Guide pins with raised portions and related systems and methods

Abstract

A catheter system may include a catheter adapter, the catheter adapter including a distal end, a proximal end, and an inner lumen extending through the distal end and the proximal end of the catheter adapter. The catheter system may include a spacer assembly disposed within the inner lumen of the catheter adapter. The catheter system may include a catheter extending from the distal end of the catheter adapter. The catheter system may include a guide needle, the guide needle including a proximal end, a sharp distal tip, and a ridge disposed between the proximal end and the sharp distal tip. The proximal end of the guide needle may be secured within a needle hub of the catheter system. In response to the ridge contacting the spacer assembly, the sharp distal tip of the guide needle is positioned distal to the distal end of the catheter.

Description

[0001] Related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 114,276, filed November 16, 2020, entitled “Introducer Needle Having a Bump and Relatted Systems and Methods,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to vascular access devices, systems, and methods. In particular, this disclosure relates to guide needles including bulges and related systems and methods. Background Technology

[0004] Catheters are commonly used in a variety of infusion therapies. They can be used to deliver saline solutions, various medications, total parenteral nutrition solutions, or other fluids into a patient. Catheters can also be used to draw blood from a patient for diagnostic or other purposes.

[0005] A common type of catheter is the "needle-feather" peripheral venous catheter ("PIVC"). As the name suggests, a needle-feather PIVC can be mounted on a guide needle with a sharp distal tip. The PIVC and guide needle can be assembled such that the distal tip of the guide needle extends beyond the distal tip of the PIVC, with the bevel of the needle facing upwards and 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.

[0006] To verify proper placement of the guide needle and / or peripheral intravenous catheter in the blood vessel, clinicians typically check for blood "flashback" in the reflux lumen of the catheter assembly. Once needle placement is confirmed, the clinician can remove the guide needle and leave the peripheral intravenous catheter in place for future fluid infusions.

[0007] The subject matter claimed herein is not limited to implementations that address all drawbacks or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0008] This disclosure generally relates to vascular access devices, systems, and methods. In particular, this disclosure relates to guide needles including a raised portion and related systems and methods. In some embodiments, the catheter system may include a catheter adapter that may include a distal end, a proximal end, and an inner lumen extending through the distal and proximal ends of the catheter adapter. In some embodiments, the catheter system may include a spacer assembly disposed within the lumen of the catheter adapter. In some embodiments, the spacer assembly may include a spacer and / or a spacer tube.

[0009] In some embodiments, the catheter system may include a catheter extending from the distal end of a catheter adapter. In some embodiments, the catheter system may include a needle hub coupled to the proximal end of the catheter adapter. In some embodiments, the catheter system may include a guide needle, which may include a proximal end, a pointed distal tip, and a ridge disposed between the proximal end and the pointed distal tip. In some embodiments, the proximal end of the guide needle is secured within the needle hub. In some embodiments, in response to the ridge contacting a spacer assembly, the pointed distal tip of the guide needle is disposed distal to the distal end of the catheter.

[0010] In some embodiments, the distal tip of the guide needle may include a bevel. In some embodiments, the distance between the ridge and the spacer assembly may be less than or equal to the lie distance between the distal end of the catheter and the proximal end of the bevel of the guide needle. In some embodiments, the spacer assembly may include a proximal end, and the ridge may contact the proximal end of the spacer assembly. In some embodiments, the ridge may be proximal to and spaced apart from the spacer assembly. In some embodiments, the ridge may be no more than 2 mm away from the spacer assembly. In some embodiments, the guide needle may include a notch distal to the ridge.

[0011] In some embodiments, the duct assembly may include a wing extending outward from the duct adapter. In some embodiments, the needle assembly may include a propeller seat extending outward from the needle hub. In some embodiments, the propeller seat may include a lip configured to abut the wing and prevent the wing from moving proximally relative to the propeller seat. In some embodiments, the wing may be configured to slide distally relative to the propeller seat.

[0012] In some embodiments, the ridge is a first ridge, and the guide needle may include a second ridge distal to the first ridge. In some embodiments, in response to the second ridge contacting the spacer assembly, a sharp distal tip of the guide needle may be positioned distal to the distal end of the catheter. In some embodiments, the sharp distal tip of the guide needle may include a bevel, and the distance between the second ridge and the spacer assembly may be less than or equal to the positioning distance between the distal end of the catheter and the proximal end of the bevel of the guide needle.

