JP7518903B2 - Retractable Needle Catheter Delivery Device - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Patent No. 63/023,699, filed May 12, 2020 (Attorney Docket No. 56880-705.103), U.S. Provisional Patent No. 62/985,182, filed March 4, 2020 (Attorney Docket No. 56880-705.102), U.S. Provisional Patent No. 62/941,541, filed November 27, 2019 (Attorney Docket No. 56880-705.101), and U.S. Provisional Patent No. 62/941,211, filed November 27, 2019 (Attorney Docket No. 56880-704.101), the disclosures of which are incorporated herein by reference in their entireties.
FIELD OF THEINVENTION

The present invention relates generally to the field of medical devices and methods. More specifically, the present invention relates to catheter insertion devices, through-the-needle catheters, and related methods of their use.

Catheters are used in a variety of medical procedures to administer fluids to a patient and/or withdraw bodily fluids from a patient's veins. Catheters are generally made from flexible plastic materials or various polymers, and a needle is used to access a vein or artery in the body to introduce the catheter into the vessel. One catheter insertion technique is known as the "through-the-needle" technique. In this technique, a needle is inserted through the skin and into the blood vessel until the needle tip is properly located within the vessel. The proper location of the needle tip is usually recognized by a slight flow of blood through the needle and into a flush chamber in the needle hub. After the needle is in the proper position, the catheter is advanced through the needle and into the vessel. The needle is then withdrawn from the body, leaving the catheter embedded with the distal end of the catheter located within the vessel. However, typically the needle cannot be easily removed and discarded due to the interference of the catheter hub at the proximal end of the catheter. Thus, a common solution to this problem with through-the-needle catheters is to remove the needle from the catheter by splitting the needle. For example, the needle can be made splittable by forming two longitudinally aligned halves of the needle or by making a longitudinal cut or perforation in the body of the needle.

However, even with splittable needles, the needle portion presents a safety/disposal risk. Additionally, the catheter is typically manipulated by the operator while passing the catheter through the needle lumen. As a result, the catheter often becomes contaminated by bacteria from the patient's skin or due to manipulation by the operator.

Commonly assigned US 2019/0076628 describes a splittable needle catheter insertion tool that keeps the catheter free of contamination prior to and during needle penetration into a patient's target vein. The splittable needle catheter insertion tool design is a significant advancement in the art, but still requires a separate needle/handle removal step during deployment and needle disposal at the time of use.

It would therefore be desirable to provide a needle-type catheter insertion tool that does not require splitting or other disassembly of the insertion tool during catheter insertion. Moreover, it would be desirable for any such catheter insertion tool to be inherently safe and non-traumatic to the patient during use, and in particular to reduce any risk of accidental needlestick injury to medical personnel and patients. At least some of these objectives will be met by the present invention as described and claimed below.
(List of Background Art)

US2019/0076628 is described above. Other related patents and publications include US 8,974,411, US 4,957,489, US 2017/0209671, US 2019/328954, US 2019/314614, US 2019/351192, US 2019/201667, US 2009/264825, US 2004/116855, US 10,525,236, US 10,238,840, US 9,162,037, US 5,935,110, US 5,911,705, and US 5,129,884.

US Patent Application Publication No. 2019/0076628

In a first aspect, the present invention provides a catheter insertion system including both a catheter insertion device and a catheter to be inserted into a patient's venous system using the catheter insertion device. The catheter insertion device includes a housing extending along a longitudinal axis and a needle extending distally, typically coaxially, from a distal end of the housing. The needle will typically have a longitudinal passage aligned coaxially with the longitudinal axis of the housing. The catheter will typically be configured (typically having a suitable length, diameter, and shape) to allow the configured catheter to be advanced from a retracted position in the longitudinal passage within the needle, beyond the distal tip of the needle, to an extended position that typically has 25%-90%, usually 50%-75%, of the catheter length extending beyond the distal end of the needle when the catheter is in its extended position. The needle will be configured to be retracted back into the housing after the catheter has been advanced distally through the needle. In this manner, the needle can be safely retracted within the housing, and the housing can be secured to the patient, typically taped or otherwise secured to a location on the patient's skin adjacent the catheter entry site.

In an exemplary embodiment, the catheter insertion tool further comprises a slider, which is typically coupled to the proximal end of the needle. The slider may be mounted on an exterior surface of the housing such that the user may manually retract the needle proximally after the catheter has been advanced distally through the needle. In a specific embodiment, the slider may be configured to be retracted through or into an axial slot on the housing. In many embodiments, the needle and/or slider will be configured to prevent distal advancement of the needle after it has been retracted. In many cases, the catheters of the present invention will have an atraumatic distal tip. For example, the catheter may have a bullet tip, and a port is typically formed in or through the bullet tip by beveling a hemisphere or other rounded surface of the bullet tip at an angle to provide laterally deflected flow from the distal tip of the catheter. For example, the port may be beveled or otherwise oriented at an angle of 35° to 75° relative to the longitudinal axis of the catheter near the distal end.

In certain aspects of the invention, a venous or other luminal access catheter has a distal port (relative to the axial direction of the needle) configured to direct the outflow in a lateral direction. The distal port has a fixed rotational orientation relative to the longitudinal axis of the housing. In this manner, a user can easily control the rotational orientation of the distal port of the catheter as the catheter is advanced from the needle. Typically, a user will rotatably orient a catheter insertion device carrying the catheter such that the distal port on the catheter is positioned in the venous lumen at the desired rotational orientation. Typically, the distal region of the catheter will be advanced against the wall of the venous lumen and the distal port will be oriented to direct fluid flow from the distal port toward the center of the venous lumen. Such an orientation is advantageous as it promotes mixing of the fluid with more blood flow.

In other specific embodiments of the invention, the port may be configured to direct the outflow near its distal end at an angle in the range of 30° to 75° relative to the longitudinal axis of the catheter.

In other specific aspects, the catheter may have an atraumatic tip, such as a bullet tip, and the outflow port may be formed by an angled chamfer on one side of the bullet tip.

In a second aspect, the invention provides a method of inserting a catheter into a vein. The method includes manually advancing a needle such that it extends distally from a housing into the vein. The catheter is manually advanced from the needle such that a distal port of the catheter is at a desired location within the vein or other vascular lumen. The needle may then be manually retracted over the catheter into the housing. After the catheter is thus positioned, the housing may be secured to an area of the patient's skin, typically adjacent the catheter insertion site, and a fluid source may be connected to a connector at the proximal end of the catheter.

In certain method embodiments, the catheter has an atraumatic tip, such as a bullet tip, and the port may be formed by beveling one side of the bullet tip, e.g., oriented at an angle of 30° to 75° relative to the longitudinal axis of the catheter near the distal end. The method may further include releasing fluid from the non-longitudinally oriented port in a direction transverse to the blood flow to promote mixing. For example, the distal region of the catheter is advanced to be along one side of the venous wall, and the user orients the outlet port to direct fluid flow toward the center of the venous lumen to promote mixing.

In yet a further aspect, the present invention provides an integrated catheter insertion apparatus comprising a housing, a needle, and a venous access catheter. By "integrated" it is meant that the housing, needle, and catheter are provided as a single assembly or structure. In particular, the components of the integrated apparatus are intended to be used without disassembly, although the various components of the single assembly will be rearranged during use, and the apparatus will include a luer or other connector for subsequent attachment to external devices and equipment, both for venous access and for various purposes, including delivery of intravenous fluids, medications, transfusions, and the like, and for blood sampling and other treatments.

Any of these catheter insertion devices may further include a valve in the luer or other proximal connector that is configured to open in response to engagement with the external connector when the external connector is attached to the proximal connector. For example, the valve in the proximal connector may include a split valve that opens when advanced distally against a male rod or other fitting in an axial passage in the proximal connector.

