CN211301660U

CN211301660U - Catheter system

Info

Publication number: CN211301660U
Application number: CN201921758834.3U
Authority: CN
Inventors: M·纳特桑
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2019-10-18
Filing date: 2019-10-18
Publication date: 2020-08-21
Anticipated expiration: 2029-10-18

Abstract

The present disclosure relates to a catheter system. The catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The catheter adapter may include a side port and a hub removably coupled to a proximal end of the catheter adapter. The side port may include a septum, a septum actuator, and a connector. The catheter system may include an extension set configured to removably couple to a connector of the side port.

Description

Catheter system

Technical Field

The present disclosure belongs to the technical field of medical instruments. In particular, the present disclosure relates to a catheter system.

Background

The vascular access device may facilitate infusion therapy, a common healthcare procedure. For example, hospitalized, home care, and other patients receive fluids, pharmaceuticals, and blood products through a vascular access device inserted into the vascular system. Blood drawing is another common health care procedure and may be assisted by a vascular access device.

The vascular access device may access a peripheral or central blood vessel of a patient. The vascular access device may be indwelling for short term (days), medium term (weeks), or long term (months to years). The vascular access device may be used for continuous infusion therapy or intermittent therapy.

A common type of vascular access device is a trocar peripheral intravenous catheter ("PIVC"). As the name suggests, a "needle-in-cannula" PIVC may be mounted on an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce the skin and blood vessels of a patient. After inserting the PIVC into the blood vessel, the blood vessel is punctured by the needle. The needle and PIVC are typically inserted through the skin at a shallow angle into a patient's blood vessel with the bevel of the needle facing away from the patient's skin.

The PIVC assembly may be coupled with an extension set that may allow for coupling of an infusion or blood collection device at a location removed from an insertion site of the PIVC. While extension sets may reduce the risk of disturbing the insertion site or dislodging the catheter from the patient's blood vessel, drawing blood through the extension set may result in residual blood remaining in the extension set. The extension set is then shielded from the residue and may become clogged, making it difficult to administer fluid to the patient through the extension set.

The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided merely to illustrate one exemplary technical field in which some embodiments described herein may be practiced.

SUMMERY OF THE UTILITY MODEL

The present disclosure relates to a catheter system configured to facilitate successful blood collection and avoid blood collection residue in an extension set. The present disclosure will also improve the administration of fluids and/or drugs to a patient by extending the kit. In some embodiments, a catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal and proximal ends. The catheter adapter may include a side port and a hub removably coupled to a proximal end of the catheter adapter. The side port may include a septum, a septum actuator, and a connector. The catheter system may further comprise an extension set. The extension kit may be configured as a connector that is removably coupled to the side port of the catheter adapter. In some embodiments, the connector may be a luer lock connector. In other embodiments, the connector may be a luer slip connector.

In some embodiments, the extension set can include a blood collection device having a connector configured to couple to a side port of a catheter adapter. The extension set may include a needle assembly having a housing with a first tip extending from a first end of the housing and a second tip extending from a second end of the housing. The second end and the first end may be in fluid communication with each other through a cannula, and the needle assembly may be configured such that: upon insertion of the catheter system into a patient, blood flows through the extension set; and upon application of the empty container to the second end, blood is withdrawn from the patient and into the empty container.

In some embodiments, the extension set is a first extension set, and upon removal of the first extension set, a second extension set can be configured to couple to the side port of the catheter adapter. The second extension set may include an extension tube having a distal end including a luer connector and a proximal end having a second connector. The luer connector may be transparent.

In some embodiments, the second connector may be a needleless connector. In other embodiments, the second connector may be a multiport connector. In other embodiments, the extension set may be an end cap.

In some embodiments, the side port of the catheter adapter can include a septum, a septum actuator, and a connector. When the extension set is coupled to the connector, the septum activator can extend through the septum, thereby establishing a fluid path through the septum. The extension kit may be configured to be removably coupled to a connector of the side port. Upon disconnection from the extension set, the septum activator may be detached from the septum and the septum reseals.

