Vascular access device having an extendable catheter
The vascular access device with an extendable catheter and seal assembly addresses the challenges of prolonged catheter indwelling by improving blood collection efficiency and reducing thrombus formation, enhancing patient comfort and dwell time.
Patent Information
- Application Number
- JP2024568806
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-05-19
- Filing Date
- 2023-05-18
- Publication Date
- 2025-05-30
AI Technical Summary
Existing vascular access devices face challenges with prolonged catheter indwelling, leading to issues such as stenosis, collapse, kinking, occlusion, and adhesion, which complicate blood sampling and increase patient discomfort and costs.
A vascular access device with an extendable catheter and a seal assembly that includes a seal body and an actuator, allowing the catheter to be extended and retracted relative to the adapter body, thereby improving blood collection and reducing thrombus formation.
The extendable catheter design enhances blood collection efficiency, reduces thrombus formation, and minimizes adverse events such as infiltration and extravasation, improving patient comfort and potentially extending the dwell time of the catheter.
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Figure 2025516871000001_ABST
Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Application Serial No. 63 / 343,743, filed on May 19, 2022, entitled "Vascular Access Device with an Extendable Catheter", the entire disclosure of which is hereby incorporated by reference in its entirety.
Background Art
[0002] Background of the Invention Field of the Invention The present disclosure relates to a vascular access device having an expandable catheter.
[0003] Description of the Related Art Catheters are frequently used for the administration of fluids into and out of the body. Patients are administered fluids, pharmaceuticals, and blood products via vascular access devices inserted into the patient's vasculature in a variety of environments, including hospitals and home care. Catheters of various types and sizes are widely used in a variety of procedures, including, but not limited to, the treatment of infectious diseases, the provision of anesthesia and analgesia, nutritional supplementation, the treatment of cancerous growths, the maintenance of blood pressure and heart rhythm, and many other medical applications. A common vascular access device is a plastic catheter that is inserted into a patient's blood vessel. Catheter lengths vary from 2 or 3 centimeters for peripheral access to many centimeters for central access. Catheters are generally incorporated into a catheter adapter to assist in the use, access, and utility of the catheter. The catheter adapter is adapted to receive one end of the catheter such that one end of the catheter is supported by the catheter adapter and the body and tip of the catheter may extend beyond the first end of the catheter adapter. The catheter adapter generally further includes a second end that is adapted to receive additional infusion components for use with the catheter. For example, the second end of the catheter adapter may include a set of threaded portions for attaching an intravenous line or connecting a syringe to the catheter adapter, thereby providing access to the patient's vasculature through the attached catheter.
[0004] Catheters may be inserted percutaneously. When inserted percutaneously, the insertion of the catheter is generally assisted by an introducer needle. The introducer needle is generally housed inside the lumen of the catheter and is sized such that the gauge of the needle substantially matches the inner diameter of the catheter. The needle is positioned within the catheter such that the needle tip extends beyond the tip of the catheter and is used to penetrate the patient's blood vessel to provide an opening for catheter insertion.
[0005] For the purpose of verifying the proper placement of an introducer needle and / or catheter within a blood vessel, the operator generally checks for the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once the placement of the needle is verified, the operator may temporarily occlude the flow of the vascular system, remove the needle, and leave the catheter in place for future blood withdrawal, fluid injection, or probe access.
[0006] Withdrawal or injection of blood using a catheter can be difficult for several reasons, particularly when the catheter has been left in the patient for more than one day. For example, when the catheter remains inserted in the patient for an extended period, the blood vessel and catheter are susceptible to effects such as stenosis, collapse, kinking, occlusion by debris (e.g., fibrin, platelet clot, or thrombus), and adhesion of the catheter tip to the vascular system. For this reason, a catheter is often used to obtain a blood sample at the time of catheter placement, but is not often used to obtain a blood sample during the catheter indwelling period. Thus, when a blood sample is required, additional needle punctures are used to provide vascular access for blood collection, which is painful for the patient and can be costly in terms of materials.