In particular, a second exemplary embodiment of a catheter insertion device according to the present invention comprises an integrated structure comprising a housing having a longitudinal passage. A needle is slidably mounted within the longitudinal passage of the housing and has an axial lumen extending from a proximal end to a tissue-piercing distal tip. A catheter is slidably mounted within the needle lumen and has a distal port and a proximal connector. In an initial configuration of the catheter insertion device, the needle extends distally of the housing and the catheter is retracted proximally into the needle. The proximal connector of the catheter is distally advanceable and engages the proximal end of the housing. Such distal advancement extends the distal port of the catheter distally from the distal tip of the needle, and the needle is fully retractable over the catheter and into the housing after the catheter has been advanced distally.

In exemplary embodiments, the needle will typically have a length in the range of 0.5 cm to 3 cm, often 1.5 cm, but occasionally as short as 1 cm or more. The catheter may have an exposed length (catheter tube length when fully extended distally from the housing) in the range of 2 cm to 8 cm, typically 3 cm to 6 cm.

In certain embodiments, the spring assembly is disposed within the longitudinal passage of the housing and configured to retract the needle after the catheter is advanced distally from the needle. Typically, the spring assembly is configured to automatically retract the needle after the catheter is fully advanced distally from the needle. In a specific case, the spring assembly includes a coiled spring disposed coaxially over the needle and a locking mechanism that holds the needle in its distally advanced position with the spring in an axially compressed configuration. Release of the locking mechanism allows the spring to expand axially and drive the needle proximally, fully retracting the needle into the housing. In a specific case, the locking mechanism may be configured to automatically release the spring when the catheter is fully advanced and/or when the catheter retraction mechanism is actuated. Alternatively, in some embodiments, the spring assembly may be configured to be manually released, for example, by a button or other trigger on the housing.

In more specific aspects, the catheter locks into the housing after the catheter is fully advanced. In yet other specific embodiments, the housing may be configured to be taped or otherwise secured to the patient after the needle is retracted. In yet more specific cases, the proximal connector of the catheter includes a luer fitting for attachment to external structures such as fluid delivery tubing used in conventional medical systems.

In yet a further aspect of the invention, a catheter insertion device includes a housing having a longitudinal passage. A needle assembly is slidably mounted within the longitudinal passage of the housing and has an axial lumen extending from a proximal carriage to a tissue-piercing distal tip. Typically, a needle of the needle assembly extends distally from a distal end of the housing when the catheter insertion device is in an initial configuration. The device further includes a catheter assembly including a catheter slidably mounted within the needle lumen. The catheter typically includes a distal port, a proximal connector, and at least one arm extending distally from the proximal connector. The catheter is typically retracted proximally within the needle in the initial configuration of the catheter insertion device. The device typically further includes an axially compressed coil spring coaxially disposed over a proximal portion of the needle. The coil spring has a distal end that engages an inner surface of the longitudinal passage of the housing and a proximal end that engages a distal surface of a proximal hub of the needle when the insertion device is in its initial configuration. A locking disk is configured to hold the coil spring in its axially compressed configuration. Typically, the locking disk is further configured to be engaged by at least one arm of the catheter assembly when the catheter assembly is advanced distally relative to the housing. Typically, rotation of the catheter assembly will release the locking disk after full advancement, thus allowing the spring to expand axially and retract the needle. In certain instances of the catheter insertion device of the present invention, prior to rotation of the catheter assembly, the locking disk engages one or more retaining features on the interior surface of the longitudinal passage. In such instances, rotation of the catheter assembly rotates the locking disk and disengages it from the one or more retaining features, thus allowing the coil spring to expand and retract the needle assembly proximally.

In still further specific embodiments, the distal end of at least one arm of the catheter assembly may have a slot that engages with a retaining feature on the interior surface of the longitudinal passage after the catheter assembly is rotated. Thus, in a single motion of rotating the catheter assembly, the catheter assembly both engages with the retaining feature and releases the needle so that the needle is automatically retracted by the expansion of the spring.

In another specific aspect of the catheter insertion device, once the needle is fully retracted into the housing and the catheter is fully advanced out of the housing, the integrated device can be taped to the patient and connected to any conventional fluid or other drug source. There is no need to remove the needle, it is fully protected and locked within the housing and therefore does not present a safety issue.

In yet a further aspect of the invention, a method of inserting a catheter into a patient's vein. A needle on a housing is manually advanced into the vein, and the needle and housing carry the retracted catheter. The catheter is then manually advanced from the needle into the vein, and the needle is retracted over the catheter into the housing while the catheter remains in the vein. Once the needle is within the housing, the housing can be secured to the patient's skin and is available for connection to a conventional fluid delivery or other drug system.

In certain aspects of the method, the needle remains fully retracted within the housing when the housing is secured to the patient's skin. The needle may be retracted manually, e.g., a user retracts a slider on the housing. Alternatively, the needle may be retracted automatically, e.g., by releasing a restrained spring and axially translating the needle relative to the catheter and housing.

In yet other embodiments, automatic needle retraction is provided by mechanically coupling the catheter assembly to the needle, thus accomplishing "automatic" needle retraction while eliminating the need for a spring. For example, a pulley assembly can be provided by attaching the pulling end of one or more tethers to the needle and the drive end of each tether to the catheter. The tethers will be threaded over "pulley" features on the body such that as the drive ends of the tethers are translated distally as the catheter is pushed forward, the pulling ends of the tethers will advance proximally, pulling the needle proximally into the housing.

In still other cases, an elastic band or other element may be attached to the needle and housing and loaded under tension. The tensioned element may then be released, either automatically or manually, to drive the needle proximally into the housing.

In a third exemplary embodiment of the present invention, the integrated catheter includes, and in a preferred embodiment consists of, a housing, a needle cannula, a venous access catheter, and a spring configured to automatically retract the needle after the venous access catheter is advanced through the needle.

In particular, the catheter insertion device may comprise or consist of a housing having a longitudinal passage and a cannula or other needle assembly slidably mounted within the longitudinal passage of the housing. The longitudinal passage typically extends from a proximal extension to a distal end of the housing, and the needle cannula extends from a proximal hub to a tissue-piercing distal tip. In an initial configuration, the needle cannula extends distally from the distal end of the housing, fully exposing the tissue-piercing distal tip and allowing percutaneous introduction into the patient's venous lumen.

A venous access catheter is typically formed as an assembly including a catheter body or shaft having a distal port and slidably mounted within the needle lumen, a proximal connector, and at least one arm extending distally from the proximal connector. The catheter shaft is proximally disposed (retracted) within the needle lumen when the catheter insertion device is in its initial configuration. The spring typically comprises an axially compressed coil spring coaxially disposed over the proximal hub or other portion of the needle cannula, such that the distal end of the spring engages the inner surface of the longitudinal passage of the housing and the proximal end of the spring engages the distal face of the proximal hub of the needle when the catheter insertion device is in its initial configuration. A latch on the needle hub engages a locking feature on the inner surface of the longitudinal passage of the housing to hold the needle in place against the force of the compressed spring, and at least one arm of the catheter assembly is configured to disengage the latch from the locking feature after the catheter is advanced distally, allowing the spring to decompress and retract the needle into the housing.

In a specific example of the third embodiment of the catheter insertion device, the needle assembly may include a needle hub with at least one spring-loaded latch that engages a locking feature on the inner surface of the longitudinal passage in the housing to hold the needle in place, and at least one arm that engages and releases the at least one spring-loaded latch from the locking feature as the catheter is advanced. The at least one spring-loaded latch may include a cantilevered hook on the needle hub, and the locking feature may include an undercut or other slot formed on the inner surface of the longitudinal passage in the housing. The proximal connector of the catheter typically includes a female luer taper, and the proximal extension of the housing typically includes a male luer thread, which join to form a complete luer fitting when the catheter is fully advanced through the housing. In most cases, the housing is configured to be taped to the patient after the needle is retracted.

