Oocyte Retrieval Tubing System

Abstract

An oocyte retrieval tubing system comprising a manifold for receiving a supply of heated air and an outer tubing for accommodating an internal transfer tube that extends between a collection container and an oocyte retrieval needle in use, the outer tubing comprising first and second separate insulating tubes connected to each other via a manifold, the first and second insulating tubes each configured to be adjustable in length, whereby adjusting their working lengths relative to each other regulates the flow of heated air within the outer tubing received through the manifold disposed therebetween to maintain a stable and uniform temperature distribution within the outer tubing for oocyte retrieval.

Description

[Technical Field]

[0001] The present invention relates generally to oocyte retrieval tubing systems, and more particularly to units with insulated passageways for accommodating transfer tubing of oocyte retrieval needles, as well as systems and methods incorporating and / or using said units. [Background technology]

[0002] In vitro fertilization (IVF) is a medical procedure used to overcome a variety of fertility problems, in which eggs and sperm are fertilized outside the body.

[0003] A key step in the IVF cycle is the retrieval, or collection, of developing eggs known as oocytes. Oocytes are suspended in follicular fluid from follicles within a female patient's ovaries. During the IVF procedure, an oocyte retrieval needle penetrates the vaginal wall and enters the ovary under ultrasound guidance. The guided oocyte retrieval needle is used to puncture and penetrate each follicle, and follicular fluid is expelled from the follicle under induced negative pressure. The follicular fluid is then communicated through the needle and along the length of a transfer tube into a collection container, such as a test tube, via a vacuum pump.

[0004] Collected oocytes contain an intracellular structure known as the meiotic spindle. The meiotic spindle is a microtubule-based structure that facilitates chromosome separation during the fertilization process. The integrity of the meiotic spindle is paramount to oocyte survival. The microtubules of the spindle are particularly sensitive to temperature changes, especially cooling, and studies have shown that even temperature changes as small as 1°C can adversely affect the meiotic spindle. The greater the magnitude and / or duration of the temperature drop, the greater the potential for physical damage to the oocyte.

[0005] In view of the above, existing IVF processes attempt to minimize the temperature drop of collected follicular fluid. For example, the collection container is typically placed on a heat block and warmed to body temperature of 37°C. The oocytes are then stored in an incubator that substantially maintains the oocyte temperature at this desired level.

[0006] However, a drawback of the conventional IVF process is the inability to regulate the temperature of the follicular fluid as it is transferred from the body to the collection container. Due to the small diameter of the transfer tube, the temperature of the follicular fluid containing the oocytes drops rapidly between the time it is removed from the follicle and the time it reaches the collection container. Furthermore, the (cooler) follicular fluid from the transfer tube mixes with the (warmer) follicular fluid in the collection container, resulting in fluctuations in the temperature within the solution and, therefore, the temperature of the oocytes upon reaching the collection container.

[0007] In these circumstances, there is a need for improved heat exchangers or at least to provide the public with a useful choice.The present invention was devised with these shortcomings in mind. Summary of the Invention [Means for solving the problem]

[0008] In a first aspect, the present invention provides an oocyte retrieval tubing system comprising a manifold for receiving a supply of heated air and outer tubing for accommodating an internal transfer tube that in use extends between a collection container and an oocyte retrieval needle, the outer tubing comprising first and second separate insulating tubes connected to each other via a manifold, the first and second insulating tubes each configured to be adjustable in length, whereby adjusting their working lengths relative to each other regulates the flow of heated air within the outer tubing received through the manifold disposed therebetween to maintain a stable and uniform temperature distribution within the outer tubing for oocyte retrieval.

[0009] The manifold can include a body having a first end and a second end, a first insulating member coupled to the manifold proximate the first end, and a second insulating member coupled to the manifold proximate the second end. The manifold body can have a tapered diameter from a first diameter at the first end to a reduced second diameter at the second end.

[0010] In some embodiments, the manifold can include receiving portions extending from the first and second ends of the body, and the first and second members can be coupled to the manifold via the receiving portions. The receiving portions can include constant diameter portions protruding linearly from each of the first and second ends of the body. The receiving portion at the second end can include an engagement element for securing the second insulating member to the manifold.