[0013] In some embodiments, the spacer assembly may include a proximal end. In some embodiments, a first protrusion may contact the proximal end of the spacer assembly. In some embodiments, the first protrusion may be proximal to and spaced apart from the spacer assembly. In some embodiments, a second protrusion may be located no more than 2 mm from the spacer assembly.

[0014] In some embodiments, the first and / or second raised portion may include a loop. In some embodiments, the first raised portion may be disposed between the notch and the proximal end of the guide needle. In some embodiments, the second raised portion may be disposed between the notch and the proximal end of the guide needle and proximal to the first raised portion. In some embodiments, the catheter may include a peripheral venous catheter. In some embodiments, the guide needle may be configured to extend through the peripheral venous catheter.

[0015] It should be understood that the foregoing overview and the following detailed description are illustrative and exemplary of the claimed invention, and not restrictive. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined or other embodiments may be utilized, and structural changes may be made (unless required). Therefore, the following detailed description should not be considered restrictive. Attached Figure Description

[0016] Example implementations will be described and explained with additional specificity and detail using the accompanying drawings, wherein:

[0017] Figure 1A This is an enlarged view of the distal end of an existing catheter system before it is inserted into the patient's body;

[0018] Figure 1B This is an enlarged view of the distal end of an existing catheter system during insertion into a patient.

[0019] Figure 2A This is a top-view perspective view of a conduit system according to some embodiments;

[0020] Figure 2B It is based on some implementation methods Figure 2A A partially exploded view of the duct system;

[0021] Figure 2C It is based on some implementation methods Figure 2A A top-view perspective view of an example needle assembly and an example spacer assembly of a catheter system;

[0022] Figure 2D It is based on some implementation methods Figure 2A A magnified stereoscopic view of the needle assembly and spacer assembly viewed from above;

[0023] Figure 2E It is based on some implementation methods Figure 2A A cross-sectional view of the catheter system;

[0024] Figure 2F It is based on some implementation methods Figure 2A A cross-sectional view of the catheter system;

[0025] Figure 3A An example pin assembly according to some implementation methods and Figure 2A A three-dimensional view of the spacer assembly from above;

[0026] Figure 3B It is based on some implementation methods Figure 3A A magnified 3D view of the needle assembly and spacer assembly from above; and

[0027] Figure 3C According to some implementation methods, including Figure 3A Another example of a catheter system with needle and spacer components. Detailed Implementation

[0028] Now refer to Figure 1A The diagram shows the distal end 10 of a prior art catheter system before insertion into a patient. Before insertion into the patient and during its manufacture and assembly, a guide needle 12 can be inserted through the catheter 14 such that the sharp distal tip 16 of the guide needle 12 is distal to the distal end 18 of the catheter 14. The guide needle 12, extending beyond the distal end 18 of the catheter 14, facilitates puncture of the patient's skin and vascular system, allowing insertion of the prior art catheter system into the vascular system. In the assembled state, the distance between the distal end 18 of the catheter 14 and the proximal end 20 of the bevel 22 of the guide needle 12 is referred to as the positioning distance 24.

[0029] Now refer to Figure 1B In some cases, during the insertion of an existing technology catheter system through a patient's skin into a vascular system, a clinician may inadvertently advance the catheter 14 distally beyond the proximal end 20 of the bevel 22 or may inadvertently withdraw the guide needle 44 proximally, thereby reducing or eliminating the positioning distance 24. This reduces the success rate of insertion, causes catheter 14 to dislodge, and causes pain to the patient.

[0030] Now refer to Figure 2A-2BIn some embodiments, the catheter system 26 may include a catheter adapter 28, which may include a distal end 30, a proximal end 32, and an inner lumen 34 extending through the distal end 30 and the proximal end 32 of the catheter adapter 28. In some embodiments, the catheter system 26 may be similar to or identical to the prior art catheter systems discussed with respect to FIG1 in one or more features or operations. In some embodiments, the catheter system 26 may include a spacer assembly 36 disposed within the inner lumen 34 of the catheter adapter 28. In some embodiments, the spacer assembly 36 may include a spacer 38 and / or a spacer tube 40.

[0031] In some embodiments, the catheter system 26 may include a catheter 42 extending from the distal end 30 of the catheter adapter 28. In some embodiments, the catheter system 26 may include a needle hub 43 coupled to the proximal end 32 of the catheter adapter 28. In some embodiments, the catheter system 26 may include a guide needle 44, which may include a proximal end 46 and a pointed distal tip 48. In some embodiments, the proximal end 46 of the guide needle 44 may be secured within the needle hub 43.

