DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT
20220355080 · 2022-11-10
Inventors
Cpc classification
A61B5/150396
HUMAN NECESSITIES
A61M25/0637
HUMAN NECESSITIES
A61M2025/0681
HUMAN NECESSITIES
A61B5/150992
HUMAN NECESSITIES
A61M25/0113
HUMAN NECESSITIES
International classification
Abstract
A delivery device for delivering an instrument into a catheter assembly may include a housing having a proximal end, a distal end, and a slot. The delivery device may include a guide feature, which may be disposed within the housing. The guide feature may extend through the slot. The delivery device may include an instrument disposed within the housing and extending through the guide feature. In response to movement of the guide feature along the slot in the distal direction a first distance, a first end of the instrument may be advanced in the distal direction a second distance, which may be greater than the first distance. A second end of the instrument may be stationary with respect to the housing.
Claims
1. A delivery device for delivering an instrument into a catheter assembly, comprising: a housing having a proximal end, a distal end, and a slot; a guide feature disposed within the housing, wherein the guide feature extends through the slot, wherein the guide feature comprises a channel, wherein the channel is generally U-shaped; and an instrument disposed within the housing and extending through the channel, wherein in response to movement of the guide feature along the slot in a distal direction, the instrument moves through the channel and a first end of the instrument is advanced in the distal direction, wherein a second end of the instrument is stationary with respect to the housing.
2. The delivery device of claim 1, wherein in response to movement of the guide feature along the slot in the distal direction a first distance, the first end of the instrument is advanced in the distal direction a second distance, wherein the second distance is greater than the first distance.
3. The delivery device of claim 1, wherein the first end of the instrument is advanced in the distal direction beyond the distal end of the housing in response to the guide feature being fully advanced along the slot in the distal direction.
4. The delivery device of claim 1, wherein the housing further comprises extension tubing extending outwardly from a distal portion of the housing, wherein the second end of the instrument is coupled to the extension tubing, wherein the instrument comprises a catheter.
5. The delivery device of claim 1, wherein the instrument comprises a catheter, further comprising a guidewire disposed within the catheter, wherein in response to movement of the guide feature along the slot in the distal direction, the guidewire and the catheter move through the channel.
6. The delivery device of claim 5, wherein the first end of the guidewire is advanced in the distal direction beyond the distal end of the housing in response to the guide feature being fully advanced along the slot in the distal direction.
7. The delivery device of claim 5, wherein in response to movement of the guide feature along the slot in the distal direction a first distance, the first end of the guidewire is advanced in the distal direction a second distance, wherein the second distance is greater than the first distance.
8. The delivery device of claim 1, further comprising support tubing extending from the guide feature and coupled to the guide feature, wherein in response to movement of the guide feature along the slot in the distal direction a first distance, the instrument moves through the support tubing and the first end of the support tubing is advanced in the distal direction the first distance.
9. The delivery device of claim 1, wherein the channel is horizontally oriented within the housing.
10. The delivery device of claim 1, wherein the channel is vertically oriented within the housing.
11. The delivery device of claim 1, wherein a portion of the instrument between the second end of the instrument and the guide feature is generally parallel with a longitudinal axis of the delivery device.
12. The delivery device of claim 1, wherein a portion of the instrument between the second end of the instrument and the guide feature is angled with respect to a longitudinal axis of the delivery device.
13. The delivery device of claim 1, wherein a portion of the instrument between the first end and the guide feature is parallel with a longitudinal axis of the delivery device.
14. The delivery device of claim 1, wherein a portion of the instrument between the first end and the guide feature is angled with respect to a longitudinal axis of the delivery device.
15. The delivery device of claim 1, wherein the guide feature further comprises an advancement tab configured to be moved by a hand of a user.
16. A delivery device for delivering an instrument into a catheter assembly, comprising: a housing having a proximal end, a distal end, and a slot; a guide feature disposed within the housing, wherein the guide feature extends through the slot; and an instrument disposed within the housing and extending through the guide feature, wherein a second end of the instrument is stationary with respect to the housing, wherein in response to movement of the guide feature along the slot in a distal direction a first distance, the first end of the instrument is advanced in the distal direction a second distance, wherein the second distance is greater than the first distance.
