Instrument delivery device

Abstract

This invention relates to a device delivery device. A device delivery device is coupled to a vascular access device. The device delivery device may include a housing, which may include a distal connector, a proximal connector, and an internal lumen extending through the distal and proximal connectors. The device delivery device may include a vascular access device, which may include a distal and a proximal end. The vascular access device may be arranged in a coiled position within the lumen of the housing. The vascular access device may be configured to move from a coiled position to a non-coiled position and advance through the distal connector. The vascular access device may extend through the vascular access device into the patient's vascular system.

Description

Technical Field

[0001] This invention relates to a device for delivering medical instruments. Background Technology

[0002] Catheters are commonly used to deliver fluids into a patient's vascular system. For example, catheters can be used to infuse routine saline solutions, various medications, and total parenteral nutrition solutions. Catheters can also be used to draw blood from a patient.

[0003] The catheter may include an over-the-needle peripheral intravenous (“IV”) catheter. In this case, the catheter can be mounted on a guide needle with a sharp distal tip. The catheter and guide needle can be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, with the bevel of the needle facing upwards and away from the patient’s skin. The catheter and guide needle are typically inserted into the patient’s vascular system through the skin at a shallow angle.

[0004] To verify proper placement of the guide needle and / or catheter in the blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback lumen of the catheter assembly. Once needle placement has been confirmed, clinicians can temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0005] Blood collection using catheters can be difficult for a variety of reasons, especially when the catheter remains in the vascular system for more than a day. When a catheter is left in place for an extended period, the catheter or vein can become more prone to narrowing, collapse, twisting, blockage by debris (e.g., fibrin or platelet clots), and the catheter tip can adhere to the vascular system. Consequently, the catheter is often used to collect blood samples at the moment of insertion, and rarely during its indwelling period. Therefore, when a blood sample is needed, additional needle puncture is often required to provide venous access for blood collection, which can be painful for the patient and result in higher material costs.

[0006] The subject matter claimed herein is not limited to implementations that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0007] This disclosure generally relates to a device delivery apparatus configured to couple to and deliver a vascular access device through the vascular access device. In some embodiments, the device delivery apparatus may include a housing that may include a distal connector, a proximal connector, and an internal cavity extending through the distal and proximal connectors. In some embodiments, the device delivery apparatus may include a vascular access device that may include a distal and a proximal end. In some embodiments, the vascular access device may be arranged in a compact position within the cavity of the housing, the compact position including one or more bends in the vascular access device. In some embodiments, the compact position may include a coiled position. In some embodiments, the vascular access device may be configured to move from the compact position to an extended or extended position that may include a non-coiled position and advance through the distal connector.

[0008] In some embodiments, the instrument delivery device may include another housing that can be coupled to a distal connector. In some embodiments, the other housing may include another distal connector, another proximal connector, and another cavity extending through the other distal connector and the other proximal connector. In some embodiments, the other housing may include a one-way valve disposed within the other cavity.

[0009] In some embodiments, the vascular access device may include a wire. In some embodiments, the wire may be helical. In some embodiments, the vascular access device may include a cannula. In some embodiments, the distal connector may include a cannula or a male Luer connector. In some embodiments, the proximal connector may include a female Luer connector.

[0010] In some embodiments, the proximal end of the vascular access device may include a stop. In some embodiments, the outer diameter of the stop may be larger than the diameter of the lumen to prevent the proximal end of the vascular access device from moving through the distal connector. In some embodiments, the stop may be spherical, wedge-shaped, or other suitable shape. In some embodiments, the stop may include a fluid path extending through the stop. In some embodiments, the stop may be configured to prevent fluid flow through the stop.

[0011] In some embodiments, a method may include inserting a catheter assembly into a patient's vascular system. In some embodiments, the catheter assembly may include a catheter adapter, the catheter adapter including a distal end, a proximal end, and an inner lumen extending through the distal and proximal ends. In some embodiments, the catheter assembly may include a catheter extending distally from the distal end of the catheter adapter. In some embodiments, the method may include coupling a device delivery device to the catheter assembly. In some embodiments, coupling a device delivery device to the catheter assembly may include coupling another distal connector to the catheter assembly.

[0012] In some embodiments, after inserting the catheter assembly into the patient's vascular system, the method may include advancing the vascular access device through the catheter. In some embodiments, advancing the vascular access device through the catheter may include coupling a pre-filled syringe to a proximal connector and pressing the plunger of the pre-filled syringe.