[0032] In some embodiments, the conduit assembly may include a wing 50 extending outwardly from the conduit adapter 28. In some embodiments, the conduit assembly may also include the conduit adapter 28 and the conduit 42, and the needle assembly may include a needle hub 43 and a guide needle 44. In some embodiments, the needle assembly may include a propeller seat 52 extending outwardly from the needle hub 43. In some embodiments, the propeller seat 52 may include a lip 53 configured to abut the wing 50 and prevent the wing 50 from moving proximally relative to the propeller seat 52. In some embodiments, the wing 50 may be configured to slide distally relative to the propeller seat 52. In some embodiments, another wing 54 may extend outwardly from the conduit adapter 28 in the opposite direction to the wing 50.

[0033] In some embodiments, the sharp distal tip 48 of the guide needle 44 may include a bevel 56. In some cases, during insertion of the catheter 42 through the skin into the patient's vascular system, there may be a tendency for the distal tip 58 of the catheter 42 to be positioned distal to the proximal end 60 of the bevel 56. This may reduce or eliminate the positioning distance 62 in response to a clinician accidentally advancing the catheter 14 distally beyond the proximal end 20 of the bevel 22 or withdrawing the guide needle 44 proximally (see [link to documentation]). Figure 2EThis can occur due to low friction between the wings 50 and the paddle seat 52 during catheter 42 insertion, assembly conditions that reduce the positioning distance, or the clinician holding the wings 50 and paddle seat 52 together (leading to premature "money grip" advance). Eliminating the positioning distance 62 during initial insertion through the skin and vascular system walls is not desirable, as this reduces insertion success, leads to catheter 42 dislodgement, and can cause patient discomfort.

[0034] In some embodiments, the catheter system 26 may be configured to provide tactile indication to the clinician to prevent the distal end 58 of the catheter 42 from being positioned distal to the proximal end 60 of the ramp 56. Referring now... Figure 2C-2E In some embodiments, the guide needle 44 may include a ridge 64 disposed between the proximal end 46 and the sharp distal tip 48. In some embodiments, the ridge 64 may provide tactile indication to the clinician to prevent the distal end 58 of the catheter 42 from being positioned distal to the proximal end 60 of the ramp 56. More specifically, in some embodiments, the clinician may sense the ridge 64 of the contact spacer assembly 36, which may instruct the clinician to be careful not to withdraw the guide needle 44 further (proximal) relative to the catheter 42 and / or not to advance the catheter 42 further (distal) relative to the guide needle 44. In some embodiments, the ridge 64 may not only provide tactile indication but may also increase the force required by the clinician to position the distal end 58 of the catheter 42 distal to the proximal end 60 of the ramp 56, thereby reducing the risk of eliminating the positioning distance 62.

[0035] In some embodiments, in response to the protrusion 64 contacting the spacer assembly 36, the sharp distal tip 48 of the guide pin 44 may be positioned distal to the distal end 58 of the conduit 42. Therefore, the sharp distal tip 48 remains exposed from the conduit 42, thereby facilitating successful insertion.

[0036] Under assembly conditions (e.g., in) Figures 2A-2F (As shown in the diagram) The distance between the distal end 58 of the catheter 42 and the proximal end 60 of the bevel 56 is referred to as the positioning distance 62. The catheter system 26 is ready to be inserted into the patient in the assembled state. In some embodiments, the distance between the bulge 64 and the spacer assembly 36 (in the assembled state) may be less than or equal to the positioning distance 62 between the distal end 58 of the catheter 42 and the proximal end 60 of the bevel 56. Therefore, the bulge 64 may impede movement between the catheter 42 and the guide needle 44 by a distance greater than or equal to the positioning distance 62.

[0037] In some embodiments, the spacer assembly 36 may include a proximal end 66. In some embodiments, the proximal end 66 may include a spacer 38, which may be a low-resistance spacer and / or made of a flexible material. In some embodiments, the proximal end 66 may include a spacer cylinder 40.

[0038] In some embodiments, spacer 38 may include any suitable spacer. In some embodiments, spacer tube 40 may include any suitable spacer tube. In some embodiments, catheter system 26 may include or correspond to any suitable catheter assembly, such as, for example, BD NEXIVA. 商标 Closed intravenous catheter system, BD CATHENA 商标 Catheter system, BDVENFLON 商标 Pro safety shielded intravenous catheter system or other suitable catheter system.

