Apparatus for creating a fibrin blood clot

Abstract

The present disclosure relates to an apparatus to aid in surgical procedures. In a particular embodiment, the present disclosure relates to an apparatus for forming a fibrin clot, which includes a means for supporting a container, a means for supporting a rod in a position for stirring blood within the container, and a means for moving at least one of either the rod support or the container support relative to the other so as to create a relative stirring motion.

Description

APPARATUS FOR CREATING A FIBRIN BLOOD CLOTPRIORITY DOCUMENTS

[0001] The present application claims priority from Australian Provisional Patent Application No. 2024902984 titled “APPARATUS FOR CREATING A FIBRIN BLOOD CLOT” and fded on 18 September 2024, the content of which is hereby incorporated by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates to an apparatus for assisting surgical procedures.BACKGROUND

[0003] Owing to evidence of improved outcomes, Orthopaedic surgeons try and save the meniscus of a patient by repair whenever possible. Historically, meniscal lesions, particularly those greater in size and located in the white-white region of the meniscus, have been shown to have poor healing. In recent years, there has been an increasing interest in the use of fibrin clots to help stimulate and expedite this healing.

[0004] Fibrin clots are formed by an intrinsic clotting process and by stirring of the patient’s blood. Furthermore, fibrin clots allow surgeons to more precisely localize desired biologic factors at the site of repair.

[0005] A fibrin clot is formed by collecting peripheral blood (30-60 mL) from the arm of the patient using a sterile syringe and transferring into a beaker. The blood is then gently stirred with a glass rod (such as 10 mL glass syringe plunger) for 5 to 15 minutes until a 3-5 ml fibrin clot precipitates around the rod. Then, the clot is placed on damp gauze to remove excess fluid and trimmed to proper size. This clot can then be inserted as required to promote and expedite healing.

[0006] This simple but time-consuming stirring task is not an effective use of either of a Surgeon’s or a Theatre Nurse’s time.

[0007] It is against this background and the problems and difficulties associated therewith, that the present invention has been developed.SUMMARY

[0008] According to a first aspect of the present disclosure, there is provided an apparatus for forming a fibrin clot, the apparatus comprising means for supporting a container, a means for supporting a rod in aposition for stirring blood in the container, and a means for moving at least one of either of the rod support or the container support relative to the other so as to create a relative stirring motion.

[0009] In one form, the apparatus comprises a container support configured to support the container, a rod support configured to support the rod in a suspended position from which it extends into the container supported by the container support, and a means for moving at least one of either of the rod support or the container support relative to the other with a relative stirring motion.

[0010] In one form, the rod support is stationary, and the container support is moved.

[0011] In one form, in an alternative, the container support is stationary, and the rod support is moved.

[0012] In one form, in a further alternative, both the container support and the rod support are moved.

[0013] In one form, the apparatus comprises a base, the base comprising the container support.

[0014] In one form, the container support comprises a turntable.

[0015] In one form, the container support comprises a seat for the container.

[0016] In one form, the seat is inset with respect to the turntable.

[0017] In one form, the apparatus further comprises a housing for the container support and the container seated thereon.

[0018] In one form, the rod support depends from the housing.

[0019] In one form, the base comprises a mechanism for moving the turntable.

[0020] In one form, the base comprises a mechanism for moving the seat for the container with respect to the turntable.

[0021] In one form, the base comprises a motor for driving the turntable.

[0022] In one form, the mechanism rotates the container around a central axis of the apparatus.

[0023] In one form, the mechanism rotates the container around its own central axis (i.e. the central axis of the container).

[0024] In one form, in an alternative, the base comprises a motor for driving the mechanism.

[0025] In one form, in an alternative, the mechanism for moving the turntable is hand driven.

[0026] In one form, the housing comprises a Luer lock port.

[0027] In one form, the base is circular.

[0028] In one form, the housing is cylindrical.

[0029] In one form, there is a control system for controlling operation of the apparatus.

