The present invention is directed to intravenous equipment and more particularly, to IV catheter (delivery) systems that each includes an actuatable obturator that is configured to facilitate placement of the IV catheter system within the vein by blunting a sharp needle tip of the needle that is used to guide the delivery of the IV catheter system.
As is well understood, IV stands for intravenous and concerns delivery fluids or medicines through a needle or tube (catheter) into a vein. The needle is usually placed in a vein near the elbow, the wrist or in the back of the hand. IV fluids or medicine are delivered in a wide array of different settings. One specific application in which medicine is delivered by an IV is the field of anesthesia which uses drugs or other methods to create a loss of awareness and block feelings of pain. It increases patient comfort and safety during medical procedures. Under general anesthesia, the patient is unaware and does not sense pain. Because the patient cannot breathe without help, a breathing machine is required. A breathing tube or other airway device delivers general anesthesia and maximizes patient safety. General anesthesia uses a variety of drugs and methods. The most common method is through breathing gas after an intravenous (IV) injection. The patient breathes in gases that are absorbed by the lungs and delivered through the bloodstream to the brain and spinal cord.
An IV catheter is the primary means for delivering the IV fluid/medicine to the patient. Intravenous (IV) cannulation is a technique in which a cannula (IV catheter) is placed inside a vein to provide venous access. Venous access allows sampling of blood, as well as administration of fluids, medications, parenteral nutrition, chemotherapy, and blood products.
Veins have a three-layered wall composed of an internal endothelium surrounded by a thin layer of muscle fibers that is surrounded by a layer of connective tissue. Venous valves encourage unidirectional flow of blood and prevent pooling of blood in the dependent portions of the extremities; they also can impede the passage of a catheter through and into a vein.
An IV catheter is introduced into the vein by a needle and then is fixed by being taped to a patient's skin. Most modern day IV catheters are equipped with a safety mechanism to shield the user from the needle as the needle is exposed and then later removed and retracted.
IV cannulation is typically performed by completing the following steps:
Unfortunately, there has been little improvement on the placement of an IV catheter over the years and most advancements have been in improvement in IV safety (prevention of needle sticks). There have been minimal design features to help novices achieve high rates of first attempt success when inserting and starting an IV. As mentioned, once the sharp tip of needle (beveled tip) enters vein, a flash of blood (a flashback) is seen in a chamber visible to the practitioner. However, when the tip of the needle enters the vein, the tip of catheter is still set back a short distance from the needle point. If a practitioner attempts to advance the catheter before the entire tip of the catheter is in the vein as well, it will not advance and will possibly disrupt and jeopardize the integrity of the vein. To prevent this from happening, once the flash is seen, the practitioner, must advance the needle further forward (a distance which depends on how big the needle is and how far the catheter tip is from the needle point) until the catheter is in the vein. This additional advancement runs the risk of “back-walling” the vein, or the needle point puncturing the other side of the vein and thus disrupting the integrity of the vein.
There is therefore a need for an IV catheter device that addresses and overcomes the above noted deficiencies and one that allows for proper placement of the catheter without the risk of “back-walling” the vein.
An IV catheter device according to one embodiment includes a needle component having an elongated needle with a sharp distal tip and a catheter component having a hollow body through which the needle passes. The IV catheter device further includes an actuatable obturator that is disposed within the needle component and moves between a pre-deployment position and a deployed position. In the deployed position, the actuatable obturator is disposed within an inner lumen of the elongated needle and a blunt distal end of the obturator is located distal to the sharp distal tip so as to blunt the elongated needle.
The present disclosure also sets forth a method for selectively blunting a sharp distal end of a needle that is part of an IV catheter device comprising the step of: actuating an obturator that is part of an IV catheter device to cause the obturator to travel within an inner lumen of the needle until a blunt distal end of the obturator is located distal to the sharp distal end of the needle so as to blunt the needle.
In accordance with the present disclosure, improved IV catheter devices are provided and are illustrated in the appended figures. It will be understood that components/elements that are used and present in multiple embodiments are numbered alike.