17. The delivery device of claim 16, wherein the first end of the instrument is advanced in the distal direction beyond the distal end of the housing in response to the guide feature being fully advanced along the slot in the distal direction.
18. The delivery device of claim 16, wherein the instrument comprises a catheter.
19. The delivery device of claim 16, wherein the guide feature comprises a channel, further comprising a guidewire disposed within the catheter, wherein in response to movement of the guide feature along the slot in the distal direction, the guidewire moves through the channel.
20. A catheter system, comprising: a delivery device, comprising: a housing having a proximal end, a distal end, and a slot; a guide feature disposed within the housing, wherein the guide feature extends through the slot; and an instrument disposed within the housing and extending through the guide feature, wherein a second end of the instrument is stationary with respect to the housing, wherein in response to movement of the guide feature along the slot in a distal direction a first distance, the first end of the instrument is advanced in the distal direction a second distance, wherein the second distance is greater than the first distance; and a catheter assembly coupled to the distal end of the housing, the catheter assembly comprising a catheter adapter and a catheter extending distally from the catheter adapter, wherein the first end of the instrument is advanced in the distal direction beyond the distal end of the housing or a distal end of the catheter in response to the guide feature being fully advanced along the slot in the distal direction.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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DESCRIPTION OF EMBODIMENTS
[0033] Referring now to
[0034] In some embodiments, the delivery device 10 may include a housing 14. In some embodiments, the housing may include a distal end 16, a proximal end 18, and a slot 20. In some embodiments, the housing 14 may encase or enclose the instrument when the instrument is in a retracted position. In some embodiments, the housing 14 may be cylindrical. In some embodiments, the housing 14 may be non-transparent. In some embodiments, as illustrated in
[0035] In some embodiments, the delivery device 10 may include a guide feature 22, which may be disposed within the housing 14. In some embodiments, the guide feature 22 may extend through the slot 20. In some embodiments, the guide feature 22 may include an advancement tab 26, which may be configured to be moved by a hand of a user. In some embodiments, the guide feature 22 may be moveable along the slot 20 to advance the instrument in a distal direction 23 and/or retract the instrument in a proximal direction 25.
[0036] In some embodiments, the advancement tab 26 may include various shapes, sizes, and configurations. In some embodiments, the advancement tab 26 may be disposed on a top, side, or bottom of the delivery device 10. In some embodiments, the slot 20 may be disposed in any portion of the housing 14. In some embodiments, the slot 20 may be disposed in a left or right side of the housing 14. In some embodiments, the slot 20 may be disposed in a top or bottom of the housing 14. In some embodiments, the slot 20 may be aligned with a longitudinal axis 27 of the delivery device 10. In some embodiments, the housing 14 may include multiple slots 20, which may allow for a particular guide feature 22 with an increased width to extend through the slots 20.
[0037] In some embodiments, the guide feature 22 may include an instrument support structure, such as, for example, a channel 24. In some embodiments, the channel 24 may be generally U-shaped. In some embodiments, the channel 24 may include a U-shape having arms that are generally parallel to each other (as illustrated in
[0038] In some embodiments, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, a first end 28 of the instrument may be advanced distally. In some embodiments, a second end 30 of the instrument may be stationary with respect to the housing 14. For example, in some embodiments, the second end 30 of the instrument may be fixed inside and/or to the housing 14.
[0039] In some embodiments, the delivery device 10 may include a blood control septum 31, which may be disposed within a lumen of the delivery device 10. In some embodiments, the septum 31 may be disposed proximate or towards the distal end 16 of the delivery device 10. In some embodiments, the instrument may penetrate the septum 31 when the instrument is fully retracted or the instrument may penetrate the septum 31 in response to being advanced. In some embodiments, the septum 31 may prevent blood from entering an interior of the delivery device 10.