[0030] In one form, in an alternative, the container support is stationary, and the rod support is moved. In this form, the apparatus further comprises a lid comprising a motor and a mechanism for moving the rod support, and a base for supporting the container.

[0031] In one form, withdrawing the rod from the rod support removes the fibrin clot formed around the rod for subsequent processing.

[0032] According to a second aspect, there is provided an apparatus for forming a fibrin clot, the apparatus comprising a container support configured to support a container, a rod support configured to support a rod in a suspended position from which it extends into the container supported by the container support, and a means for moving at least one of either the rod support or the container support relative to the other with a relative stirring motion.

[0033] According to a further aspect, there is provided a method of use for the herein described apparatus for forming a fibrin clot, the method comprising the steps of placing blood in the container, placing the container on the container support of the apparatus, putting the rod in the rod support, and then switching the apparatus on.

[0034] For ease of description, an apparatus embodying the present features is described below in its usual assembled position as shown in the accompanying drawings and terms such as front, rear, upper, lower, horizontal, longitudinal etc., may be used with reference to this usual position. However, the apparatus may be manufactured, transported, sold, or used in orientations other than that described and shown here.BRIEF DESCRIPTION OF DRAWINGS

[0035] Embodiments of the present disclosure will be discussed with reference to the accompanying drawings wherein:

[0036] Figure 1 is an isometric view of an apparatus for forming a fibrin clot, in this embodiment, a rod is stationary and a container moves relative to the rod with a relative stirring motion;

[0037] Figure 2 is a front view of the apparatus of Figure 1 ;

[0038] Figure 3 is a side view of the apparatus of either Figure 1 or 2;

[0039] Figure 4 is a top view of the apparatus of any one of Figures 1 to 3;

[0040] Figure 5 is an isometric view of an alternative embodiment of an apparatus for forming a fibrin clot, in this alternative embodiment, a container is stationary and a rod moves relative to the container with a relative stirring motion;

[0041] Figure 6 is another isometric view of the apparatus of Figure 5;

[0042] Figure 7 is a side view of the apparatus of either Figure 5 or 6;

[0043] Figure 8 is a rear view of the apparatus of any one of Figures 5 to 7;

[0044] Figure 9 is a top view of the apparatus of any one of Figures 5 to 8;

[0045] Figure 10 is an isometric view of an arthroscopic cannula for use with either the apparatus in Figures 1 to 4, or the apparatus in Figures 5 to 8;

[0046] Figure 11 is a rear isometric view of the arthroscopic cannula of Figure 10;

[0047] Figure 12 is an exploded view of the arthroscopic cannula of either Figure 10 or 11;

[0048] Figure 13 is an isometric view of a forceps for use with either the apparatus in Figures 1 to 4, the apparatus in Figures 5 to 8, or the arthroscopic cannula in Figures 10 to 12;

[0049] Figure 14 is a rear isometric view of the forceps of Figure 14; and

[0050] Figure 15 is a side view of the forceps of either Figure 14 or 15.

[0051] In the following description, like reference characters designate like or corresponding parts throughout the figures.DESCRIPTION OF EMBODIMENTS

[0052] According to a first embodiment in any one of Figures 1 to 4, there is illustrated an apparatus 1 for forming a fibrin clot. In apparatus 1, a rod 10 is held stationary, and a container 100 is moved so as to provide a relative stirring motion between the rod 10 and the container 100. This first embodiment is the reverse of how it would be done if the stirring were to be done by hand, in which case the container 100 would be held still and the rod 10 moved with the stirring action.

[0053] The apparatus 1 comprises a base 2, and this base 2 comprises a container support.

[0054] The base 2 is circular and comprises a turntable 4 atop of it. An upper surface of the turntable 4 comprises a seat for the container in the form of a circular recess 6 for receiving a base of the container 100. This circular recess 6 is eccentrically positioned on the turntable 4. In this embodiment then, the turntable 4 provides the container support.

[0055] The apparatus 1 further comprises a housing 20 for the container support and any container 100 supported thereon. The housing 20 sits on top of the base 2 and is separable from the base 2 so that the container 100 can be put into and removed from the apparatus 1. The housing 20 comprises a cylindrical side wall 22 and a top 24. The housing 20 is transparent, so that formation of the fibrin clot can be observed.

