facilitate the return of the septum 44 from the proximal to the distal position and multiple uses of the septum 44. In some embodiments, an inner surface of the septum 44 forming the distal cavity 52 may include one or more protrusions 68. In other embodiments, the portion 70 of the inner surface of the septum 44 forming the distal cavity 52 may be smooth. With reference now to Figure 6, a top perspective view of partition 44 is illustrated, according to some embodiments. In some embodiments, an outer surface of partition 44 can generally be cylindrical. All examples and conditional language cited in this document are intended for pedagogical purposes. The following paragraphs are intended to help the reader understand the invention and the concepts contributed by the inventor to advance the technique, and should be interpreted without limitation to the conditions and examples specifically cited. Although five embodiments of the present inventions have been described in detail, it should be understood that various changes, substitutions, and alterations could be made without departing from the spirit and scope of the invention. It is hereby stated that, as of this date, the best method known to the applicant for putting the aforementioned invention into practice is the one that is clear from the present description of the invention.

Claims

1. A catheter assembly, characterized in that it comprises: a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; a septum disposed within the lumen, wherein the septum comprises a distal end, a proximal end, and a barrier disposed between the distal end of the septum and the proximal end of the septum, wherein the barrier divides the interior of the septum into a distal cavity and a proximal cavity, wherein the barrier comprises a slit, wherein the septum is configured to move from a proximal position to a distal position in response to the insertion of a medical device into the proximal end of the catheter adapter; a septum actuator fixed within the lumen, wherein the septum actuator is configured to penetrate the slit in response to the movement of the septum from the proximal position to the distal position;and a spring disposed within the lumen distal to the septum, wherein the spring is configured to return the septum from the distal position to the proximal position in response to the removal of the medical device from the proximal end of the catheter adapter.

2. The catheter assembly according to claim 1, characterized in that the spring surrounds the septum actuator.

3. The catheter assembly according to claim 1, characterized in that the spring and the septum are constructed of an elastomer.

4. The catheter assembly according to claim 1, characterized in that the spring and the septum are constructed of silicon.

5. The catheter assembly according to claim 1, characterized in that the spring and the septum are formed monolithically as a single unit.

6. The catheter assembly according to claim 1, characterized in that the septum actuator comprises a tubular body and an annular flange extending outwards from an outer surface of the tubular body, wherein the annular flange is disposed at a proximal end of the septum actuator.

7. The catheter assembly according to claim 6, characterized in that an outer surface of the tubular body is smooth. CORO Ln / įZРZ / B / YΙΛΙ 8. The catheter assembly according to claim 6, characterized in that the annular flange comprises a generally truncated cone shape.

9. The catheter assembly according to claim 6, characterized in that an inner surface of the septum forming the distal cavity comprises a protrusion, wherein the annular flange is configured to pass the protrusion in response to movement of the septum from the proximal to the distal position.

10. The catheter assembly according to claim 1, characterized in that a portion of the inner surface of the septum forming the distal cavity is smooth, wherein the portion is distal to the barrier, and wherein the portion is aligned with or close to the annular rim when the septum is disposed in the proximal position.

11. The catheter assembly according to claim 1, characterized in that the spring comprises a coil, wherein the coil surrounds the septum actuator, wherein the coil comprises a helical shape or a plurality of waves.

12. The catheter assembly according to claim 11, characterized in that the coil is constructed of metal.

13. A catheter assembly, characterized in that CORO Ln / įZРZ / B / YILI comprises: a catheter adapter, comprising a distal end, a proximal end and a lumen extending through the distal end and the proximal end; a septum disposed within the lumen, wherein the septum comprises a distal end, a proximal end and a barrier disposed between the distal end of the septum and the proximal end of the septum, wherein the barrier divides an interior of the septum into a distal cavity and a proximal cavity, wherein the barrier comprises a slit, wherein the septum is configured to move from a proximal position to a distal position in response to the insertion of a medical device into the proximal end of the catheter adapter;a septum actuator fixed within the lumen, wherein the septum actuator comprises a tubular body and an annular flange extending outwards from an outer surface of the tubular body, wherein the annular flange is disposed at a proximal end of the septum actuator, wherein the septum actuator is configured to penetrate the slit in response to the movement of the septum from the proximal position to the distal position;and a spring disposed within the lumen distal to the septum, wherein the spring is configured to return the septum from the distal to the proximal position in response to the withdrawal of the medical device from the proximal end of the catheter adapter, wherein a portion of an inner surface of the septum forming the distal cavity is smooth, wherein the portion is distal to the barrier, and wherein the portion is aligned with or close to the annular rim when the septum is disposed in the proximal position.

14. The catheter assembly according to claim 13, characterized in that the spring surrounds the septum actuator.

15. The catheter assembly according to claim 14, characterized in that the spring and the septum are formed monolithically as a single unit.

16. The catheter assembly according to claim 15, characterized in that the spring and the septum are constructed of an elastomer.

17. The catheter assembly according to claim 16, characterized in that the annular flange comprises a generally truncated cone shape.

18. The catheter assembly according to claim 13, characterized in that the spring comprises a coil, wherein the coil surrounds the septum actuator.

19. A catheter assembly, characterized in that it comprises: a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; a septum disposed within the lumen, wherein the septum comprises a distal end, a proximal end, and a barrier disposed between the distal end of the septum and the proximal end of the septum, wherein the barrier divides the interior of the septum into a distal cavity and a proximal cavity, wherein the barrier comprises a slit, wherein the septum is configured to move from a proximal position to a distal position in response to the insertion of a medical device into the proximal end of the catheter adapter;a septum actuator fixed within the lumen, wherein the septum actuator comprises a tubular body and an annular flange extending outwards from an outer surface of the tubular body, wherein the annular flange is disposed at a proximal end of the septum actuator, wherein the septum actuator is configured to penetrate the slit in response to the movement of the septum from the proximal position to the distal position;and a spring disposed within the lumen distal to the septum, wherein the spring is configured to return the septum from the distal to the proximal position in response to the withdrawal of the medical device from the proximal end of the catheter adapter, wherein an inner surface of the septum forming the distal cavity comprises a protrusion, wherein the annular flange is configured to pass the protrusion in response to the movement of the septum from the proximal to the distal position. 5 20. The catheter assembly according to claim 19, characterized in that the spring and the septum are constructed of an elastomer and formed monolithically as a single unit.

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