Catheter assembly and diaphragm

Abstract

Catheter assembly, comprising: a catheter adapter including a lumen extending through the catheter adapter; a catheter extending distally from the catheter adapter; a septum including: a housing fixed within the lumen, the housing including a distal opening, a proximal opening, and a lumen extending from the distal opening to the proximal opening; a hollow body slidable relative to the housing from a closed position to an open position, the hollow body being at least partially disposed within the housing and including a distal end, a proximal end, and a passage extending therebetween, and including a plurality of holes; first and second seals coupled to the distal and proximal ends of the hollow body, in response to the hollow body being in the closed position, the second seal plugs the proximal opening of the housing and the plurality of holes are disposed within the housing, in response to the hollow body sliding from the closed position to the open position, the plurality of holes are disposed distally of the housing and the second seal is removed from the proximal opening of the housing, such that fluid from the lumen of the catheter adapter can flow into the plurality of holes and through the proximal opening of the housing.

Description

Technical Field

[0001] The present disclosure relates to a catheter assembly and a septum. Background Art

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

[0003] Common types of intravenous catheters are peripheral IV catheters ("PIVC"), peripherally inserted central catheters ("PICC"), and midline catheters. Intravenous catheters can include "over-the-needle" catheters that can be mounted over a needle having a sharp distal end. The sharp distal end can be used to pierce the skin and vasculature of a patient. The intravenous catheter can be inserted into the vasculature after the vasculature has been pierced by the needle. The needle and the intravenous catheter are typically inserted through the skin into the patient's vasculature at a relatively small angle, with the bevel of the needle facing upward and away from the patient's skin.

[0004] To verify proper placement of the guide needle and / or intravenous catheter within the vasculature, a user typically confirms the presence of a blood flashback that can be visible to the user. In some cases, the guide needle can include a notch disposed toward the distal end of the guide needle, and in response to the distal end of the guide needle being positioned within the vasculature, blood can flow proximally through the needle lumen, exit the needle lumen through the notch, and then travel proximally between the outer surface of the guide needle and the inner surface of the intravenous catheter.

[0005] Thus, in the case where the intravenous catheter is at least partially transparent, a user can visually observe a small amount of blood "flashback" and thereby confirm placement of the intravenous catheter within the vasculature. The presence of a vasculature entry sign, such as a flashback, can assist in the successful placement of the intravenous catheter. Once placement of the guide needle within the vasculature has been confirmed, the user can temporarily occlude flow within the vasculature and withdraw the guide needle, leaving the intravenous catheter in place for future blood draws and / or fluid infusions.

[0006] 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 art is provided to merely illustrate an exemplary technical field in which some of the embodiments described herein may be practiced. Summary of the Invention

[0007] The present disclosure generally relates to a diaphragm and related devices and methods. In certain embodiments, the diaphragm may include a housing that may include a distal opening, a proximal opening, and a cavity extending from the distal opening to the proximal opening. In certain embodiments, the housing may be generally cylindrical.

[0008] In certain embodiments, the diaphragm may include a hollow body that may slide relative to the housing from a closed position to an open position. In certain embodiments, the hollow body may be generally cylindrical. In certain embodiments, the hollow body may be at least partially disposed within the housing. In certain embodiments, the hollow body may include a distal end, a proximal end, and a channel extending between the distal end and the proximal end. In certain embodiments, the hollow body may include one or more holes.

[0009] In certain embodiments, the diaphragm may include a first seal that may be coupled to the distal end of the hollow body. In certain embodiments, the diaphragm may include a second seal that may be coupled to the proximal end of the hollow body. In certain embodiments, in response to the hollow body being in the closed position, the second seal may block the proximal opening of the housing, and the hole may be disposed within the housing. In certain embodiments, in response to the hollow body sliding from the closed position to the open position, the hole may be disposed distal to the housing, and the second seal may be removed from the proximal opening of the housing such that fluid may flow proximally into the hole and through the proximal opening of the housing.

[0010] In certain embodiments, the first seal may extend proximally to the hole and may cover the hole. In certain embodiments, the first seal may include a one-way check valve. In certain embodiments, the first seal and / or the second seal may be made of silicon or another suitable material. In certain embodiments, the second seal may include a plug, a duckbill valve, or another suitable seal.