[0013] In some embodiments, the housing may include a pre-filled syringe, which may include a distal connector. In some embodiments, a vascular access device may be disposed within the pre-filled syringe. In some embodiments, in response to the pressing of the plunger of the pre-filled syringe, the vascular access device may be configured to move from a compact position to an extended position and advance through the distal connector.

[0014] In some embodiments, vascular access devices can facilitate blood collection from a patient, fluid delivery to a patient, patient or device monitoring, or other clinical needs by utilizing existing catheters placed in a patient's vascular system. In some embodiments, vascular access devices can facilitate one or more of the following: reduced trauma to the vascular system, reduced blood collection time, and overcoming thrombi or fibrin sheaths in or around the catheter that may prevent blood collection. In some embodiments, vascular access devices can be used to extend the lifespan of catheters placed in the vascular system and can reduce the number of needle pricks. In some embodiments, vascular access devices can include one or more of a spiral wire, guidewire, probe, and tube. In some embodiments, vascular access devices can include sensors.

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

[0016] Example embodiments will be described and illustrated with additional features and details using the accompanying drawings, wherein:

[0017] Figure 1A This is a top perspective view of an exemplary instrument delivery device according to some embodiments, showing an exemplary housing;

[0018] Figure 1B This is a cross-sectional view of an instrument delivery device coupled to another housing according to some embodiments;

[0019] Figure 2AThis is a top perspective view of an instrument delivery device coupled to another housing according to some embodiments, showing an exemplary vascular access device in a forward position;

[0020] Figure 2B This is a cross-sectional view of a device delivery device coupled to another housing according to some embodiments, showing a vascular access device in the forward position;

[0021] Figure 3A This is a cross-sectional view of a device delivery device coupled to another housing according to some embodiments, showing another exemplary vascular access device in a coiled position;

[0022] Figure 3B This is a cross-sectional view of a device delivery device coupled to another housing according to some embodiments, showing another vascular access device in a forward position;

[0023] Figure 4A This is a cross-sectional view of an exemplary wedge according to some embodiments;

[0024] Figure 4B This is a cross-sectional view of another exemplary wedge according to some embodiments;

[0025] Figure 5 This is a top perspective view of an exemplary vascular access system according to some embodiments;

[0026] Figure 6 This is a top perspective view of a portion of a vascular access system according to some embodiments, showing an exemplary other distal connector;

[0027] Figure 7A This is a cross-sectional view of another device delivery device according to some embodiments, showing a vascular access device in a coiled position;

[0028] Figure 7B This is a cross-sectional view of another device delivery device according to some embodiments, showing a vascular access device in the forward position. Detailed Implementation

[0029] Now for reference Figure 1AIn some embodiments, the device delivery device 10 may be configured to couple to a vascular access device and deliver the vascular access device 12 into and / or through the vascular access device. In some embodiments, the device delivery device 10 may include a housing 14, which may include a distal connector 16, a proximal connector 18, and a lumen 20 extending through the distal connector 16 and the proximal connector 18. The distal connector 16 may include a cannula, a male Luer connector, or other suitable connector. In some embodiments, the proximal connector 18 may include a female Luer connector or other suitable connector. In some embodiments, the female Luer connector may include one or more features of a needleless access connector or a needleless access connector. For example, the female Luer connector may include a diaphragm or a valve.

[0030] In some embodiments, the device delivery device 10 may include a vascular access device 12, which may include a distal end 22 and a proximal end 24. In some embodiments, the vascular access device 12 may be arranged in a compact position within the cavity 20 of the housing 14, the compact position including one or more bends in the vascular access device 12. Figure 1A As shown, in some embodiments, the compact position may include a coiled position. In some embodiments, the coiled position can prevent tangling of the vascular access device 12 when it moves from the compact position to the extended or extended position.

[0031] In some embodiments, the length of the vascular access device 12 in its compact position may be less than the length of the vascular access device 12 in its extended position. In some embodiments, the vascular access device 12 in its extended position may be generally straight. In some embodiments, the compact position of the vascular access device 12 may facilitate the storage of a vascular access device 12 with a length sufficient to extend through the vascular access device within the housing 14, while also allowing the housing 14 to be compact. In some embodiments, the distal end 22 of the vascular access device 12 may be arranged adjacent to the distal opening 25 within the distal connector 16, which may prevent tangling of the vascular access device 12 when it is moved from the compact position to the extended position.