SUMMARY OF THE INVENTION
[0007] In one aspect or embodiment, a vascular access device includes an adapter body having a first end and a second end located opposite the first end, the adapter body defining a passageway, a catheter received by the adapter body, a needle received by the adapter body with a portion of the needle positioned within the catheter, and a seal assembly including a seal body and an actuator positioned within the passageway of the adapter body. The seal body forms a seal with the adapter body, and the catheter is connected to the seal body. The actuator is configured to move the seal body from a first position within the adapter body to a second position spaced from the first position within the adapter body.
[0008] The vascular access device may include an end cap positioned at a first end of the adapter body, and the end cap may be configured to engage with the seal body to limit the movement of the seal body. The catheter may be connected to the seal body via a wedge. A portion of the catheter may be positioned on the wedge, and the wedge may be connected to the seal body via an interference fit.
[0009] The actuator may be an extension member connected to the seal body and extending outside the passage of the adapter body. The actuator seal may be positioned within the passage of the adapter body, and the extension member and the needle may be received by the actuator seal.
[0010] The actuator may be a handle having a first magnet and a second magnet connected to the seal body, at least a portion of the handle being positioned outside the passage of the adapter body, and the movement of the handle may be configured to move the seal body between a first position and a second position via the interaction between the first magnet and the second magnet. The first magnet may be arc-shaped, and the second magnet may be annular. The handle and the first magnet may be received within a slot defined by the adapter body.
[0011] The actuator may be a knob having a pinion gear and a rack connected to the seal body and engaging with the pinion gear, and the rotation of the knob may be configured to rotate the pinion gear to move the seal body between a first position and a second position. The knob is positioned outside the passage of the adapter body, and the pinion gear and the rack are received within the passage of the adapter body. The actuator may include a seal bearing positioned between the knob and the pinion gear, and the seal bearing may be configured to seal an opening of the adapter body that receives the knob. The rack may be integrally formed with the seal body.
[0012] The seal body may include a plurality of seal rings. The adapter body may include a side port extending between the first and second ends of the adapter body, defining a side passage in which the side port is in fluid communication with the passage of the adapter body. The side port may extend at an angle of 25 to 75 degrees from the adapter body.
Brief Description of the Drawings
[0013] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent by reference to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings, and the present disclosure itself will be better understood.
[0014]
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DETAILED DESCRIPTION OF THE INVENTION
[0015] Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein are illustrative of exemplary embodiments of the present disclosure and are not to be construed in any way as limiting the scope of the present disclosure.
[0016] DETAILED DESCRIPTION OF THE INVENTION Spatial or directional terms such as "left", "right", "inward", "outward", "upward", "downward", etc. are not considered limiting since the present invention can envision various alternative directions.
[0017] For the purposes of the following description, the terms "upward", "downward", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as oriented in the drawing figures. However, it is to be understood that the present invention can envision various alternative variations unless explicitly specified to the contrary. Also, it is to be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention.
[0018] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood as encompassing the starting and ending values, as well as any and all sub-ranges or sub-ratios subsumed therein. For example, a range or ratio of "1 to 10" is to be considered as including any and all sub-ranges or sub-ratios between (and including) the minimum value of 1 and the maximum value of 10, i.e., all sub-ranges or sub-ratios that begin with a value of 1 or more and end with a value of 10 or less.
[0019] Terms such as "first", "second", etc. are not intended to refer to a particular order or chronology, but rather to different conditions, characteristics, or elements.
[0020] As used herein, "at least one" is synonymous with "one or more". For example, the expression "at least one of A, B, and C" means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, "at least one of A, B, and C" includes only one or more of A, or only one or more of B, or only one or more of C, or one or more of A and one or more of B, or one or more of A and one or more of C, or one or more of B and one or more of C, or one or more of all of A, B, and C.
[0021] Referring to FIGS. 1-6, in one aspect or embodiment of the present application, the vascular access device 10 includes an adapter body 12 having a first end 14 and a second end 16 positioned opposite the first end 14, a catheter 18 received by the adapter body 12, a needle 20 received by the adapter body 12, and a seal assembly 22. The adapter body 12 defines a passageway 24, and a portion of the needle 20 is positioned within the catheter 18. The seal assembly 22 includes a seal body 26 positioned within the passageway 24 of the adapter body 12 and an actuator 28. The seal body 26 forms a seal with the adapter body 12. The catheter 18 is connected to the seal body 26. The actuator 28 is configured to move the seal body 26 from a first position within the adapter body 12 to a second position spaced from the first position within the adapter body 12. When the catheter 18 is connected to the seal body 26, the catheter 18 is extended and retracted relative to the adapter body 12 as the seal body 26 is moved between the first and second positions.