[0011] In certain embodiments, the proximal end of the hollow body may include a first cam element. In certain embodiments, the first cam element may include a first groove. In certain embodiments, the inner surface of the housing may include a track. In certain embodiments, the diaphragm may include a second cam element that may be disposed within the housing. In certain embodiments, the second cam element may include a second groove and a stop surface. In certain embodiments, the diaphragm may include a spring that may be disposed within the housing. In certain embodiments, the spring may bias the second cam element proximally against the first cam element.

[0012] In some embodiments, when the hollow body is in the closed position, the track may be disposed within the first slot and the second slot. In some embodiments, when the hollow body is in the closed position, the track may prevent the second cam element from rotating relative to the first cam element. In some embodiments, in response to the first cam and the second cam moving distally such that the track is removed from the second slot, the second cam element may rotate such that the track is misaligned with the second slot. In some embodiments, in response to the first cam and the second cam moving distally such that the track is removed from the second slot, the stop surface of the second cam may contact the track to prevent the second cam from moving proximally and lock the hollow body in the open position. In some embodiments, in response to the hollow body moving distally beyond the open position, the hollow body may be unlocked and configured to return to the closed position.

[0013] In some embodiments, a catheter assembly may include a catheter adapter that may include a lumen extending through the catheter adapter. In some embodiments, the housing may be fixed within the lumen of the catheter adapter. In some embodiments, the catheter may extend distally from the catheter adapter. In some embodiments, in response to the hollow body sliding from the closed position to the open position, the aperture may be disposed distally of the housing, and the second seal may be removed from the proximal opening of the housing such that fluid from the lumen of the catheter adapter may flow proximally into the aperture and through the proximal opening of the housing.

[0014] In some embodiments, the diaphragm may include an O-ring that may be coupled to the distal end of the housing. In some embodiments, the O-ring may be disposed between the housing and the catheter adapter and may prevent fluid from flowing between the outer surface of the housing and the inner surface of the catheter adapter.

[0015] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit the invention as claimed. 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 embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Accordingly, the following detailed description should not be construed as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Exemplary embodiments will be described and explained with additional features and details by using the drawings, wherein:

[0017] Figure 1A An upper perspective view of an exemplary septum according to some embodiments, showing an exemplary proximal end of the septum;

[0018] Figure 1B Is Figure 1A An upper perspective view of a septum according to some embodiments, showing an exemplary distal end of the septum;

[0019] Figure 2A A cross-sectional view of an exemplary catheter assembly according to some embodiments, showing Figure 1A The septum in a closed configuration;

[0020] Figure 2B Is Figure 1A An upper perspective view of a septum in a closed configuration according to some embodiments;

[0021] Figure 3A Is Figure 2A A cross-sectional view of a catheter assembly according to some embodiments, showing the septum in an open configuration;

[0022] Figure 3B Is Figure 1A An upper perspective view of a septum in a closed configuration according to some embodiments;

[0023] Figure 4 Is Figure 1A An upper perspective view of a septum returning to a closed configuration according to some embodiments;

[0024] Figure 5A A cross-sectional view of another exemplary catheter assembly according to some embodiments, showing another exemplary septum in a closed configuration; and

[0025] Figure 5B Is Figure 5A An upper perspective view of a catheter assembly according to some embodiments, showing the septum in an open configuration. DETAILED DESCRIPTION

[0026] All of the examples and conditional language recited herein are for pedagogical purposes to aid the reader in understanding the invention and the concepts contributed by the inventor to further the art, and are to be construed as not being limited 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 without departing from the spirit and scope of the present invention.

[0027] Now refer to Figure 1A-4, in certain embodiments, the septum 10 may include a housing 12, the housing 12 may include a distal opening 14, a proximal opening 16, and a cavity 18 extending from the distal opening 14 to the proximal opening 16. In certain embodiments, the housing 12 may be generally cylindrical.

[0028] In certain embodiments, the septum 10 may include a hollow body 20, the hollow body 20 may slide relative to the housing 12 from a closed position as shown, for example, in Figure 1A-2B to an open position as shown, for example, in Figure 3A-3B . In certain embodiments, the hollow body 20 may be generally cylindrical. For example, the outer surface of the hollow body 20 may be generally cylindrical and / or the inner surface of the hollow body 20 may be generally cylindrical. In certain embodiments, the hollow body 20 may be at least partially disposed within the housing 12. In certain embodiments, the hollow body 20 may include a distal end 22, a proximal end 24, and a passage 26 extending between the distal end 22 and the proximal end 24. In certain embodiments, the hollow body 20 may include one or more holes 28, the holes 28 may be disposed at the distal end 22 of the hollow body 20.

