Reusable blood control catheter assembly

Abstract

This invention relates to a catheter assembly that may include a catheter adapter, the adapter including 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 diaphragm disposed within the lumen, a diaphragm actuator fixed within the lumen, and a spring disposed within the lumen remotely from the diaphragm. The diaphragm may include a distal end, a proximal end, and a barrier that divides the interior of the diaphragm into a distal lumen and a proximal lumen. In response to insertion of a medical device into the proximal end of the catheter adapter, the diaphragm may move from a proximal position to a distal position, and the diaphragm actuator may penetrate the diaphragm. The spring may return the diaphragm from the distal position to the proximal position in response to removal of the medical device.

Description

Technical Field

[0001] This invention relates to reusable blood control catheter assemblies. Background Technology

[0002] Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse fluids such as saline solutions, various medications, and total parenteral nutrition into a patient. Catheters can also be used to draw blood from a patient.

[0003] A common type of catheter is the covered needle peripheral venous catheter (“PIVC”). As the name suggests, a covered needle PIVC is mounted on top of a guide needle with a sharp distal end. The PIVC and guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the PIVC, and the bevel of the needle faces upward away from the patient's skin. The PIVC and guide needle are typically inserted into the patient's vascular system through the skin at a shallow angle.

[0004] To verify proper placement of the guide needle and / or PIVC in a vein, the user typically confirms a “flashback” of blood in the flashback chamber of the PIVC assembly. Once needle placement has been confirmed, the user can temporarily occlude blood flow in the vein and remove the guide needle, leaving the PIVC in the proper position within the vein. The PIVC can then be used for fluid infusion and / or blood aspiration or collection.

[0005] The subject matter claimed herein is not limited to embodiments that address any shortcomings, nor is it limited to embodiments that operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which some of the embodiments described herein can be practiced. Summary of the Invention

[0006] This disclosure generally relates to vascular access devices and related systems and methods. More specifically, this disclosure relates to catheter assemblies. In some embodiments, the catheter assembly may include a catheter adapter that may include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the catheter adapter.

[0007] In some embodiments, the catheter assembly may include a septum disposed within a lumen. In some embodiments, the septum may include a distal end, a proximal end, and a barrier disposed between the distal and proximal ends of the septum. In some embodiments, the barrier may divide the interior of the septum into a distal lumen and a proximal lumen. In some embodiments, the barrier may include a slit. In some embodiments, the septum may be configured to move from a proximal position to a distal position in response to insertion of a medical device into the proximal end of the catheter adapter.

[0008] In some embodiments, the catheter assembly may include a diaphragm actuator that may be secured within the lumen. In some embodiments, the diaphragm actuator may be configured to penetrate the slit in response to movement of the diaphragm from a proximal position to a distal position.

[0009] In some embodiments, the catheter assembly may include a spring disposed distal to the septum within the lumen. In some embodiments, the spring may be configured to return the septum from a distal position to a proximal position in response to removal of a medical device from the proximal end of the catheter adapter. In some embodiments, the spring may surround a septum actuator.

[0010] In some embodiments, the spring and / or diaphragm may be made of an elastomer. For example, the spring and / or diaphragm may be made of silicone or other suitable materials. In some embodiments, the spring and diaphragm may be integrally formed as a single unit. In some embodiments, the spring may include a coil that surrounds the diaphragm actuator. In some embodiments, the coil may be made of metal or other suitable materials. In some embodiments, the coil may include a helical shape or multiple corrugations.

[0011] In some embodiments, the diaphragm actuator may include a tubular body. In some embodiments, the outer surface of the tubular body may be smooth. In some embodiments, the tubular body may be generally cylindrical or conical.

[0012] In some embodiments, the diaphragm actuator may include an annular lip extending outward from the outer surface of the tubular body. In some embodiments, the annular lip may extend distally from the outer surface of the tubular body. In some embodiments, the annular lip may be located at the proximal end of the diaphragm actuator. In some embodiments, the annular lip may include a generally frustoconical shape.

[0013] In some embodiments, the inner surface of the diaphragm forming the distal cavity may include one or more protrusions. In some embodiments, the one or more protrusions may be annular. In some embodiments, an annular lip may be configured to pass over the one or more protrusions in response to movement of the diaphragm from a proximal position to a distal position. In some embodiments, an annular lip may be configured to contact the one or more protrusions when the diaphragm moves from a proximal position to a distal position.