In some embodiments, the catheter system further comprises an introducer needle extending through the catheter tube. The proximal end of the introducer needle may be secured within the needle hub and an extension set configured to removably couple to a connector of the side port of the catheter adapter.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. It should be understood that the various embodiments of the disclosure are not limited to the arrangements and instrumentality shown in the attached drawings. It is also to be understood that the embodiments may be combined, or that other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. The following detailed description is, therefore, not to be taken in a limiting sense.

Drawings

Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 is a perspective view of an example catheter system according to some embodiments;

FIG. 2A is a perspective view of an exemplary catheter system having a blood collection device coupled to a catheter adapter;

FIG. 2B is a cross-sectional view of an exemplary blood collection device;

FIG. 2C is a perspective view of an exemplary catheter system having a blood collection device coupled to a catheter adapter and a vacuum container for blood collection;

FIG. 3A is a perspective view of an exemplary catheter system having an extension set coupled to a catheter adapter;

FIG. 3B is a perspective view of an exemplary catheter system having an extension set coupled to a catheter adapter, and the extension set including a multiport connector;

FIG. 4 is a perspective view of an exemplary catheter system having an end cap connected to a catheter adapter;

FIG. 5A is a cross-sectional view of the catheter adapter connector prior to coupling the extension set to the connector;

FIG. 5B is a cross-sectional view of the catheter adapter connector with the extension set coupled to the connector; and

figure 5C is a cross-sectional view of the catheter adapter connector with the extension set disconnected from the connector.

It is to be understood that the drawings are for purposes of illustrating the concepts of the disclosure and may not be to scale. Furthermore, the drawings illustrate exemplary embodiments and are not meant to limit the scope of the disclosure.

Detailed Description

Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus and system, as represented in the figures, is not intended to limit the scope of the disclosure, as claimed in this application or any other application claiming priority to this application, but is merely representative of exemplary embodiments of the disclosure.

The present disclosure generally relates to a catheter system configured to facilitate blood collection, elimination, or substantially reduce prefill, and to facilitate elimination of blood carryover in an extension tube. Referring now to fig. 1, an exemplary catheter system 10 is shown ready for insertion into a vein of a patient (not shown in fig. 1). In some embodiments, the catheter system 10 may include a catheter adapter 12 and a catheter tube 14. The catheter adapter 12 may include a distal end, a proximal end, and a lumen extending between the distal and proximal ends. The catheter tube 14 may extend distally from the catheter adapter 12.

In some embodiments, catheter system 10 includes a needle hub 16. Hub 16 may be removably coupled to catheter adapter 12 at the proximal end of catheter adapter 12. The needle hub 16 may include a paddle grip 18. The paddle grip 18 may assist the user in inserting the catheter into the patient's vein. After the catheter has been properly created within the vein, the clinician may use the paddle grip to withdraw introducer needle 20 from the catheter adapter. Introducer needle 20 may be coupled to needle hub 16 and extend through catheter adapter 12 and catheter tube 14, extending beyond catheter tube 14. In some embodiments, introducer needle 20 and needle hub 16 may be removed once the catheter has been verified as being located within a vein. Once removed, an extension set or other device may be coupled to the proximal end of the catheter adapter for administration to effect a medical procedure, or to couple other medical devices to the catheter adapter 12.

In some embodiments, the catheter adapter 12 may include a side port 22. The side ports 22 may extend laterally from the catheter adapter at an angle that facilitates clinician access to the catheter system 10 or patient comfort. The side port 22 may include a connector 24. Connector 24 may couple catheter adapter 12 to an extension set or other medical device and/or facility for administering medication to a patient, as will be explained further below.

