FULLY DISPOSABLE SUCTION AND IRRIGATION APPARATUS FOR USE IN MEDICAL PROCEDURES

Abstract

A medical suction & irrigation system used for removing bodily fluid and debris from a surgical site and particularly a hand-held medical device that utilizes suction tips and suction/irrigation tips during medical procedures. The system features use of a fully disposable suction and irrigation devices. This system comprises a series of devices which includes a universal handle member, interchangeable tip members, a storage member, and a receptacle member. This system will improve the workflow of users at all skill levels while integrating seamlessly into existing common practice. It is a fully integrated and optimized system which recognizes and utilizes the interaction between two distinct user groups with the overall benefit of reducing procedural times and increasing patient safety.

Claims

1. A system for supporting a medical procedure, comprising: a handle member configured to attach to a source of suction at one end, and further configured with a receiving portion at another end; a plurality of tip members configured to attach to the handle member at the receiving portion, the plurality of tip members including tip members of at least two different types; a receptacle member configured to receive a used tip member in permanent and secure manner; a storage member configured for receiving and holding the plurality of tip members in a removable manner, said storage member also being configured for receiving the receptacle member.

2. The system of claim 1, wherein the universal handle member includes a female luer connection at the one end that is configured to be connected to a source of irrigation.

3. The system of claim 2, wherein at least one of said plurality of tip members has both a channel for transmitting suction and also a channel for transmitting irrigation.

4. The system of claim 2, wherein the universal handle member includes a check valve to only allow fluid from the source of irrigation to be transmitted through the handle member when an appropriate interchangeable tip member is connected.

5. The system of claim 2, wherein the universal handle member includes an internal continuous irrigation channel connecting the source of irrigation attached to the luer connection to a tip member installed at the receiving portion.

6. The system of claim 5, wherein the universal handle member also includes an internal continuous suction channel connecting the source of suction attached to the one end to a tip member installed at the receiving portion.

7. The system of claim 1, wherein the universal handle member is configured of a size to be comfortably held in the hand of a physician for long periods of time.

8. The system of claim 1, wherein the receiving portion of the universal handle member is configured to allow the attachment of multiple variations of interchangeable tip members.

9. The system of claim 8, wherein each variation of the tip members has a common engagement section to allow all variations to connect to the universal handle member at the receiving portion.

10. The system of claim 9, wherein the common engagement section is designed to mate with the receiving portion in a secure but easily releasable snap fit engagement.

11. The system of claim 1, wherein the universal handle member includes a check valve to only allow fluid to be released when an appropriate interchangeable tip member is connected.

12. The system of claim 1, wherein the plurality of tip members have indication that identifies the storage member of origin.

13. The system of claim 12, wherein the storage member and the plurality of tip members are provided with a common matching color for providing said identification.

14. The system of claim 1, wherein the receptacle is provided with transparent walls so that tip members received therein may be seen from outside of the receptacle.

15. The system of claim 1, wherein the geometry of the handle member includes a bend allowing the interchangeable tip members to be manufactured straight.

16. The system of claim 1, wherein the receptacle is configured to be removable from said storage member.

17. The system of claim 1, wherein the universal handle member includes an internal continuous suction channel connecting the source of suction attached to the one end to a tip member installed at the receiving portion.

18. A method of performing a medical procedure, comprising the steps of: using a suction device having a handle device and an original tip member in a medical procedure; replacing the original tip member by performing the steps of: removing the original tip member from the handle device, placing the original tip member in a receptacle provided in a storage device, selecting a replacement tip member, and attaching the replacement tip member to the handle device; and continuing the medical procedure using the handle device with the replacement tip member installed thereon.

19. The method of claim 18, wherein the replacement tip member is of a different type than the original tip member.

20. The method of claim 18, wherein the suction device is also configured to provide irrigation through either the original tip member or the replacement tip member or both, said irrigation for use during said medical procedure.

21. The method of claim 18, further comprising the step of disposing of the original tip member during or after said medical procedure.

22. The method of claim 18, further comprising the step of disposing of the handle device during or after said medical procedure.

23. The method of claim 18, further comprising the step of providing the storage device with a plurality of slots each for holding a respective tip member, said storage device also being adapted for holding the receptacle that is configured for holding a plurality of used tip members in a secure manner.