[0029] In certain embodiments, the septum 10 may include a first seal 30, the first seal 30 may be coupled to the distal end 22 of the hollow body 20. In certain embodiments, the first seal 30 may seal the distal opening of the distal end 22 of the hollow body 20, thereby preventing fluid flow through the distal opening of the distal end 22. In certain embodiments, the first seal 30 may include a round cap. In certain embodiments, the septum 10 may include a second seal 32, the second seal 32 may be coupled to the proximal end 24 of the hollow body 20. In certain embodiments, the second seal 32 may seal the proximal opening of the proximal end 24 of the hollow body 20, thereby preventing fluid flow through the proximal opening of the proximal end 24. In certain embodiments, the first seal 30 and / or the second seal 32 may be made of silicone or another suitable material.

[0030] In certain embodiments, in response to the hollow body 20 being in the closed position, the second seal 32 may block the proximal opening 16 of the housing 12, and the hole 28 may be disposed within the housing 12. In certain embodiments, the hollow body 20 may slide from the closed position to the open position in response to a first external force being applied at the proximal end of the septum 10. In certain embodiments, in response to the hollow body 20 sliding from the closed position to the open position, the hole 28 may be disposed distal to the housing 12, and the second seal 32 may be removed from the proximal opening 16 of the housing 12 such that fluid may flow proximally into the hole 28 and through the proximal opening 16 of the housing 12.

[0031] In some embodiments, the proximal end 24 of the hollow body 20 may include a first cam element 34 that is non-rotatable. In some embodiments, the first cam element 34 may include a first slot or groove 36. In some embodiments, the inner surface of the housing 12 may include a track 38. In some embodiments, the diaphragm 10 may include a second cam element 40 that is disposed within the housing 12 and is configured to rotate. In some embodiments, the second cam element 40 may include a second slot or groove 42 and a stop surface 44.

[0032] In some embodiments, the diaphragm 10 may include a spring 46 that is disposed within the housing 12 and surrounds the hollow body 20. In some embodiments, the proximal end of the spring 46 may contact the second cam element 40. In some embodiments, the spring 46 may bias the second cam element 40 proximally against the first cam element 34. Thus, in some embodiments, the spring 46 may bias the hollow body 20 into a closed position. In some embodiments, the spring 46 may include a coil. In some embodiments, the spring 46 may be constructed of metal, an elastomer, or another suitable material.

[0033] In some embodiments, when the hollow body 20 is in the closed position, the track 38 may be disposed within the first slot 36 and the second slot 42. In some embodiments, when the hollow body 20 is in the closed position, the track 38 may prevent the second cam element 40 from rotating relative to the first cam element 34. In some embodiments, in response to the first cam element 34 and the second cam element 40 moving distally such that the track 38 is removed from the second slot 42, the second cam element 40 may rotate such that the track 38 is misaligned with the second slot 42.

[0034] In some embodiments, in response to the first cam element 34 and the second cam element 40 moving distally such that the track 38 is removed from the second slot 42, the stop surface 44 of the second cam element 40 may contact the track 38 to prevent the second cam element 40 from moving proximally and lock the hollow body 20 in the open position, even after the first external force is removed. In some embodiments, the first cam element 34 and the second cam element 40 may include one or more angled surfaces or teeth that may contact. In some embodiments, the contact between the angled surfaces of the teeth of the first cam element 34 and the second cam element 40, along with the force applied by the spring 46 in the proximal direction, may cause the second cam element 40 to rotate relative to the first cam element 34. In some embodiments, the stop surface 44 may stop the rotation of the second cam element 40.

[0035] In some embodiments, in response to the hollow body 20 moving distally beyond the open position, the hollow body 20 can be unlocked and configured to return to, for example, the closed position as shown in Figure 4 . In some embodiments, the hollow body 20 can be moved distally beyond the open position by applying a second external force to the proximal end of the diaphragm 10. In some embodiments, the hollow body 20 can be unlocked when the track 38 aligns with the second slot 42 or another slot of the second cam element 40. In some embodiments, the other slot of the second cam element 40 can be similar to the second slot 42 and can be spaced from the second slot 42 around the circumference of the second cam element 40. In some embodiments, the hollow body 20 can slide to a position distal to the open position before being locked in the open position.

