Patent Application
20180361036
Since it s development in 1907 by Dr. Charles Yankauer, the Yankauer suction tip has become the most commonly used suction instrument in the world. Most often, it is used by connecting it to a tube and suction source and implemented by a surgeon or dentist to aspirate fluid and debris from either a surgical site or body orifice (i.e., airway or mouth). It is used by in surgical, dental and veterinary operations, as its design permits effective suctioning of unwanted liquids and debris without significant damage to surrounding tissues.
Typically, the Yankauer suction tip is manufactured of metal or a ridged or semi-ridged plastic includes a large suction portion having large orifice surrounded by a bulbous head. The suction portion of the Yankauer suction tip is unitary with an elongated suction tube, which is grasped by the operator to maneuver the suction end where needed, and which is connectable, at its non-suction tip end, to a suction source. In current practice, the Yankauer suction tips used in procedures in most developed medical systems are disposable for reasons of hygiene and operational efficiency.
In certain types of surgery, such as, for example, orthopedic surgeries, particularly hip replacement surgeries, the Yankauer suction tip is called upon to remove both liquids and a significant amount of highly viscous matter and/or particulate debris (remnants of tissue and bone). In such instances, the tip frequently becomes clogged or occluded with the debris. When this occurs, the surgeon has to stop the surgery and spend time replacing the clogged tip with a new, unclogged tip. Anecdotal reports by surgeons using Yankauer suction tips in these contexts indicate that such “develop clog, remove tip, replace tip” procedures can occur upwards of 50 times in a single, routine hip replacement, creating in aggregate a significant distraction for the surgeons and medical personnel, extending significantly the time the patient is in surgery (and under anesthetic), and increasing the overall cost of the procedure.
Accordingly, this disadvantage of the Yankauer suction tip can be detrimental to both the patients' health, to his chances for a positive outcome and to the financial bottom line of the patient and/or the hospital. For at least these reasons, a need exists in the art for Yankauer suction tip systems and related methods that permit the surgeon or other operator to remove any clog or occlusion in the tip relatively quickly without replacement of the tip, and which can be used with commercially available disposable Yankauer suction tips.
This invention includes Yankauer suction tip systems and assemblies that permit the operator to eliminate clogs and occlusion of the tip relatively quickly and without removal and replacement of the tip.
Contemplated within the scope of the invention are Yankauer suction systems having clog removal functionality and related methods. Specifically, the system, for use with a Yankauer suction tip, includes a medial tube that is hollow and has a coupling end and a distal outlet. The coupling end is connectable to a Yankauer suction tip and the distal outlet is in fluid communication with each of a flow pump and a suction source.
Also included are systems having a medial tube that is hollow and comprises a coupling end, wherein the coupling end is connectable to a Yankauer suction tip; a suction conduit that extends distally from the medial tube to a suction source, wherein the suction conduit is in fluid communication with the suction source and the coupling end; and a flow conduit that extends distally from the medial tube and is in fluid communication with a flow pump and the coupling end.
Methods of eliminating clogging debris from a Yankauer suction tip are also included within the scope of the invention.
The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:
FIG. A is shows an example of a prior art Yankauer suction tip;
The invention encompasses a Yankauer suction system that has clog removal functionality and related methods of clearing an occluded or clogged Yankauer suction tip. The systems and methods described herein are designed to be used with commercially available Yankauer suction tips, preferably the disposable type. Such tips are available from numerous suppliers throughout the world in various sizes and bulb shapes. When used herein, the term “Yankauer suction tip” refers to these prior art devices.
Since the systems and methods can be used with these tips, the operator of the systems/practitioner of the methods need not alter his or her technique when using the Yankauer suction tips. Essentially no “learning curve” on the part of the operator is necessary, so the systems and methods described herein can be seamlessly implemented in any surgery or procedure that uses a conventional, prior art, Yankauer suction tip catheter or device.
The invention in some embodiments will be described with reference to the drawings or schematics provided herein. In the specification, words such as “inner” and “outer,” “upper” and “lower,” “superior” and “inferior,” “distal” and “proximal”, “inwardly” and “outwardly,” and “uppermost” and “lowermost,” and words of similar import are used for assisting in the understanding of the invention when referring to the drawings and absent a specific definition or meaning otherwise given by the specification for such terms, should not be considered limiting to the scope of the invention.