[0039] In some embodiments, the protrusion 64 may be proximal to and spaced apart from the spacer assembly 36, for example, as Figure 2D-2E As shown. In some embodiments, the bulge 64 may be no more than 2 mm away from the spacer assembly. In some embodiments, the guide needle 44 may be covered after initial insertion through the skin and the wall of the vascular system. Covering the guide needle 44 reduces the risk of damage to the inner surface of the vascular system as the catheter 42 is advanced and further secured within the vascular system. When the guide needle 44 is covered, it is slightly retracted relative to the catheter 42, resulting in the bevel 56 being at least partially disposed within the catheter 42. In some embodiments, the bulge 64 may be positioned about 2 mm or no more than 2 mm away from the spacer cylinder 40 (in the assembled state) to cover the sharp distal tip 48 after initial insertion through the skin and the wall of the vascular system.

[0040] In some embodiments, the protrusion 64 may be more than 2 mm away from the spacer assembly 36 (in the assembled state). In some embodiments, the protrusion 64 may be less than 2 mm away from the spacer assembly 36 (in the assembled state). In some embodiments, the spacer assembly 36 may include a proximal end 66, and the protrusion 64 may contact the proximal end 66 of the spacer assembly 36 (in the assembled state). In some embodiments, the protrusion 64 may be positioned between 2 and 3 mm away from the spacer assembly 36 (in the assembled state).

[0041] In some embodiments, the guide needle 44 may include a notch 68 located distal to the bulge 64. In some embodiments, the notch 68 may be in fluid communication with the inner lumen of the guide needle 44 and may facilitate observation of flashback within the catheter 42.

[0042] Now refer to Figure 2FIn some embodiments, the proximal end 66 may include a spacer 38, which may be a low-resistance spacer and / or made of a flexible material. In some embodiments, the proximal end 66 may include a spacer cylinder 40, for example... Figure 2F As shown. In some embodiments, the spacer tube 40 may be made of a rigid or semi-rigid material, which may provide greater resistance and / or greater tactile indication in response to contact with the protrusion 64. In some embodiments, the spacer tube 40 may be made of metal.

[0043] In some embodiments, the protrusion 64 may contact the proximal end 66 of the spacer assembly 36 (in the assembled state), which can reduce the risk of any movement between the guide needle 44 and the catheter and facilitate maintaining the positioning distance 62. Embodiments of this disclosure may be combined. For example, Figure 2E It may include a low-resistance spacer 38 and / or include a proximal end 66 of a spacer cylinder 40.

[0044] Now refer to Figures 3A-3C In some embodiments, the ridge 64 is a first ridge, and the guide pin 44 may include a second ridge 70 distal to the first ridge. Figures 3A-3C A catheter system 26 in an assembled state, ready for insertion into a patient, is shown according to some embodiments. In some embodiments, a second protrusion 70 may provide additional tactile indication to prevent the distal end 58 of the catheter 42 from being positioned distal to the proximal end 60 of the bevel 56. In some embodiments, the second protrusion 70 may also provide greater force that clinicians need to overcome to position the distal end 58 of the catheter 42 distal to the proximal end 60 of the bevel 56 (a position that may be undesirable).

[0045] In some embodiments, in response to the second protrusion 70 contacting the spacer assembly 36, the sharp distal tip 48 of the guide needle 44 may be positioned distal to the distal end 58 of the catheter 42. In some embodiments, the sharp distal tip 48 of the guide needle 44 may include a bevel 56, and the distance between the second protrusion 70 and the spacer assembly 36 may be less than or equal to the positioning distance 62 between the distal end 58 of the catheter 42 and the proximal end 60 of the bevel 56 of the guide needle 44.

[0046] In some embodiments, the spacer assembly 36 may include a proximal end 66. In some embodiments, a second protrusion 70 may contact the proximal end 66 of the spacer assembly 36 (in the assembled state), the spacer assembly including a spacer 38 and / or a spacer tube 40. In some embodiments, this may reduce the risk of any movement between the guide needle 44 and the catheter and help maintain the positioning distance 62.