[0036] In some embodiments, the catheter assembly 48 can include a catheter adapter 50, and the catheter adapter 50 can include a lumen 52 extending therethrough. In some embodiments, the catheter adapter 50 can include a distal end 54, a proximal end 56, and a lumen 52 extending through the distal end 54 and the proximal end 56. In some embodiments, the proximal end 56 can include a proximal opening 57. In some embodiments, the housing 12 can be fixed within the lumen 52 of the catheter adapter 50. In some embodiments, the catheter 58 can extend distally from the catheter adapter 50. In some embodiments, in response to the hollow body 20 sliding from the closed position to the open position, a hole 28 can be provided distal to the housing 12, and the second seal 32 can be removed from the proximal opening 16 of the housing 12 such that fluid from the lumen 52 of the catheter adapter 50 can flow proximally into the hole 28 and through the proximal opening 16 of the housing 12. In some embodiments, in response to the hollow body 20 being in the closed position, the second seal 32 can block the proximal opening 16 of the housing 12, and the hole 28 can be provided within the housing 12. Thus, the passageway 26 can be not in fluid communication with the lumen 52 of the catheter adapter 50.

[0037] In some embodiments, a needle assembly that can include a guide needle can be coupled to the proximal end 56 of the catheter adapter 50. In some embodiments, after the needle assembly is detached and removed from the catheter assembly 48, a blood collection device can be coupled to and / or inserted into the proximal end 56 of the catheter adapter 50. In some embodiments, the blood collection device can include a needle 60. In some embodiments, the needle 60 can include a sharp distal tip. In other embodiments, the needle 60 can be blunt. In some embodiments, the second seal 32 can be pierced by the needle 60. In some embodiments, the needle 60 can extend through the second seal 32. In some embodiments, before moving the hollow body 20 to the closed position, the user can aspirate blood and / or irrigate the catheter assembly 48 from the interior of the hollow body 20.

[0038] In some embodiments, the opening 62 of the needle 60 of the blood collection device may be disposed proximally to or near the aperture 28 within the hollow body 20. In some embodiments, when the hollow body 20 is in the open position, blood may be configured to flow proximally from the patient within the catheter assembly 48 through the lumen 52 of the catheter adapter 50, through the aperture 28, and into the opening of the needle 60. In some embodiments, the needle 60 may comprise a guide needle.

[0039] In some embodiments, the septum 10 may comprise an O-ring 64 that may be coupled to the distal end of the housing 12. For example, the housing 12 may comprise an annular groove that may receive the O-ring 64. In some embodiments, the O-ring 64 may be disposed between the housing 12 and the catheter adapter 50 and may prevent fluid flow between the outer surface of the housing 12 and the inner surface of the catheter adapter 50. In some embodiments, the housing 12 may be integrally formed or monolithically formed as a single unit.

[0040] Now referring Figure 5A-5B to, there is shown a catheter assembly 66 according to some embodiments. In some embodiments, the catheter assembly 66 may comprise a septum 68. In some embodiments, the catheter assembly 66 and the septum 68 may be similar or identical to the catheter assembly 48 and the septum 10 described with respect to Figure 1A-4 one or more of the included components and / or operations. In some embodiments, the first seal 30 may extend proximally to the aperture 28 and may cover the aperture 28. In some embodiments, the first seal 30 may comprise a one-way check valve. In some embodiments, the second seal 32 may comprise a plug, a duckbill valve, or another suitable seal.

[0041] Without departing from the structure, method, or other basic characteristics of the invention as broadly described herein and claimed hereinafter, the invention may be embodied in other specific forms. The described embodiments are to be considered in all respects only as illustrative and not restrictive. Thus, the scope of the invention is indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A catheter assembly, characterized in that, The catheter assembly includes: A catheter adapter, the catheter adapter including a lumen extending therethrough; A catheter extending distally from the catheter adapter; and A septum, the septum including: A housing fixed within the lumen of the catheter adapter, the housing including a distal opening, a proximal opening, and a lumen extending from the distal opening to the proximal opening; A hollow body that slides relative to the housing from a closed position to an open position, wherein the hollow body is at least partially disposed within the housing, wherein the hollow body includes a distal end, a proximal end, and a passage extending between the distal end and the proximal end, wherein the hollow body includes a plurality of holes; A first seal coupled to the distal end of the hollow body; and A second seal coupled to the proximal end of the hollow body, wherein, in response to the hollow body being in the closed position, the second seal plugs the proximal opening of the housing and the plurality of holes are disposed within the housing, and wherein, in response to the hollow body sliding from the closed position to the open position, the plurality of holes are disposed distal to the housing and the second seal is removed from the proximal opening of the housing such that fluid from the lumen of the catheter adapter can flow proximally into the plurality of holes and through the proximal opening of the housing, wherein the proximal end of the hollow body includes a first cam element, wherein the first cam element includes a first groove, and wherein the inner surface of the housing includes a track, and wherein the septum further includes: A second cam element disposed within the housing and including a second groove and a stop surface; A spring disposed within the housing and biasing the second cam element proximally against the first cam element, wherein, when the hollow body is in the closed position, the track is disposed within the first groove and the second groove and prevents rotation of the second cam element relative to the first cam element, and wherein, in response to the first cam element and the second cam element moving distally such that the track is removed from the second groove, the second cam element rotates such that the track is not aligned with the second groove, and the stop surface of the second cam element contacts the track to prevent proximal movement of the second cam element and lock the hollow body in the open position.