[0022] Referring to FIGS. 1 and 2, an end cap 30 is positioned at the first end 14 of the adapter body 12 and is configured to engage the seal body 26 to limit movement of the seal body 26. The end cap 30 may be integrally formed with the adapter body 12 or may be formed separately from the adapter body 12 and subsequently attached to the adapter body 12. The adapter body 12 includes a side port 32 extending between the first and second ends 14, 16 of the adapter body 12, and the side port 32 defines a side passageway 34 in fluid communication with the passageway 24 of the adapter body 12. The side port 32 extends at an angle of 25-75 degrees from the adapter body 12, although other suitable angles may be utilized.
[0023] Referring to FIGS. 2, 3, 5, and 6, the catheter 18 is connected to the seal body 26 via the wedge 36, although other suitable arrangements may be utilized. The portion of the catheter 18 is positioned over the wedge 36, and the wedge 36 is connected to the seal body 26 via an interference fit. The wedge 36 may be press-fit or bonded to the seal body 26. The wedge 36 defines a central passage 39 along the catheter 18. The wedge 36 has a tapered portion 38 configured to receive the catheter 18 and a flare portion 40, and the flare portion 40 has a diameter larger than that of the tapered portion 40. The seal body 26 defines a passage for receiving the catheter 18 and the flare portion 40. The passage 41 of the seal body 26 may be tapered to facilitate an interference fit with the wedge 36 and / or may include a portion with a reduced diameter. The seal body 26 includes a plurality of seal rings 42 that form a seal with the adapter body 12. In one aspect or embodiment, the seal body 26 is formed from a polymer and the seal rings 42 are formed from an elastomer or silicone.
[0024] Referring to FIGS. 5 and 6, in one aspect or embodiment, the actuator 28 is an extension member 44 that is connected to the seal body 26 and extends outside the passage 24 of the adapter body 12. The extension member 44 may be integrally formed with the seal body 26 or may be formed separately and subsequently fixed to the seal body 26. The actuator seal 46 is positioned within the passage 24 of the adapter body 12, and the extension member 44 and the needle 20 are received within the actuator seal 46. The actuator seal 46 is positioned at the second end 16 of the actuator body 12, although other suitable arrangements may be utilized. The length of the actuator seal 46 is configured such that it is not in fluid communication with any portion of the actuator 28 where the catheter 18 can be positioned outside the passage 24 of the adapter body 12. The extension member 44 includes a handle 48, although other suitable arrangements may be utilized.
[0025] Referring to FIGS. 7 - 10, in a further aspect or embodiment, the actuator 28 is a handle 60 having a first magnet 62 and a second magnet 64 connected to the seal body 26, with at least a portion of the handle 60 positioned outside the passage 24 of the adapter body 12. The movement of the handle 60 is configured to move the seal body 26 between a first position and a second position via the interaction between the first magnet 62 and the second magnet 64. In one aspect or embodiment, the first and second magnets 62, 64 are rare earth magnets. In one aspect or embodiment, the first magnet 62 is attached to the second magnet 64. The first magnet 62 is arcuate and the second magnet 64 is annular, although other suitable shapes and configurations may be utilized. The handle 60 and the first magnet 62 are received within a slot 66 defined by the adapter body 12. The slot 66 is generally T - shaped, and a portion of the slot 66 may conform to the arcuate shape of the first magnet 62.
[0026] Referring to FIGS. 11 - 17, in a further aspect or embodiment, the actuator 28 is a knob 80 having a pinion gear 82 and a rack 84 connected to the seal body 26 and engaging the pinion gear 82. Rotation of the knob 80 rotates the pinion gear 82 and moves the seal body 26 between a first position and a second position. The knob 80 is positioned outside the passage 24 of the adapter body 12, and the pinion gear 82 and the rack 84 are received within the passage 24 of the adapter body 12. A seal bearing 86 is positioned between the knob 80 and the pinion gear 82 to seal an opening of the adapter body 12 that receives the knob 80. The rack 84 may be integrally formed with the seal body 26 or formed separately and subsequently attached to the seal body 26. The rack 84 extends in a direction extending from the first end 14 to the second end 16 of the adapter body 12.