[0056] An upper edge of the base 2 comprises a lip 3 on which the housing 20 can be seated.

[0057] The top 24 of the housing 20 comprises an opening 26 for receiving a rod support 30. This opening 26 is positioned at a centre of the top 24 of the housing 20.

[0058] The base 2 may comprise a motor driving a mechanism (likely comprising a gear system, not illustrated) for rotating the turntable 4 with respect to a remainder of the base 2. A motorised mechanism is preferable to a hand driven one because the apparatus 1 then does not occupy a medical specialist, such as a Surgeon or a Theatre Nurse, for the duration of its operation. The base 2 is of sufficient thickness that it can house the motor and the mechanism. A side wall 5 of the base 2 comprises buttons for control of the apparatus 1. At a minimum there is an on / off button 7. Other buttons can be provided as necessary if control of additional aspects is required.

[0059] The motorised mechanism may be configured to receive electrical power from a mains power source, or alternatively, may be powered by a portable energy source, such as a battery. In another embodiment, the motorised mechanism may be configured to operate using a vacuum source (i.e. suction)or a pneumatic power source, such as those commonly available in hospital or surgical theatre environments.

[0060] The base 2 might house a control system for the apparatus 1 that may comprise a processor (such as a Programmable Logic Controller, PLC, or a CPU), a memory, storage, and a user interface. The control system may be controlled by software. The control system may provide users with precise control, diagnostic information, and performance information for governing the apparatus 1.

[0061] The rod support 30 comprises a slender cylindrical body 32. One end of the body 32 is configured for use as a handle 34, and a distal end comprises an opening to an internal bore which extends up into the body 32, and in which a rod 10 can be inserted. The body 32 of the rod support 30 comprises an outwardly extending flange 36 at a position toward the distal end.

[0062] The housing 20 comprises a syringe port 28 at the comer between the side wall 22 and the top 24. This syringe port 28 comprises a Luer lock fitting, or a slip Luer fitting.

[0063] An exemplary use of the apparatus 1 will now be described. A sterile syringe (not illustrated) is used to collect peripheral blood from the arm of a patient. The base of the container 100 is placed within the circular recess 6 on the turntable 4. The housing 20 is positioned over the container 100 and seated against the lip 3 on the base 2. The peripheral blood is then injected through a sterile tube set (not illustrated) into the container 100 by engaging the tube set with the Luer lock in the syringe port 28. A rod 10 with a sintered (or frosted, textured, rough, matte) finish is inserted into the rod support 30, and the rod support 30 is in turn engaged with the housing 20 by seating the outwardly extending flange 36 of the rod support 30 in the opening 26 provided for this on the top 24 of the housing 20. This in turn dips the free end of the rod 10 into the blood in the beaker 100. The apparatus 1 can then be switched on using the on / off button 7.

[0064] Depending on the mechanism employed, the container 100 might be rotated around a central axis of the apparatus 1, and possibly around its own central axis (i.e. the central axis of the beaker 100) as well, resulting in a stirring action.

[0065] Moreover, depending on programming of the control system, the apparatus 1 might provide the stirring action for a specified period of time, or until some pre-selected condition is met such as given resistance of the blood is reached which is indicative of suitable clot formation.

[0066] By use of the apparatus 1 in this way, a fibrin clot will form around the rod 10 with a general tube shape.

[0067] The rod 10 is then withdrawn from the container 100 and the housing 20 by lifting the rod support 30 via its handle 34.

[0068] The rod 10 may be withdrawn from the rod support 30, before or after the rod support 30 is lifted from the housing 20. Withdrawal of the rod 10 from the rod support 30 removes the fibrin clot formed around the rod 10, which allows the clot to be placed for subsequent processing as required for further use in the surgical procedure. The formed fibrin clot is dislodged, or separated, from the rod 10 by a scraping action, such that the clot is scraped off the rod 10 as it is withdrawn from the rod support 30. The inventors envisage that the scraping may be affected by a fixed edge, lip, or surface associated with the rod support 30, configured to engage the rod 10 during removal. It will be appreciated that the formed fibrin clot may be placed on a gauze mat or the like, before subsequent processing, or further use in the surgical procedure.