[0040] In some embodiments, the instrument may include the catheter 12, and the second end 30 of the instrument may be coupled to extension tubing 32. In some embodiments, the extension tubing 32 may be coupled to a blood collection device. In some embodiments, the blood collection device may include any suitable type of blood collection device. In some embodiments, the blood collection device may include a reservoir. In some embodiments, the blood collection device may include a vacuum tube, test tube, or syringe. In some embodiments, the blood collection device may include an adapter, which may be configured to hold a test tube or syringe. In some embodiments, a fluid pathway of the delivery device 10 may include the catheter 12 and the extension tubing 32.
[0041] In some embodiments, the catheter 12 may be used for fluid infusion and/or blood withdrawal. In some embodiments, a guidewire 34 may be disposed within the catheter 12. In some embodiments, the guidewire 34 may be used to facilitate placement of the catheter 12 within the vein of the patient, which may result in less vein-related trauma and may support the catheter 12 during advancement to prevent collapse or buckling of the catheter 12 as it advances through a second catheter (such as, for example, the catheter 65, illustrated in
[0042] In some embodiments, the guidewire 34 may include a first end 36 and a second end 38. In some embodiments, the guidewire 34 and the catheter 12 may be advanced and/or retracted together. In some embodiments, the second end 38 of the guidewire 34 may be stationary with respect to the housing. For example, in some embodiments, the second end 38 of the guidewire may be fixed inside the catheter 12 and/or the housing 14.
[0043] In some embodiments, the catheter 12 may include a multi-diameter catheter, such as described, for example, in U.S. Pat. No. 11,173,277, granted Oct. 24, 2019, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS,” which is incorporated herein by reference. In some embodiments, the multi-diameter catheter may allow improved blood flow rates during blood collection. In some embodiments, an outer diameter of the guidewire 34 may be less than an inner diameter of the catheter 12 such that blood may flow around the guidewire 34 during blood collection.
[0044]
[0045] In some embodiments, the delivery device 10 may include a connector 40, which may be disposed at the distal end 16 of the housing 14. In some embodiments, the connector 40 may be configured to couple the delivery device 10 to the intravenous catheter assembly (as illustrated, for example, in
[0046] In some embodiments, the channel 24 may be horizontally oriented within the housing, as illustrated in
[0047] In some embodiments, the delivery device 10 may include one or more markings 29, which may provide a visual and/or tactile indication to the user of a position of the instrument. In further detail, in some embodiments, the markings 29 may indicate a distance that the instrument is advanced and/or retracted. For example, a particular marking 29 may correspond to a position of the guide feature 22 to position the distal end of the instrument at or near a tip of the catheter 12 or another location. In some embodiments, the markings 29 may be disposed on an outer surface of the delivery device 10. In some embodiments, at least some of the markings 29 may include detents and/or protrusions. In some embodiments, at least some of the markings 29 may include detents, which may be configured to hold the guide feature 22 at pre-determined positions and/or provide resistance to movement of the guide feature 22 from the detents.
[0048] Referring now to
[0049] In some embodiments, the first end 28 of the instrument may be advanced in the distal direction 23 beyond the distal end of the housing 14 in response to the guide feature 22 being partially and/or fully advanced along the slot 20 in the distal direction 23. In some embodiments, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23 a first distance, the first end 28 of the instrument may be advanced in the distal direction 23 a second distance greater than the first distance. In some embodiments, the second distance may be two times the first distance (“a 1:2 advancement ratio”).
[0050] If a particular guide feature were to be moved along a particular slot in the distal direction 23 the first distance, and a first end of a particular instrument advanced in the distal direction 23 a distance equal to the first distance (a “1:1 advancement ratio”), a length of a particular delivery device may need to be increased proportionally with a length of the instrument. Particularly when the instrument is long to provide a distant reach, this means the particular delivery device may also be long, which can significantly impact its use-ability, cost, and performance. As the length of the particular delivery device is increased, the instrument may be more likely to kink or collapse during advancement. In some embodiments, the 1:2 advancement ratio (or another advancement ratio where the second distance is greater than the first distance) between the guide feature 22 and the first end 28 of the instrument may provide reliability and structural support as the instrument is advanced, while also providing an instrument with long reach.