24. The method of claim 23, wherein said step of selecting a replacement tip member includes the step of selecting said replacement tip member from a slot in the storage device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0054] The features and advantages of the example embodiments described herein will become apparent to those skilled in the art to which this disclosure relates upon reading the following description, with reference to the accompanying drawings, in which:

[0055] FIG. 1 provides a schematic drawing of an example universal handle member;

[0056] FIG. 2 provides a schematic drawing of another view of the example universal handle member of FIG. 1;

[0057] FIG. 3 provides a schematic drawing of still another view of the example universal handle member of FIG. 1 showing interior structure;

[0058] FIG. 4 provides a schematic drawing of an example replaceable tip member having only a suction cannula;

[0059] FIG. 5 provides a schematic drawing of an example replaceable tip member having both a suction cannula and an irrigation cannula;

[0060] FIG. 6 provides a schematic drawing of the example universal handle member of FIG. 1 mating with the example replaceable tip member of FIG. 5;

[0061] FIG. 7 provides a schematic drawing of an example unblocking member;

[0062] FIG. 8 provides a schematic drawing of an example storage member;

[0063] FIG. 9 provides a schematic drawing of an example disposable receptacle member;

[0064] FIG. 10 provides a schematic drawing of the example storage member of FIG. 8 having received the example receptacle member of FIG. 9;

[0065] FIG. 11 provides a schematic drawing of the example storage member of FIG. 8 having received the example receptacle member of FIG. 9 with the storage member having a plurality of replaceable tip members of FIGS. 4 and 5 stored therein;

[0066] FIG. 12 provides a schematic drawing of another example handle member with replaceable tip member;

[0067] FIG. 13 provides a schematic drawing of yet another example handle member with replaceable tip member;

[0068] FIG. 14 provides a schematic drawing of still another example handle member with replaceable tip member;

[0069] FIG. 15 provides a schematic drawing of another example storage member with integral receptacle member and replaceable tip members stored therein; and

[0070] FIG. 16 provides a schematic drawing of still another example storage member with integral receptacle member and replaceable tip members stored therein.

DETAILED DESCRIPTION OF THE EXAMPLE EMBODIMENTS

[0071] Disclosed, for example, is a fully disposable suction and irrigation apparatus for use in medical procedures. This apparatus is provided in an example embodiment as a series of devices to be used as part of a system which includes a universal handle member, interchangeable tip members of different types, a storage member, a receptacle member, and an unblocking member.

[0072] The apparatus can be used to reduce time delays during medical procedures. The ethos of this time saving apparatus is to empower all users with a structured system to improve workflow and reduce downtime.

[0073] The system is based on two distinct user groups engaging with the system simultaneously. The two distinct groups will herein be described as primary users and secondary users. The primary user will, more often than not, be a physician, such as a surgeon, for example. The secondary user will, more often than not, be an assisting nurse or other assistant who is assisting the primary user during a medical procedure being performed on a patient.

[0074] The primary user is in control and possession of a universal handle member 100 while performing the procedure. An example universal handle member is shown in an example embodiment in FIGS. 1 and 2. The universal handle member 100 is specifically designed to be comfortably used by the primary user for long periods of time without leaving his/her control. The universal handle member has a handle portion 1, and features connecting geometry 5 at the rear to allow suction tubing to be connected via friction (see the alternative view in FIG. 2). The universal handle member 100 also features a female luer connection 6 at the rear to allow an irrigation source to be connected. The universal handle member 100 also features receiving geometry 7 at the front of the handle. This receiving geometry 7 allows any type of interchangeable tip member (described below) to be connected to the handle member 100.

[0075] The universal handle member 100 is designed to provide separate and unbroken suction and irrigation channels, which do not fluidly communicate with each other at any stage, within the universal handle member 100 (See FIG. 3 showing an interior of the handle member). The first suction channel runs in a continuous pathway from the connecting geometry 5 at the rear of the handle, through the first internal suction channel 11, right to the header 101 having channel port 111 exiting therefrom, connecting to the tip of the suction cannula 8, when an appropriate tip member 2, 200 is attached to the universal handle member 100 (see FIGS. 4, 5). Correspondingly, the irrigation channel runs in a continuous pathway from the luer geometry 6 and the rear of the handle, through the second internal irrigation channel 12 and right to the tip of the irrigation cannula 9 via port 112, when an appropriate tip member 200 is attached to the universal handle member 100 (see FIG. 5).

[0076] The secondary user is typically in control and possession of the storage member 3 with installed receptacle member 4 and tip members 2, 200 (see FIG. 11). The storage member is color coded, with the color matching the variation of the interchangeable tip member 2, 200 (see FIGS. 4, 5) which is held in the storage member 3. This allows for rapid recognition of tip specification by the secondary user. The storage member 3 is designed to have all tip members presented in a fashion to be easily gripped and removed from the storage member 3 for installation on the universal handle member 100 (See FIGS. 6, 11). The secondary user can also easily count how many interchangeable tip members have been used, or are in use, at any one time. Rapid recognition and presentation of the interchangeable tip members to the secondary user will increase ease of use, reduce delays, identify missing parts, and level the playing field between highly experienced secondary users and relatively novice secondary users.