[0011] The passageway may be a flexible passageway. In particular, the first and second insulating members may comprise flexible conduits. The interior temperature of the passageway is selected to substantially approximate the in vivo temperature of the patient from which the oocytes are to be collected. Preferably, the interior temperature of the outer tubing is substantially maintained within the range of about 36.8°C to 37.2°C during use.

[0012] In some embodiments, the first insulating tube and / or the second insulating tube may be elastic members. The first and second insulating tubes may each include a collapsible concertina-type section for length adjustment. The first insulating tube may have a longer length than the second insulating tube. When the first insulating tube is in the extended configuration, the working length of the first insulating tube may be approximately four times the working length of the second insulating tube.

[0013] In some embodiments, the first insulating tube has a working length of about 40-65 cm and the second insulating tube has a working length of about 10-25 cm, hi some embodiments, the first insulating tube has a diameter of about 20 mm and the second insulating tube has a diameter of about 15 mm.

[0014] In some embodiments, a supply of heated air is received through a manifold and enters the outer tubing at a flow rate of about 30-35 liters per minute.

[0015] The manifold may include an opening for receiving a supply of heated air, the opening being in fluid communication with the first and second ends of the body. The manifold may include a branch portion extending from the body between its first and second ends, the opening for the supply of heated air being provided by an open end of the branch portion. The branch portion may extend outward from the body portion toward the second end.

[0016] In some embodiments, the unit may further include an air supply line extending from the opening in the manifold to the heat source. The diameter of the air supply line may be smaller than the diameters of the first and second insulating tubes. A connector configured to connect to the heat source may be disposed at the free end of the air supply line. The heated air may be supplied at a temperature of 37.0°C to 37.4°C.

[0017] In a second aspect, the present invention provides an oocyte retrieval system comprising an oocyte retrieval needle, a transfer tube attached to the retrieval needle and extending from the needle to a collection container, and an oocyte retrieval tubing system as described above.

[0018] In a third aspect, the present invention provides a method for oocyte retrieval, the method comprising the steps of communicating heated air into a passage to maintain a selected internal temperature within the passage, and transferring follicular fluid from the oocyte retrieval needle to a collection container along a transfer tube contained within the passage, the internal temperature of the passage being selected to maintain the temperature of the follicular fluid within the transfer tube.

[0019] The invention will now be described, by way of non-limiting example, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 is a perspective view of a temperature regulation unit according to one embodiment of the present invention, showing the unit in a preparatory retracted configuration. [Figure 2] 2 is a perspective view of the temperature adjustment unit of FIG. 1 showing the unit in an extended configuration during operation. [Figure 3] FIG. 2 is a diagram showing a manifold of the temperature adjustment unit of FIG. [Figure 4] FIG. 2 is a diagram showing a manifold of the temperature adjustment unit of FIG. [Figure 5] FIG. 2 is a diagram showing a manifold of the temperature adjustment unit of FIG. [Figure 6] FIG. 1 is a schematic diagram of an oocyte recovery system including a temperature regulation unit according to one embodiment of the present invention. [Figure 7] 1 is a flow chart that schematically illustrates a method for oocyte retrieval that includes the use of a temperature regulation unit according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0021] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the drawings, can be arranged, substituted, combined, separated, and designed in a variety of different configurations, all of which are contemplated by the present disclosure.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, only a limited number of exemplary methods and materials are described herein.

[0023] Generally speaking, the oocyte retrieval tubing system shown in the drawings is an instrument comprising an insulated, actively heated passageway adapted to accommodate the transfer tubing of an oocyte retrieval needle. In particular, the passageway includes an opening adapted to receive a supply of heated air from an external heat source. The heated air is supplied into the passageway at a temperature that substantially approximates the in vivo temperature of the patient from which the follicular fluid and oocytes contained therein are collected. In use, the passageway extends substantially along the length of the transfer tubing, thereby avoiding or at least reducing temperature changes in the follicular fluid as the collected fluid is transferred from the patient to a collection container.

[0024] With particular reference to Figures 1 and 2, one embodiment of the present invention is in the form of a temperature regulation unit 10 including a passageway 12 (outer tubing) adapted to receive an internal transfer tube extending between a collection container and an oocyte retrieval needle. As shown, the passageway is defined, at least in part, by a first insulating member 14 (tubing) and a second insulating member 16 (tubing) in fluid communication therewith. Each of the insulating members 14, 16 is coupled to a manifold 18. The manifold 18 provides fluid communication between the first insulating member 14 and the second insulating member 16. The manifold 18 is described in more detail below, with particular reference to Figures 3-5.