[0014] In some embodiments, a portion of the inner surface of the diaphragm forming the distal cavity may be smooth. In these and other embodiments, the inner surface of the diaphragm forming the distal cavity may not include one or more protrusions. In some embodiments, the portion of the inner surface may be distal to the barrier member. In some embodiments, when the diaphragm is positioned in a proximal position, the portion of the inner surface may be aligned with or proximal to an annular lip. In some embodiments, the annular lip may be spaced apart from the portion of the inner surface of the diaphragm such that the annular lip does not contact the portion of the inner surface when the diaphragm moves from the proximal position to the distal position. In some embodiments, the portion of the inner surface may be adjacent to and / or proximal to an opening at the distal end of the diaphragm.

[0015] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the drawings. It should also be understood that these embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless otherwise stated. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0016] The exemplary embodiments are described and illustrated with additional features and details using the accompanying drawings, wherein:

[0017] Figure 1 This is a top perspective view of an exemplary catheter system according to some embodiments;

[0018] Figure 2A This is a partial cutaway view of an exemplary catheter assembly according to some embodiments, showing an exemplary spring and an exemplary diaphragm disposed in a proximal position;

[0019] Figure 2B According to some embodiments Figure 2A A cross-sectional view of the catheter assembly, showing the spring and diaphragm positioned proximally;

[0020] Figure 2C According to some embodiments Figure 2A A cross-sectional view of the catheter assembly, showing the spring and diaphragm positioned in the distal location;

[0021] Figure 3A This is a partial cutaway view of a catheter assembly according to some embodiments, showing additional exemplary springs and diaphragms disposed in a proximal position;

[0022] Figure 3BThis is a cross-sectional view of a catheter assembly according to some embodiments, showing additional springs and diaphragms disposed in the proximal position;

[0023] Figure 3C This is a cross-sectional view of a catheter assembly according to some embodiments, showing additional springs and diaphragms disposed in a distal position;

[0024] Figure 4A This is a partial cutaway view of a catheter assembly according to some embodiments, showing an additional exemplary diaphragm disposed in a proximal position;

[0025] Figure 4B This is a cross-sectional view of a catheter assembly according to some embodiments, showing an additional diaphragm disposed in a distal position;

[0026] Figure 5A This is a partial cutaway view of a catheter assembly according to some embodiments, showing an additional diaphragm and an exemplary diaphragm actuator disposed in a proximal position;

[0027] Figure 5B This is a cross-sectional view of a catheter assembly according to some embodiments, showing an additional diaphragm and said diaphragm actuator disposed in a proximal position;

[0028] Figure 5C This is a cross-sectional view of a catheter assembly according to some embodiments, showing a further diaphragm and said diaphragm actuator disposed in a distal position; and

[0029] Figure 6 This is a top perspective view of a diaphragm or another diaphragm according to some embodiments. Detailed Implementation

[0030] Now for reference Figure 1 This image illustrates a catheter system 10 according to some embodiments. In some embodiments, the catheter system 10 may include a needle guard 12 and a catheter assembly 14. In some embodiments, 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 embodiments, the catheter assembly 14 may include a catheter 22, which may include a distal end 24 and a proximal end 26. In some embodiments, the catheter 22 may include a peripheral venous catheter (“PIVC”), a midline catheter, a peripherally inserted central catheter (“PICC”), or other suitable catheters. In some embodiments, the proximal end 26 of the catheter 22 may be secured within the catheter adapter 16.

[0031] In some embodiments, catheter system 10 may include one or more features of a safety catheter assembly described in U.S. Patent Application No. 15 / 012,013, filed February 1, 2016, entitled “Releasable Catheter Seat Retainer,” the entire contents of which are incorporated herein by reference. In some embodiments, catheter system 10 may include one or more features of a safety catheter assembly described in U.S. Patent Application No. 62 / 808,133, filed February 20, 2019, entitled “Improved Connection Between Retractable Needle Protector and Catheter Adapter,” the entire contents of which are incorporated herein by reference.

[0032] In some embodiments, the needle protection device 12 may include a needle housing 30, which may be removably coupled 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 may be slidably coupled to the needle housing 30.

[0033] In some embodiments, the needle assembly 34 may include a guide needle 36, which may include a pointed distal end 38. In some embodiments, when the catheter system 10 is in an insertion position ready for insertion into a patient's vascular system, the guide needle 36 may extend through the catheter 22, for example as... Figure 1 As shown. In some embodiments, the needle assembly 34 may include a needle handle 40, which the user can grasp and move proximally to withdraw the guide needle 36 from the vascular system once the catheter 22 has been confirmed to be in place within the vascular system.