[0032] Now for reference Figure 1BIn some embodiments, the instrument delivery device 10 may include another housing 26, which may be coupled to the distal connector 16. In some embodiments, the other housing 26 may include another distal connector 28, another proximal connector 30, and another cavity 32 extending through the other distal connector 28 and the other proximal connector 30. In some embodiments, the other housing 26 may include a one-way valve 34 disposed within the other cavity 32. The one-way valve 34 may include a duckbill valve. In some embodiments, the one-way valve 34 may allow fluid to flow through in a distal direction but not in a proximal direction.

[0033] In some embodiments, the distal connector 16 and / or another distal connector 28 may include a cannula, a male Luer connector, or other suitable connector. In some embodiments, the proximal connector 18 and / or another proximal connector 30 may include a female Luer connector or other suitable connector. In some embodiments, the distal connector 16 may be coupled to another proximal connector 30. In some embodiments, the outer diameter of the distal end 22 of the vascular access device 12 may be smaller than the diameter of the distal connector 16, allowing the vascular access device 12 to move distally through the distal connector 16.

[0034] In some embodiments, the proximal end 24 of the vascular access device 12 may include a stop 36. In some embodiments, the outer diameter 38 of the stop 36 may be larger than the diameter 40 of the lumen 20 to prevent the proximal end 24 of the vascular access device 12 from moving through the distal connector 16. In some embodiments, the stop 36 may be spherical, wedge-shaped, hemispherical, conical, or other suitable shape. In some embodiments, the outer diameter of the proximal portion of the stop 36 may be larger than the outer diameter of the distal portion of the stop 36, which may facilitate fluid flow to carry the device in a distal direction. In some embodiments, the stop 36 may be free within the lumen 20. In other embodiments, the stop 36 may be fixed within the lumen 20. For example, the stop 36 may be fixed to the inner surface of the housing 14 forming the lumen 20.

[0035] In some embodiments, housing 14 and the other housing 26 may be separate units, connected together via a compatible connector. In some embodiments, the instrument delivery device 10 may not include the other housing 26, because, for example, a one-way valve 34 may not be required for a particular procedure or a particular catheter assembly. In some embodiments, housing 14 and the other housing 26 may be integrally formed as a single unit.

[0036] Now for reference Figure 2A-2BIn some embodiments, the vascular access device 12 may be configured to move from a compact position to an extended position that may include a non-coiled position and advance distally through the distal connector 16. In some embodiments, the vascular access device 12 in the non-coiled position may be completely non-coiled or less coiled compared to its coiled position. In some embodiments, the vascular access device 12 may include a tube, such as... Figure 1A-2B As shown. In some embodiments, the tube may include a variable outer diameter and / or a variable inner diameter along its length. In some embodiments, the tube may include a constant outer diameter and / or a constant inner diameter along its length.

[0037] In some embodiments, the tube may be constructed of polymeric and / or elastomeric materials. In some embodiments, the tube may be constructed of a soft material having a lower stiffness than that of a standard peripheral intravenous catheter, which may reduce damage to the vascular system during the advancement of the vascular access device 12.

[0038] In some embodiments, the tube may comprise one or more hardness and / or materials. In some embodiments, the tube may comprise or correspond to the tubular device further described in U.S. Patent Application No. 17 / 143,095, filed January 6, 2021, entitled "Tubular Instrument and Related Devices and Methods," which is incorporated herein by reference in its entirety. In some embodiments, the tube may comprise an extrusion or construction of a single or multiple materials. In some embodiments, the tube may comprise multiple segments that may be joined by solvent bonding, adhesive bonding, forging, ultrasonic welding, tipping, etc. In some embodiments, the tube may be integrally formed into a single unit. In some embodiments, the tube may include one or more of a distal opening, a proximal opening, and one or more side holes.

[0039] Now for reference Figures 3A-3BIn some embodiments, the vascular access device 12 may include a filament. In some embodiments, the filament may be helical in addition to being arranged in a coiled position. More specifically, in some embodiments, the filament may include smaller coils arranged along all or part of its length, and the filament may also be wound into larger coils when in the coiled position, such that the overall shape of the filament is coil-shaped. In some embodiments, at least the portion of the filament extending distally beyond the vascular access device may include smaller coils, which may facilitate thrombosis prevention. In some embodiments, due to the smaller coils, the space for thrombus to enter the vascular access device may be reduced during insertion of the vascular access device into the patient's vascular system. Similarly, in some embodiments, the smaller coils may reduce the likelihood of damage to the vascular system in response to the advancement of the vascular access device 12 through the vascular access device and into the vascular system. Furthermore, in some embodiments, the smaller coils may facilitate blood flow under negative pressure through the vascular access device 12 and into the vascular access device. In some embodiments, the filament may be constructed of metal or other suitable materials.