In a further aspect, the invention provides a catheter insertion system including both a catheter insertion device and a catheter to be inserted into a patient's venous system using the catheter insertion device. The catheter insertion device includes a housing extending along a longitudinal axis and a needle extending distally, typically coaxially, from a distal end of the housing. The needle will have a longitudinal passageway coaxially aligned with the longitudinal axis of the housing. The catheter has a length and is sized and shaped to be advanced from a retracted position within the longitudinal passageway of the needle to an extended position when at least a portion of the catheter length, typically one-half or more, extends beyond the distal tip of the needle.

In certain aspects of the invention, the catheter has a distal port (relative to the axial direction of the needle) configured to direct the outflow in a lateral direction. The distal port has a fixed rotational orientation relative to the longitudinal axis of the housing. In this manner, a user can easily control the rotational orientation of the distal port of the catheter as the catheter is advanced from the needle. Typically, a user will rotatably orient a catheter insertion device carrying the catheter such that the distal port on the catheter is positioned in the venous lumen at a desired rotational orientation. Typically, the distal region of the catheter will be advanced against the wall of the venous lumen and the distal port will be oriented to direct fluid flow from the distal port toward the center of the venous lumen. Such an orientation is advantageous as it promotes mixing of the fluid and blood flow.

In a further embodiment of the invention, the housing of the catheter insertion device may have an upper side and the outflow from the distal port of the catheter may be aligned in a direction toward the upper side of the housing. This allows the user to easily control the direction of the distal port since it will always be aligned with the upper side of the housing remaining visible at all times during catheter placement.

In other specific embodiments of the invention, the port may be configured to direct the outflow near its distal end at an angle in the range of 30° to 75° relative to the longitudinal axis of the catheter.

In other specific aspects, the catheter can have an atraumatic tip, such as a bullet tip, and the outflow port can be formed by an angled chamfer on one side of the bullet tip.