[0025] The insulating members 14, 16 are elongated conduits having a diameter suitable to accommodate standard transfer tubing associated with oocyte retrieval needles. The flexible conduits are preferably formed from a soft, highly flexible material. Examples of suitable materials include polymeric materials such as polyethylene and polypropylene. Preferably, the second member 16 is coil reinforced.

[0026] The lengths and / or diameters of the first and second members 14 and 16 are selected to ensure substantially uniform and consistent heat distribution and flow of heated air throughout the passageway 12. Preferably, the first and / or second members 14 and 16 are configured to be adjustable in length, thereby enabling their operating lengths to be adjusted relative to one another to regulate the flow of heated air within the passageway 12. Specifically, the operating lengths and diameters of the members 14 and 16 are calculated according to Hagen-Poiseuille's law based on the desired overall length of the passageway 12, which is approximately equal to the length of the transfer tubing extending between the oocyte retrieval needle and the collection container. Typically, the transfer tubing can be up to 75 cm long. With particular reference to the illustrated embodiment, the inner diameter of the first insulating member 14 is approximately 20 mm, and the inner diameter of the second insulating member 16 is approximately 15 mm. These diameters also facilitate simple and easy insertion and manipulation of the oocyte retrieval needle and the connected transfer tubing through the respective members 14 and 16. Further, as shown, the working length of the second insulating member 16 is approximately 10 cm to 25 cm. Preferably, the length ratio of the first member 14 to the second member 16 is approximately 4:1. Applicant has found that a 4:1 ratio provides optimal positioning of the manifold within the passageway 12 and minimizes ergonomic impact on the surgeon's and / or nurse's work when switching and / or attaching collection tubes to collection containers during an IVF procedure. However, it will be understood that the length and / or diameter of the first member 14 and the second member 16 may vary based on the required length and / or required minimum inner diameter of the passageway 12 in accordance with Hagen-Poiseuille's law. It will be understood that the two insulating tubes and their respective working lengths and diameters are designed to handle the heated air flowing through the manifold into the passageway 12 at a flow rate of approximately 30 to 35 liters per minute.

[0027] The adjustable lengths of the first and second members 14, 16 facilitate the insertion and delivery of the internal transfer tube and oocyte retrieval needle through the passageway 12. As shown, in one embodiment, the first and second members 14, 16 are configured to provide a portion of their length as a collapsible, concertina-style conduit. FIG. 1 depicts the first member 14 in a collapsed or contracted state, representing a preparatory configuration of the temperature regulation unit 10 associated with the preparatory steps of the oocyte retrieval process. FIG. 2 depicts the first member 14 in an extended state, representing an operational configuration of the unit 10 associated with the operational steps of the oocyte retrieval process. In the extended state, the operational length of the first member 14 is approximately 40 cm to 65 cm. When the first member 14 is in the extended state, the passageway 12 extends along substantially the entire length of the transfer tube. A further advantage of the first member 14 and / or second member 16 having collapsible or adjustable length portions is that when the members 14, 16 are collapsed, the process of inserting the inner transfer tube and oocyte retrieval needle through the passageway 12 is facilitated. Once the inner transfer tube is inserted and the system is ready for use, the lengths of the members 14, 16 are extended to the appropriate relative lengths. Furthermore, in the collapsed or retracted configuration, the first member 14 and second member 16 provide a smaller, more compact unit 10, thereby improving the handling of the unit 10 in preparation for oocyte collection.

[0028] The temperature regulation unit 10 also includes an air supply line 20. The air supply line 20 is adapted to communicate heated air from a heat source (not shown) to the passageway 12. Specifically, the air supply line 20 is connected to the manifold 18 and communicates the air through an opening 22 therein. The diameter of the air supply line 20 can affect the rate at which heated air is delivered to the passageway 12. As shown, the air supply line 20 is provided as a flexible conduit having an inner diameter of approximately 10 mm and a length of approximately 30 cm to 60 cm. Preferably, the heated air has a temperature of approximately 37°C to 37.4°C. Experiments by the inventors have demonstrated that supplying heated air within this range results in an internal temperature within the passageway 12 of 36.8°C to 37.2°C. Providing an internal passageway temperature within this range is particularly desirable because it approximates the average in vivo temperature of human follicular fluid.