[0027] The vascular access device 10 is configured to be inserted into a patient's vasculature like a shorter catheter, but by moving the seal body 26 from a first position to a second position and then back to the first position for blood aspiration, it enables the catheter 18 to be extended. Extending the catheter 18 allows for improved blood collection and, because the distal end is located further away from the insertion site, enables reduced thrombus formation around the distal end of the catheter 18. Also, extending the catheter 18 reduces the risk of infiltration and extravasation due to the additional length of the catheter 18 inside the blood vessel. All of these advantages can reduce the occurrence of such adverse events, enhance patient comfort, and potentially extend the dwell time. The vascular access device 10 may be inserted by nursing staff without the use of ultrasound guidance or a specialized insertion team. Many hospitals require the use of ultrasound-guided PIVC insertion when the catheter length exceeds 1.25 inches (3.175 centimeters). However, the vascular access device 10 may be inserted into a patient's vasculature by typical insertion methods without the need for ultrasound guidance or a specialized insertion team.
[0028] The present invention has been described in detail for the purpose of explanation based on what is currently considered to be the most practical and preferred embodiment, but such details are for that purpose only, and the present invention is not limited to the disclosed embodiments. On the contrary, it is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
Claims
1. A vascular access device, comprising: An adapter body having a first end and a second end positioned opposite the first end, the adapter body defining a passageway, A catheter received by the adapter body, A needle received by the adapter body, a portion of the needle being positioned within the catheter, and A seal assembly including a seal body and an actuator positioned within the passageway of the adapter body, the seal body forming a seal with the adapter body, the catheter being connected to the seal body, and the actuator being configured to move the seal body from a first position within the adapter body to a second position within the adapter body spaced from the first position. A vascular access device comprising the above.
2. The vascular access device according to claim 1, further comprising an end cap positioned at the first end of the adapter body, the end cap being configured to engage the seal body and limit movement of the seal body.
3. The vascular access device according to claim 1, wherein the catheter is connected to the seal body via a wedge.
4. The vascular access device according to claim 3, wherein a portion of the catheter is positioned on the wedge, and the wedge is connected to the seal body via an interference fit.
5. The vascular access device according to claim 1, wherein the actuator comprises an extension member connected to the seal body and extending outside the passageway of the adapter body.
6. The vascular access device according to claim 5, further comprising an actuator seal positioned within the passageway of the adapter body, the extension member and the needle being received by the actuator seal.
7. The vascular access device according to claim 1, wherein the actuator comprises a handle having a first magnet and a second magnet connected to the seal body, at least a portion of the handle being positioned outside the passageway of the adapter body, and the movement of the handle being configured to move the seal body between the first position and the second position via an interaction between the first magnet and the second magnet.
8. The vascular access device according to claim 7, wherein the first magnet is arc-shaped and the second magnet is annular.
9. The vascular access device according to claim 7, wherein the handle and the first magnet are received in a slot defined by the adapter body.
10. The actuator according to claim 1, comprising a knob having a pinion gear and a rack connected to the seal body and engaging with the pinion gear, wherein rotation of the knob rotates the pinion gear to move the seal body between the first position and the second position.
11. The vascular access device according to claim 10, wherein the knob is positioned outside the passage of the adapter body, and the pinion gear and the rack are received in the passage of the adapter body.
12. The vascular access device according to claim 10, wherein the actuator includes a seal bearing positioned between the knob and the pinion gear, and the seal bearing is configured to seal an opening of the adapter body that receives the knob.
13. The vascular access device according to claim 10, wherein the rack is integrally formed with the seal body.
14. The vascular access device according to claim 1, wherein the seal body includes a plurality of seal rings.
15. The vascular access device according to claim 1, wherein the adapter body includes a side port extending between a first end and a second end of the adapter body, and the side port defines a side passage in fluid communication with the passage of the adapter body.
16. The vascular access device according to claim 15, wherein the side port extends at an angle of 25 to 75 degrees from the adapter body.