[0047] In some embodiments, the second protrusion 70 may be located proximal to and spaced apart from the spacer assembly 36 (in the assembled state). In some embodiments, the second protrusion 70 may be no more than 2 mm away from the spacer assembly 36 (in the assembled state). In some embodiments, the second protrusion 70 may be positioned about 2 mm or no more than 2 mm away from the spacer assembly 36 (in the assembled state) to help cover the sharp distal tip 48 after initial insertion through the skin and vascular system walls. In some embodiments, the second protrusion 70 may be more than 2 mm away from the spacer assembly 36 (in the assembled state). In some embodiments, the second protrusion 70 may be less than 2 mm away from the spacer assembly 36 (in the assembled state). In some embodiments, the second protrusion 70 may be positioned between 2 and 3 mm away from the spacer assembly 36 (in the assembled state).

[0048] In some embodiments, the first and / or second raised portion 70 may include a loop. In some embodiments, the first raised portion may be disposed between the notch 68 and the proximal end 46 of the guide needle 44 and / or the second raised portion 70 may be disposed between the notch 68 and the proximal end 46 of the guide needle 44 and proximal to the first raised portion. In some embodiments, the catheter 42 may include a peripheral intravenous catheter, a peripherally inserted central catheter, a midline catheter, or other suitable catheter. In some embodiments, the guide needle 44 may be configured to extend through the peripheral intravenous catheter in the assembled state.

[0049] All examples and conditional language described herein are intended for illustrative purposes to aid the reader's understanding of the invention and the inventive conceptions made by the inventors for further development of the art, and should be construed 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 system comprising: a catheter adapter having a distal end, a proximal end, and a lumen extending therethrough; a septum assembly disposed within the lumen of the catheter adapter, the septum assembly including a septum and a septum barrel having a distal end; a catheter extending from the distal end of the catheter adapter; a needle hub coupled to the proximal end of the catheter adapter; and a guide needle having a proximal end secured within the needle hub, a sharp distal tip including a bevel, and a hump disposed between the proximal end and the sharp distal tip; wherein, when the guide needle is withdrawn proximally from an assembled state, the hump first contacts a distal end of the septum assembly, and in response to the hump contacting the distal end of the septum assembly, the sharp distal tip of the guide needle is disposed distally of a distal end of the catheter, and in the assembled state, the hump is distal of the septum assembly and the distance between the hump and the septum assembly is less than or equal to the standoff distance between the distal end of the catheter and the proximal end of the bevel of the guide needle. In the assembled state, the hump is in contact with the distal end of the septum assembly.

2. The catheter system of claim 1, wherein, In the assembled state, the hump is distal of and spaced apart from the distal end of the septum assembly.

3. The catheter system of claim 1, wherein, In the assembled state, the hump is no more than 2 mm from the septum assembly.

4. The catheter system of claim 3, wherein, 5. The catheter system of claim 1, further comprising a wing extending outwardly from the catheter adapter, and a paddle seat extending outwardly from the needle hub, the paddle seat including a lip configured to abut the wing and prevent proximal movement of the wing relative to the paddle seat, and wherein the wing is configured to slide distally relative to the paddle seat. wherein the hump is a first hump, and the guide needle further includes a second hump distal of the first hump.

6. The catheter system of claim 1, wherein, in response to the second hump contacting the septum assembly, the sharp distal tip of the guide needle is disposed distally of a distal end of the catheter.

7. The catheter system of claim 6, wherein, the sharp distal tip of the guide needle includes a bevel, wherein, in the assembled state, the second hump is distal of the septum assembly and the distance between the second hump and the septum assembly is less than or equal to the standoff distance between the distal end of the catheter and the proximal end of the bevel of the guide needle.

8. The catheter system of claim 6, wherein, the first hump is in contact with the distal end of the septum assembly.

9. The catheter system of claim 6, wherein, In the assembled state, the first hump is distal of and spaced apart from the distal end of the septum assembly.

10. The catheter system of claim 6, wherein, In the assembled state, the second hump is no more than 2 mm from the septum assembly.

11. The catheter system of claim 6, wherein, the first hump and the second hump each include a loop.

12. The catheter system of claim 6, wherein, the guide needle includes a notch distal of the hump.

13. The catheter system of claim 1, wherein, the catheter is a peripheral intravenous catheter.

14. The catheter system of claim 1, wherein, the hump includes a loop.

15. The catheter system of claim 1, wherein, the distal end of the septum assembly includes the septum barrel.

16. The catheter system of claim 1, wherein, the distal end of the septum assembly includes the septum.

17. The catheter system of claim 1, wherein, ​

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