[0069] In a second embodiment in any one of Figures 5 to 9, an alternative apparatus 1 ’ is shown that is configured to hold a container 100’ stationary and move a rod 10’ so as to provide a relative stirring motion between the rod 10’ and the container 100’. It will be appreciated that this second alternative embodiment is the reverse arrangement described for the first embodiment apparatus 1.

[0070] The alternative apparatus 1’ comprises a container support 2’ and a housing 3’. The container support 2’ enables the container 100’ to be supported within the housing 3’ of the apparatus 1’. The housing 3’ comprises an opening 4’ that allows the container 100’ to pass therethrough to an interior of the housing 3’, such that the container 100’ can be detachably secured and supported by the container support 2’. The housing 3’ and the container 100’ are transparent, so that formation of the fibrin clot can be observed.

[0071] The housing 3’ further comprises a lid 5’ that is circular and comprises atumtable 6’ comprising a handle 7’ atop of it. The turntable 6’ further comprises an opening for receiving a rod support 20’, this opening of the turntable 6’ is positioned at a centre of the lid 5’ at the top of the housing 3’. The rod support 20’ is eccentrically located within the opening of the turntable 6’.

[0072] The rod support 20’ is configured to support a rod 10’ in a suspended position from which it extends into the container 100’ that is supported by the container support 2’ within the housing 3’.

[0073] The handle 7’ is coupled to the turntable 6’ such that rotation of the handle 7’ causes rotation of the turntable 6’ that results in rotation of the rod support 20’, and thus rotation of the rod 10’ relative to the container 100’ in a relative stirring motion. In this way, the lid 5’, turntable 6’ and the handle 7’ may constitute a means for moving the rod 10’ within the rod support 20’ relative to the container 100’ with a relative stirring motion.

[0074] In an alternative, non-illustrated embodiment of apparatus 1’, the lid 5’ may comprise a motor driving a mechanism (likely a gear system, not illustrated) for rotating the turntable 6’, and thus the rod support 20’ with the rod 10’ with respect to the container 100’ that is supported by the container support 2’ within the housing 3’. In this alternative, the rod support 20’ and the rod 10’ would be suspended from this mechanism within the lid 5’ into the container 100’. Also in this alternative, the lid 5’ is of sufficient thickness that it can house the motor and the mechanism. A side wall of the lid 5’ may comprise buttons for control of the apparatus 1’ . At a minimum there is an on / off button (not illustrated) . Other buttons can be provided as necessary if control of additional aspects is required.

[0075] The housing 3’ may further comprise an adhesive portion 9’ at a bottom thereof, where the adhesive portion 9’ enables the apparatus 1’ to be secured to a surface, such as a surgical table / bench, keeping the apparatus 1’ stable while it is in use. In one form, the adhesive portion 9’ is an adhesive tape that comprises a release liner removably adhered to an adhesive side of the tape, wherein the release liner is configured to be peeled away to expose the adhesive side of the tape for use and securement of the apparatus 1 ’ to the surface of a surgical table / bench.

[0076] It will be appreciated that the rod support 20’ of this apparatus 1 ’ may comprise the same features of the rod support 30 of apparatus 1, and descriptions of these are not repeated.

[0077] Still referring to Figures 5 to 9, the apparatus 1 ’ is illustrated with a tube 30’ that is connected to a syringe port 8’ at the container support 2’ within the housing 3’ . This syringe port 8’ comprises a Luer lock fitting, or a slip Luer fitting. The tube 30’ is a disposable item that enables the connection of a sterile syringe (not illustrated), that has collected peripheral blood from a patient, to the Luer lock in the syringe port 8’, so that the collected peripheral blood can be injected into the container 100’ . It will be appreciated that the use of the tube 30’ allows flexibility of holding and dispensing collected peripheral blood into the container 100’, and allows for some tolerance in movement of the sterile syringe without moving the apparatus 1 ’ .