In yet other specific embodiments of the invention, the catheter may have an advancer (typically on the proximal hub) that is positioned through a channel in the top side of the housing such that the advancer is aligned with the outlet flow of the distal port. The needle may be retractable into the housing so that the housing may be secured to the patient without removing the needle. Alternatively, the housing and needle may be "splittable" to facilitate removal of the housing and needle from the catheter after the catheter has been introduced into the vein, as described in commonly assigned US 2019/0076628, the entire disclosure of which is incorporated herein by reference.
The present invention provides, for example, the following:
(Item 1)
1. A catheter insertion system, comprising:
a housing extending along a longitudinal axis;
a needle extending distally from a distal end of the housing and having a longitudinal passageway coaxially aligned with the housing;
a catheter having a length;
Equipped with
the catheter is sized and shaped to be advanced from a retracted position within the longitudinal passage of the needle to an extended position in which at least one-half of the catheter length extends beyond the distal tip of the needle;
A catheter insertion system, wherein the needle is configured to be retracted over the catheter back into the housing after the catheter has been advanced distally through the needle.
(Item 2)
2. The catheter insertion system of claim 1, wherein at least half of the catheter length extends beyond the distal tip of the needle after the catheter has been advanced.
(Item 3)
2. The catheter insertion system of claim 1, further comprising a slider coupled to a proximal end of the needle, the slider mounted on an exterior surface of the housing such that a user can manually retract the needle proximally after the catheter has been advanced distally through the needle.
(Item 4)
4. The catheter insertion system of claim 3, wherein the slider is configured to be retracted into an axial slot in the housing.
(Item 5)
2. The catheter insertion system of claim 1, wherein the needle and/or slider are configured to prevent distal advancement of the needle after the needle has been retracted.
(Item 6)
6. The catheter insertion system of any one of claims 1 to 5, wherein the housing is configured to be taped to a patient after the needle is retracted.
(Item 7)
7. The catheter insertion system of any one of claims 1 to 6, wherein the catheter has an atraumatic distal tip.
(Item 8)
8. The catheter insertion system of claim 7, wherein the distal end of the catheter has a bullet tip and a port is chamfered on the side of the bullet tip.
(Item 9)
4. The catheter insertion system of claim 1, wherein the port is oriented at an angle of 30° to 75° relative to the longitudinal axis of the catheter near the distal end.
(Item 10)
1. A method of inserting a catheter into a patient's vein, the method comprising:
manually advancing a needle from a housing into the vein, the needle carrying a catheter;
manually advancing the catheter from the needle;
manually retracting the needle over the catheter and into the housing;
securing the housing to the patient's skin;
connecting a fluid source to a connector at a proximal end of said catheter;
A method comprising:
(Item 11)
11. The method of claim 10, wherein the catheter has an atraumatic distal tip.
(Item 12)
2. The method of claim 1, wherein the distal end of the catheter has a bullet tip and a port is beveled on the side of the bullet tip.
(Item 13)
13. The method of claim 12, wherein the port is oriented at an angle of 30° to 75° relative to the longitudinal axis of the catheter near the distal end.
(Item 14)
14. The method of any one of claims 1-13, further comprising introducing a fluid through the catheter, the fluid being released from the non-longitudinally oriented port in a direction transverse to the direction of blood flow to promote mixing.
(Item 15)
1. An integrated catheter insertion device, comprising:
a housing having a longitudinal passage;
a needle slidably mounted within the longitudinal passage of the housing, the needle having an axial lumen extending from a proximal end to a tissue-piercing distal tip, the needle extending distally from the distal end of the housing in an initial configuration of the catheter insertion device;
a catheter slidably mounted within said needle lumen;
Equipped with
the catheter having a distal port and a proximal connector, the catheter being retracted proximally within the needle in an initial configuration of the catheter insertion device;
the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle;
The catheter insertion device, wherein the needle is fully retractable within the housing.
(Item 16)
16. The catheter insertion device of claim 15, wherein the needle is held in place by a releasable latch.
(Item 17)
17. The catheter insertion device of claim 16, wherein the catheter is configured to release the releasable latch when the catheter is fully advanced within the needle lumen, allowing the needle to be retracted.
(Item 18)
18. The catheter insertion device of claim 17, wherein the needle comprises a proximal hub having at least one spring-loaded latch that engages a locking feature on an inner surface of the longitudinal passage in the housing to hold the needle in place, and the catheter comprises at least one latch release feature that engages and releases the at least one spring-loaded latch when the catheter is advanced.
(Item 19)
20. The catheter insertion device of claim 18, wherein the at least one spring-loaded latch comprises a cantilevered hook on the needle hub and the locking feature comprises an undercut on the inner surface of the longitudinal passage in the housing.
(Item 20)
16. The catheter insertion device of claim 15, further comprising a slider coupled to a proximal end of the needle, the slider mounted on an exterior surface of the housing such that a user can manually retract the needle proximally after the catheter has been advanced distally through the needle.
(Item 21)
21. The catheter insertion device of claim 20, wherein the slider is configured to be retracted into an axial slot in the housing.
(Item 22)
16. The catheter insertion device of claim 15, further comprising a spring assembly within the longitudinal passage of the housing, the spring assembly configured to retract the needle after the catheter has been advanced distally from the needle.
(Item 23)
23. The catheter insertion device of claim 22, wherein the spring assembly is configured to automatically retract the needle after the catheter has been advanced distally from the needle.
(Item 24)
24. The catheter insertion device of claim 23, wherein the spring comprises a coil coaxially disposed on the needle and a locking mechanism that holds the needle in its distally advanced position with the spring in an axially compressed configuration, and release of the locking mechanism allows the spring to axially expand and retract into the needle.
(Item 25)
25. The catheter insertion device of claim 24, wherein the locking mechanism is configured to automatically release the spring when the catheter is fully advanced.
(Item 26)
26. The catheter insertion device of any one of claims 15-25, wherein the catheter locks into the housing after the catheter has been fully advanced.
(Item 27)
27. The catheter insertion device of any one of claims 15-26, wherein the housing is configured to be taped to a patient after the needle is retracted.
(Item 28)
28. The catheter insertion device of any one of claims 15-27, wherein the proximal connector of the catheter comprises a luer fitting.
(Item 29)
29. The catheter insertion device of any one of items 15-28, wherein the proximal connector of the catheter comprises a female Luer taper and a proximal portion of the housing comprises a male Luer thread, the female Luer taper and the male Luer thread mating when the catheter is fully advanced through the housing to form a complete Luer fitting.
(Item 30)
30. The catheter insertion device of any one of items 15-29, further comprising a valve in the proximal connector, the valve configured to open in response to engagement with an external connector when the external connector is attached to the proximal connector.
(Item 31)
31. The catheter insertion device of claim 30, wherein the valve in the proximal connector comprises a split valve that opens when advanced distally against a male fitting in an axial passage in the proximal connector.
(Item 32)
A catheter insertion device, comprising:
a housing having a longitudinal passage;
a needle assembly slidably mounted within the longitudinal passage of the housing, the needle assembly having an axial lumen extending from a proximal carriage to a tissue-piercing distal tip, the needle of the needle assembly extending distally from a distal end of the housing in an initial configuration of the catheter insertion device;
a catheter assembly including a catheter slidably mounted within the needle lumen, the catheter having a distal port, a proximal connector, and at least one arm extending distally from the proximal connector, the catheter being proximally retracted within the needle when the catheter insertion device is in an initial configuration;
an axially compressed coil spring coaxially disposed over a proximal portion of the needle, the axially compressed coil spring having a distal end that engages an interior surface of the longitudinal passage of the housing and a proximal end that engages a distal surface of the proximal hub of the needle when the catheter insertion device is in an initial configuration;
a locking disk for holding the coil spring in its axially compressed configuration;
Equipped with
The locking disk is configured to be engaged by the at least one arm of the catheter assembly when the catheter assembly is fully advanced distally relative to the housing, and rotation of the catheter assembly after the catheter assembly is fully advanced releases the locking disk, allowing the spring to expand axially and retract the needle.
(Item 33)
33. The catheter insertion device of claim 32, wherein prior to rotation of the catheter assembly, the locking disk engages one or more retaining features on an interior surface of the longitudinal passage, and rotation of the catheter assembly causes the locking disk to rotate and disengage from the one or more retaining features.
(Item 34)
34. The catheter insertion device of claim 33, wherein a distal end of the at least one arm of the catheter assembly has a slot that engages with the retaining feature after rotation of the catheter assembly.
(Item 35)
35. The catheter insertion device of any one of claims 32-34, wherein the housing is configured to be taped to a patient after the needle is retracted.
(Item 36)
36. The catheter insertion device of any one of claims 32-35, wherein the proximal connector of the catheter assembly comprises a luer fitting.
(Item 37)
1. A method of inserting a catheter into a patient's vein, the method comprising:
manually advancing a needle on a housing into the vein, the needle and housing carrying a catheter;
manually advancing the catheter from the needle into the patient's vein;
retracting the needle over the catheter and into the housing while the catheter remains in the patient's vein;
securing the housing to the patient's skin while the needle remains within the housing;
A method comprising:
(Item 38)
40. The method of claim 37, wherein the needle remains fully retracted within the housing when the housing is secured to the patient's skin.
(Item 39)
40. The method of claim 38, further comprising connecting a fluid source to a connector at a proximal end of the catheter and delivering fluid to the patient through the catheter.
(Item 40)
40. The method of claim 37, wherein retracting the needle over the catheter comprises manually retracting the needle by retracting a slider on the housing.
(Item 41)
40. The method of claim 37, wherein retracting the needle over the catheter comprises releasing a constrained spring and axially translating the needle relative to the catheter.
(Item 42)
A catheter insertion device, comprising:
a housing having a longitudinal passage;
a needle assembly slidably mounted within the longitudinal passage of the housing, the needle assembly having an axial lumen extending from a proximal hub to a tissue-piercing distal tip, the needle of the needle assembly extending distally from a distal end of the housing in an initial configuration of the catheter insertion device;
a catheter assembly including a catheter slidably mounted within the needle lumen, the catheter having a distal port, a proximal connector, and at least one arm extending distally from the proximal connector, the catheter being proximally retracted within the needle when the catheter insertion device is in an initial configuration;
an axially compressed coil spring coaxially disposed over a proximal portion of the needle, the axially compressed coil spring having a distal end that engages an interior surface of the longitudinal passage of the housing and a proximal end that engages a distal surface of the proximal hub of the needle when the catheter insertion device is in an initial configuration;
a latch on the needle hub;
Equipped with
the latch is configured to engage a locking feature on an inner surface of the longitudinal passage of the housing, the locking feature holding the needle in a fixed position against the force of the compressed spring, and the at least one arm of the catheter assembly is configured to disengage the latch from the locking feature, allowing the spring to be decompressed and retract the needle into the housing.
(Item 43)
43. The catheter insertion device of claim 42, wherein the needle assembly comprises a needle hub having at least one spring-loaded latch that engages with the locking feature on an inner surface of the longitudinal passage in the housing to hold the needle in place, and the at least one arm engages and releases the at least one spring-loaded latch from the locking feature as the catheter is advanced.
(Item 44)
Item 44. The catheter insertion device of item 43, wherein the at least one spring-loaded latch comprises a cantilevered hook on the needle hub, and the locking feature comprises an undercut on the inner surface of the longitudinal passage in the housing.
(Item 45)
45. The catheter insertion device of claim 42, wherein the proximal connector of the catheter comprises a female Luer taper and a proximal portion of the housing comprises a male Luer thread, the female Luer taper and the male Luer thread mating when the catheter is fully advanced through the housing to form a complete Luer fitting.
(Item 46)
46. The catheter insertion device of any one of claims 42-45, wherein the housing is configured to be taped to a patient after the needle is retracted.
(Item 47)
1. A catheter insertion system, comprising:
a housing extending along a longitudinal axis;
a needle extending distally from a distal end of the housing, the needle having a longitudinal passageway coaxially aligned with the housing;
a catheter having a length;
Equipped with
the catheter is sized and shaped to be advanced from a retracted position within the longitudinal passage of the needle to an extended position in which at least one-half of the catheter length extends beyond the distal tip of the needle;
the catheter has a distal port configured to direct an outflow in a lateral direction, the distal port having a fixed rotational orientation relative to the longitudinal axis when the catheter of the housing is advanced.
(Item 48)
Item 48. The catheter insertion system of item 47, wherein the housing has an upper side and the outflow is directed toward the upper side of the housing.
(Item 49)
49. The catheter insertion system of claim 47 or 48, wherein the outflow is directed at an angle of 30° to 75° relative to the longitudinal axis of the catheter near the distal end.
(Item 50)
50. The catheter insertion system of any one of claims 47-49, wherein the catheter has an atraumatic distal tip.
(Item 51)
51. The catheter insertion system of claim 47-50, wherein the distal end of the catheter has a bullet tip and a port is chamfered on the side of the bullet tip.
(Item 52)
52. The catheter insertion system of any one of items 47-51, wherein the catheter has an advancer, the advancer being positioned through a channel in the upper side of the housing such that the advancer is aligned with the outlet flow of the distal port.
(Item 53)
53. The catheter insertion system of claim 52, wherein both the housing and the needle are splittable to allow for removal of the catheter from above after the catheter has been introduced into a vein.
(Item 54)
53. The catheter insertion system of claim 52, wherein the needle is retractable into the housing.
(Item 55)
1. A method of inserting a catheter into a vein, the method comprising:
manually advancing a needle on a housing into the vein, the needle carrying a catheter having a length, a port at a distal end of the catheter being held in a fixed, non-longitudinal orientation relative to the needle;
manually advancing the catheter from the needle;
Including,
The port at the distal end of the catheter is positioned at a desired rotational orientation relative to the vein.
(Item 56)
56. The method of claim 55, wherein the port is oriented at an angle of 30° to 75° relative to the longitudinal axis of the catheter near the distal end.
(Item 57)
57. The method of claim 55 or 56, wherein the catheter has an atraumatic distal tip.
(Item 58)
58. The method of claim 57, wherein the distal end of the catheter has a bullet tip and the port is beveled on the side of the bullet tip.
(Item 59)
59. The method of any one of claims 55-58, further comprising introducing a fluid through the catheter, the fluid being released from the non-longitudinally oriented port in a direction transverse to the direction of blood flow to promote mixing.
(Incorporated by reference)

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention may be obtained by reference to the following detailed description, in which the principles of the invention are utilized, and the accompanying drawings.

