Catheter system inserts and related methods

Abstract

An insert for a catheter system may include a distal end, a proximal end, and an intermediate portion disposed between the distal and proximal ends. The distal end of the insert may include a male port, and the proximal end of the insert may include a female port opposite the male port. The insert may be configured to extend through an adapter and / or a needleless connector of the catheter system to reduce exposure of the adapter and / or the needleless connector to blood that may flow through an inner lumen of the insert. The inner lumen of the insert may extend through the male port, the intermediate portion, and the female port.

Description

Background Art

[0001] Intravenous catheters are commonly used for a variety of infusion therapies. For example, intravenous catheters can be used to infuse fluids into patients, such as saline solutions, various medications, and total parenteral nutrition. Intravenous catheters can also be used to draw blood from patients.

[0002] Common types of intravenous catheters include peripherally inserted central catheters ("PIVCs"), peripherally inserted central catheters ("PICCs"), and midline catheters. An intravenous catheter may include an "over-the-needle" catheter, which may be mounted on a needle having a sharp distal tip. The sharp distal tip may be used to pierce the patient's skin and vasculature. Insertion of the intravenous catheter into the vasculature may be performed after the needle has penetrated the vasculature. The needle and intravenous catheter are typically inserted through the skin into the patient's vasculature at a shallow angle, with the bevel of the needle facing upward and away from the patient's skin.

[0003] To verify proper placement of the introducer needle and / or intravenous catheter within the vasculature, the user typically confirms the presence of blood flashback, which may be visible to the user. In some cases, the introducer needle may include a notch disposed toward the distal end of the introducer needle, and in response to the distal tip of the introducer needle being positioned within the vasculature, blood may flow proximally through the needle lumen, exit the needle lumen through the notch, and then travel proximally between the outer surface of the introducer needle and the inner surface of the intravenous catheter.

[0004] Thus, with the IV catheter at least partially transparent, the user can visualize a small amount of blood "backflow" and thus confirm the placement of the IV catheter within the vascular system. The presence of a vascular system entry indicator (such as a flashback) can facilitate successful placement of the IV catheter. Once the placement of the introducer needle within the vascular system has been confirmed, the user can temporarily block flow in the vascular system and withdraw the introducer needle, leaving the IV catheter in place for future blood draws and / or infusions.

[0005] During a blood draw, blood can pass through an adapter and / or needleless connector, which is in fluid communication with the intravenous catheter via an extension tube. After collecting the blood sample, the user typically rinses the adapter with saline and replaces the needleless connector to prevent contamination with blood. Flushing the adapter and replacing the needleless connector adds additional steps to the user's workflow and can increase the risk of blood exposure. Furthermore, there is a risk of hemolysis when blood flows through the uneven, non-uniform path of the needleless connector.

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in the environments described above. Rather, this background is provided only to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0007] The present disclosure generally relates to inserts and related systems and methods. In some embodiments, an insert for a catheter system can include a distal end, a proximal end, and a midsection disposed between the distal and proximal ends. In some embodiments, the distal end of the insert can include a convex port, and the proximal end of the insert can include a concave port opposite the convex port. In some embodiments, the insert can be configured to extend through an adapter and / or a needleless connector of the catheter system to reduce exposure of the adapter and / or the needleless connector to blood that can flow through the lumen of the insert. In some embodiments, the lumen of the insert can extend through the convex port, the midsection, and the concave port.

[0008] In some embodiments, the middle portion may include an elongated tubular portion and a tapered portion or a stepped portion. In some embodiments, the tapered portion or the stepped portion may be proximal to the elongated tubular portion and adjacent to the elongated tubular portion. In some embodiments, the outer diameter of the elongated tubular portion may be uniform. In some embodiments, the outer diameter of the tapered portion may increase in a proximal direction.

[0009] In some embodiments, the insert can include a septum that can be disposed within the concave port. In some embodiments, the septum can seal the concave port. In some embodiments, the septum can include a split septum. In some embodiments, the insert can be integrally formed or integrally formed as a single unit. In some embodiments, the elongated tubular portion can have a length greater than the length of the tapered or stepped portion.