A traditional IV catheter is made up of a number of components that are assembled together to form an IV catheter device 10 as shown in
At the distal end 22 of the main catheter body 21, an elongated catheter tip 30 is provided and extends distally from the distal end 22. The catheter tip 30 is a small hollow structure that has a center lumen formed therein and is integrally connected to the distal end 22 of the main catheter body 21. For example, the main catheter body 21 and the catheter tip 30 are typically formed as a single integral structure (e.g., single injection molded part).
The elongated catheter tip 30 is the portion of the IV catheter component 20 that is driven into a vein 5 (
The IV catheter component 20 can include a valve 29 to allow for injection of fluid (e.g., drugs) with a syringe. Any number of suitable valves 29 can be used. Alternatively, the IV catheter component 20 can have a simple construction with no valve as shown in
The proximal end 24 is the end which allows connection to an intravenous infusion line (tubing) and capping in between uses. As is known, the infusion line is placed in fluid communication with the main catheter body 21 for delivering fluid from a source, such as an IV bag or the like, to the vein through the catheter tip 30.
The needle component 40 serves as a guidewire for inserting the cannula (catheter tip 30) into the vein. As shown, the needle component 40 is a separate part from the IV catheter component 20. The needle component 40 includes a hub portion 42 for grasping the needle component 40 and includes of course, an elongated hollow needle 44. The hub portion 42 is much wider than the needle and an inner shoulder 45 (
The needle 44 is usually formed of metal. As shown, the needle 44 is sized so that it is received within the hollow main catheter body 21 and travels into the hollow catheter tip 30. The needle 44 can be advanced beyond the distal tip.
Typically, the open distal end of the needle 44 is beveled to create a sharp end that can be advanced through the skin into the vein.
As described herein, the hub portion 42 can be also referred to as a flash chamber since one of the primary features of the hub portion 42 is to define and contain the flash chamber.
The needle component 40 can also include a structure that serves to assist in retention of the IV catheter component 20 and more specifically, a boss 49 or the like can be provided and is sized to establish a friction fit between the IV catheter component 20 and the needle and in particular, the boss 49 as shown in
Blood in a person's veins is under a higher than atmospheric pressure and therefore, when the IV needle 44 is placed in a vein, the higher pressure forces blood to travel through the needle 44. The blood can flow because the other end of the needle, called the flash chamber, that is located within the hub portion 42, has a fiber filter or the like in it that allows air to escape. After the catheter component 20 is advanced into the vein, the needle component 40 is removed and discarded.
The cover or protection cap 50 is designed to fit over the catheter tip 30 and shield the needle that is located inside the catheter tip 30. Before use, the cover 50 is removed and discarded.
As described herein, in accordance with the present disclosure, the actuatable obturator functions to selectively transform the sharp distal tip of the needle 44 into a blunt end after the needle is inserted into the vein.
In accordance with the present disclosure, an actuatable obturator 200 is provided as part of an IV catheter device 100 for selectively transforming the sharp distal tip of the needle 44 into a blunt end (See,
The obturator 200 also includes a hub portion 210 to which the elongated structure 202 is coupled. The elongated structure 202 thus extends distally from the hub portion 210. The hub portion 210 is thus an enlarged part compared to the elongated structure 202. The elongated structure 202 terminates in a distal blunt end 205. In this embodiment, the obturator 200 can be a solid structure.
In the embodiment shown in
The obturator 200 is a biased structure in that a biasing element 220, such as a spring, is provided and is disposed within the hub portion 42 adjacent the obturator 200. Spring 220 can be located between the proximal end of the obturator 200 and a mounting surface located internally within the needle hub 42. In the pre-deployment position, the spring 220 is in a compressed state and stores energy. An actuator 230 is provided and is operatively coupled to the obturator 200 such that when the actuator 230 is manipulated, the obturator 200 is released and the energy that is released from the spring 220 causes forward advancement (firing) of the obturator 200 within the needle lumen to the deployed position. The actuator 230 can take any number of different forms including a switch, button, slider, etc. The actuator 230 can have a catch or claw or the like that engages the obturator 200.