The invention will be understood from the following description of the preferred embodiments considered in conjunction with the accompanying drawings.

FIG. 1 is a perspective view of a top view of a catheter insertion device constructed in accordance with the principles of the present invention.

FIG. 2 is a side view of the catheter insertion device of FIG.

FIG. 3 illustrates an intravenous catheter having an atraumatic distal tip with a laterally offset outflow port that can be delivered using the catheter insertion tool of the present invention.

FIG. 4 is a detailed view of the distal end of the intravenous catheter of FIG.

FIG. 5 is a detailed view of the distal end of the intravenous catheter of FIG. 5 shown in cross-section.

6A-6C illustrate the use of the catheter insertion tool of FIGS. 1 and 2 to deliver a venous catheter into a venous lumen. 6A-6C illustrate the use of the catheter insertion tool of FIGS. 1 and 2 to deliver a venous catheter into a venous lumen.

FIG. 7 is a perspective view of an integrated catheter insertion device constructed in accordance with the principles of the present invention.

8A-8C illustrate the integrated catheter insertion device of FIG. 7 and show steps in placing a catheter and retracting a needle according to the principles of the method of the present invention.

9 is an exploded view illustrating various components of the integrated catheter insertion device of FIG.

10A and 10B illustrate details of the spring-loaded needle retraction assembly of the present invention.

11A-11C illustrate steps of a method of the present invention for advancing a venous access catheter and retracting a venous access needle in accordance with a method of the present invention. 11A-11C illustrate steps of a method of the present invention for advancing a venous access catheter and retracting a venous access needle in accordance with a method of the present invention. 11A-11C illustrate steps of a method of the present invention for advancing a venous access catheter and retracting a venous access needle in accordance with a method of the present invention.

12A-12C are cross-sectional views taken along lines 12A-12A, 12B-12B, and 12C-12C in FIGS. 11A-11C.

13A and 13B are perspective views of a further embodiment of an integrated catheter insertion device constructed in accordance with the principles of the present invention shown in overall and cross-sectional views, respectively.

FIG. 14 is an exploded view illustrating various components of the integrated catheter insertion device of FIGS. 13A and 13B.

FIG. 15 is a perspective view of the housing of the integrated catheter insertion device of FIGS. 13A and 13B.

15A and 15B are detailed views of a partial luer fitting incorporated into the proximal end of the housing of FIG. 15 shown in overall and cross-sectional views, respectively.

FIG. 16 is a perspective view of a cannula of the integrated catheter insertion device of FIGS. 13A and 13B.

16A-16C are detailed views of the hub disposed at the proximal end of the cannula illustrated in FIG.

17A and 17B are detailed views illustrating how the partial luer fitting incorporated into the proximal end of the housing of FIG. 15 mates with a partial luer fitting incorporated into the proximal end of the catheter assembly to form a complete luer fitting.

FIG. 18 is a cross-sectional view of the housing illustrating channels formed in the interior walls of the housing that receive the two arms of the catheter assembly and allow for advancement and alignment of the catheter assembly within the housing.

19A-19C illustrate method steps of the present invention for deploying the integrated catheter insertion device of FIGS. 13A and 13B according to the principles of the present invention, where the integrated catheter insertion device is shown in a top cross-sectional view.

20A-20C illustrate method steps of the present invention for deploying the integrated catheter insertion device of FIGS. 13A and 13B according to the principles of the present invention, where the integrated catheter insertion device is shown in a side cross-sectional view.

21A and 21B illustrate the integrated catheter insertion device of FIGS. 13A and 13B after the catheter has been introduced into the vein and the cannula has been retracted into the housing.

22A-22C illustrate an optional blood control valve disposed within the catheter hub that opens from a proximal closed configuration (FIG. 22A) to a distal open configuration (FIG. 22C) as it is advanced distally into the hub passageway by attachment of an external Luer connector.

The illustrations presented herein are not actual views of any particular catheter insertion device, but are merely idealized representations employed to describe exemplary embodiments of the present disclosure. The following description provides specific details of the embodiments of the present disclosure to provide a complete description thereof. However, those skilled in the art will appreciate that the embodiments of the present disclosure may be practiced without employing many of such specific details. In fact, the embodiments of the present disclosure may be practiced in conjunction with conventional techniques employed in the industry. In addition, the description provided below does not include all elements to form a complete structure or assembly. Only those process acts and structures necessary to understand the embodiments of the present disclosure are described in detail below. Additional conventional acts and structures may also be used. Please also note that any drawings accompanying the drawings are for illustrative purposes only and therefore are not drawn to scale. In addition, elements common between the figures may have corresponding numerical designations.

As used herein, the terms "comprising," "including," and their grammatical equivalents do not exclude additional unrecited elements or method steps, and are inclusive or open-ended terms including the more restrictive terms "consisting of," "consisting essentially of," and their grammatical equivalents.

As used herein, the term "may" in reference to a material, structure, feature, or method act indicates that such term is contemplated for use in implementing the embodiments of the present disclosure, and such term is used in preference to the more restrictive term "is" to avoid any implication that other compatible materials, structures, features, and methods that may be used in combination therewith are or must be excluded.

As used herein, the term "configure" refers to the size, shape, material composition, and arrangement of at least one structure and at least one device that facilitates the operation of the structure or device in a predetermined manner.

As used herein, the singular forms following "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

As used herein, spatially relative terms such as "lower," "lower," "bottom," "upper," "top," and the like may be used for ease of description to describe the relationship of one element or feature to another as depicted in the figures. Unless otherwise specified, spatially relative terms are intended to encompass different orientations of materials in addition to the orientation depicted in the figures. For example, spatially relative terms may refer to a catheter insertion device when the device is placed on a horizontal surface (e.g., the position depicted in FIG. 1).

As used herein, the term "substantially" referring to a given parameter, characteristic, or condition means and includes the extent to which one of ordinary skill in the art would understand that the given parameter, characteristic, or condition is met, with some variance, such as within acceptable manufacturing tolerances. As an example, depending on the particular parameter, characteristic, or condition that is substantially met, the parameter, characteristic, or condition may be met at least 90.0%, at least 95.0%, at least 99.0%, or even at least 99.9%.

As used herein, the term "vascular catheter" means and includes any catheter that may be used to provide access to a patient's vascular system, such as one or more veins or one or more arteries, such as a midline catheter, a basicutaneous catheter, a cephalic catheter, a puncture catheter (for placement within a patient's chest or abdominal region), or another type of catheter. Vascular catheters as described herein may comprise arterial or venous catheters.

With reference to Figures 1 and 2, a catheter insertion tool 10 comprises a housing 12 and a needle 14. The needle has a sharp distal tip 16, which allows for transcutaneous insertion through a patient's skin and into a vascular lumen, such as a venous lumen. The sharp distal tip 16 defines an opening 18 at the distal end of the needle lumen through which a catheter may be introduced into a vein or other vascular lumen, as will be described in more detail below.

The slider 20 is slidably mounted on the surface of the housing 12. The slider 20 is coupled to or near the proximal end of the needle 14, as will be further described below, and allows a user to manually retract the needle into the interior space within the housing. Typically, the slider 20 will be connected through an axial slot 21 or other feature formed in the surface of the housing 12.

A catheter 22 is slidably mounted within the housing 12. The catheter 22 will have a proximal housing 24 (typically being or including a Luer connector) and a distal end 30 (typically a bullet tip), as described in more detail elsewhere herein.
Catheter 22 moves freely within housing 12 and needle 14, such that catheter 22 can be manually advanced by pushing the catheter, typically by pushing proximal portion 24 in a proximal direction. However, to prevent such movement during needle insertion, a locking sheath 28 is provided around the proximal portion of catheter 22. As long as locking sheath 28 is in place, as illustrated in Figures 1 and 2, distal tip 30 of the catheter cannot be advanced further into the needle, as shown in dashed lines.