[0010] In some embodiments, the catheter system may include a catheter assembly that may include one or more of the following options: a catheter adapter; a catheter that extends distally from the catheter adapter; an extension tube; an adapter that is connected to the proximal end of the extension tube; and a needleless connector that is connected to the adapter. In some embodiments, the extension tube may include a proximal end and a distal end, and the distal end may be connected to the catheter adapter. In some embodiments, the insert may be inserted through the needleless connector and adapter such that the convex port is arranged within the extension tube and / or such that the tapered or stepped portion is proximal to the needleless connector. In some embodiments, in response to the insert being inserted through the needleless connector and adapter of the catheter system, blood may be configured to flow through the insert and may not contact the needleless connector or adapter.

[0011] In some embodiments, the catheter system may include a needle assembly and / or a blood collection tube holder connected to the needle assembly. In some embodiments, the needle assembly may include a body that may include a distal end, a proximal end, and a lumen extending through the distal end of the body and the proximal end of the body. In some embodiments, the distal end of the body may include a convex port. In some embodiments, the needle assembly may include a needle extending from the proximal end of the body and configured to receive an evacuated blood collection tube.

[0012] In some embodiments, a blood sampling method may include inserting an insert through a needleless connector and adapter of a catheter system. In some embodiments, the insert may be inserted through the needleless connector and adapter such that the male port is disposed within the extension tube and at least a portion of the tapered portion or stepped portion is proximal to the needleless connector.

[0013] In some embodiments, the method may include inserting the needle assembly into a concave port of the insert. In some embodiments, after the insert is inserted through the needleless connector and the adapter, and after the needle assembly is inserted into the concave port of the insert, the catheter may be inserted into the patient's vein. In some embodiments, the catheter assembly may include an introducer needle that may extend through the catheter and may be used to insert the catheter into the vein. In some embodiments, after the catheter is inserted into the vein, the introducer needle may be removed from the catheter system and the patient.

[0014] In some embodiments, after the catheter is inserted into the patient's vein, the needle can be inserted into the evacuated blood collection tube and blood can be collected in the evacuated blood collection tube. In some embodiments, after the blood is collected in the evacuated blood collection tube, the needle assembly can be removed from the female port of the inserter and a syringe can be connected to the female port.

[0015] In certain embodiments, concave port can be threaded.In certain embodiments, syringe being connected to concave port can comprise syringe being screwed to concave port.In certain embodiments, conduit and catheter assembly can be flushed by starting or depressing syringe so that the fluid in the syringe is discharged into catheter assembly.In certain embodiments, after flushing conduit, during the indwelling period of conduit in patient's vein or when conduit stays in patient's vein, can remove insert from catheter system.

[0016] It should be understood that the summary description above and the detailed description below are illustrative examples and do not limit the invention as summarized in the claims. It should be understood that the various embodiments are not limited to what is depicted in the accompanying drawings. It should also be understood that these embodiments can be combined, other embodiments can be used, and structural changes can be made (unless so claimed) without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be considered to have a limiting meaning. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0018] Figure 1A is an upper perspective view of an example insert according to some embodiments;

[0019] Figure 1B is a cross-sectional view of an insert according to some embodiments;

[0020] Figure 2 is a partially exploded view of an example catheter system according to some embodiments;

[0021] Figure 3A is an upper perspective view of a catheter system according to some embodiments;

[0022] Figure 3B is a cross-sectional view of a catheter system according to some embodiments;

[0023] Figure 4 is an upper perspective view of a catheter system according to some embodiments, showing an example blood collection device connected to the catheter system;

[0024] Figure 5 is an upper perspective view of a catheter system showing an example syringe connected to the catheter system according to some embodiments; and

[0025] Figure 6 is an upper perspective view of a catheter system showing the catheter system with an insert removed, according to some embodiments. DETAILED DESCRIPTION

[0026] All examples and conditional language listed here are intended to help readers understand the present invention and the concepts contributed by the inventors to the development of this field; the examples and language are therefore to be interpreted as not being limited to such specific examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications can be made thereto without departing from the spirit and scope of the present invention.

