Improved oocyte pickup equipment and use thereof

Abstract

The present invention relates to ovum pick-up equipment and use thereof. The existing oocyte pickup tools and procedures cause various disruptions that may lead to some undesirable results, such as having backward flow to the follicle and\or missing the oocyte in case of a large follicle. The present invention provides a temporary fluid collection member for an oocyte pickup equipment to avoid one or more of these disruptions. The temporary fluid collection member has a valve member (or self-closing valve member) before a collection tube or novel self-closing valve mechanism for an aspiration tubing to temporarily stop the flow of the fluid collected from an aspiration site.

Description

[0001] IMPROVED OOCYTE PICKUP EQUIPMENT AND USE THEREOF CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The present application claims priority to US Provisional Application No. 63 / 561,993, filed on March 6, 2024, the contentment of which is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTIONFIELD OF THE INVENTION

[0003] The present invention relates to ovum pick-up equipment and use thereof. DESCRIPTION OF RELATED ART

[0004] Various types of Oocyte Pick-Up (OPU) tools are used to retrieve oocytes. Referring to Figures 1 and 2, a general structure of the existing OPU tool includes an aspiration needle (i.e. stainless steel) including a channel for aspiration and a channel for delivering flushing fluid to an aspiration site. The aspiration needle is connected to a needle hub / handle, receiving a flushing tubing and an aspiration tubing. The flushing tubing is in communication with the channel in the aspiration needle for delivering flushing fluid (i.e. follicular flushing) through the needle hub. The aspiration tubing is in communication with the channel for aspiration in the aspiration needle via the needle hub. The tool also includes a silicone rubber bung that air-tightly fits to a collection tube. The aspiration tubing passes through the silicon rubber bung and is in communication with an inner volume of the collection tube. A vacuum tubing also passes through the silicone rubber bung and connected to a suction pump. The suction pump is in communication with the inner volume of the collection tube for creating a negative pressure in the inner volume of the collection tube through the vacuum tubing, which causes the negative pressure within the aspiration tubing and the channel for aspiration within the aspiration needle. Oocytes are, then, collected through the aspiration needle to the collection tube and then transferred to the lab.

[0005] There are various types of aspiration needle, including wide and narrow bore, and single and double lumen, etc. Use of flushing fluid / flushing tubing may be optional.

[0006] Furthermore, while using the OPU tools, the aspiration pressure required for an efficient OPU varies according to different factors, such as the needle diameter, needle length and tubinglength. The aspiration pressure would need to be varied to maintain the same flow rate through the tool; however, it is found that the thinner the needle is, the higher the aspiration pressure is to maintain the consistent / same flow rate.

[0007] . As the follicle matures it produces more follicular fluid. This increases the intrafollicular pressure causing the bulging of the external surface. The pressure of the fluid in the follicle at the time of needle penetration might be significantly higher than the normal follicular pressure. As the needle tip is forced into the wall, the deformation of the follicular surface would cause the pressure to rise even further. Some of this fluid will flow up the needle, but a significant amount could be lost between the needle and the follicular wall. If continuous aspiration pressure has already been applied before the needle punctures the follicle, only a little follicular fluid is expected to be lost.

[0008] Upon application of vacuum, the vacuums throughout the system is equilibrated to the steady flow conditions. During this time the follicle wall collapses as the fluid volume decreases until the follicle totally collapses and blocks the needle tip. Subsequently, the vacuum in the aspiration line and needle increases to that in the collection tube. If the regulated vacuum was discontinued whilst the needle tip was still in the follicle, there will be a back flow of fluid towards the follicle.

[0009] In current / existing practice, the surgeons would aspirate the fluid from the follicles to the collecting tube in the rack. Whenever the collecting tube becomes full of fluid, the operator (or nurse) would open its cover and move the needle tip to another (empty) collecting tube in the rack. By this, this type of operation / procedure would usually cause a discontinuing in the vacuum / aspiration pressure in the system for a short time. This disruption may lead to some undesirable results, such as having backward flow to the follicle and\or missing the oocyte in case of a large follicle.

[0010] Accordingly, there has been a long-felt desire or need for a solution to the issues identified above.

[0011] Following is the list of prior art references, the contents of which are incorporated herein by reference in its entirety:

[0012] 1. Renzini, M.M., Brigante, C., Zanirato, M., Dal Canto, M.B., Brambillasca, F., Fadini, R. (2020), “Oocyte Retrieval in IVM“, In: Malvasi, A., Baldini, D. (eds) Pick Up and Oocyte Management. Springer, Cham. (htps: / / doi.org / 10.1007 / 978-3-03Q-28741-2_12, accessed on February 23, 2024)

[0013] 2. KM Morton, WMC Maxwell, G Evans. “Effect of Aspiration Pressure during Oocyte Harvesting on Oocyte Recovery and in vitro Development of Ovine Oocytes,” 25 September 2007. Reproduction in Domestic Animals.