3, 4, and 5, the bullet-tip catheter 22 includes a flexible shaft 23 having a bullet-shaped distal tip 30 (e.g., having a hemispherical distal end) and a proximal hub 24 (typically a luer fitting). As best seen in FIGS. 4 and 5, a distal outflow port 32 is formed in the rounded bullet tip 30 of the catheter shaft 23 and is oriented at an angle relative to the longitudinal axis of the shaft lumen 25. In the illustrated embodiment, the outflow port 32 is formed by cutting or "chamfering" a portion of the bulbous or domed distal end 32 of the catheter shaft. Typically, the chamfer will be formed at an angle α in the range of 30° to 75°, as illustrated in FIG. 5. Other laterally offset outflow ports may also be used. As will be explained in more detail below, the outflow port is desirably capable of directing fluid from the distal port 32 of the catheter shaft 23 only at an angle that is offset or deflected laterally from the longitudinal axis of the shaft. This allows the user to direct the outflow of the catheter 100 so that it is directed across the blood flow and will promote intravenous mixing.

In an exemplary embodiment, the length of the needle 14 is in the range of 1.5 cm to 5 cm, typically in the range of 2.5 cm to 3.5 cm. The catheter shaft 23 may have a length in the range of 6 cm to 20 cm, typically in the range of 8 cm to 14 cm. In such an embodiment, a distal region of the catheter shaft having a length in the range of 1.5 cm to 6 cm, typically in the range of 2 cm to 4 cm, is available to be advanced from the needle and positioned within the patient's vein, as described below.

As shown in Figures 6A-6C, the bullet tip catheter 22 may be placed into the patient's venous lumen VL by first selecting a target insertion site T on the patient's skin S. The sharp tip 18 on the needle 14 is manually pushed through the skin S at the target site T in a conventional manner so that the tip enters the venous lumen VL and may be positioned generally in the center of the lumen. The needle will typically be inserted through the skin S at an angle β, typically in the range of 30° to 45°, relative to the venous lumen VL, as shown in Figure 6A.

Now referring to FIG. 6B, once the needle distal tip 18 is in position within the venous lumen VL, the locking sheath 28 will be removed from around the catheter 22, allowing the user to manually push the luer connector 24 or other proximal hub distally so that the distal region of the catheter 22 enters the venous lumen VL. Typically, the proximal hub will be fully advanced to engage the proximal end 12 of the housing, as shown in FIG. 6B, although in other instances it may be desirable to only partially advance the catheter, resulting in a shorter length of the catheter within the vessel.

Now referring to FIG. 6C, once the desired length of the catheter has been introduced into the venous lumen VL, the slider 20 will be manually retracted in a proximal direction, retracting the needle 14 fully proximally into the interior space of the housing 12. The proximal fitting 24 (typically a conventional luer connector) is ready to be connected to an external fluid source in a conventional manner. The housing 12 may be taped or otherwise secured to the patient's skin S, and the catheter will be considered fully deployed.

7 and 8A-8C, a catheter insertion device 100 includes a housing 102, a cannula 104 (typically a needle with a sharp distal tip 114), and an intravenous access catheter 106. The catheter is part of a catheter assembly that includes a proximal connector 108 at the proximal end of the catheter. The proximal connector 108 may be a conventional luer type fitting having proximal threads 116 of a type that mates with conventional medical fluid delivery systems. The proximal connector 108 also typically has a gripping feature 118b, which ultimately matches the gripping feature 118a at the proximal end of the housing 102, as shown in FIG. 8C.

In the initial configuration (i.e., the configuration used for initial needle penetration into a patient's vein), the catheter 106 will be fully retracted into the needle 104 and housing 102, as shown in FIGS. 7 and 8A. The proximal connector 108 on the catheter assembly will also be spaced proximally from the proximal end of the housing 102 while being slidably attached to the housing by a pair of arms 110. The arms 110 serve several functions, as described below, but will act as a rail or guide for advancing the catheter assembly into the interior of the housing 102 as the connector 108 is pushed distally by the user, as seen in FIGS. 7 and 8A.

The catheter insertion device 100 further includes a reflux window 112 on the housing 102 and a pair of taping wings 120. The reflux window 112 allows the user to detect when blood refluxes into the device after the sharp distal tip 114 initially enters the vein, confirming that access has been achieved. The taping wings facilitate taping, wrapping, or otherwise securing the housing to the patient after the catheter 106 is positioned within the target vein.

After the needle 104 is introduced into the vein, typically by manual placement in a conventional manner, retrograde flow will be observed through the window 112 and the catheter 106 will be advanced distally from the needle 104 by advancing the proximal connector 108 distally, as shown in FIG. 8B. At this point, the catheter 106 will be advanced, but the needle 104 is still in place and the catheter is not yet locked to the housing. Both retracting the needle 104 and locking the catheter 106 can be accomplished by rotating the proximal connector 108 until the gripping features 118a and 118b are in axial alignment, as shown in FIG. 8C. Some internal mechanism is required to effect this change, but in terms of the user, it is a simple twist of the connector 108 that both retracts the needle and locks the catheter in place.

9, the internal components of the catheter insertion device 100 will be identified and described. The needle 104 has a needle carriage 138 attached to its proximal end. The needle carriage 138 has a pair of engagement wedges 140 (only one of which is visible in FIG. 9) projecting radially outward from its proximal end. A locking disk 134 is located proximally on the needle carriage 138 and includes a pair of locking tabs 136. Each of the arms 110 of the catheter assembly has a locking slot 130 formed near their respective distal ends. A coil spring 124 is disposed between the needle 104 and the housing 102 such that when the needle 104 is fully advanced relative to the housing, the spring will be compressed between the needle carriage 138 and the forward inner end (103, FIGS. 10A and 10D) of the housing 102, as will be described in more detail below.

10A and 10B, details of the internal needle retention and release mechanism will now be described. In both Figs. 10A and 10B, the needle 104 is fully extended distally and held in place by the locking disk 134, which engages and retains the needle carriage 138. The coil spring 124 is fully compressed between the distal surface of the retention flange 135 at the proximal end of the needle carriage 138 and the proximal surface 103 of the internal passageway 105 of the housing 102.

The locking disk 134 is held in place by engagement between locking tabs 136 extending radially outward from the locking disk and blocking features 144 formed on the interior surface of the interior passageway 105 of the housing 102. Rotation of the locking disk 134 about the longitudinal axis of the housing 102 (perpendicular to the plane of the locking disk) will disengage the locking tabs 136 from the blocking features 144 and allow the disk to translate proximally, urged by the expansion of the spring 124, releasing the needle carriage 138 and spring 124. The mechanism required to rotate the locking disk is described in connection with FIGS. 11A-11C and 12A-12C.

Figure 11A illustrates the needle retention and retraction mechanism in the same state as shown in Figures 10A and 10B. In addition, Figure 11 shows one arm 110 of the pair of arms that forms part of the catheter assembly shown in Figure 9. The proximal connector 108 is shown in dashed lines. All components of the catheter insertion device 100 shown in Figure 11A are in their initial configuration with the needle fully advanced and the catheter 106 retracted inside the needle as shown in Figures 7 and 8A.

To both advance the catheter 106 and release the locking disk 134, the catheter assembly may be translated distally by pushing the proximal connector 108 and engaging the distal surface of the proximal connector against the proximal end of the housing 102, as shown in FIG. 11B. Such axial translation of the connector 108 will fully extend the distal tip of the catheter 106 beyond the sharp distal tip 114 of the needle 104, as shown in FIG. 8B. However, at this point, as shown in FIG. 11B, the needle 104 remains advanced distally and the catheter 106 is not yet locked in place. In this state, the catheter 106 may be accidentally retracted by simply pulling the proximal connector 108 and/or by pushing the distal end of the catheter 106 proximally.