In some embodiments, connector 24 may be a luer connector. A luer connector may be defined as a standardized fitting for making a leak-free connection between a male fitting and a mating female fitting. In some embodiments, connector 24 may be a luer lock connector. The luer connector can be easily connected by screwing the male and female parts together. Luer connectors may refer to both male and female portions of connector 24 in this disclosure. In some embodiments, the male portion may be connected to the side port while the female portion is connected to the extension set 28. In other embodiments, the female portion may be connected to the side port 22 while the male portion is connected to the extension set 28. In some embodiments, connector 24 may be a luer slip connector. Luer slip connectors are typically fluid tight connectors, but luer slip connectors may be easier to separate than luer lock connectors.

Referring now to fig. 2A, the extension set 28 may be coupled to the connector 24. The extension set 28 may be removably coupled such that the extension set 28 cannot be considered permanently attached, but rather may be removed as desired. In some embodiments, the extension set 28 may be a blood collection device 30.

Referring now to fig. 2B-2C, in some embodiments, the blood collection device 30 can include a needle assembly 32 having a housing 34 with a first end 36 extending from a first end of the housing and a second end 38 extending from a second end of the housing. The first end 36 may be a connector that couples with a catheter adapter. In some embodiments, first end 36 may include a luer connector. The second end 38 and the first end 36 may be in fluid communication with each other through a cannula 40. The needle assembly 32 may be configured such that: upon insertion of the catheter system into the patient, blood flows through the extension set 28; and upon application of the empty container 42 to the second end 38, blood is withdrawn from the patient and into the empty container 42.

In some embodiments, the needle assembly 32 includes a porous vent 44 positioned within the housing 34 to divide the housing interior into a first chamber 46 and a second chamber 48, with the cannula 40 in fluid communication with the first chamber. Porous vent 44 may include an aperture for passage of blood from first chamber 46 to second chamber 48. First chamber 46 and second chamber 48 may be configured such that: upon insertion of introducer needle 20 into the patient and coupling of the needle assembly to catheter adapter 12, blood may flow through cannula 40 and into first chamber 46 without sealing porous vent 44. In some embodiments, the second chamber 48 may include an exhaust port to release any air from the blood collection device 30 or an extension tube coupled to the device prior to collecting blood. In some embodiments, a chamber may be provided and a conduit may couple first end 36 and second end 38 without a porous vent.

Upon application of evacuation container 42 to second end 38, blood may be drawn from first chamber 46 and air may be drawn from second chamber 48, thereby establishing a negative pressure within second chamber 48 relative to the environment external to needle assembly 32. Thereafter, blood may be drawn into the first chamber 46 and through the porous vent 44 while maintaining a negative pressure in the second chamber 48. In some embodiments, blood is drawn from the first chamber 46 to the evacuation container 42 without venting or drawing air.

Referring now to fig. 3A-3B, in some embodiments, the extension kit 28 is a first extension kit, wherein upon removal of the first extension kit, the second extension kit is configured to be coupled to the side port 22 of the catheter adapter 12. For example, in some embodiments, the first extension set 28 may include the blood collection device 30, and the second extension set may include an extension tube 50 having a luer connector distally coupled to the catheter adapter connector 24 and a second connector 52 coupling the extension tube to other medical devices or connectors.

In some embodiments, the extension kit 28 may include one or more of the following: a first end 52, a second end 54, and an extension tube 50 between the first end 52 and the second end 54. In some embodiments, the first end 52 may include a first connector 56, and the first connector 56 may be coupled to the catheter adapter connector 24 of the catheter assembly. The second end 54 of the extension set 28 may include a second connector 58, and the second connector 58 may be configured to couple to a medical device, such as an infusion device. The second connector 58 may include a male or female luer connector or other suitable connector. In some embodiments, the first connector 56 and/or the second connector 58 may include a luer slip or luer lock feature. In other embodiments, the second connector 58 may include one or more ports. In other embodiments, the second connector 58 may be a needleless connector. In some embodiments, the second connector 58 may be configured to couple to a needleless connector.