[0029] The free end of the air supply line 20 is provided with a connector 24. The free end is understood to be the end of the air supply line 20 that is not coupled to the manifold 18. The connector 24 is configured to fluidly connect the air supply line 20 to the outlet of an external heat source. The connector 24 is preferably a "quick-lock" type connector that allows for easy connection and / or disconnection between the air supply line 20 and the heat source. As shown, the connector 24 is a "universal" type connector suitable for connection to various types of widely available heat sources typically used in IVF clinics and / or surgical settings. In other embodiments, the connector 24 may be a detachable connector provided as one of multiple connectors in a kit, each connector in the kit being selectively attachable to the free end of the air supply line 20 to match a particular heat source. The heat source may include a control that allows a user of the adjustment unit 10 to select or substantially adjust the internal temperature within the passageway 12. For example, the heat source may include a control for adjusting the flow rate of heated air or its supply temperature. Alternatively, such controls may be provided as part of the conditioning unit 10 itself, with the unit 10 being configured to interact with or control the heat source via the connector 24 .

[0030] Next, the manifold 18 will be described with particular reference to FIGS.

[0031] As best shown in FIG. 3 , the manifold 18 comprises a cylindrical body 26 extending substantially linearly from a first end 28 to a second end 30. The body 26 is hollow and has a central bore 32 extending between the first end 28 and the second end 30. The bore 28 forms a portion of the passageway 12. The body 26 has a converging profile, tapering from a first outer diameter at the first end 28 to a reduced second outer diameter at the second end 30. With particular reference to the illustrated embodiment, the manifold has a length of approximately 2 cm and tapers from a first outer diameter of approximately 20 mm to a second outer diameter of approximately 15 mm. The wall thickness of the cylindrical body is approximately 1 mm, and the inner diameter of the body tapers from approximately 18 mm to approximately 13 mm from the first end 28 to the second end 30.

[0032] The manifold 18 also includes a pair of receiving portions 34 projecting outward from the first end 28 and the second end 30, respectively. The receiving portions 34 are configured to engage or couple with the insulating members 14, 16. As shown, the receiving portions 34 include constant diameter portions projecting outward from the first end 28 and the second end 30. Specifically, the length of the receiving portions 34 is approximately 10 mm, and the overall axial length of the manifold 18 is approximately 40 mm. A thread-like engaging element 36 is disposed within the receiving portion 34 at the second end 30. The threads are raised threads that allow for threaded attachment of the second member 16. It will be understood that other forms of engaging elements 36 and / or other standard means for securing the insulating members 14, 16 to the manifold 18 are also contemplated. For example, the receiving portions 34 may alternatively be provided as push-fit fittings configured to receive the first member 14 and the second member 16, respectively.

[0033] 4 and 5 . The manifold 18 also includes a branch portion 38. The branch portion 38 extends outward from the cylindrical body 26 to a free or distal end 40 that provides the opening 22. As shown, the branch portion 38 is a tubular rim that extends substantially linearly in a direction toward the second end 30 of the body 26 for a length of approximately 10 mm. The branch portion 38 is disposed at an angle of approximately 60 degrees from the longitudinal axis of the passageway 12. In the illustrated embodiment, the inner diameter of the branch portion 38 is approximately 8 mm and the outer diameter is approximately 10 mm. It will be appreciated that the length and inner diameter of the branch portion 38 will also be selected depending on the desired flow characteristics of the heated air supply from the air supply line 20. An engaging element 36 is provided along the branch portion 38, particularly near the distal end 40, to facilitate attachment of the air supply line 20. It will be appreciated that other shapes of the engaging element 36 and / or other standard means for securing the air supply line 20 to the branch portion 38 are also contemplated.