As noted above, the invention described herein is designed to exhibit clog removal functionality. By “clog removal functionality” it is meant that a clog or occlusion (partial or entire) of the Yankauer suction tip resulting from the aspiration of non-liquid debris (including higher viscosity fluids and solid particulates) is eliminatable from the Yankauer suction tip without removal from and replacement of the tip to the system. An “occlusion” or “clog”, as used herein, is understood to be any matter (solid and/or high viscosity fluids) present in any portion of the lumen of the detachable Yankauer suction tip that interferes with the capability of the system to aspirate liquid from the patient site as compared to the capability of the system in the absence of the matter, i.e., it reduces the efficiency of the aspiration. The term “patient site” as used herein, is intended to include the areas from which the operator is or intends to aspirate fluid, for example, without limitation, a wound site, a body cavity or orifice, an incision and/or a surgical site.
The invention in a broad aspect includes a medial tube that is hollow, and which is in fluid communication or is capable of being in fluid communication with each of a flow pump and a suction source. The medial tube is hollow, having a lumen of any diameter, although diameters of about 0.5 to about 5 mm may be preferred. The medial tube can be constructed if any material suitable for use in a medical context, such as for example, plastics, metal, glass and/or fiberglass. Preferably, the medial tube is fabricated from a plastic or silicone or a blend of the same. In an embodiment it may be preferred that the selected plastic, silicone rubber or blend of these materials is sufficiently rigid to maintain its shape but sufficiently pliable or flexible such that the operator is able to gently bend or twist the tube during use of the system, allowing optimum maneuverability for the aspiration process. Such materials are well known to the person of skill in the art and are readily available.
For example, in some embodiments, the material of the medial tube is a thermoplastic or thermoset polymer or copolymer as such materials are durable, relatively inexpensive and easy to fabricate and to sterilize or clean. Suitable plastics may include polyethylene terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene, polypropylene, polystyrene, polyvinylidene chloride, high impact polystyrene, polyamides, acrylonitrile butadiene styrene, polyethylene/acrylonitrile butadiene styrene, polycarbonate, polycarbonate/acrylonitrile butadiene styrene, polyurethanes, melamine formaldehyde, phenolics, polyetheretherketone, polyetherimide, polymethyl methacrylate, polytetrafluoroethylene, and/or urea-formaldehyde. Other materials include silicone rubber and/or silicone-containing elastomer or perfluoroelastomers blends.
In some embodiments, one may utilize elastomers, polymer and/or copolymer materials that have been compounded or coated with antimicrobial additives such as triclosan, zinc pyrithione, silver-containing compounds, or other suitable antimicrobial additives known in the art.
It may be preferred that walls of the medial tube are transparent or translucent so the operator can visually observe the effectiveness of the aspiration or liquid flow during the process.
The medial tube has a coupling end and a distal outlet. The length of the medial tube (i.e., the distance between the coupling and the distal outlet) may vary, depending on the specific medial or dental environment in which the system is to be used and/or the inclusion and location of any valves or other components in the system. In an embodiment, the medial tube has a length of about 6 inches to about 3 feet, about 1 foot to about 10 feet, or about 2 feet to about 8 feet.
The coupling end is adapted to be connected to a Yankauer suction tip. It can include, for example, annular threads that can be mated to the threads present on the non-suction end of the Yankauer suction tip to secure attachment of the Yankauer suction tip to the medial tube. Alternatively, the system may include a separate connector that can be used to connect the coupling end of the medial tube to the non-suction end of the Yankauer suction tip. For example, a mid portion of the Yankauer tip may be molded or overmolded with a fitting that contains a port extending from the mid portion which can be connected to the medial tube, for example, by a Luer lock fitting.
In an embodiment, the distal outlet of the medial tube may be in fluid communication with each of a flow pump and/or a suction source (or, if a valve(s) is used in the system and is closed, it is capable of being in fluid communication with each of a suction source or a flow pump). In an embodiment, the distal outlet of the medial tube is in fluid communication with the flow pump.
In an embodiment, the system further includes a suction conduit that extends to a suction source, and is in communication with the suction source. The suction conduit has a lumen that may have any diameter, although in an embodiment it may be preferred that the diameter is about 1 mm to 10 mm. In some embodiments, the proximal end of the suction conduit is in fluid communication with the coupling end of the Yankauer tip, directly or indirectly, for example, either by direct connection to the coupling end or indirectly via the medial tube.
Suction sources include any known or to be developed in the art that can provide sufficient negative pressure along the system and up to the Yankauer tip orifice to adequately aspirate fluid from the patient site. Preferred in some embodiments may be vacuum pumps commonly used with prior art Yankauer suction catheters.
In an embodiment, the suction source may in turn be in communication with a suction canister or container into which the aspirated fluids and other materials may be placed pending proper disposal. Such canisters/containers are well known in the art and can be applied to the system as described herein.
