Patent Application
20230173187
The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to large bore syringes connected with other structures, and methods for manufacturing and using such devices.
A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include syringes, aspiration devices, thrombectomy devices, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example syringe includes a barrel having a distal end region and an inner surface defining a lumen extending therein, wherein the inner surface includes a proximally facing surface, and wherein the distal end region includes a distal end. The syringe also includes a plunger having a body portion and a distal tip extending distally away from a distal end region of the body portion, wherein the distal end region includes a distally facing surface. Further, the plunger is configured to be positioned within the lumen of the barrel and a portion of the distal tip of the plunger extends distally of the distal end of the barrel when the plunger is positioned within the lumen of the barrel.
Alternatively or additionally to any of the embodiments above, wherein the distal end region of the barrel is configured to couple to a manifold of a catheter system, and wherein a portion of the distal tip of the plunger is configured to extend into a lumen of the manifold when the barrel is coupled to the manifold.
Alternatively or additionally to any of the embodiments above, wherein the portion of the distal tip extending into the manifold is configured to purge air from the lumen of the manifold.
Alternatively or additionally to any of the embodiments above, wherein the body portion of the plunger includes a first outer diameter, and wherein the distal tip portion of the plunger includes a second outer diameter smaller than the first outer diameter.
Alternatively or additionally to any of the embodiments above, wherein the distal tip of the plunger further includes a first tip portion and a second tip portion, wherein the first tip portion includes the second outer diameter, and wherein the second tip portion includes a third outer diameter smaller than the second outer diameter.
Alternatively or additionally to any of the embodiments above, wherein the first outer diameter of the plunger is about three times as large as the second outer diameter of the first tip portion.
Alternatively or additionally to any of the embodiments above, wherein the second tip portion is positioned distal to the first tip portion.
Alternatively or additionally to any of the embodiments above, wherein the first tip portion includes a first length, and wherein the second tip portion includes a second length, and wherein the first length is about twice as long as the second length.
Alternatively or additionally to any of the embodiments above, wherein the first length of the first tip portion is longer than the first diameter of the body of the plunger.
Alternatively or additionally to any of the embodiments above, wherein the distal end region of the body portion further includes a stopper, and where the stopper is configured to seal against the inner surface of the barrel.
An example catheter aspiration system includes an aspiration catheter including a tubular member coupled to a manifold, wherein the tubular member includes a first lumen extending therein, and wherein the manifold includes a second lumen extending therein, and wherein the first lumen is in fluid communication with the second lumen. The aspiration catheter system also includes a syringe configured to be coupled to the manifold, wherein the syringe includes a barrel and a plunger, the barrel having a distal end and an inner surface defining a lumen extending therein, wherein the plunger is configured to be positioned within the lumen of the barrel, and wherein the plunger includes a body portion and a distal tip extending distally away from the body portion. Further, a portion of the distal tip of the plunger is configured to extend distally of the distal end of the barrel and into the lumen of the manifold when the syringe is coupled to the manifold.
Alternatively or additionally to any of the embodiments above, wherein the portion of the distal tip extending into the manifold is configured to purge air from the lumen of the manifold.
Alternatively or additionally to any of the embodiments above, wherein the body portion of the plunger includes a first outer diameter, and wherein the distal tip portion of the plunger includes a second outer diameter smaller than the first outer diameter.
Alternatively or additionally to any of the embodiments above, wherein the distal tip of the plunger further includes a first tip portion and a second tip portion, wherein the first tip portion includes the second outer diameter, and wherein the second tip portion includes a third outer diameter smaller than the second outer diameter.
Alternatively or additionally to any of the embodiments above, wherein the first outer diameter of the plunger is about three times as large as the second outer diameter of the first tip portion.
Alternatively or additionally to any of the embodiments above, wherein the second tip portion is positioned distal to the first tip portion.
Alternatively or additionally to any of the embodiments above, wherein the first tip portion includes a first length, and wherein the second tip portion includes a second length, and wherein the first length is about twice as long as the second length.
Alternatively or additionally to any of the embodiments above, wherein the first length of the first tip portion is longer than the first diameter of the body of the plunger.
Alternatively or additionally to any of the embodiments above, wherein a distal end region of the body portion of the plunger further includes a stopper, and where the stopper is configured to seal against the inner surface of the barrel.
An example method of removing a blood clot from a blood vessel of a patient includes advancing an aspiration catheter within the blood vessel such that a distal end of the catheter is positioned adjacent to the blood clot, and wherein the catheter includes a tubular member coupled to a manifold, wherein the tubular member includes a first lumen extending therein, and wherein the manifold includes a second lumen extending therein, and wherein the first lumen is in fluid communication with the second lumen. The method further includes attaching a syringe to the manifold, wherein the syringe includes a barrel and a plunger, the barrel having a distal end and an inner surface defining a lumen extending therein, wherein the plunger is configured to be positioned is within the lumen of the barrel, and wherein the plunger includes a body portion and a distal tip extending distally away from the body portion. The method further includes advancing the plunger into the lumen of the barrel to a position in which the distal tip of the plunger extends out of the distal end of the barrel and into the lumen of the manifold. The method further includes retracting the plunger in a proximal direction, wherein retracting the plunger generates a vacuum to aspirate at least a portion of the blood clot into the first lumen of the tubular member.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.