[0077] The storage member 3 typically remains under the supervision of the secondary user at all times. There could also be multiple storage members in use at any one time during a procedure (so as to hold a larger variety of tip member types and sizes, for example). The storage member 3 securely holds a multiple of interchangeable tip members 2 or 200 (See FIG. 11), or other types, at the ready. As shown in FIG. 8, the tip members 2, 200 can be held securely via specifically designed receiving geometry 13 at the top of the storage member 3, and specifically designed geometry 14, 214 at the bottom of the storage member. FIG. 11 shows the tip members 2, 200 held securely in place in a storage member 3.

[0078] The ultimate time saving benefit is achieved when a change of a tip member is required during the medical procedure. The tip member change may be because a suction cannula 8 (see FIGS. 4, 5) has become blocked, or it may be because a change of cannula or tip member size is required for procedural reasons.

[0079] In common standard practice, when a change of tip member is needed, the primary user must hand over the entire system to the secondary user, who undertakes the cumbersome process previously described. In contrast, with the system described herein, the primary user need not hand over anything; the primary user simply presents the universal handle 100, with the interchangeable tip member 2, 200 attached, to the secondary user. The secondary user then simply removes the interchangeable tip member 2, 200 from the universal handle member 1, and replaces it with the desired interchangeable tip member 2, 200 (or other). The system does not require any disconnection or reconnection of suction or irrigation tubes. The secondary user then disposes of the used tip member by placing it in the receptacle member 4 found installed in the storage member 3, without the struggle of trying to unblock the metal suction cannula 8. This greatly improves on the entire tip replacement process.

[0080] The interchangeable tip members 2, 200 (or other types and sizes) are part of the overall system. Each specification of interchangeable tip member 2, 200 (or others) can be provided as suction only, as in tip member 2 having a suction cannula 8 (see FIG. 4) that can be provided in various sizes, and/or suction/irrigation tip members 200 having both a suction cannula 8 and an irrigation cannula 9 (see FIG. 5) also provided in various sizes. The tip members 2, 200 have a common engagement section 10 to engage with handle 100 at the proximal end at the receiving geometry 7 that allows all variations of interchangeable tip members 2, 200 (among others) to engage easily with the universal handle member 100 as shown in FIG. 6 with engagement section 10 of the tip member 200 mating with receiving geometry 7 of the universal handle member 100. Tip member 2 would be similarly attached. As well as this, each different interchangeable tip member 2, 200 is color coded to match the storage member 3 it originated from, allowing for rapid recognition and identification in the overall system (see FIG. 11).

[0081] The common engagement section 10 of each tip member 2, 200 is designed to fit securely into the universal handle member 100 via engagement section 10 and receiving geometry 7 with a secure but easily releasable snap fit engagement, such as by using tabs (ribs) and indentations, for example. The secure engagement between the interchangeable tip members 2, 200 and the universal handle member 100 can be confirmed to the user with an audible click to indicate proper engagement, for example.

[0082] In an exemplary embodiment of this apparatus, the connection of a suction/irrigation interchangeable tip member 200 will result in the engagement with an internal check valve provided within header 101, contained within the universal handle member 100. The check valve in the header 101 is opened when a suction/irrigation member 200 is connected to the universal handle member 100, otherwise it remains closed. When a suction only tip member 2 is connected, this valve remains closed.

[0083] An unblocking member 17 can also be provided as part of the apparatus described herein, as shown in FIG. 7. The unblocking member 17 can take the form of a standard stylet which will come in varying working lengths and working diameters depending on the designated procedural purpose of the kit is it provided width. However, the design of the system reduced the need for such an unblocking member, as replacement of the blocked tip member is the typical response to a blockage during the medical procedure.

[0084] To aid in unblocking the cannulas, each cannula opening will be color coded, so the openings facing the secondary user in the interchangeable tip members will show a color coding, to allow secondary users to rapidly identify which opening links to each cannula.

[0085] The storage member 3 also securely holds the receptacle member 4 in a similar manner to how the interchangeable tip members 2 are held and secured, as seen in FIG. 10. There is specifically designed holding geometry 15 at the top of the storage member 3, and specifically designed holding geometry 16 at the bottom of the storage member 3 (see FIG. 8).

[0086] The receptacle member 4 as shown in the example of FIG. 9 is designed to receive any used interchangeable tip members 2, 200 (or others) in a chamber formed within the main body 41. The receptacle member 4 has a transparent main body 41 to allow users to track and count how many tip members are in the receptacle. The top of the receptacle member 4 features a silicone seal 40. The silicone seal 40 allows the disposable tip members to be placed into the receptacle, but will not allow the tip members to come back out again. The receptacle member 4 can easily be detached and removed from the storage member 3 for separate incineration, if desired, for sanitary reasons.

[0087] FIG. 11 shows the entire system arranged in a manner for use, with storage member 3, the receptacle member 4, and various tip members 2, 200 being held therein, along with the unblocking member 17 in proximity.