[0040] Now for reference Figures 4A-4B In some embodiments, the stop 36 may include a fluid channel 41 extending through the stop 36, such as... Figure 4A As shown. In some embodiments, the fluid path 41 may be aligned with the central axis of the stop 36. In some embodiments, the stop 36 may be configured to prevent fluid flow through the stop 36, for example as... Figure 4B As shown.

[0041] In some embodiments, the proximal end 24 of the vascular access device 12 (which may include a wire, tubing, or other suitable vascular access device) may be connected to the stop 36 via an interference fit, press fit, friction fit, material bonding, or other suitable means. In some embodiments, the stop 36 may be constructed of one or more of polymeric materials, elastomeric materials, metallic materials, and other suitable materials.

[0042] Now for reference Figure 5 In some embodiments, the vascular access device may include a catheter assembly 42 that can be inserted into a patient's vascular system. In some embodiments, the catheter assembly 42 may include a catheter adapter 44, which may include a distal end 46, a proximal end 48, and an inner lumen 50 extending through the distal end 46 and the proximal end 48. In some embodiments, the catheter assembly 42 may include a catheter 52 extending distally from the distal end 46 of the catheter adapter 44. In some embodiments, the catheter 52 may include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter.

[0043] In some embodiments, the device delivery device 10 may be coupled to a catheter assembly 42, which may be left in place within a patient's vascular system. In some embodiments, coupling the device delivery device 10 to the catheter assembly 42 may include coupling another distal connector 28 to the catheter assembly 42. In some embodiments, the device delivery device 10 may be coupled to the proximal end 48 of a catheter adapter 44.

[0044] In some embodiments, the catheter assembly 42 may include an extension tube 54 integrated in a side port 55 of the catheter adapter 44. In some embodiments, the proximal end of the extension tube 54 may be coupled to an adapter 56, such as, for example, a Y-type adapter or a T-type adapter. In some embodiments, the instrument delivery device 10 may be coupled to the adapter 56. In other embodiments, another housing 26 and / or housing 14 may be integrally formed as a single unit with the adapter 56.

[0045] In some embodiments, after catheter 52 is inserted into the patient's vascular system, the vascular access device 12 can be advanced through catheter 52, such as... Figure 5 As shown. In some embodiments, advancing the vascular access device 12 through the catheter 52 may include coupling a pre-filled syringe 58 to the proximal connector 18 and pressing the plunger 60 of the pre-filled syringe 58. In some embodiments, the pre-filled syringe 58 may be filled with a flushing solution, such as, for example, a saline solution, which may flush through the catheter 52 in response to pressing the plunger 60. In some embodiments, the housing 14 may be coupled to any suitable pre-filled syringe.

[0046] In some embodiments, the vascular access device 12 may not be attached to the housing 14, which may facilitate movement of the distal end 22 of the vascular access device 12 through the distal connector 16 in response to pressure caused by the pressing of the plunger 60 of the syringe 58. In some embodiments, flushing through the catheter 52 may be referred to as “flush-in-place” because the catheter 52 may remain in the patient’s vascular system when flushing occurs. In some embodiments, as the vascular access device 12 is moved from a compact position to an extended position to advance the vascular access device 12, the distal end 22 of the vascular access device 12 may move distally in a non-torsional fluid path through one or more of the following: the distal connector 16, another housing 26, the adapter 56, the extension tube 54, the side port 55, the distal end 46 of the catheter adapter 44, and the catheter 52.

[0047] In some embodiments, the distal end of another extension tube 62 may be coupled to the adapter 56. In some embodiments, the proximal end of another extension tube 62 may be coupled to the blood collection device 64, which may include blood collection devices available from Becton Dickinson and Company in Franklin Lake, New Jersey. Or other suitable blood collection devices. In some embodiments, blood can be collected using the blood collection device 64 in response to the vascular access device 12 being in the extended position and distal to the catheter 52.