2. The catheter assembly according to claim 1, wherein, In response to the hollow body moving distally beyond the open position, the hollow body is unlocked and configured to return to the closed position.

3. The catheter assembly according to claim 1, wherein, The first seal extends proximally to the plurality of holes and covers the plurality of holes, wherein the first seal includes a one-way check valve.

4. The catheter assembly according to claim 1, wherein, The spring includes a coil surrounding the hollow body.

5. The catheter assembly according to claim 1, wherein, The housing is generally cylindrical.

6. The catheter assembly according to claim 1, wherein, The hollow body is generally cylindrical.

7. The catheter assembly according to claim 1, characterized in that, The first seal includes a rounded cap.

8. The catheter assembly according to claim 1, wherein, The catheter assembly further includes an O-ring coupled to the distal end of the housing and disposed between the housing and the catheter adapter.

9. The catheter assembly according to claim 1, wherein The second seal includes a plug or a duckbill valve.

10. A diaphragm, characterized in that, The septum includes: A housing, the housing including a distal opening, a proximal opening, and a cavity extending from the distal opening to the proximal opening; A hollow body that slides relative to the housing from a closed position to an open position, wherein the hollow body is at least partially disposed within the housing, wherein the hollow body includes a distal end, a proximal end, and a passage extending between the distal end and the proximal end, and wherein the hollow body includes a plurality of holes; A first seal coupled to the distal end of the hollow body; and A second seal coupled to the proximal end of the hollow body, wherein, in response to the hollow body being in the closed position, the second seal plugs the proximal opening of the housing and the plurality of holes are disposed within the housing, and wherein, in response to the hollow body sliding from the closed position to the open position, the plurality of holes are disposed distally of the housing and the second seal is removed from the proximal opening of the housing such that fluid can flow proximally into the plurality of holes and through the proximal opening of the housing, wherein the proximal end of the hollow body includes a first cam element, wherein the first cam element includes a first groove, and wherein the inner surface of the housing includes a track, and wherein the diaphragm further includes: A second cam element disposed within the housing and including a second groove and a stop surface; A spring disposed within the housing and biasing the second cam element proximally against the first cam element, wherein, when the hollow body is in the closed position, the track is disposed within the first groove and the second groove and prevents the second cam element from rotating relative to the first cam element, and wherein, in response to the first cam element and the second cam element moving distally such that the track is removed from the second groove, the second cam element rotates such that the track is not aligned with the second groove, and the stop surface of the second cam element contacts the track to prevent the second cam element from moving proximally and lock the hollow body in the open position.

11. The diaphragm according to claim 10, characterized in that, In response to the hollow body moving distally beyond the open position, the hollow body is unlocked and configured to return to the closed position.

12. The diaphragm according to claim 10, wherein, The spring includes a coil surrounding the hollow body.

13. The diaphragm according to claim 10, wherein The first seal includes a round cap.

14. The diaphragm according to claim 10, wherein The first seal extends proximally to the plurality of holes and covers the plurality of holes, and wherein the first seal includes a one-way check valve.

15. The diaphragm according to claim 10, wherein, The housing is generally cylindrical.

16. The diaphragm according to claim 10, wherein, The hollow body is generally cylindrical.

17. The diaphragm according to claim 10, wherein The diaphragm further includes an O-ring coupled to the distal end of the housing.

18. The diaphragm according to claim 10, characterized in that, The second seal includes a plug or a duckbill valve.

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