The present invention thus provides a solution to high failure rates of IV catheter placement in the form of the spring-loaded, actuatable (e.g. button-released) obturator 200 which creates a blunt-tipped needle after needle tip is inside vessel (vein) 5. This would allow for a practitioner to safely advance needle 44 forward until catheter tip is also within vessel lumen without fearing penetration of needle through the posterior wall of the vessel (vein 5). This would likely be most beneficial for vessels which require steep angles of attack, such as ultrasound guided peripheral IVs placed in the obese patient. A secondary benefit of this system is that it would also reduce needle stick injuries as after removal, the needle tip would be blunt.
Alternatively, in another embodiment, there is sufficient space surrounding the obturator 200 within the lumen of the needle 44 to permit the blood to flash by flowing around the obturator 200 to the flash chamber located in the wider hub portion 42 of the needle component 40. In this embodiment, in the pre-deployment position, the distal end portion of the elongated structure 202 of the obturator 200 is at least partially within the inner lumen of the needle 44. Since the diameter of the obturator 200 is less than the inner diameter of the needle 44, there is an annular space around the obturator 200. This annular shape opens into the flash chamber located in the wider hub portion 42. The wider hub portion 210 of the obturator is spaced away from the inner shoulder 45 in this pre-deployment position.
In the deployed position, the obturator 200 is advanced forward within the lumen of the needle 44 until the distal blunt end 205 is advanced distally beyond the sharp distal end of the needle 44 to once again transform the sharp needle tip into a blunt end.
In another embodiment, the obturator is hollow as opposed to the solid obturator of the previous embodiments (See,
The obturator 300 also includes a hub portion 310 to which the elongated structure 302 is coupled. The elongated structure 302 thus extends distally from the hub portion 310. The hub portion 310 is thus an enlarged part compared to the elongated structure 302. The elongated structure 302 terminates in a distal blunt end 305. The hub portion 310 is a hollow structure and within the hub portion 310, there is a flash chamber 320 that receives the blood flash.
Unlike the previous embodiments, in this embodiment, it is the obturator 300 itself that defines the blood flash pathway. In the pre-deployment position, the distal end portion of the hollow elongated structure 302 of the obturator 300 is at least partially within the lumen of the needle 44. Since the diameter of the obturator 300 is the same or slightly less than the inner diameter of the lumen of the needle 44, the obturator 300 completely occupies the lumen of the needle 44 and the two are in intimate contact with one another. As a result, blood flowing into the lumen of the needle 44 flows directly into the lumen of the hollow obturator 300. The blood first flows within the hollow elongated structure 302 and then into the flash chamber 320 (indicated by arrows). The hub portion 310 is spaced away from the inner shoulder 45 in this pre-deployment position.
In the deployed position (
Additional obturator designs are possible for use with various complementary needle components so as to define different types of IV catheter devices.
In this embodiment, the blunt end 505 is solid as a result of off-setting the entrance into the inner lumen of the elongated structure 502. This solid blunt end 505 extends beyond the beveled sharp end of the needle 44.
When the obturator 500 is advanced to its deployed position, the entrance to the inner lumen is positioned sufficiently beyond the sharp distal needle tip, thereby allowing blood from the vein 5 to flow into the open entrance into the inner lumen of the obturator 500. This feature and operation are described in more detail below.
In this embodiment, the inner lumen is thus a flow through channel in that blood enters into the inner lumen from the side of the obturator and flows through the inner lumen and then exits the obturator 550. From the exit, the blood flows radially outward into a flash chamber where it collects. The flash chamber is thus located outside the obturator 550 within the hub portion of the needle. When the obturator 550 is advanced, blood flows through the inner lumen of the obturator 550 into the flash chamber. In other words, when the obturator 550 is advanced to its deployed position, the entrance to the inner lumen is positioned sufficiently beyond the sharp distal needle tip, thereby allowing blood from the vein 5 to flow into the open entrance into the inner lumen of the obturator 550.
In this embodiment, the blunt end 577 is solid as a result of off-setting the entrance into the inner lumen of the elongated structure 581. This solid blunt end 577 extends beyond the beveled sharp end of the needle 44.
When each of the obturators 500, 550, 575 is advanced to its deployed position, the entrance to the inner lumen is positioned sufficiently beyond the sharp distal needle tip, thereby allowing blood from the vein 5 to flow into the open entrance into the inner lumen of the obturator. Thus, the inner lumen of the obturator remains open in the fully deployed position.