[0034] In some embodiments, placement of catheter 22 within the vascular system can be confirmed by blood flashback. In some embodiments, in response to insertion of guide needle 36 into the patient's vascular system, blood flashback can flow over the pointed distal end 38 of guide needle 36 and exit from the distal notch of guide needle 36 into a portion of catheter system 10. For example, blood flashback can flow over the pointed distal end 38 and exit from the distal notch into the space between the outer surface of guide needle 36 and the inner surface of catheter 22. In some embodiments, after a clinician observes blood flashback, guide needle 36 can be withdrawn, and needle assembly 34 and needle housing 30 can be removed from catheter adapter 16.

[0035] Now for reference Figure 2A-2C In some embodiments, the catheter assembly 14 may include a catheter adapter 16, which may include a distal end 18, a proximal end 20, and a lumen 42 extending through the distal end 18 and the proximal end 20 of the catheter adapter 16.

[0036] In some embodiments, the catheter assembly 14 may include a diaphragm 44 disposed within a lumen 42. In some embodiments, the diaphragm 44 may include a distal end 46, a proximal end 48, and a barrier 50 disposed between the distal end 46 and the proximal end 48 of the diaphragm 44. In some embodiments, the barrier 50 may divide the interior of the diaphragm 44 into a distal lumen 52 and a proximal lumen 54. In some embodiments, when the barrier 50 is closed, the barrier 50 may prevent fluid from flowing between the distal lumen 52 and the proximal lumen 54. In some embodiments, the barrier 50 may include a slit 56. In some embodiments, the diaphragm 44 may be configured to move from a proximal position to a distal position in response to insertion of a medical device 55 into the proximal end 20 of the catheter adapter 16.

[0037] In some embodiments, the catheter assembly 14 may include a diaphragm actuator 58, which may be secured within the lumen 42. In some embodiments, the diaphragm actuator 58 may be configured to penetrate the slit 56 in response to movement of the diaphragm 44 from a proximal position to a distal position. In some embodiments, the diaphragm 44 may include a generally H-shaped cross-section.

[0038] In some embodiments, the catheter assembly 14 may include a spring 60 disposed distal to the diaphragm 44 within the lumen 42. In some embodiments, the spring 60 may be configured to return the diaphragm 44 from a distal position to a proximal position in response to removal of the medical device 55 from the proximal end 20 of the catheter adapter 16. Thus, in some embodiments, the spring 60 may facilitate multiple uses of the catheter assembly 14 and the diaphragm 44, including multiple infusions and / or aspirations via multiple connections of the medical device 55 to the catheter adapter 16. In some embodiments, the spring 60 may be compressed in response to movement of the diaphragm 44 toward a distal position. In some embodiments, the spring 60 may be depressurized in response to movement of the diaphragm 44 toward a proximal position.

[0039] In some embodiments, the spring 60 may surround the diaphragm actuator 58, for example as... Figure 2A As shown. In some embodiments, spring 60 may include a coil, such as Figure 2AAs shown, it can surround the diaphragm actuator 58. In some embodiments, the coil can be helical. In some embodiments, the coil can be made of metal or other suitable material. In some embodiments, the coil can be made of an elastomer. For example, the coil and / or diaphragm 44 can be made of silicone or other suitable material that provides improved mechanical properties. In some embodiments, the coil and diaphragm 44 can be integrally formed as a single unit. In some embodiments, the proximal end of the spring 60 can be coupled to the diaphragm 44 and / or the distal end of the spring 60 can be coupled to the conduit adapter 16.

[0040] In some embodiments, spring 60 may include a wave spring, which may be coiled and / or may surround the diaphragm actuator 58. In some embodiments, the wave spring may be made of coiled wire, the coiled wire including corrugations to give the effect of a coiled wire spring. In some embodiments, the wave spring may be made of metal or other suitable material. In some embodiments, the wave spring may be constructed of an elastomer. For example, the wave spring and / or diaphragm 44 may be made of silicone resin or other suitable material that can provide improved mechanical properties. In some embodiments, the wave spring and diaphragm 44 may be integrally formed as a single unit. In some embodiments, the proximal end of spring 60 may be coupled to diaphragm 44 and / or the distal end of spring 60 may be coupled to conduit adapter 16.

[0041] In some embodiments, the diaphragm actuator 58 may include a tubular body 62. In some embodiments, the tubular body 62 may be generally cylindrical or conical. In some embodiments, the diaphragm actuator 58 may include an annular lip 64 extending outwardly from the outer surface 66 of the tubular body 62. In some embodiments, the annular lip 64 may extend distally from the outer surface 66 of the tubular body 62. In some embodiments, the annular lip 64 may be located at the proximal end of the diaphragm actuator 58. In some embodiments, the annular lip 64 may include a generally frustoconical shape, such as... Figure 2A As shown. In some embodiments, the annular lip 64 or generally frustoconical shape may help hold the diaphragm 44 in a proximal position before inserting the medical device 55 into the proximal end 20 of the catheter adapter 16, thereby providing resistance to distal movement of the diaphragm 44.