[0048] Now for reference Figure 6 In some embodiments, the device delivery device 10 may be coupled to a needleless access connector 65, which may be coupled to an adapter 56 or another portion of the catheter assembly 42. In some embodiments, the needleless access connector 65 may include a non-torsional or generally straight path to facilitate the passage of the vascular access device 12 through the needleless access connector 65. In some embodiments, another distal connector 28 may include a cannula 66 that can be inserted into the adapter 56, the needleless access connector 65, or the catheter adapter 44. In some embodiments, the cannula 66 may be blunt. In some embodiments, the distal connector 16 may include one or more arms 68 that may be biased inward to interfere with the outer surface of the adapter 56, the needleless access connector 65, or another portion of the catheter assembly 42. In some embodiments, the distal connector 16 may include a cannula 66 and / or arms 68. As described, in some embodiments, the distal connector 16 may include a male Luer connector or other suitable connector.

[0049] Now for reference Figures 7A-7B In some embodiments, housing 14 may include a pre-filled syringe 70, which may include a distal connector 16. In some embodiments, vascular access device 12 may be disposed within the pre-filled syringe 70. In some embodiments, in response to pressing the plunger 72 of the pre-filled syringe 70, vascular access device 12 may be configured to move from a compact position to an extended position and advance through the distal connector 16. In some embodiments, the pre-filled syringe 70 may be filled with a flushing solution, such as, for example, saline solution, which may flush through catheter 52 in response to pressing the plunger 72.

[0050] All examples and conditional language described herein are intended for illustrative purposes to aid the reader's understanding of this disclosure and the inventors' ideas for further development in the field, and should be construed as not being limited to such specific examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of this disclosure.

Claims

1. A device delivery device, said device delivery device being connected to a vascular access device, characterized in that, The device delivery device includes: Housing, the housing comprising: Distal connector, Proximal connector, and The cavity is formed within the housing and extends through the distal connector and the proximal connector; A vascular access device, the vascular access device including a distal end and a proximal end, wherein the vascular access device is disposed in a compact position within the cavity of the housing, wherein, when in the compact position, the distal end of the vascular access device is positioned within the distal connector, wherein the vascular access device is configured to move from the compact position to an extended position and advance through the distal connector. The proximal end of the vascular access device includes a stop that prevents the proximal end of the vascular access device from moving through the distal connector. The stop includes a solid member that prevents fluid flow through the stop.

2. The instrument delivery device according to claim 1, characterized in that, The instrument delivery device further includes another housing coupled to the distal connector, wherein the other housing includes another distal connector, another proximal connector, and another cavity extending through the other distal connector and the other proximal connector, and the instrument delivery device further includes a one-way valve disposed within the other cavity.

3. The instrument delivery device according to claim 1, characterized in that, The vascular access device includes a wire.

4. The instrument delivery device according to claim 3, characterized in that, The filament is spiral.

5. The instrument delivery device according to claim 1, characterized in that, The vascular access device includes a tube.

6. The instrument delivery device according to claim 1, characterized in that, The distal connector includes a cannula or a male Luer connector.

7. The instrument delivery device according to claim 1, characterized in that, The proximal connector includes a female Luer connector.

8. The instrument delivery device according to claim 1, characterized in that, The outer diameter of the stop is larger than the diameter of the inner lumen to prevent the proximal end of the vascular access device from moving through the distal connector.

9. The instrument delivery device according to claim 8, characterized in that, The stop is spherical.

10. The instrument delivery device according to claim 8, characterized in that, The stop is wedge-shaped.

11. A device delivery device, said device delivery device being coupled to a vascular access device, characterized in that, The device delivery device includes: A housing, wherein the housing includes a pre-filled syringe, wherein the pre-filled syringe includes a distal connector; and A vascular access device, the vascular access device being disposed in a compact position within a pre-filled syringe, wherein the vascular access device includes a distal end and a proximal end, wherein the vascular access device is configured to move from the compact position to an extended position and advance through the distal connector; When the vascular access device is in the compact position, the distal end of the vascular access device is positioned within the distal connector; and The proximal end of the vascular access device includes a stop that prevents the proximal end of the vascular access device from moving through the distal connector. The stop includes a solid member that prevents fluid flow through the stop.

12. The instrument delivery device according to claim 11, characterized in that, The pre-filled syringe includes a plunger, wherein the outer diameter of the stop is larger than the diameter of the lumen to prevent the proximal end of the vascular access device from moving through the distal connector.

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