[0027] Now refer to Figures 1A-1BIn some embodiments, an insert 10 for a catheter system can include a distal end 12, a proximal end 14, and an intermediate portion 16 disposed between the distal end 12 and the proximal end 14. In some embodiments, the distal end 12 of the insert 10 can include a male port 18, and the proximal end 14 of the insert 10 can include a female port 20 opposite the male port 18. In some embodiments, the insert 10 can be configured to extend through an adapter and / or a needleless connector of a catheter system to reduce exposure of the adapter and / or needleless connector to blood, which can flow through a lumen 22 of the insert 10. In some embodiments, the lumen 22 of the insert 10 can extend through the male port 18, the intermediate portion 16, and the female port 20. In some embodiments, the female port 20 can be threaded, which can facilitate connection to an irrigation device.

[0028] In some embodiments, the intermediate portion 16 can include an elongated tubular portion 24 and an increased diameter portion 26, which can include a tapered portion or a stepped portion. In some embodiments, the increased diameter portion 26 can be located proximal to and adjacent to the elongated tubular portion 24. In some embodiments, the outer diameter of the elongated tubular portion 24 can be uniform. In some embodiments, the elongated tubular portion 24 and a portion of the lumen 22 extending therethrough can be straight, which reduces the risk of hemolysis in the insert 10 compared to a needleless connector. In some embodiments, when the increased diameter portion 26 includes a tapered portion, the outer diameter of the tapered portion can increase in a proximal direction.

[0029] In some embodiments, insert 10 can include a septum 27 that can be disposed within female port 20. In some embodiments, septum 27 can seal female port 20. In some embodiments, septum 27 can include a split septum, which can include a split membrane. In some embodiments, insert 10 can be integrally formed or monolithically formed as a single unit. In some embodiments, the length of elongated tubular portion 24 can be greater than the length of enlarged diameter portion 26.

[0030] Now refer to Figure 2-3B In some embodiments, catheter system 28 can include a catheter assembly 30 that can include one or more of the following: a catheter adapter 31; a catheter 32 that extends distally from catheter adapter 31; an extension tube 34; an adapter 36 that connects to a proximal end 38 of extension tube 34; and a needleless connector 40. In some embodiments, needleless connector 40 can be coupled to adapter 36.

[0031] In some embodiments, the extension tube 34 may include a proximal end 38 and a distal end 42 that may be connected to the catheter adapter 31. In some embodiments, the extension tube 34 may be connected to or integral with a side port of the catheter adapter 31 or another portion of a particular catheter adapter. In some embodiments, the needleless connector 40 may include a BD Q-SYTE TM Connector or another suitable needleless connector.In some embodiments, adapter 36 can include a Y-shaped adapter, a straight adapter or another suitable adapter.

[0032] In some embodiments, insert 10 can be inserted through needleless connector 40 and / or adapter 36 such that male port 18 is disposed within extension tube 34. In some embodiments, male port 18 can be disposed within adapter 36 and within extension tube 34 and can not extend distally to adapter 36. In some embodiments, insert 10 can be pushed or inserted into adapter 36 until the internal shape of adapter 36 and / or extension tube 34 prevents further distal movement of insert 10. In some embodiments, male port 18 can be disposed within adapter 36 proximal to extension tube 34. In these and other embodiments, blood can be prevented from contacting adapter 36 and / or needleless connector 40. In some embodiments, the outer diameter of insert 10 can be equal to or approximately equal to the inner diameter of extension tube 34 and / or adapter 36, such that a seal is formed between insert 10 and extension tube 34 and / or adapter 36, preventing blood from entering or contacting adapter 36.