In some embodiments, the extension tube 50 may include a clamp 60. In some embodiments, the clamp 60 may selectively close the extension tube 50 to prevent fluid flow through the extension tube 50. The second connector 58 may include a Y-adapter 62 or other suitable connector. In some embodiments, a needleless connector may be coupled to the Y-shaped adapter 62. In some embodiments, the extension set 28 may include an exhaust port located near the first connector 56 to exhaust air from the extension set 28 prior to coupling the extension set 28 to the catheter adapter connector 24.

Referring now to fig. 4, in some embodiments, the extension set 28 may not be coupled to the catheter adapter connector 24. An end cap 64 may be placed over the connector to prevent contamination of the connector and to ensure a fluid tight seal. In some embodiments, the end cap 64 may be a snap-fit cap. In other embodiments, the end cap 64 may be an insert held in the connector by an interference fit. In other embodiments, end cap 64 may be a screw cap that may be screwed onto threads of connector 24. The end cap may be coupled to the catheter adapter 12 by a lanyard.

The removable extension set 28 may provide several benefits for patient care. First, drawing blood using the blood collection device 30 directly attached to the connector 24 of the catheter adapter 12 may provide a blood sample that has not been diluted or otherwise diluted or contaminated with the prefilled fluid. Second, the extension set 28 may be adapted to the desired treatment. For example, the extension set 28 may be specifically designed for a particular drug administration, with valves, vents, and/or tubing optimized for the drug. Third, as described above, the extension set may be removed and replaced with the end cap 64. The end cap 64 may require less securing material to secure the catheter adapter within the patient for a sustained period of time, and thus may provide greater patient comfort and better securement. Fourth, prefilling of the catheter system may be reduced or eliminated because the attachable extension set may be prefilled prior to coupling to the catheter system and/or long tubes and devices that may retain air or air bubbles can be eliminated. Finally, blood remnants in the extension tube can be eliminated because blood is no longer collected by the same extension set as the drug and/or saline is administered.

In some embodiments, the connector 24 may be transparent or translucent. The transparent connector may further verify that there is no or reduced blood residue in the connector 24. Any area with blood residue can be removed and cleaned and/or replaced.

In some embodiments, a method of administering to a patient using a removable/attachable extension set 28 may involve first blood sample administration and second fluid drug administration. For example, the PIVC may be inserted into a blood vessel of a patient, wherein the catheter tube 14 may puncture the blood vessel following the introducer needle 20. Introducer needle 20 and PIVC can be inserted into a patient's blood vessel by piercing the skin at a shallow angle. Introducer needle 20 can be withdrawn from catheter adapter 12 and discarded, and catheter tube 14 can remain in the blood vessel while end cap 64 can be placed in place over side port 22 of catheter adapter 12. After proper placement of the catheter tube 14 within the vein and securement of the catheter system 10 to the patient is determined, the end cap 64 may be removed and the blood collection device 30 may be coupled to the connector 24 for the blood sample.

In some embodiments, the blood collection device 30 may be coupled directly to the connector 24. The blood collection set 30 may include the needle assembly 32 described above, wherein the needle assembly is configured such that upon application of an empty container to the second tip 38, blood may be withdrawn from the patient and into the empty container. After the blood sample is collected, the blood collection device 30 may be removed and/or disconnected from the connector 24.

After the blood sample is collected, in some embodiments, the end cap 64 may be replaced on the connector 24. In other embodiments, an extension set 28 having an extension tube 50 may be coupled to the connector 24. The extension set 28 may include a second connector 58 on the proximal end so that a saline container may be coupled to the extension set 28 and/or the medication may be administered. In the above example, the extension set 28 would not include blood collection remnants because the blood collection device 30 has been removed. In some embodiments, after administration of the fluid and/or drug, the extension set 28 may be disconnected and/or separated from the catheter adapter and the end cap may be replaced on the connector 24. In other embodiments, another blood sample may be obtained by reconnecting the blood collection set 30 to the connector 24.