[0042] In some embodiments, the inner surface of the diaphragm 44 forming the distal cavity 52 may include one or more protrusions 68. In some embodiments, the one or more protrusions 68 may be annular. In some embodiments, an annular lip 64 may be configured to pass through the one or more protrusions 68 in response to movement of the diaphragm from a proximal position to a distal position. In some embodiments, the annular lip 64 may be configured to contact the one or more protrusions 68 when the diaphragm 44 moves from a proximal position to a distal position. In some embodiments, the one or more protrusions 68 may contact the tubular body 62, or the one or more protrusions 68 may not contact the tubular body 62.

[0043] In some embodiments, the one or more protrusions 68 and / or the annular lip 64 may provide resistance to the septum 44 returning from a distal position to a proximal position in response to removal of the medical device 55. More specifically, the one or more protrusions 68 may contact or engage with the annular lip 64 as the septum 44 moves from the distal position to the proximal position, and / or the annular lip 64 may contact or engage with the barrier member 50 as the septum 44 moves from the distal position to the proximal position. However, the spring 60 may overcome the resistance to facilitate movement of the septum 44 from the distal position to the proximal position. In this way, in some embodiments, the spring 60 may facilitate multiple uses of the catheter assembly 14 and the septum 44.

[0044] Now for reference Figures 3A-3C In some embodiments, the spring 60 and / or diaphragm 44 may be made of an elastomer. For example, the spring 60 and / or diaphragm 44 may be made of silicone resin or other suitable materials that provide improved mechanical properties. In some embodiments, the spring 60 and diaphragm 44 may be integrally formed as a single unit. In some embodiments, the spring 60 may surround the diaphragm actuator 58.

[0045] Now for reference Figures 4A-4B In some embodiments, the portion 70 of the inner surface of the diaphragm 44 forming the distal cavity 52 may be smooth. In these and other embodiments, the inner surface of the diaphragm 44 forming the distal cavity 52 may not include the one or more protrusions 68. In some embodiments, the portion 70 of the inner surface may be distal to the barrier member 50. In some embodiments, removing the one or more protrusions 68 may facilitate the return of the diaphragm 44 from a proximal position to a distal position and the multiple uses of the diaphragm 44.

[0046] In some embodiments, when the diaphragm 44 is positioned in the proximal position, a portion 70 of the inner surface may be aligned with or proximal to the annular lip 64. In some embodiments, the annular lip 64 may be spaced apart from the portion 70 of the inner surface of the diaphragm 44 such that the annular lip 64 does not contact the portion 70 of the inner surface when the diaphragm 44 moves from the proximal position to the distal position. In some embodiments, the portion 70 of the inner surface may be adjacent to the opening 72 at the distal end of the diaphragm 44 and / or proximal to the opening 72 at the distal end of the diaphragm 44.

[0047] Now for reference Figures 5A-5C In some embodiments, the outer surface of the proximal end 74 of the diaphragm actuator 58 may be smooth and may not include the annular lip 64. More specifically, in some embodiments, the outer surface of the tubular body 62 may be smooth and may not include the annular lip 64. In some embodiments, removal of the annular lip 64 may facilitate the return of the diaphragm 44 from a proximal position to a distal position and multiple uses of the diaphragm 44. In some embodiments, the inner surface of the diaphragm 44 forming the distal cavity 52 may include one or more protrusions 68. In other embodiments, a portion 70 of the inner surface of the diaphragm 44 forming the distal cavity 52 may be smooth.

[0048] Now for reference Figure 6 The image shows a top perspective view of a diaphragm 44 according to some embodiments. In some embodiments, the outer surface of the diaphragm 44 may be generally cylindrical.

[0049] All examples and conditional language described herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the inventors' concepts for further development in the field, and should be interpreted as not being limited to such specific examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made therein without departing from the spirit and scope of the invention.