[0078] Note that for brevity, other features of this second embodiment of the apparatus 1 ’ that are like those in the reverse arrangement in apparatus 1’ described above are not repeated.

[0079] In either the first or second embodiment of the apparatus 1, 1’ disclosed herein, the rod 10, 10’ may comprise a surface finish selected from sintered, frosted, textured, rough, or matte finishes. Other surface finishes are also contemplated. The inventors have observed that each of the aforementioned finishes facilitates the formation of a fibrin clot on the rod 10, 10’, as such surfaces are more conductive to blood adhesion.

[0080] Also, in either the first or second embodiment of the apparatus 1, 1’ disclosed herein, the rod 10, 10’ may be manufactured of a plastic, metal, or glass material. Where the selected material the rod 10, 10’ is manufactured from comprises a surface finish that is more conductive to blood adhesion, such as sintered, frosted, textured, rough, or matte finishes.

[0081] Further, in either the first or second embodiment of the apparatus disclosed herein, the container 100 may be a beaker, or a vessel, or another containment means suitable for storing and stirring blood therein. The inventors have observed that the container 100 may preferably be manufactured of plastic or glass, where either of these materials is preferably transparent, so that it is possible to observe the blood and fibrin clot being formed.

[0082] Further still, in either the first or second embodiment of the apparatus 1, 1’ disclosed herein, the apparatus 1, 1’ may form a part of a kit for forming a fibrin blood clot. The kit, or package, comprises:1. Apparatus 1 and / or 1’ such as in Figures 1 to 9;2. Tube set 30’ such as in Figures 5 to 9 for connecting to the Luer lock fitting of apparatus 1 and / or 1’ and to a sterile syringe;3. Syringe (not illustrated) with a Luer lock port, such as a female Luer lock port to connect to a male Luer lock port of the Tube set or the Luer lock fitting of the syringe port 28, 8’ of the apparatus 1, 1’;4. Arthroscopic cannula 40 such as in Figures 10 to 12. The arthroscopic cannula 40 comprising a trocar 41 and a cannula 42 for inserting into an arthroscopy port for the transport and safe passage of a fibrin clot formed by the apparatus 1 or 1 ’ into a patient. The trocar 41 comprises an end 43 that may be inserted through skin and soft tissue of the patient to allow placement of an arthroscopy port (i.e. cannula 42). The illustrated trocar 41 comprises a handle 44 opposite to the end 43 that allows a user to handle the trocar 41. The illustrated cannula 42 comprises ribbing on its outer surface, wherein the ribbing is configured to increase surface friction between the cannula 42 and the surrounding tissue into which it is inserted, thereby inhibiting unintended movement of the cannula 42 when positioned within an incision; and5. Fibrin clot holder 50 such as in Figures 13 to 15. The fibrin clot holder 50, which also functions as suture preparation forceps, are designed for a user to hold the fibrin clot formed by the apparatus 1 or 1 ’ and then the user able to pass a suture through it to tie knots, or alternatively, the suture can be loaded into one or more cutaway sections of the forceps 50 and subsequently be used to ‘luggage tag’ the fibrin clot. The forceps 50 at a distal end thereof, comprises aroughened, or textured, surface that is configured to hold the fibrin clot firmly in place while passing the required sutures. The suture can subsequently be passed through a pathology site and the fibrin clot can be pulled into a desired location within a joint using the cannula 42 of the arthroscopic cannula 40.

[0083] Advantageously, the apparatus disclosed herein largely automates the time intensive task of creating a fibrin clot. Moreover, its operation is simple, and the apparatus itself is composed of a minimum number of separable components. A simplified and inexpensive version of the apparatus might be a single use, disposable item. A more sophisticated version with more features and more sophisticated control might be reusable, and in this case the apparatus is easy to disassemble, keep clean, and to re-use.

[0084] The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that such prior art forms part of the common general knowledge.