The movable center portion 85 can be in the form of a hinged door that in a normal at rest position (when the obturator 301 is in the pre-deployment position) is closed. The door is hinged such that when a forward force is applied by the obturator 301, as it is fired forward, the door opens outward toward the shoulder 45. The door opens sufficiently such that the obturator 301 can advance forward and travel into the inner lumen of the needle 44 and exit the inner lumen as shown in
The outer peripheral portion 87 can be angled as shown and can define a seat for the obturator hub. In particular, the obturator hub in the deployed position seats against the outer peripheral portion 87 which has a complementary shape relative to the shape of the obturator hub and acts as a stop. When the outer peripheral portion 87 is angled, the obturator hub can be angled and mirror the shape of the seat (stop).
The movable center portion 85 can be biased or constructed so that at rest it assumes the closed position and it takes an applied force, such as the driving action of the obturator, to move the movable center portion 85 to the open position.
The obturator hub thus defines the flash chamber 320 in this embodiment and is preferably transparent to allow the blood flash to be seen.
In this particular embodiment, the open space 98 defines two different flash chambers, namely, a first flash chamber 94 that receives a first blood flash and a second flash chamber 96 that receives a second blood flash. The second flash chamber 96 is closed off in the pre-deployment position of the obturator 550, while the first flash chamber 94 remain open.
Thus, when the needle 44 enters the vein (vessel), the first blood flash travels up the inner lumen of the needle and is directed by the inner wall into the first flash chamber 94. The second flash chamber 96 remains closed and as a result, the blood flash is directed into the first flash chamber 94.
The movable center portion 95 can be in the form of a hinged door that in a normal at rest position (when the obturator 550 is in the pre-deployment position) is closed. The door is hinged such that when a forward force is applied by the obturator 550, as it is fired forward, the door opens outward toward the shoulder 45. The door opens sufficiently such that the obturator 550 can advance forward and travel into the inner lumen of the needle 44 and exit the inner lumen as shown in
The outer peripheral portion 97 can be angled as shown and can define a seat for the obturator hub. In particular, the obturator hub in the deployed position seats against the outer peripheral portion 97 which has a complementary shape relative to the shape of the obturator hub and acts as a stop. When the outer peripheral portion 97 is angled, the obturator hub can be angled and mirror the shape of the seat (stop).
Once the obturator 550 is fired, the second flash chamber 96 opens up due to the pivoting of the movable center portion 95 as well as the fluid force applied by the blood which can, as shown in
When the needle 44 is first inserted into the vein, the first blood flash flows into and with the inner lumen of the needle 44 and flows into the first flash chamber 717 but not the second flash chamber 719.
In the deployed position of
In the pre-deployment position of
Once the needle 44 is in the proper position, the obturator 200 is fired forward and this action causes the obturator 200 to strike and force open the hinged door 819 to allow the elongated structure 202 to travel into the needle 44. As with the other embodiments, in the deployed position, the distal blunt end 205 of the obturator 200 is advanced beyond the sharp tip of the needle 44 and the hub portion 210 of the obturator 200 strikes and is biased against the inner wall 814 which acts a stop as shown in
In the pre-deployment position of
Once the needle 44 is in the proper position, the obturator 900 is fired forward and this action causes the obturator 900 to strike and force open the hinged door 819 to allow the elongated structure 902 to travel into the needle 44. As with the other embodiments, in the deployed position, the distal blunt end 905 of the obturator 200 is advanced beyond the sharp tip of the needle 44 and the hub portion 910 of the obturator 900 strikes and is biased against the inner wall 814 which acts a stop as shown in
The hollow obturator 900 design thus accommodates blood flow through the obturator 900 in the deployed position. Blood can flow into and through the inner lumen of the obturator 900 and then exits through the exit in the hub portion 910 and into the second compartment 815 which acts as a second flash chamber. Since the hub portion of the needle is preferably transparent, this second blood flash will be visible.
The needle component 950 includes needle 44 and a hollow hub portion 952. Within the hollow hub portion 952 has an inner wall 953 that acts as a stop. The inner wall 953 can be an angled wall.