[0033] In some embodiments, inserter 10 may be inserted through needleless connector 40 and / or adapter 36 such that enlarged diameter portion 26 is located proximal to and / or adjacent to needleless connector 40. In some embodiments, in response to insertion of inserter 10 through needleless connector 40 and adapter 36 of catheter system 28, blood may be configured to flow through inserter 10 and may not contact needleless connector 40 and / or adapter 36.

[0034] In some embodiments, catheter system 28 can include a needle assembly 44 and / or a blood collection tube holder (not shown) connected to needle assembly 44. In some embodiments, needle assembly 44 can include a body 48 that can include a distal end 50, a proximal end 52, and a lumen 54 extending through distal end 50 and proximal end 52 of body 48. In some embodiments, distal end 50 of body 48 can include a male port 56. In some embodiments, needle assembly 44 can include a needle 58 extending from the proximal end of body 48 and configured to receive an evacuated blood collection tube.

[0035] In some embodiments, an elastomeric sheath 49 can be connected to the body 48 of the needle assembly 44. In some embodiments, the proximal end of the needle 58 can be enclosed within the elastomeric sheath 49. In some embodiments, the elastomeric sheath 49 can include an open distal end and a closed proximal end. In some embodiments, in response to the evacuated blood collection tube pushing the elastomeric sheath 49 distally, the needle 58 can pierce the elastomeric sheath 49 and be inserted into the lumen of the evacuated blood collection tube.

[0036] In some embodiments, a blood sampling method may include inserting insert 10 through needleless connector 40 and / or adapter 36 of catheter system 28. In some embodiments, the method may include coupling needle assembly 44 to female port 20 of insert 10. In more detail, in some embodiments, the method may include inserting needle assembly 44 into female port 20 of insert 10. For example, distal end 50 of body 48 may be inserted into female port 20. In some embodiments, after insert 10 is inserted through needleless connector 40 and / or adapter 36, and after needle assembly 44 is inserted into female port 20 of insert 10, catheter 32 may be inserted into a vein of the patient.

[0037] like Figure 2 As shown, in some embodiments, the catheter system 28 can include an introducer needle 60 that can extend through the catheter 32 and can be used to insert the catheter 32 into a vein. In some embodiments, the proximal end of the introducer needle 60 can be secured within a needle hub 62. In some embodiments, after the catheter 32 is inserted into the vein, the introducer needle 60 can be removed from the catheter system 28 and the patient.

[0038] Now refer to Figure 4 In some embodiments, after the catheter 32 is inserted into the patient's vein, the needle 58 can be inserted into the evacuated blood collection tube 64, and blood can be collected in the evacuated blood collection tube 64. According to some embodiments, when the patient's blood is collected through the inserter 10, both the adapter 36 and the needleless connector 40 can be bypassed and thus avoid contamination.

[0039] Now refer to Figure 5In some embodiments, after blood is collected in the evacuated blood collection tube 64, the female port 20 of the insert 10 can be removed and a syringe 66 or another flushing device can be coupled to the female port 20. In some embodiments, connecting the syringe 66 to the female port 20 can include threading the syringe 66 to the female port 20. In some embodiments, the syringe 66 can be connected to the female port 20 by another suitable mechanism. In some embodiments, the catheter 32 and the catheter assembly 30 can be flushed by activating or depressing the syringe 66 to release fluid in the syringe 66 into the catheter assembly 30.

[0040] Now refer to Figure 6 In some embodiments, inserter 10 may be removed from catheter system 28 after catheter 32 has been flushed, during an indwelling period of catheter 32 in the patient's vein, or while catheter 32 remains in the patient's vein.

[0041] The present invention may be embodied in other specific forms without departing from its structure, method, or other essential features as generally described herein and claimed below. The described embodiments are to be considered in all respects as illustrative only and not restrictive. Therefore, the scope of the present invention is specified by the appended claims rather than by the foregoing description. All variations that fall within the meaning and range of equivalents of the claims are to be included within their scope.