[0014] 3. FOLLICLES K.-P. BRUSSOW1 , H. TORNER1 , J. RATKY2 , M.G. HUNTER3 and G. NURNBERG., “OVUM PICK UP IN SWINE: THE INFLUENCE OF ASPIRATION VACUUM PRESSURE ON OOCYTE RECOVERY FROM PREOVULATORY,” Acta Vet Hung 45 (1997) 189-196.

[0015] 4. RC. Fry, E.M. Niall, T.L. Simpson, T.J. Squires, J. Reynolds., “The collection of oocytes from bovine ovaries,” Theriogenology, Volume 47, Issue 5, 1997

[0016] 5. Robert Home, Christopher J. Bishop, Geoff Reeves, Carl Wood and Gabor T.Kovacs. “Aspiration of oocytes for in-vitro fertilization,” Human Reproduction Update 1996, Vol. 2, No. 1 pp. 77-85 y

[0017] 6. ESHRE Working Group on Ultrasound in ART, D'Angelo A, Panayotidis C, Amso N, Marci R, Matorras R, Onofriescu M, Turp AB, Vandekerckhove F, Veleva Z, Vermeulen N, Vlaisavljevic V., “Recommendations for good practice in ultrasound: oocyte pick up, Hum Reprod Open. 2019 Dec 10;2019(4):hoz025. doi: 10.1093 / hropen / hoz025. PMID: 31844683; PMCID: PMC6903452.SUMMARY OF THE INVENTION

[0018] The present invention relates to ovum pick-up equipment and use thereof.

[0019] According to an object of the present invention, it provides a temporary fluid collection member for an oocyte pickup equipment / tool and use thereof.

[0020] According to another object of the present invention, it provides an improved oocyte pickup equipment / tool and use thereof.

[0021] According to one embodiment of the present invention, it provides an oocyte pickup tool having a bung for receiving an aspiration tubing and a vacuum tubing to collect fluid through the aspiration tubing from an aspiration site in a collection tube, comprising, a temporary fluidcollection member, defining a first opening for air-tightly receiving the bung and a second opening for air-tightly engages with the collection tube, the temporary fluid collection member comprises a valve member operable between an open and close position, wherein when the valve member is in the closed position, defines an air-tight volume between the bung and the valve member.

[0022] According to yet another embodiment of the present invention, it provides an oocyte pickup tool having a bung for receiving an aspiration tubing to collect fluid through the aspiration tubing from an aspiration site in a collection tube, comprising, a temporary fluid collection member, defining a first opening for air-tightly receiving the bung and a second opening for air-tightly engages with the collection tube, the temporary fluid collection member comprises a self-closing valve member operable between an open and close position, the temporary fluid collection member defines a first space between the first opening and the selfclosing valve member and a second space between the self-closing valve member and the second opening, wherein the second space is adapted to receive a vacuum source for creating a negative pressure therein, wherein the self-closing valve member allows the fluid to flow from the first space to the second space. The self-closing valve member may be a duckbill valve. The selfclosing valve member may also be an x-valve, split valve, or umbrella valve.

[0023] According to yet another embodiment of the present invention, it provides an oocyte pickup tool having a bung for receiving an aspiration tubing and a vacuum tubing being connection with a vacuum source for collecting fluid in a collection tube through the aspiration tubing from an aspiration site, the bung is adapted to air-tightly engage with the collection tube for creating a negative pressure in the collection tube by the vacuum source, comprising: a selfclosing valve member at a collection end of the aspiration tubing, wherein the self-closing valve member allows the fluid to flow from the aspiration site to the collection tube. The self-closing valve member may be a duckbill valve. The self-closing valve member may be an x-valve, split valve, or umbrella valve.

[0024] According to further embodiment of the present invention, it provides a temporary fluid collection member, defining a first opening for air-tightly receiving a bung for receiving an aspiration tubing to collect fluid through the aspiration tubing from an aspiration site and a second opening for air-tightly engages with a collection tube, the temporary fluid collectionmember comprising a self-closing valve member operable between an open position and a close position, the temporary fluid collection member defines a first space between the first opening and the self-closing valve member and a second space between the self-closing valve member and the second opening, wherein the second space is adapted to receive a vacuum source for creating a negative pressure therein, wherein the self-closing valve member allows the fluid to flow from the first space to the second space. The self-closing valve member is a duckbill valve.