The proximal connector 108 may be rotated to the position shown in FIGS. 8C and 11C to both lock the catheter 106 to the housing 102 and release the locking disk 134 and allow the needle 104 to retract under the force of the spring 124. Such rotation causes the distal surface 142 of the arm 110 to engage and rotationally displace the locking tab 136 on the locking disk 134. Such rotation causes the locking tab 136 to move out of axial alignment with the blocking feature 144. With the locking tab displaced, the locking disk 134 is free to translate proximally under the force of the spring 124, which is released from compression.

At the same time, as the locking arm 112 rotates, the locking slot 130 on the arm will engage and lock onto the blocking feature 144 on the inner wall of the housing 102, as shown in FIG. 11C. Such engagement and locking prevents further axial translation of the catheter assembly. As an additional safety feature, subsequent rotation of the proximal connector 108 is prevented by capturing the locking tab 136 on the locking disk 134 between one side of the alignment rail 148 and an opposing surface of the proximal end of the arm 110, as shown in FIG. 11C. It should be appreciated that the alignment rail 148 serves as a guide for the locking tab as it is translated proximally by the expansion of the spring 124, thus ensuring that the locking tab is positioned between the alignment rail and the arm 110 when the needle is fully retracted and the catheter is fully advanced. This safety feature is particularly advantageous because it prevents accidental release of the needle after the housing is taped to the patient and connected to the fluid delivery system.

The positioning of the alignment rail 148 and arm 110 of the catheter assembly during various stages of operation of the catheter insertion device 100 can be seen in Figures 12A-12C, which are cross-sectional views taken along lines 12A-12A, 12B-12B, and 12C-12C of Figures 11A-11C.

13A and 13B, a catheter insertion and attachment apparatus 200 according to a third embodiment of the present invention includes a housing 202, a needle cannula 204, such as a hypotube needle or similar injection device having a sharp distal tip 214, and an venous access catheter 206. The venous access catheter 206 is received within an axial passage 203 (FIG. 13B) in the housing 202 and has a partial (internal) luer fitting 218 at its proximal end. A pair of arms 210 are attached to the partial luer fitting 218 and extend therefrom in a distal direction parallel to the longitudinal axis of the venous access catheter 206. The distal end of each arm 210 terminates in a wedge tip 228 configured to release the needle cannula 204 from its temporary attachment to the housing 202 when the catheter 206 is advanced distally within the passage 203 of the housing 202. A second partial (outer) luer fitting 208 is formed on the proximal extension 234 at the proximal end of the housing 202. The second partial luer fitting includes external luer threads 208a, which form the attachment portion of the luer when the external tubing is attached to the catheter. In particular, the luer becomes functional when the inner luer fitting 218 is inserted into the outer luer fitting 208, as will be described in more detail below. Typically, the housing 202 will include a pair of taped wings 216 to facilitate fastening of the housing 202 to the patient's skin after catheter insertion and needle retraction.

13A and 13B, in the initial configuration of the catheter insertion and attachment device 200, the needle cannula 204 is fully extended distally from the housing 202 and the access catheter 206 is fully retracted proximally into the housing 202. In this configuration, the cannula needle 204 is ready to be percutaneously inserted into the patient's vein. The sharp distal tip 214 is inserted into the lumen of the target vein and entry is confirmed by observing reflux in the window 212 formed in the wall of the housing 202. A complete description of needle insertion, catheter advancement, needle retraction, and external tubing connections is provided below with reference to FIGS. 19A-19C and 20A-20C.

14, the components of the catheter insertion and attachment device 200 are illustrated in isolation. The catheter insertion and advancement device 200 will typically consist of only four components. In addition to the previously described housing 202, needle cannula 204, and venous access catheter 206, the device 200 will typically include only a coil or other compression spring 224. It is a particular advantage of this embodiment of the invention that only four separate components are required, substantially simplifying the manufacture and assembly of the complete product. As best seen in FIG. 14, the partial luer fitting 218 on the access catheter 206 includes a plurality of locking or retention teeth 200a formed on its exterior surface. As seen in FIG. 13B, a plurality of locking or retention teeth 220b are also formed on the interior surface of the proximal extension 234 of the housing 202. When the catheter 206 is fully advanced into the housing 202, the locking teeth 220a on the partial luer fitting 218 will engage with the locking teeth 218b on the proximal extension of the housing. In this manner, the teeth 220a and 220b, formed as an interlocking ratchet, will engage one another and lock or attach the catheter to the housing, preventing accidental backout. The venous access catheter 206 further includes a distal catheter port 226. The distal catheter port 226 may take any conventional form, but will typically have an upward configuration similar to those previously described.

14, the needle cannula 204 has a hub 238 at its proximal end opposite a sharp distal tip 214 formed at the distal end. The needle hub 238 has a pair of engaging hooks or tangs 242 that serve to "releasably" lock the needle cannula in a distal forward configuration after the catheter has been advanced and prior to retraction of the needle, as will be described in more detail below.

15, 15A, and 15B, the proximal extension 234 of the housing 202 will be described in more detail. The proximal extension 234 comprises a pair of semi-cylindrical shell elements 232 having a pair of laterally opposed gaps 230 therebetween. The luer threads 208 extend around the semi-cylindrical shell elements 238 and beyond the gaps 230, as best seen in FIG. 18, allowing the wedge tip 228 on the arm 210 of the catheter assembly 206 to be advanced under the external threads 208 and through a channel 250 on the inner wall of the axial passageway 203 of the housing 202. In this manner, the wedge tip 228 can be advanced to the needle cannula hub 238 as the catheter 206 is advanced through the needle cannula 204. When the wedge tips 228 reach the needle cannula hub 238, they will disengage the needle cannula hub from the housing wall, allowing the compressed spring 224 to be decompressed and retract the needle proximally over the catheter and into the axial passage 203 of the housing 202, as described in more detail below.

16 and 16A-16C, the needle cannula assembly 204 will be described in more detail. The needle cannula assembly 204 includes a conventional needle shaft 204a having a sharp distal tip 215 at its distal end. A cannula hub 238 is attached to the proximal end of the shaft 204 and includes a cylindrical wall having a pair of opposed cantilever spring elements 240 formed therein. The cantilever springs are attached to the walls at their distal ends, as will be described below, such that engaging hooks or tangs 242 at their proximal ends may be resiliently compressed inwardly to release the needle hub from engagement with the housing wall. Each tang or hook 242 has a beveled surface 244 that is configured to be engaged and compressed by the wedge tip 228 of the arm 210 to effect the desired release. As shown in FIG. 16C, spring coil 224 is maintained in a compressed configuration prior to release of the needle for retraction into the housing. Release of needle cannula hub 238 from engagement with housing 202 allows spring 228 to decompress and drive needle cannula assembly 204 proximally, thereby causing needle cannula assembly 204 to fully retract into the housing prior to attachment of outer tubing.

17A and 17B, the engagement between the partial luer fitting 218 on the venous access catheter 206 and the partial luer fitting 208 on the housing 202 will be described. In FIG. 17A, the partial luer fitting 218 has been advanced to a point where the locking teeth 220a nearly enter the interior of the proximal extension 234 of the housing 202. It can be seen that the arm 210 enters the housing 202 through a gap 230 that exists in the wall of the proximal extension 234. In particular, the arm 210 passes under the luer threads 208. When the partial luer fitting 208 on the catheter 206 is fully advanced into the proximal extension 234, the combination of the partial luer fittings 208 and 218 will form a complete male luer fitting that is suitable for attachment to a conventional female luer fitting such as commonly found on medical tubing. After full insertion of the catheter 206 into the housing 202, the locking teeth 220a on the partial luer fitting 218 will engage with the locking teeth 220b (FIG. 15B) on the inside surface of the proximal extension 234. In this manner, the catheter will be locked in place within the housing.