Claims

1. A catheter assembly, characterized in that, The catheter assembly includes: A catheter adapter, the catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; A diaphragm disposed within the lumen, wherein the diaphragm includes a distal end, a proximal end, and a barrier disposed between the distal end and the proximal end of the diaphragm, wherein the barrier divides the interior of the diaphragm into a distal lumen and a proximal lumen, wherein the barrier includes a slit, and wherein the diaphragm is configured to move from a proximal position to a distal position in response to insertion of a medical device into the proximal end of the catheter adapter. A diaphragm actuator, the diaphragm actuator being fixed within the lumen, wherein the diaphragm actuator includes a tubular body and an annular lip extending outwardly from the outer surface of the tubular body, wherein the annular lip is disposed at a proximal end of the diaphragm actuator, wherein the diaphragm actuator is configured to penetrate the slit in response to movement of the diaphragm from the proximal position to the distal position; and A spring disposed distal to the diaphragm in the lumen, wherein when the diaphragm is in the distal position, the annular lip contacts or engages with the barrier member, wherein the spring is configured to return the diaphragm from the distal position to the proximal position in response to 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 diaphragm actuator.

3. The catheter assembly according to claim 1, characterized in that, The spring and the diaphragm are made of elastomers.

4. The catheter assembly according to claim 1, characterized in that, The spring and the diaphragm are made of silicone resin.

5. The catheter assembly according to claim 1, characterized in that, The spring and the diaphragm are integrated into a single unit.

6. The catheter assembly according to claim 1, characterized in that, The outer surface of the tubular body is smooth.

7. The catheter assembly according to claim 1, characterized in that, The annular lip has a generally truncated conical shape.

8. The catheter assembly according to claim 1, characterized in that, The spring includes a coiled element surrounding the diaphragm actuator, wherein the coiled element includes a helical shape or multiple corrugations.

9. The catheter assembly according to claim 8, characterized in that, The coiled part is made of metal.

10. A catheter assembly, characterized in that, The catheter assembly includes: A catheter adapter, the catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; A diaphragm disposed within the lumen, wherein the diaphragm includes a distal end, a proximal end, and a barrier disposed between the distal end and the proximal end of the diaphragm, wherein the barrier divides the interior of the diaphragm into a distal lumen and a proximal lumen, wherein the barrier includes a slit, and wherein the diaphragm is configured to move from a proximal position to a distal position in response to insertion of a medical device into the proximal end of the catheter adapter. A diaphragm actuator, the diaphragm actuator being fixed within the lumen, wherein the diaphragm actuator includes a tubular body and an annular lip extending outwardly from the outer surface of the tubular body, wherein the annular lip is disposed at a proximal end of the diaphragm actuator, wherein the diaphragm actuator is configured to penetrate the slit in response to movement of the diaphragm from the proximal position to the distal position; and A spring, disposed distal to the septum within the lumen, wherein when the septum is in the distal position, the annular lip contacts or engages with the barrier member, wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter. The portion of the diaphragm forming the inner surface of the distal cavity is smooth, wherein the portion is distal to the barrier member, and wherein when the diaphragm is positioned proximally, the portion is aligned with or proximal to the annular lip.

11. The catheter assembly according to claim 10, characterized in that, The spring surrounds the diaphragm actuator.

12. The catheter assembly according to claim 11, characterized in that, The spring and the diaphragm are integrated into a single unit.

13. The catheter assembly according to claim 12, characterized in that, The spring and the diaphragm are made of elastomers.

14. The catheter assembly according to claim 13, characterized in that, The annular lip has a generally truncated conical shape.

15. The catheter assembly according to claim 10, characterized in that, The spring includes a coiled element surrounding the diaphragm actuator.

16. A catheter assembly, characterized in that, The catheter assembly includes: A catheter adapter, the catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; A diaphragm disposed within the lumen, wherein the diaphragm includes a distal end, a proximal end, and a barrier disposed between the distal end and the proximal end of the diaphragm, wherein the barrier divides the interior of the diaphragm into a distal lumen and a proximal lumen, wherein the barrier includes a slit, and wherein the diaphragm is configured to move from a proximal position to a distal position in response to insertion of a medical device into the proximal end of the catheter adapter. A diaphragm actuator, the diaphragm actuator being fixed within the lumen, wherein the diaphragm actuator includes a tubular body and an annular lip extending outwardly from the outer surface of the tubular body, wherein the annular lip is disposed at a proximal end of the diaphragm actuator, wherein the diaphragm actuator is configured to penetrate a slit in response to movement of the diaphragm from the proximal position to the distal position; and A spring, disposed distal to the septum within the lumen, wherein when the septum is in the distal position, the annular lip contacts or engages with the barrier member, wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter. The inner surface of the diaphragm forming the distal cavity includes protrusions, wherein the annular lip is configured to pass through the protrusions in response to the diaphragm moving from the proximal position to the distal position.

17. The catheter assembly according to claim 16, characterized in that, The spring and the diaphragm are made of elastomers and are integrally formed into a single unit.

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