[0034] As best shown in FIG. 5 , the branch portion 38 is fluidly connected to the bore 28 of the main body 26. This means that the flow of heated air from the air supply line 20 is transferred through the branch portion 38 to the bore 28 of the manifold 18. The angle at which the branch portion intersects with the bore 28 directs the flow of heated air toward the first end 28 and the connected first member 14. It will be appreciated that the counterflow of heated air circulates the air along the passageway 12. Specifically, the angle of the branch portion 38 toward the first end 28 creates a preferential flow of heated air toward the longer, more voluminous portion of the passageway 12, maintaining an accumulation of heated air there. This allows for consistent flow in this direction when the length of the passageway 12 is in the extended configuration, as determined by Hagen-Poiseuille's law. Furthermore, the angle of the branch portion 38 also improves the ergonomics of the device 10 during an oocyte retrieval procedure.

[0035] The manifold 18 is preferably integrally formed in a molding operation, meaning that the branched portion 28 and the cylindrical body 26 are one piece. Suitable polymeric materials include PTFE, nylon, and polypropylene. PTFE, in particular, is particularly preferred because it has low-friction properties that aid in the installation and subsequent removal of the first and second insulating members 14, 16 and the air supply line 20. It will be further understood that the material selection for the manifold 18 and insulating members 14, 16 is selected to permit sterilization of the unit 10 by gamma irradiation.

[0036] The unit 10 may form part of an oocyte retrieval system 100. The oocyte retrieval system 100 will now be described with reference to Figure 6 .

[0037] The oocyte retrieval system 100 includes an oocyte retrieval needle 150 configured to harvest or collect oocytes from the ovaries of a female patient. The oocyte retrieval needle 150 is preferably a single-lumen needle, although dual-lumen needles are contemplated. The needle 150 is adapted to be introduced into the vagina with the aid of a needle guide 152. The needle guide 152 may be attached to or coupled to an ultrasound probe 154. The ultrasound probe 154 is used by a surgeon to assist in locating and identifying the follicle to be emptied. A distal end 156 of the needle 150 is configured to puncture the vaginal wall and enter the follicle. A flexible transfer tube 160 is connected to a proximal end 158 of the needle, which may include a surgeon's handle. The transfer tube 160 is adapted to aspirate follicular fluid (with oocytes suspended therein) from the follicle, as indicated by the arrow in the figure, and transfer it to a collection container 162. As shown, the collection container 162 is a test tube. Test tube 162 is preferably placed on a heating pad or similar heating device to maintain the collected fluid at a temperature substantially equivalent to the subject's in vivo temperature. For human patients, in vivo temperature is approximately 37° C. Alternatively, test tube 162 may be heated or warmed by other means. For example, test tube 162 may be contained within a heating vessel or encased in a heating jacket.

[0038] The temperature regulation unit 10 described herein is mounted around a transfer tube 160. In the drawings, the passageway 12 of the unit 10 is shown schematically in dashed outline for clarity. The passageway 12 extends along substantially the entire length of the transfer tube 160 between the proximal end 158 of the needle 150 and the collection container 162. The interior volume of the passageway 12 provides an insulated, heated, and humidified environment that eliminates, or at least substantially reduces, the temperature drop of the follicular fluid as it is conveyed along the transfer tube 160. The second member 16 of the unit 10 may be configured with an open end located above or near a silicone stopper 164 that provides a lid for the collection container 162, thereby maintaining a substantially localized, heated, and humidified environment. The open end of the second member 16 may include a restriction adapted to focus the exhaust of heated air away from the passageway 12. In other embodiments, the second member 16 may be directly coupled to the stopper 164. Additionally, the first member 14 of the unit 10 may be configured with an open end located above or near the distal end of the needle 150. The open end of the first member 14 may include a restriction adapted to focus the exhaust of heated air away from the passageway 12. The first member may, for example, extend along a portion of the length of the handle portion of the needle 150, the handle portion including the portion of the needle 150 that is outside the needle guide 152. In other embodiments, the first member may be directly coupled to the distal end of the needle 150. Advantageously, the flexibility of the passageway 12 of the unit 10 ensures that undesirable ergonomic effects or interference with the maneuverability of the needle 150 and associated equipment used by surgeons and / or scrub nurses during an oocyte retrieval procedure are minimized.