[0085] It will be understood that the terms “comprise” and “include” and any of their derivatives (e.g. comprises, comprising, includes, including) as used in this specification, and the claims that follow, is to be taken to be inclusive of features to which the term refers, and is not meant to exclude the presence of any additional features unless otherwise stated or implied.

[0086] In some cases, a single embodiment may, for succinctness and / or to assist in understanding the scope of the disclosure, combine multiple features. It is to be understood that in such a case, these multiple features may be provided separately (in separate embodiments), or in any other suitable combination. Alternatively, where separate features are described in separate embodiments, these separate features may be combined into a single embodiment unless otherwise stated or implied. This also applies to the claims which can be recombined in any combination. That is a claim may be amended to include a feature defined in any other claim. Further a phrase referring to “at least one of’ a list of items refers to any combination of those items, including single members. As an example, “at least one of: a, b, or c” is intended to cover: a, b, c, a-b, a-c, b-c, and a-b-c.

[0087] It will be appreciated by those skilled in the art that the disclosure is not restricted in its use to the particular application or applications described. Neither is the present disclosure restricted in its preferred embodiment with regard to the particular elements and / or features described or depicted herein. It will be appreciated that the disclosure is not limited to the embodiment or embodiments disclosed, but is capable of numerous rearrangements, modifications and substitutions without departing from the scope as set forth and defined by the following claims.

Claims

CLAIMS1. An apparatus for forming a fibrin clot, the apparatus comprising a means for supporting a container, a means for supporting a rod in a position for stirring blood in the container, and a means for moving at least one of either of the rod support or the container support relative to the other so as to create a relative stirring motion.

2. The apparatus of claim 1, wherein the apparatus comprises a container support configured to support the container, a rod support configured to support the rod in a suspended position from which it extends into the container supported by the container support, and a means for moving at least one of either of the rod support or the container support relative to the other with a relative stirring motion.

3. The apparatus of claim 2, wherein the rod support is stationary, and the container support is moved.

4. The apparatus of claim 2, wherein both the container support and the rod support are moved.

5. The apparatus according to any one of claims 2 to 4, wherein the apparatus comprises a base, the base comprising the container support.

6. The apparatus of claim 5, wherein the container support comprises a turntable.

7. The apparatus of claim 5 or claim 6, wherein the container support comprises a seat for the container.

8. The apparatus as in claim 7, wherein the seat is inset with respect to the turntable.

9. The apparatus as in any one of claims 2 to 8, wherein the apparatus further comprises a housing for the container support and the container seated thereon.

10. The apparatus of claim 9, wherein the rod support depends from the housing.

11. The apparatus as in any one of claims 6 through 10, wherein the base comprises a mechanism for moving the turntable.

12. The apparatus as in any one of claims 7 through 11, wherein the base comprises a mechanism for moving the seat for the container with respect to the turntable.

13. The apparatus of claim 11 or claim 12, wherein the mechanism rotates the container around a central axis of the apparatus.

14. The apparatus as in any one of claims 11 through 13, wherein the mechanism rotates the container around its own central axis (i.e. the central axis of the container).

15. The apparatus as in any one of claims 11 through 14, wherein the base comprises a motor for driving the mechanism.

16. The apparatus of claim 1 or claim 2, wherein the container support is stationary, and the rod support is moved.

17. The apparatus of claim 16, further comprising a lid comprising a motor and a mechanism for moving a rod support, and a base for supporting the container.

18. The apparatus as in any one of the preceding claims, wherein withdrawing the rod from the rod support removes the fibrin clot formed around the rod for subsequent processing.

19. An apparatus for forming a fibrin clot, the apparatus comprising a container support configured to support a container, a rod support configured to support a rod in a suspended position from which it extends into the container supported by the container support, and a means for moving at least one of either of the rod support or the container support relative to the other with a relative stirring motion.

20. A method of use for the apparatus according to any one of claims 2 through 19, the method comprising the steps of placing blood in the container, placing the container on the container support of the apparatus, putting the rod in the rod support, and then switching the apparatus on.

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