[0025] According to yet further embodiment of the present invention, it provides an oocyte pickup tool comprising the temporary fluid collection member as stated above.

[0026] According to further embodiment of the present invention, it provides use of a selfclosing valve adapted to be disposed at a distal end of an aspiration tubing for restricting fluid to flow from an aspiration site to a collection tube. The self-closing valve is a duckbill valve.

[0027] According to yet further embodiment of the present invention, it provides use of the oocyte pickup tool as defined above for retrieving oocytes.BRIEF DESCRIPTON OF DRAWINGS

[0028] Figure 1 shows an example of existing oocyte retrieval / aspiration needle set (prior art);

[0029] Figure 2 shows an exemplary block diagram of an existing oocyte retrieval system (prior art);

[0030] Figure 3 shows a block diagram of an exemplary embodiment of the present invention;

[0031] Figures 4a, 4b and 4c show block diagrams of the exemplary embodiment of the present invention when used;

[0032] Figure 5 shows another exemplary embodiment of the present invention;

[0033] Figure 6 shows yet another exemplary embodiment of the present invention; and

[0034] Figure 7 shows a cross-sectional view of the self-closing valve (a duckbill valve).DETAILED DESCRIPTION OF THE INVENTION

[0035] Referring to Figures 3, according to the present invention, it provides a temporary fluid collection member 20, having a first opening 21 for air-tightly receiving a silicone rubber bung 10, a second opening 22 for air-tightly connecting to an opening of a collection tube 30. The temporary fluid collection member 20 comprises a valve member 25 being operable betweenopened and closed positions, and, when the valve member 25 is in the closed position, defines an air-tight volume 23 between the silicone rubber bung 10 and the valve member 25. The valve member 25 is operable manually by an operator.

[0036] Referring to Figures 4a, 4b and 4c, in operation, an operator operates the valve member 25 in the closed position first, engage the second opening 22 to a collection tube 30, 30a, 30b or 30c, then operates the valve member 25 in the open position such that any matters / fluid 50 collected in the air-tight volume 23 would be transferred to the collection tube 30 / 30a / 30b / 30c. When the collection tube 30 / 30a / 30b / 30c becoming full of the fluid 50’ collected through the needle, the operator operates the valve member 25 from the open position to the closed position, which allows continued operation of the aspiration pump using the air-tight volume between the silicone rubber bung 10 and the valve member 25.

[0037] Then, the operator disengages the second opening 22 of the temporary fluid collection member 20 from the opening of the collection tube 30 / 30a / 30b / 30c (which is full), then engages the second opening 22 of the temporary fluid collection member 20 to an opening of another collection tube (empty) 30 / 30a / 30b / 30c in an air-tight manner. Once engaged, the operator operates the valve member 25 from the closed position to the open position. This allows application of continuous aspiration pressure (or minimize the pressure changes) through the process of the operator / nurse swapping collection tubes 30 / 30a / 30b / 30c, thus enables continuously applying aspiration pressure, during the oocyte retrieval procedure, which demands sequential collection of a number of follicles from each ovary. These are possible since the temporary fluid collection member 20 and the operation of the valve would allow the continuous operation of vacuum source, without turning it off during the operator / nurse swapping the collection tubes 30 / 30a / 30b / 30c.

[0038] According to the preferred embodiment of the present invention, the shape of the temporary fluid collection member 20 is cylindrical; however, it can be in a different shape as long as it provides such an air-tight volume between the silicone rubber bung 10 and the valve member 25.

[0039] According to the preferred embodiment of the present invention, the air-tight volume 23 of the temporary fluid collection member 20 may be less than or equal to the volume available in the collection tube 30 / 30a / 30b / 30c. In a preferred embodiment of the present invention, theair-tight volume 23 of the temporary fluid collection member 20 would be at least or about half of the volume available in the collection tube 30 / 30a / 30b / 30c. For example, commonly used collection tubes have 14 ml capacity. Accordingly, the volume of the air-tight volume 23 of the temporary fluid collection member 20 may be about 14 ml or less, preferably about 7ml, or the volume that would be sufficiently large to allow collection of fluid ranging from, for example, a few seconds to a minute. While the volume of the air-tight volume of the temporary fluid collection member 20 is preferably less than or equal to the volume of the collection tube; however, the volume of the air-tight volume of the temporary fluid collection member 20 can be larger than the volume of the collection tube 30 / 30a / 30b / 30c as the operator may be able to manipulate / operate the valve to ensure no loss of fluid or to avoid overflow of the fluid from the temporary fluid collection member 20 to a collection tube 30 / 30a / 30b / 30c.