Referring now to fig. 5A-5C, in some embodiments, blood and/or liquid leakage may be prevented by providing a blood control system 66 within side port 22 of catheter adapter 12. Blood control system 66 may include a septum 68 and a septum actuator 70. When the extension set 28 is coupled to the connector 24, the diaphragm actuator 70 may extend through the diaphragm 68 such that a fluid path may be established through the diaphragm 68, and when the extension set 28 is disconnected, the diaphragm actuator 70 retracts from the diaphragm 68 and/or separates from the diaphragm 68, and the diaphragm reseals. In some embodiments, the diaphragm 68 creates a fluid tight seal when the diaphragm actuator 70 is retracted from the diaphragm 68.

Septum 68 may be a pre-slit elastic septum that functions as a valve that forms a fluid-tight seal and selectively allows fluid to flow to or from catheter adapter 12. The diaphragm may be seated against the diaphragm flange 72 to limit movement and hold the diaphragm in place. Septum 68 may include at least one slit that opens when septum actuator 70 extends through septum 68. When the catheter tube 14 is initially inserted into the patient, the introducer needle 20 is removed and the septum 68 prevents blood flow through the side port 22.

In some embodiments, an actuator 70 is positioned in the side port 22 and is axially movable in the side port to engage the septum 68 and open the septum 68 by insertion into the septum slit. Actuator 70 may be a tubular member that allows fluid to flow within the interior of actuator 70. In some embodiments, the actuator has one or more openings that allow fluid to flow through the actuator 70 and/or around the actuator 70. In some embodiments, the actuator is made from a single piece of rigid or semi-rigid material (e.g., a rigid polymer).

In some embodiments, the diaphragm 68 and diaphragm actuator 70 may be coupled with a return member 74 that allows the diaphragm actuator 70 to engage and disengage the diaphragm 68. The return member 74 may be a biasing member that is in communication with the diaphragm actuator and biases the diaphragm actuator 70 away from the diaphragm 68. The biasing member may be a spring coupled to an inner surface of the side port 22, or the biasing member may be an elastomer that maintains a preferred shape. When the extension set 28 is coupled to the connector 24, the return member 74 may be compressed and the septum activator 70 pierces the septum 68 such that fluid may flow through the side port 22 and into the extension set 28. When the extension set 28 is disconnected from the connector 24, the return member 74 may return to its original, non-compressed orientation, and the septum activator 70 is separated from the septum 68 and the septum is sealed.

As another example, in some embodiments, side-port 22 may include a BLOOD CONTROL system 66 similar to that described in U.S. patent application publication No. US 2017/0035992 a1 entitled "MULTI-USE BLOOD CONTROL valve safety assembly" published on 2017, 2/9, which is hereby incorporated by reference in its entirety.

Reference throughout this specification to "one embodiment" or "the embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the recitation of reference phrases or variations thereof throughout this specification is not necessarily all referring to the same embodiment. It should be understood that any embodiment of the present disclosure, or any portion of any embodiment of the present disclosure, may be combined together in any number of different ways.

Similarly, it should be appreciated that in the foregoing description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. However, the format of the present disclosure should not be interpreted to reflect the following intent: any claim requires more features than are expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in combinations of less than all features of any single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment. The present disclosure includes all permutations of the independent claims and their dependent claims.

The term "first" in the claims with respect to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements recited in a device plus function format should be interpreted in accordance with 35u.s.c. § 112, paragraph 6. It will be apparent to those skilled in the art that changes may be made in the details of the above-described embodiments without departing from the underlying principles set forth herein.

The phrases "connected to," "coupled to," "engaged with …," and "in communication with …" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term "abutting" refers to items that are in direct physical contact with each other, although the items do not necessarily have to be attached together. The phrase "in fluid communication" refers to two features that are connected together such that fluid within one feature can enter the other feature.