[0051] In some embodiments, the 1:2 advancement ratio (or another advancement ratio where the second distance is greater than the first distance) between the guide feature 22 and the first end 28 of the instrument may be accomplished by creating a U-shape in the instrument inside the housing 14 and supporting the instrument within the guide feature 22. Thus, in some embodiments, the delivery device 10 may facilitate support and advancement of an instrument having an increased length. In particular, in some embodiments, the channel 24 or another suitable structure of the guide feature 22 may support the instrument as the instrument is advanced through the channel 24 and distally into the vasculature. In some embodiments, the 1:2 advancement ratio between the guide feature 22 and the first end 28 of the instrument may include an approximately 1:2 advancement ratio between the guide feature 22 and the first end 28. In some embodiments, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23 the first distance, the first end 28 of the instrument may be advanced in the distal direction 23 a second distance that is more than two times the first distance, which may include at least two times the first distance. In these and other embodiments, the instrument may be configured in multiple U-shapes and/or the delivery device 10 may include multiple U-shaped channels or other suitable support structures.
[0052] In some embodiments, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, the guidewire 34 may move through the channel 24 with the catheter 12. In some embodiments, the first end 36 of the guidewire 34 may be advanced in the distal direction 23 beyond the distal end of the housing 14 in response to the guide feature 22 being partially and/or fully advanced along the slot 20 in the distal direction 23.
[0053] In some embodiments, the first end 36 of the guidewire 34 may be disposed proximal and/or proximate to a transition in an inner diameter of the catheter 12 to allow blood or other fluid to flow in an annular space between an inner diameter of the catheter 12 and an outer diameter of the guidewire 34. In some embodiments, the guidewire 34 may provide support to the catheter 12 along a full or partial length of the catheter 12. In some embodiments, the guidewire 34 may improve structural reliability of the catheter 12, provide adequate blood collection fill time performance, reduce blood hemolysis risks or maintain adequate blood hemolysis risks, and reduce a risk of kinking of the catheter 12. In some embodiments, the housing 14 may facilitate full enclosure of the guidewire 34 and/or the catheter 12 upon completion of blood sampling.
[0054] Referring now to
[0055] In some embodiments, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23, the instrument may move through the support tubing 52. In some embodiments, the support tubing 52 may include a larger inner diameter than an outer diameter of the instrument such that the instrument may move through the support tubing 52. In some embodiments, the support tubing 52 may provide support to the first end 28 or the free end of the instrument. In some embodiments, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23 the first distance, a distal end 56 of the support tubing 52 may be advanced in the distal direction 23 a distance equal to the first distance (a “1:1 advancement ratio”), while the first end 28 of the instrument may be advanced a distance greater than that of the first distance, such as for example, twice the first distance (“a 1:2 advancement ratio”). In some embodiments, the differing advancement ratios of the guide feature 22 with respect to the first end 28 and guide feature 22 with respect to the support tubing 52 may result in the support tubing 52 not advancing distally beyond a decreased diameter portion of the instrument, and the decreased diameter portion of the instrument advancing distally through the catheter assembly and into the vasculature.
[0056] Referring now to
[0057] In some embodiments, given the 1:2 advancement ratio (or another advancement ratio where the second distance is greater than the first distance) between the guide feature 22 and the first end 28 of the instrument and the 1:1 advancement ratio between the guide feature 22 and the distal end 56 of the support tubing 52, the first end 28 of the instrument may exit the distal end 56 of the support tubing 52. In some embodiments, the first end 28 of the instrument may exit the distal end 56 of the support tubing 52 to facilitate entry of the instrument into a portion of the catheter assembly that may be too narrow for the support tubing 52 to enter.