[0040] According to the present invention, the structure of the valve member 25 is appropriately structured, such that it prevents the oocyte from becoming stuck within or about the valve member 25. The valve member 25 is made of medical grade silicone, plastic, glass, metal or other suitable material while providing air-tight closure when the valve member 25 is in the closed position. In a preferred embodiment of the present invention, the valve member 25 is made of the same medical-grade plastic material used for collection tubes.

[0041] According to the present invention, it provides an improvement to an oocyte pickup equipment including the temporary fluid collection member as described above.

[0042] Figure 5 shows another exemplary embodiment of the present invention, providing a temporary fluid collection member 20’, defining a first opening 21’ for air-tightly receiving a silicone rubber bung 10, a second opening 22’ for air-tightly connecting to an opening of a collection tube 30. The temporary fluid collection member 20’ comprises a self-closing valve member 25’ being operable between opened and closed positions, and, when the self-closing valve member 25’ is in the closed position, defines an air-tight volume (or a first space) 23’ between the silicone rubber bung 10 and the self-closing valve member 25’. The self-closing valve member 25’ is operable depending on the pressure condition between the self-closing valve member 25’ and the collection tube 30. A vacuum tubing to the bung 10 would be terminated / disconnected from the vacuum source 100, but the vacuum source 100 is connectedto a second space 24’ between the second opening of 22’ of the temporary fluid collection member 20’ and the self-closing valve member 25’.

[0043] When operation, an operator would air-tightly seal the first opening 21’ of the temporary fluid collection member 20’ with the silicon rubber bung 10. In this embodiment, the vacuum source 100 connection to the bung 10 is modified to be disconnected, and the connection to the vacuum source 100 is rerouted to the second space 24’ between the second opening of 22’ of the temporary fluid collection member 20’ and the self-closing valve member 25’. Then, the second opening 22’ of the temporary fluid collection member 20’ is air-tightly connected to a collection tube 30. The vacuum source 100, then creates a negative pressure in the second space 24’, causing the self-closing valve member 25’ to open / be in the opened position to allow flow of the fluid from the aspiration needle 15 through aspiration tubing 120 to the collection tube 30. When the collection tube 30 is filled with fluid, the operator may open an air-tight connection between the second opening 22’ and the collection tube 30, which causes the negative pressure in the space 24’ to drop instantaneously, allowing the self-closing valve member 25’ to close / be in the closed position by itself, creating an air-tight volume (or a first space) 23’ between the first opening 21’ and the valve member 25’ to temporary hold any fluid that may be remained therein. Because of this arrangement, it allows continuous operation of the vacuum source 100 when switching over from one collection tube to the other.

[0044] When the operator moves the temporary fluid collection member 20’ and air-tightly engages the second opening 22’ to an empty collection tube 30, which would, again, create negative pressure in the second space 24’, causing the self-closing valve member 25’ to open / be in the opened position to allow flow of the fluid from the aspiration needle 15 through aspiration tubing 120 to the collection tube 30.

[0045] Figure 6 shows yet another exemplary embodiment of the present invention, where a silicon rubber bung receives an aspiration tubing 110 and vacuum tubing 110. The aspiration tubing 110 has a needle end (not shown) and a collection / distal end 125. At the collection end (or distal end) 125 of the aspiration tubing 120, a self-closing valve member 25” is provided. In operation, when the bung 10 is engaged air-tightly engages with a collection tube (not shown), negative pressure built in the collection tube causes the self-closing valve member 25” to be in the opened position to allow fluid to flow to the collection tube. When the bung 10 is disengagedfrom the collection tube, which breaks air-tight engagement and negative pressure built in the collection tube will drop suddenly, causing the self-closing valve member 25” to be in the closed position to stop the fluid from flowing. This arrangement, while it does not provide any temporary fluid collection space like other embodiments shown above, provides a solution for swiftly switching from one collection tube to another, while minimizing the spillage of fluid flowing through the aspiration tubing 120.

[0046] According to the present invention, the self-closing valve member 25’ / 25” may be an x-valve, split valve, or umbrella valve. More preferably, the self-closing valve member 25’ / 25” is a duckbill valve.