FIG. 18 shows a cross-sectional view of the needle cannula 204 and catheter assembly 206 within the housing 202. In particular, it can be seen that the arm 210 has been advanced through a channel 250 formed on the inner wall of the axial passage 203 within the housing 202. As shown in FIG. 18, the venous access catheter 206 remains within the inner lumen of the needle cannula 204 after the catheter has been advanced and the needle catheter has been retracted.

19A-19C and 20A-20Cxx, the step-by-step advancement of the catheter assembly 206 into the housing 202 and retraction of the needle cannula 204 into the housing will be described. As shown in FIG. 19A, the sharp distal tip 214 of the needle cannula 204 extends fully distally of the housing 202 and is ready for insertion through the patient's skin and into the venous lumen. At this point, the catheter assembly 206 is fully retracted proximally and held in place by the engagement of the wedge tip 228 of the arm 210 with the proximal extension 234 of the housing 202. The wedge tip 228 on the distal end of the arm is initially positioned under the lower thread 208 and within the gap 230.

After the needle 204 has been advanced into the venous lumen, the catheter 206 is advanced into the venous lumen by pushing the partial luer fitting 218 distally into the partial luer fitting 208 formed on the proximal extension 234 of the housing, as shown in FIGS. 19B and 20B. The external lower threads 208 are disposed on the exterior of the partial lower fitting 218 in one orientation (FIG. 19B) and are attached to a semi-cylindrical element of the proximal extension in the other orientation (FIG. 20B). As the wedge tips 228 are advanced distally, they engage engagement hooks or tangs 242 on the needle hub 238. In particular, the sloped surface of the wedge tip 228 engages the beveled surface 244 (FIGS. 16A and 16B) of the cantilever spring 240, as best seen in FIG. 19B, forcing the spring inward and disengaging the engagement hook or tang 242 from the retention slot 252 formed on the inner wall of the axial passage 203 of the housing 202. When the engagement hook 42 is released from the engagement slot 52, the needle hub 238 is released and free to translate, and the compressed spring 24 will decompress, translating the needle hub 238 proximally and retracting the needle cannula 204 completely into the housing, as shown in FIGS. 19C and 20C.

21A and 21B, placement of the catheter 206 into the lumen of the vein V is accomplished by percutaneously advancing the needle through the patient's skin S, advancing the catheter further into the venous lumen, and then retracting the needle, as just described. In a preferred embodiment, the distal port 226 of the catheter 206 is directed upwardly, which would provide the advantages previously described in this patent application.

22A-22C, an alternative inner luer fitting 318 (shown without an outer luer fitting for ease of illustration) may be modified by increasing its length (relative to the previously illustrated inner luer fitting 218a) and providing a short male fitting 320 which defines a blood outflow port 322 on a distal surface 324 of its internal axial passage 330. A blood control valve 328 having a split valve element 334 may be translatably disposed within the axial passage 330 of the inner luer fitting 318.
The blood control valve 328 is typically formed from a blood compatible polymer such as a silicone polymer and may conveniently have a "top hat" configuration with a rim 332 formed circumferentially around its proximal end and a split valve element 334 formed in its distal surface. The rim 332 is configured to act as both a seal and a bearing surface that allows the blood control valve 328 to be advanced from a proximal location, as shown in FIG. 22A, to a distal location, as shown in FIG. 22C. As will be explained in more detail below, the split valve element 334 closes when the needle initially penetrates the target vein or other vessel, allowing blood backflow and gas venting but preventing blood leakage from the hub. After penetration is confirmed by observing backflow, an external IV connector 340 or other connector is attached to the internal luer fitting.

The external IV connector 340 is typically attached to a fluid delivery tube 342, which may be connected to a conventional saline or other fluid delivery bag (not shown). As shown in FIG. 22B, the external IV connector 340 typically has an internal male rod 344 molded into the body of the external IV connector 340, which has a central lumen 346 that may receive fluid flow from the tube 342 when such flow is initiated. When a needle (e.g., needle 204 in FIG. 16) is inserted distally into a target vein or other patient vessel, blood flows proximally through the needle lumen into the hub 318, which is typically clear or has a clear window that will allow the user to observe the blood "backflow" that confirms that the needle has entered the vessel. The split valve element 334 of the blood control valve 328 allows gases initially present in the hub 318 to be released while preventing blood loss from the hub. To open the valve element and allow injection, the tip 344a of the male rod 344 engages the rim 332 of the blood control valve 328 and presses the split valve element 334 against the male posts 320, which force the split valve element open, as shown in FIG. 22C. The silicone or other polymeric material of the valve element is displaced to fit around the male posts inside the catheter assembly hub and will remain there for the remainder of the procedure.

While the present invention has been described herein with respect to certain illustrated embodiments, those skilled in the art will recognize and understand that it is not so limited. Rather, many additions, deletions, and modifications to the illustrated embodiments may be made without departing from the scope of the invention as claimed, including its legal equivalents. In addition, features from one embodiment may be combined with features of another embodiment as envisioned by the inventors while still falling within the scope of the invention. Furthermore, embodiments of the present disclosure have utility with different and various tool types and configurations.

Claims (13)

1. An integrated catheter insertion device, comprising:
a housing having a longitudinal passage;
a needle slidably mounted within the longitudinal passage of the housing, the needle having an axial lumen extending from a proximal end to a tissue-piercing distal tip, the needle extending distally from the distal end of the housing in an initial configuration of the catheter insertion device, the needle being held in place by a releasable latch;
a catheter slidably mounted within the axial lumen , the catheter having a distal port and a proximal connector, the catheter being retracted proximally within the needle in the initial configuration of the catheter insertion device, the catheter being configured to release the releasable latch when the catheter is fully advanced within the axial lumen , allowing the needle to be retracted;
the proximal connector of the catheter is distally advanceable to a proximal end of the housing to extend the distal port of the catheter distally from the distal tip of the needle;
The catheter insertion device, wherein the needle is fully retractable within the housing. The catheter insertion device of claim 1, wherein the needle comprises a proximal hub, the releasable latch comprises at least one spring-loaded latch element that engages a locking feature on an inner surface of the longitudinal passage in the housing to hold the needle in place, and the catheter comprises at least one latch release feature that engages and releases the at least one spring-loaded latch element when the catheter is advanced. 3. The catheter insertion device of claim 2, wherein the at least one spring-loaded latch element comprises a cantilevered hook on the proximal hub and the locking feature comprises an undercut on the inner surface of the longitudinal passage in the housing. The catheter insertion device of claim 1, further comprising a spring assembly in the longitudinal passage of the housing, the spring assembly configured to retract the needle after the catheter is advanced distally from the needle. The catheter insertion device of claim 4, wherein the spring assembly is configured to automatically retract the needle after the catheter is advanced distally from the needle. The catheter insertion device of claim 5, wherein the spring assembly comprises a coil coaxially disposed on the needle, and the releasable latch holds the needle in an advanced position distal to the needle with the spring in an axially compressed configuration, and release of the releasable latch allows the spring to axially expand and retract into the needle. The catheter insertion device of claim 6, wherein the releasable latch is configured to automatically release the spring when the catheter is fully advanced. The catheter insertion device of claim 1, wherein the catheter engages with the housing after the catheter is fully advanced. The catheter insertion device of claim 1, wherein the housing is configured to be taped to a patient after the needle is retracted. The catheter insertion device of claim 1, wherein the proximal connector of the catheter comprises a luer fitting. The catheter insertion device of claim 1, wherein the proximal connector of the catheter comprises a female luer taper and the proximal portion of the housing comprises a male luer thread, and the female luer taper and the male luer thread join to form a complete luer fitting when the catheter is fully advanced through the housing. The catheter insertion device of claim 1, further comprising a valve in the proximal connector, the valve configured to open in response to engagement with an external connector when the external connector is attached to the proximal connector. The catheter insertion device of claim 12, wherein the valve in the proximal connector comprises a split valve that opens when advanced distally against a male fitting in an axial passage in the proximal connector.

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