[0058] In some embodiments, when the delivery device 50 includes the support tubing 52, the catheter 12 may be constructed of a softer material than polyimide, which may be less damaging to the vein wall. In these and other embodiments, the catheter 12 may include a tube constructed of one or more of polyurethane, silicon, thermoplastic elastomer (“TPE”), thermoplastic polyurethane (“TPU”), and another suitable compliant material.
[0059] In some embodiments, the channel 24 may be disposed in various orientations within the housing 14. Referring now to
[0060] In some embodiments, the delivery device 60 may include or correspond to the one or more of the following: the delivery device 10, the delivery device 50, and the delivery device 58. In further detail, in some embodiments, the delivery device 60 may include one or more features of the delivery device 10, the delivery device 50, and/or the delivery device 58. Similarly, in some embodiments, the delivery device 10, the delivery device 50, and/or the delivery device 58 may include one or more features of the delivery device 60.
[0061] In some embodiments, a curvature of the U-shape may vary depending on, for example, on a bend radius of a material from which the instrument 24 is constructed. In some embodiments, the curvature of the U-shape may be configured to prevent kinking of or damage to the instrument 24.
[0062] Referring now to
[0063] In some embodiments, the delivery device 84 may be coupled to the catheter assembly 62, which may include a catheter adapter 64 and a catheter 65. In some embodiments, the catheter 65 may be indwelling. In some embodiments, the catheter 65 may include a PIVC. In some embodiments, the catheter 65 may be secured to the catheter adapter 64 and may extend distally from the catheter adapter 64. In some embodiments, the catheter adapter 64 may include a distal end 66, a proximal end 68, and a lumen 70 extending between the distal end 66 and the proximal end 68. In some embodiments, the distal end 66 and the proximal end 68 of the catheter adapter 64 may be axially aligned.
[0064] In some embodiments, the catheter system 61 may include a straight or non-integrated catheter adapter 64. In some embodiments, the catheter system 61 may include an integrated catheter adapter 64, as illustrated, for example, in
[0065] In some embodiments, the catheter assembly 62 may include an extension set 74, which may be coupled to the catheter adapter 64. In some embodiments, the extension set 74 may include the extension tube 76, which may include a distal end 78 and a proximal end 80. In some embodiments, the extension tubing 76 may extend from the side port 72.
[0066] In some embodiments, the catheter assembly 62 may include a connector 82, which may be configured to couple the delivery device 84 to the catheter assembly 62. In some embodiments, the connector 82 may be coupled to the proximal end 80 of the extension tubing 76. In other embodiments, the connector 82 may be disposed at the proximal end 68 of the catheter adapter 64 or another location. In some embodiments, the connector 82 may include a luer adapter, such as a male or female luer adapter, or another suitable connector.
[0067] In some embodiments, the first end 36 of the guidewire 34 and/or the first end 28 of the instrument may be disposed distal to the distal end of the catheter 65 when the instrument and the guidewire 34 are fully and/or partially advanced. In some embodiments, the catheter 12 may provide structural support to the catheter 65. In some embodiments, the catheter 12 may allow the user to draw a blood sample or infuse fluid through the catheter 65 when the catheter 65 is no longer functional or safe due to, for example, debris build up on a tip 85 of the catheter 65 and/or collapse of the catheter 65. Thus, in some embodiments, the catheter 12 may reduce a number of needle sticks that the patient experiences as the catheter 65 may be replaced less frequently.
[0068] In some embodiments, delivery of the catheter 12 into the catheter system 61 and/or the vasculature of the patient may reduce blood hemolysis and a risk of kinking of the catheter 65. In some embodiments, the delivery device 84 may allow use of the guidewire 34, which may improve placement of the catheter 12 within the vasculature. In some embodiments, the connector 82 may be disposed remotely from the patient, which may reduce a risk of disturbing an insertion site of the catheter 65.
[0069] It is understood that in some embodiments, the catheter 12 and/or the guidewire 36 may be replaced with another instrument, such as, for example, a probe (which may include a sensor), a light tube for disinfection, or another suitable instrument.
[0070] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.