[0047] Figure 7 shows a cross-sectional view of the self-closing valve member 25’ / 25”, which is a duckbill valve, which works as one-way valve to ensure the flow of fluid from the aspiration site to the collection tube. Duckbill valve is preferrable since it provides laminar flow, reduces turbulence, minimizes oocyte entrapment risk; and, is capable of maintaining a consistent vacuum while allowing smooth fluid passage. According to the present invention, the duckbill valve is made of medical grade silicone rubber that would comply with various standards for medical application with flexibility and elasticity. The materials suitable therefor may also provide sufficient durability during the usage, and compression resistance for retaining shape over the time.

[0048] Further according to the present invention, it provides an improved method for collecting oocyte using the improvement to the oocyte pickup equipment as described above.Further according to the present invention, it provides use of the improved oocyte pickup equipment as described above.List of Reference Numerals:

[0049] 10 ... silicon rubber bung

[0050] 15 ... aspiration needle

[0051] 20, 20’ ... temporary fluid collection member

[0052] 21, 21’ ... first opening

[0053] 22, 22’ ... second opening

[0054] 23, 23’ ... air tight volume / first space

[0055] 24’ ... second space

[0056] 25 . . . valve member

[0057] 25’, 25” ... self-closing valve member

[0058] 30, 30a, 30b, 30c ... collection tube(s)

[0059] 40 . . . direction of movement

[0060] 50 . . . fluid collected in temporary fluid collection member during swapping collection tube

[0061] 50’ ... transferred fluid collected in temporary fluid collection member

[0062] 100 ... Vacuum source

[0063] 110, 110’ ... vacuum tubing

[0064] 120 ... aspiration tubing

[0065] 125 ... collection end of aspiration tubing

Claims

CLAIMS1. An oocyte pickup tool having a bung for receiving an aspiration tubing to collect fluid through the aspiration tubing from an aspiration site in a collection tube, comprising: a temporary fluid collection member, defining a first opening for air-tightly receiving the bung and a second opening for air-tightly engages with the collection tube, the temporary fluid collection member comprises a self-closing valve member operable between an open and close position, the temporary fluid collection member defines a first space between the first opening and the self-closing valve member and a second space between the self-closing valve member and the second opening, wherein the second space is adapted to receive a vacuum source for creating a negative pressure therein, wherein the self-closing valve member allows the fluid to flow from the first space to the second space.

2. The oocyte pickup tool as recited in claim 1, wherein the self-closing valve member is a duckbill valve.

3. The oocyte pickup tool as recited in claim 1, wherein the self-closing valve member is an x-valve, split valve, or umbrella valve.

4. A temporary fluid collection member, defining a first opening for air-tightly receiving a bung for receiving an aspiration tubing to collect fluid through the aspiration tubing from an aspiration site and a second opening for air-tightly engages with a collection tube, the temporary fluid collection member comprising a self-closing valve member operable between an open position and a close position, the temporary fluid collection member defines a first space between the first opening and the self-closing valve member and a second space between the self-closing valve member and the second opening, wherein the second space is adapted to receive a vacuum source for creating a negative pressure therein, wherein the self-closing valve member allows the fluid to flow from the first space to the second space.

5. The temporary fluid collection member as recited in claim 4, wherein the self-closing valve member is a duckbill valve.

6. An oocyte pickup tool comprising the temporary fluid collection member as recited in claim 5 or 6.

7. An oocyte pickup tool having a bung for receiving an aspiration tubing and a vacuum tubing being connection with a vacuum source for collecting fluid in a collection tube through the aspiration tubing from an aspiration site, the bung is adapted to air-tightly engage with the collection tube for creating a negative pressure in the collection tube by the vacuum source, comprising: a self-closing valve member at a collection end of the aspiration tubing, wherein the self-closing valve member allows the fluid to flow from the aspiration site to the collection tube.

8. The oocyte pickup tool as recited in claim 7, wherein the self-closing valve member is a duckbill valve.

9. The oocyte pickup tool as recited in claim 7, wherein the self-closing valve member is an x-valve, split valve, or umbrella valve.

10. Use of a self-closing valve adapted to be disposed at a distal end of an aspiration tubing for allowing fluid to flow to a collection tube.

11. The use as recited in claim 10, wherein the self-closing valve is a duckbill valve.

12. An oocyte pickup tool having a bung for receiving an aspiration tubing and a vacuum tubing to collect fluid through the aspiration tubing from an aspiration site in a collection tube, comprising: a temporary fluid collection member, defining a first opening for air-tightly receiving the bung and a second opening for air-tightly engages with the collection tube, the temporary fluid collection member comprises a valve member operable between an open and close position, wherein when the valve member is in the closed position, defines an air-tight volume between the bung and the valve member.

13. Use of the oocyte pickup tool as defined in any one of claims 1 to3, 6 to 9 and 12 for retrieving oocytes.