[0088] In another exemplary embodiment of the storage member (not shown), the storage member is pre-loaded with a particular selection of varying interchangeable tip members to be used in a certain procedure, for example a middle ear or temporal bone case. In these cases a selection of three 3fr, one 5fr and one 7fr would be an excellent selection. Two unblocking members would be provided with this particular arrangement, of two differing specifications, one to match the 3fr tip and one to match the 5fr and 7fr tip respectively.

[0089] Another example embodiment for attaching interchangeable tip members 300 to a universal handle member 301 is shown in FIG. 12. In this embodiment, the connecting geometry is formed from a soft rubber that will deform in shape to allow secure fixing to the universal handle member 301. To disconnect, a user is required to squeeze the rubber section 305 at the tip while pulling the interchangeable tip members 300 in order to release it from the universal handle member 301.

[0090] Another example embodiment for attaching interchangeable tip members 400 to the universal handle member 401 is shown in FIG. 13. In this embodiment, the connecting geometry features a flexible snap fit lock 405 designed to securely hold the interchangeable tip members 400 to the universal handle member 401. The user is required to squeeze the protruding arm 407 on the interchangeable tip member 400 to release the snap fit lock while retracting the interchangeable tip member 400.

[0091] Still another example embodiment for attaching the interchangeable tip members 500 to the universal handle member 501 is shown in FIG. 14. In this embodiment the connecting geometry is designed with specific keyed geometry 502, 503 to securely hold the interchangeable tip member 500 to the universal handle member 501. The keyed geometry is only releasable when the interchangeable tip member 500 is strongly pulled in either of the vertical directions.

[0092] Another example embodiment of a storage member 600 is shown in FIG. 15. In this embodiment, the storage member 600 has a receptacle member 610 that are combined into a single unit, which does not disassemble. Tip members 615 are taken from their initial position, and as they are used they are moved into a specific holding position 620 that indicates that tip has been used. When a procedure is complete, the combined unit is disposed of in its entirety.

[0093] Still another example embodiment of a storage member 700 is shown in FIG. 16. In this embodiment the storage member 700 and the receptacle member 701 are combined into a single unit which does not disassemble and holds tip members 704. In this embodiment, the used interchangeable tip members 705 are placed into the transparent receptacle 701 at the base of the unit. The entire unit features a lid 702 which when opened can be utilized as a stabilizing member that can allow the quite narrow unit to sit on the sterile field and be taped into position, if needed.

[0094] The various components can be constructed of appropriate medical grade materials, such as plastics, or metals, for example. Where strength and sterilizability is most desirable, such as in the tip member (particularly the cannula portion), stainless steel might be used, or some other metal, whereas the engagement section may be plastic. The handle member, in contrast, might be made of a metal or plastic. The storage and receptacle members might be made of a plastic that can be sterilized, for example, and rubber can be used for seals or other portions, such as connectors. In particular where disposability is desired, plastic parts, where practical, can save costs.

[0095] Table 1, provided below, shows some example materials for the various components of the system of a preferred embodiment.

TABLE-US-00001 TABLE 1 Numerical Reference Part Description Material #1 Handle Portion Plastic - Polypropylene (PP) #3 Storage Member Plastic - Polypropylene (PP) #4 Receptacle Member Plastic - Polystyrene (PS) #5 Connecting geometry Plastic - Polypropylene (PP) #6 Female luer connection Plastic - Clear Polyvinylchloride (PVC) #8 Suction Cannula Metal - Stainless Steel #9 Irrigation Cannula Metal - Stainless Steel #11 First Internal Suction Metal - Stainless Steel Channel #12 Second Internal Suction Plastic - Polyvinylchloride (PVC) Channel #17 Unblocking Member Metal - Stainless Steel #41 Transparent Body Plastic - Clear Polystyrene (PS) #101 Header Plastic - TPE

[0096] The combination of the elements described herein, creates an apparatus and system of use that should improve the workflow of users at all skill levels while integrating seamlessly into existing common practice. It is a fully integrated and optimized system which recognizes and utilizes the interaction between two distinct user groups with the overall benefit of reducing procedural times and increasing patient safety.

[0097] Many other example embodiments can be provided through various combinations of the above described features. Although the embodiments described hereinabove use specific examples and alternatives, it will be understood by those skilled in the art that various additional alternatives may be used and equivalents may be substituted for elements and/or steps described herein, without necessarily deviating from the intended scope of the application. Modifications may be necessary to adapt the embodiments to a particular situation or to particular needs without departing from the intended scope of the application. It is intended that the application not be limited to the particular example implementations and example embodiments described herein, but that the claims be given their broadest reasonable interpretation to cover all novel and non-obvious embodiments, literal or equivalent, disclosed or not, covered thereby.