Thromboembolism may be characterized as an adverse medical condition whereby a blood clot forms an occlusion in a blood vessel. In some instances, a blood clot (thrombus) having formed in a blood vessel, dislodges and blocks another blood vessel. Blood clots in both the arterial system and the venous system may cause serious harm. For example, when an artery is occluded by a thrombus, tissue ischemia may develop. The ischemia may eventually progress to tissue infarction if the occlusion persists. Similarly, in the venous system, thrombus may also cause serious harm. For is example, thrombus may develop in the veins of the legs, a condition known as deep venous thrombosis (DVT). DVT can obstruct the flow of venous blood from the legs, thereby leading to adverse conditions such as swelling and infection. Additionally, in some instances a blood clot in the legs may break loose, travel through the bloodstream to the lungs and cause a sudden blockage in a lung artery, a condition known as a pulmonary embolism. Pulmonary embolism can lead to permanent damage to the lungs, low oxygen levels in the blood and damage to other organs due to the lack of oxygen.
However, it can be appreciated that the re-establishment of sufficient blood flow may significantly reduce harm caused by thromboembolism. A variety of medical treatments exist to re-establish blood flow through an occluded vessel. For example, in some instance medicines which include anticoagulants may be utilized to prevent the blood clots from forming while thrombolytics may be utilized to dissolve existing blood clots. However, not all patients can be treated with anticoagulants and/or thrombolytics. Therefore, in some instances, medical devices may be utilized to mechanically extract (e.g., aspirate) a volume of thrombus via a catheter-based intervention. For example, a catheter coupled to a large-bore aspiration device (e.g., syringe) may be utilized to aspirate thrombus. Accordingly, it can be appreciated that the syringe may be designed to create maximum vacuum power sufficient to dislodge and extract the thrombus through the catheter lumen. Large-bore aspiration devices designed to maximize vacuum power through an aspiration catheter are disclosed herein.
Additionally,
As will be discussed in greater detail below,
It can be appreciated that the stopper 30 of the syringe 10 may be designed to seal against an inner surface of the of the barrel 12. For example, as illustrated in
As discussed above,
Referring to
As described above,
Additionally,
It can be appreciated that the catheter aspiration system (including the syringe 10 and the aspiration catheter 48) shown in
However, as described above, it can be appreciated that a portion of the second tip portion 34 may extend out of the barrel 12 as the clinician attaches the distal end region 14 of the barrel 12 to the manifold 42. Accordingly, the second tip portion 34 may replace and/or purge any air which may be present in the distal end of the lumen of the manifold 42. Accordingly, because the second tip portion 34 extends into the lumen of the manifold 42, it may assure that a continuous column of fluid extends from the distal end 19 of the barrel (or the end 21 of the distal tip portion 27) to the distal end 46 of the tubular member 40. This solid column of fluid assures a maximum vacuum force as the clinician retracts the plunger 18 to aspirate clot material positioned adjacent the distal end 46 of the aspiration catheter 48.
As described above, in some instances the clinician may utilize the clamp 44 to control initiation of the vacuum force generated by the syringe 10. For example, the clinician may prep the syringe 10 and the aspiration catheter 48 as described above, however, prior to retracting the plunger 18 to generate the vacuum force, the clinician may close the clamp 40. After closing the clamp 44, the clinician may retract the plunger 18 relative to the barrel 12, thereby generating vacuum forces within the barrel 12, the manifold and a portion of the tubular member 40. Further, after positioning the distal end 46 of the tubular member 40 in the desired location adjacent the blood clot, the clinician my open the clamp 44, thereby transferring the generated vacuum force to the distal end 46 of the tubular member 40. Further, it can be appreciated that the clinician may control the volume of the vacuum by withdrawing the plunger 18 more or less to provide a is desired amount of suction (e.g., aspiration) upon opening of the clamp 44.
Additionally, in another example technique, a clinician may bury the distal end 46 of the tubular member 40 in the clot material prior to retracting and generating a vacuum forces to aspirate the clot. For example, a clinician may prep and connect the syringe 10 to the aspiration catheter 48 as described above such that a continuous column of fluid extends from the distal end 19 of the barrel (or the end 21 of the distal tip portion 27) to the distal end 46 of the tubular member 40. Further, the clinician may advance the catheter within a blood vessel such that the distal end 46 of the tubular member 40 is adjacent a target clot material. The clinician may then bury the distal end 46 of the tubular member 40 into the clot material. Next, the clinician may retract the plunger 18 relative to the barrel 12, thereby generating a vacuum force in the tubular member 40. The vacuum force builds until it is strong enough to embolize and aspirate the thrombus. This technique can be repeated until the entire vacuum capacity of the syringe is used.
The materials that can be used for the various components of the medical device 10 and the various other medical devices disclosed herein may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), is polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.
Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.
In at least some embodiments, portions or all of the medical device 10 and the various other medical devices disclosed herein may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the medical device 10 and the various other medical devices disclosed herein in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the medical device 10 and the various other medical devices disclosed herein to achieve the same result.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The disclosure's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of priority under 35 U.S.C. § 119 of U.S. Provisional Application No. 63/285,555, filed Dec. 3, 2021, the entire disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63285555 | Dec 2021 | US |