Claims

1. An insert for a catheter system, wherein the use of the catheter system includes collecting a blood sample, the insert comprising: a distal end, the distal end comprising a male port; a proximal end comprising a female port opposite the male port; a middle portion disposed between the distal end and the proximal end, wherein the middle portion includes an elongated tubular portion and a tapered or stepped portion proximal to and adjacent to the elongated tubular portion, wherein an outer diameter of the elongated tubular portion is uniform, and wherein the outer diameter of the tapered or stepped portion increases in a proximal direction; and an inner lumen extending through the male port, the intermediate portion, and the female port; wherein the insert is integrally formed as a single unit; Wherein, the catheter system comprises: A catheter assembly, comprising: catheter adapters; a catheter extending distally from the catheter adapter; an extension tube, the extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is connected to the catheter adapter; an adapter connected to the proximal end of the extension tube; and a needleless connector connected to the adapter; wherein, in response to inserting the inserter through the needleless connector and adapter of the catheter system, blood is configured to flow through the inserter and away from the needleless connector and adapter, and The insert creates a smooth and uniform path in the needleless connector, so that when blood flows through the smooth and uniform path in the needleless connector, there is no risk of hemolysis.

2. The insert of claim 1 further comprising a septum disposed within the female port.

3. The insert according to claim 2, wherein The diaphragm comprises a split diaphragm.

4. The insert of claim 1, wherein: The use of the catheter system also includes any of the following options: connecting to an injection device using the female port of the inserter of the catheter system; and The female port of the insert of the catheter system is connected to an irrigation device.

5. The insert of claim 1, wherein: The length of the elongated tubular portion is greater than the length of the tapered or stepped portion.

6. A catheter system, wherein the use of the catheter system includes collecting a blood sample, the catheter system comprising: A catheter assembly, comprising: catheter adapters; a catheter extending distally from the catheter adapter; an extension tube comprising a distal end and a proximal end, wherein the distal end is connected to the catheter adapter; an adapter connected to the proximal end of the extension tube; and a needleless connector connected to the adapter; and An insert, comprising: a distal end, the distal end comprising a male port; a proximal end comprising a female port opposite the male port; a middle portion disposed between the distal end and the proximal end, wherein the middle portion includes an elongated tubular portion and a tapered or stepped portion proximal to and adjacent to the elongated tubular portion, wherein an outer diameter of the elongated tubular portion is uniform, and wherein the outer diameter of the tapered or stepped portion increases in a proximal direction; and a lumen extending through the male port, the intermediate portion, and the female port, wherein the insert is inserted through the needleless connector and the adapter such that the male port is disposed within the extension tube and the tapered or stepped portion is proximal to the needleless connector, wherein the insert is integrally formed as a single unit; wherein, in response to inserting the inserter through the needleless connector and adapter of the catheter system, blood is configured to flow through the inserter and away from the needleless connector and adapter; and The insert creates a smooth and uniform path in the needleless connector, so that when blood flows through the smooth and uniform path in the needleless connector, there is no risk of hemolysis.

7. The catheter system of claim 6, wherein: The insert also includes a septum disposed within the female port.

8. The catheter system of claim 7, wherein: The diaphragm comprises a split diaphragm.

9. The catheter system of claim 6, wherein: After the insert is inserted through the needleless connector and adapter of the catheter system for collecting a blood sample, blood can flow through the insert without contacting the needleless connector or the adapter, so that there is no need to flush the adapter or replace the needleless connector after collecting the blood sample.

10. The catheter system of claim 6, further comprising a needle assembly and a blood collection tube holder connected to the needle assembly, wherein The needle assembly includes a body including a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the body, wherein the distal end of the body includes a male port, wherein the needle assembly further includes a needle extending from the proximal end of the body and configured to receive an evacuated blood collection tube.

11. The catheter system of claim 6, wherein: The use of the catheter system also includes any of the following options: connecting to an injection device using the female port of the inserter of the catheter system; and The female port of the insert of the catheter system is connected to an irrigation device.

12. The catheter system of claim 6, wherein: The length of the elongated tubular portion is greater than the length of the tapered or stepped portion.

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