In an embodiment, the system may also include a flow conduit that extends from the medial tube to the flow pump. The flow conduit has a lumen that may have any diameter, although in an embodiment it may be preferred that the diameter is 1 mm to about 15 mm.
The flow pump may be any known or developed in the art that is capable of providing a stream of fluid to the Yankauer tip via the components of the system. It an embodiment, the fluid is pumped through the system such that, upon reaching the coupling end of the medial tube, it exerts sufficient force to carry with it at least about 0.01 to about 0.5 or about 0.1 to about 0.3 grams-worth of particulate matter from the Yankauer tip.
The liquid pumped through the system by the flow pump may be any suitable liquid and at any viscosity desired. It an embodiment, it may be desirable that the viscosity of the liquid is about 1.0 to about 3.0 millipascal seconds at 20° C. (i.e., a viscosity similar to that of distilled water or normal saline solution), although slightly higher viscosities may be acceptable, depending on the flow pump used. The fluid may be an aqueous fluid or a non-aqueous fluid. It may be a normal saline solution.
In an embodiment, pharmaceutical agents that may be beneficial to the patient can be dissolved or suspended within the liquid. Such agents may include antibiotics, minerals, anticoagulants, antioxidants, anti-inflammatory agents, topical anesthetics, etc. Preferably, the fluid is sterile.
The liquid may be supplied to the pump via any means, for example, a plumbed in source or a reservoir that is refilled by the operator before use of the system.
In some embodiments, the system may include a valve assembly that is disposed between the distal outlet of the medial tube and the flow pump. The valve assembly may include at least one valve—any valve known or to be developed for use with liquids, particularly pressurized liquids, may be used. Examples may include, without limitation, gate valves, ball valves, globe valves, piston valves, poppet valves, etc. In an embodiment, the valve is a check valve that automatically closes when negative pressure is applied, cutting off the liquid flow and eliminating the need for the operator to open and close the valve manually.
The valve assembly may also include an actuator that is operably connected to the valve. The actuator can be, for example, a pressable button or switch that is operably connected to the valve, by, for example, a mechanical, an electrical or an electromechanical mechanism, and which enables the operator or his/her colleague to open or to close the valve upon demand.
Other valves and/or check valves may be included in the system as may be desired.
In an embodiment, to use the system, an operator attaches a Yankauer suction tip to the coupling end of the medial tube (this may be accomplished by use of a connector, if such is present). Negative pressure from the suction source is applied across the system, and the operator maneuvers the suction end of the Yankauer suction tip within the patient site as necessary to remove unwanted liquids and small tissue debris.
When the Yankauer suction tip is occluded and no longer effectively aspirates, the operator disengages the suction source so that the pressure within the system returns to ambient. The operator then applies a liquid flow from the flow source, either by turning on the flow pump or by opening a valve that is disposed between the flow pump and the medial tube. The liquid flow flows downstream from the flow pump to the coupling end of the medial tube and into the Yankauer suction tip. At such point the liquid flow will pick up the occluding debris or viscous matter and carry it out the end of the suction tip via the suction orifices already present on the Yankauer tip.
The debris bearing liquid exiting from the tip orifices can be deposited into a waster receptacle or into the patient site. Once the clog has been removed, the operator removes the liquid flow from the system, either by shutting off the flow pump or by closing the valve.
With reference to the Figures, several non-limiting embodiments are illustrated. FIG. A is a representation of a type of prior art, conventional Yankauer suction tip A, that includes a non-suction end B and a suction tip C, which includes one or more suction orifices. Yankauer suction tip A includes a grip region D, where the operator grasps the device to maneuver it within the patient site. In an embodiment, the actuator (not shown) of the valve assembly described above may be adapted to clip on to or otherwise attach to the grip region so the operator may actuate the valve with the same hand that is grasping the grip region D. In this Figure, the non-suction end B bears a region containing annular threads E which can be used to attach the Yankauer suction tip A to the coupling end of the medial tube when corresponding threads are present on the coupling end.
However, it is noted that in some embodiments the suction conduit may not be unitary with the medial tube. For example, a noted above, the medial tube may be connect or join a portion of the Yankauer tip via a port or a “Y” type junction.
For clarity of operation, a schematic diagram of the process in which the systems of the invention are employed is provided as
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
This application claims the benefit of an earlier filing date under 35 U.S.C. § 120 to pending PCT Application No. PCT/US2017/019007, filed Feb. 23, 2017, which is turn claims the benefit of an earlier filing date under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/468,345, filed Mar. 7, 2017, the entire disclosures of each of which are incorporated herein by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 62298605 | Feb 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2017/019007 | Feb 2017 | US |
| Child | 16110776 | US |