The word "exemplary" is used herein to mean "serving as an example, instance, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

While particular embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of the appended claims is not limited to the precise construction and components disclosed herein. Various modifications, changes, and variations apparent to those skilled in the art may be made in the arrangement, operation, and details of the devices and systems disclosed herein.

All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the concepts of the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the invention.

Claims

1. A catheter system, comprising:

a catheter adapter, the catheter adapter comprising:

a distal end, a proximal end, and a lumen extending between the distal and proximal ends;

a needle hub removably coupled to a proximal end of the catheter adapter;

a side port comprising a septum, a septum actuator, and a connector; and

an extension kit, wherein the extension kit is configured to be removably coupled to the connector of the side port.

2. The catheter system of claim 1, wherein the connector comprises a luer connector.

3. The catheter system of claim 1, wherein the extension set includes a blood collection device having a connector configured to couple to a side port of the catheter adapter.

4. The catheter system of claim 3, wherein the extension set includes a needle assembly having a housing, the needle assembly having a first tip extending from a first end of the housing and a second tip extending from a second end of the housing, the second tip and the first tip being in fluid communication with one another through a cannula, wherein the needle assembly is configured such that upon insertion of the catheter system into a patient, blood flows through the extension set and upon application of a purge container to the second tip, blood is withdrawn from the patient and into the purge container.

5. The catheter system of claim 1, wherein the extension set is a first extension set, wherein upon removal of the first extension set, a second extension set is configured to be coupled to a side port of the catheter adapter.

6. The catheter system of claim 5, wherein the second extension set includes an extension tube having a distal end including a luer connector and a proximal end including a second connector.

7. The catheter system of claim 6, wherein the luer connector is transparent.

8. The catheter system of claim 6, wherein the second connector comprises a needleless connector.

9. The catheter system of claim 6, wherein the second connector comprises a multiport connector.

10. The catheter system of claim 1, wherein the extension set comprises an end cap.

11. A catheter system, comprising:

a catheter adapter, the catheter adapter comprising:

a distal end, a proximal end, and a lumen extending therebetween;

a side port comprising a septum, a septum actuator, and a connector, wherein, when an extension set is coupled to the connector, the septum actuator extends through the septum, thereby establishing a fluid path through the septum, wherein the extension set is configured to be removably coupled to the connector of the side port.

12. The catheter system of claim 11, wherein upon disconnection of the extension set, the septum activator separates from the septum and the septum reseals.

13. The catheter system of claim 11, wherein the connector comprises a luer lock connector.

14. The catheter system of claim 11, wherein the connector comprises a luer slip connector.

15. The catheter system of claim 11, wherein the extension set includes a blood collection device having a connector configured to couple to a side port of the catheter adapter.

16. The catheter system of claim 11, wherein the extension set is a first extension set, wherein the catheter system comprises a second extension set configured to be coupled to a side port of the catheter adapter.

17. The catheter system of claim 16, wherein the second extension set includes an extension tube having a distal end and a proximal end, the distal end of the extension tube including a luer connector configured to couple to the side port of the catheter adapter, the proximal end of the extension tube including a second connector.

18. A catheter system, comprising:

a catheter adapter, the catheter adapter comprising:

a distal end, a proximal end, and a lumen extending therebetween;

a side port comprising a septum, a septum actuator, and a connector;

a catheter tube extending distally from the catheter adapter;

a needle hub removably coupled to a proximal end of the catheter adapter;

an introducer needle extending through the catheter tube, wherein a proximal end of the introducer needle is secured within the needle hub; and

19. The catheter system of claim 18, wherein the extension set includes a blood collection device having a connector configured to couple to a side port of the catheter adapter.

20. The catheter system of claim 18, wherein the extension set is a first extension set, wherein the catheter system comprises a second extension set configured to be coupled to a side port of the catheter adapter.