In the deployed position, the blood thus flows axially and longitudinally through the inner lumen of the obturator 970 to a flash chamber formed in the hub portion 952 of the needle component 950. The hollow obturator 970 design thus accommodates blood flow through the obturator 970 in the deployed position. Biasing element (spring) 920 is provided.
It will be appreciated that after deployment of the actuatable obturator 200, a mechanism can be provided to ensure that the actuatable obturator remains in the deployed position and does not back into the inner lumen of the needle after deployment. If the actuatable obturator 200 backs into the inner lumen of the needle, the sharp tip would be exposed again.
To ensure that the actuatable obturator 200 remains in the deployed position several techniques can be used.
One technique is the use of a lock mechanism or the like which itself is operable after the actuatable obturator 200 is deployed as shown in
This type of lock mechanism can be configured so that the user can reverse and release the lock mechanism, thereby freeing the actuatable obturator. This would allow the manual retracting of the actuatable obturator 200 to purposefully recreate the sharp tip, but the retraction should not be from pressure applied at the forward tip.
In addition, the lock mechanism can be automated and tripped by the deployment of the actuatable obturator 200. For example, the enlarged hub portion of the actuatable obturator 200 can contact and trip a locking mechanism that then engages the hub portion, such as the proximal end of the hub portion, to create a mechanical interference that prevents retraction of the actuatable obturator within the inner lumen of the needle (i.in the proximal direction).
Alternatively, the spring element 220 has a selected high compressive strength that prevents unintended retraction of the actuatable obturator 200 within the inner lumen of the needle during normal use of the device within the vessel (vein).
It will also be understood that the obturators shown in
In addition, it will be understood that the lock mechanism illustrated in the figures and described herein can be implemented in all of the embodiments described and illustrated herein. In other words, while the figures do not show the lock mechanism incorporated into each of the illustrated embodiments, each of these embodiments preferably includes a lock mechanism to ensure that the deployed obturator does not freely move rearward when a force is applied to the blunt distal end.
In another aspect of the present disclosure shown in
It will also be appreciated that the teachings illustrated in the obturator 400 of
The obturator 400 contains design features which allow for increased echogenicity and improved visualization when placed under ultrasound guidance. The features could contain either materials which are inherently more echogenic than the surrounding materials or entail etchings in the obturator which increase the number of ultrasound beams returning to the probe. This increased echogenicity would be used after deployment of the obturator 400 upon obtaining a flash of blood. The improved visualization of the obturator 400 would provide additional information about how far and at what orientation to advance the system into the vessel. The features may be placed at predetermined intervals to aid in determining how far into the vessel the user has advanced.
One skilled in the art would understand that there are many different types of materials that are echodense to provide visualization under traditional imaging techniques (e.g. ultrasound). Etchings provide different scattering patterns to allow for improved visualization.
As mentioned herein, the provision of one or more regions of echodense material provide for increased visualization of the obturator especially post deployment. When more than one region of echodense material is provided at spaced intervals, the degree of deployment can be determined. For example, as shown in
While the applications of the present catheter devices are discussed in terms of being used in intravenous access, it will be appreciated that the present devices can be used in other applications. For example, the present devices can be used in other kinds of vascular access (intra-arterial) or other procedures where it might be useful to move from a sharp to a blunt tip, such as peripheral nerve blocks or neuraxial procedures.
In all of the embodiments described herein, the obturator can be formed of a transparent material to allow the user to see the blood flash. In addition, the hollow hub portion of the needle component is also typically transparent.
It is to be understood that like numerals in the drawings represent like elements through the several figures, and that not all components and/or steps described and illustrated with reference to the figures are required for all embodiments or arrangements.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising”, when used in this specification, specify the presences of stated features, integers, steps, operations, elements, and/or components, but do not precludes the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having,” “containing,” “involving,” and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
The subject matter described above is provided by way of illustration only and should not be construed as limiting. Various modifications and changes can be made to the subject matter described herein without following the example embodiments and applications illustrated and described, and without departing from the true spirit and scope of the present invention, which is set forth in the following claims.
The present application claims priority to and the benefit of U.S. provisional patent application Ser. No. 63/065,088, filed Aug. 13, 2020, which is hereby expressly incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/045187 | 8/9/2021 | WO |
Number | Date | Country | |
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63065088 | Aug 2020 | US |