[0039] As described herein, the temperature regulation unit 10 is a separate device from the needle 150 and its associated transfer tube 160. An advantage of this is that the temperature regulation unit 10 can be retrofitted and / or integrated into existing surgical equipment typically used in IVF settings. In this manner, modifications and / or interruptions to the existing / standard workflow of surgeons performing oocyte retrieval procedures are minimized. The temperature regulation unit 10 thus functions to improve the success rate of oocyte retrieval without complicating and / or introducing unnecessary drawbacks to established procedures and methodologies. However, it will be appreciated that in other embodiments, the temperature regulation unit 10 can be integrated with and / or form part of other surgical equipment used for oocyte retrieval. For example, the temperature regulation unit 10 can be provided with an integral internal channel that essentially functions as a transfer tube, extending along a passageway and adapted to receive follicular fluid from the needle 150 and communicate said fluid to the collection container 160.

[0040] A method 200 of retrieving oocytes from a female patient as part of an IVF procedure using the system 100 described herein will now be described with reference to FIG.

[0041] In a preparatory insertion step 210, the oocyte retrieval needle 150 and connected transfer tubing 160 are inserted into the temperature regulation unit 10 via the second member 16. The needle 150 and tubing 160 are then passed along the passage 12 so that the needle 150 protrudes therefrom. During insertion of the needle 150, the temperature regulation unit is in a preparatory configuration and the extendable first member 14 is in a collapsed or contracted state. Once the needle 150 passes through the passage 12, the first member 14 expands, thereby extending along a substantial length of the passage 12 and the connected transfer tubing 160.

[0042] In a subsequent warming step 220, heated air is pumped or otherwise communicated into the passageway 12. Preferably, before the inflow of heated air from the external supply is initiated, the air supply line 20 is first connected to the opening 22 of the manifold 18. The heated air is supplied at a temperature substantially equivalent to the in vivo temperature of a female patient, e.g., 37°C. As the heated air is pumped into the manifold 18 through the opening 22, the air flow is distributed substantially evenly through the first end 28 and the second end 30 to the connected insulating members 14, 16. The supply of heated air creates a warm, substantially stable, constant-temperature air jacket within the passageway 12, which encases the transfer tube 160. Temperature and / or pressure sensors (not shown) may be positioned within the passageway 12 to monitor the internal environment of the passageway 12. The sensors may communicate with a controller (not shown) of the external heat source to adjust the flow characteristics to achieve desired environmental conditions within the passageway 12.

[0043] Once the environmental conditions within the passageway 12 have reached a desired steady-state level, the oocyte retrieval process continues according to common practice. Specifically, in the collection step 230, a retrieval needle 150 is inserted into a selected follicle and guided along a needle guide 152. Preferably, the needle 150 is guided into position with the aid of an ultrasound probe 154 adapted to carry the needle guide 152.

[0044] Once the tip or distal end 156 of the needle 150 punctures the follicle, suction is initiated and vacuum pressure is applied by an external vacuum source to expel follicular fluid from the follicle, through the needle 150, and into a transfer tube 160. During the transfer step 240, the follicular fluid is drawn along said transfer tube 160 contained within the passageway 12 and into a collection container 162. Advantageously, because the internal environment of the passageway 12 substantially surrounds the transfer tube 160, little or no temperature drop occurs within the follicular fluid during this transfer step 240.

[0045] In summary, the temperature regulation units described herein can advantageously improve the viability of oocytes retrieved from female patients as part of an IVF process. In particular, the temperature regulation units provide a substantially stable, constant temperature environment within a passageway substantially surrounding the transfer tubing used to communicate the fluid from the oocyte retrieval needle to a collection container. In this manner, temperature drops within the follicular fluid are substantially avoided or at least minimized, thereby reducing the likelihood of damage to the meiotic spindle within the oocyte, which could adversely affect the ability of the oocyte to be used to form a viable embryo.

[0046] The reference in this specification to any prior document (or information derived therefrom) or to any known matter should not be construed as an acknowledgement or admission or in any way suggestion that the prior document (or information derived therefrom) or known matter forms part of the common general knowledge in the field to which this specification pertains.

[0047] Throughout this specification and the claims that follow, unless the context clearly indicates otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to include a stated integer or step or group of integers or steps but not to exclude any other integer or step or group of integers or steps. [Explanation of symbols]

[0048] 10. Oocyte Retrieval Tubing System 12 Passage (outer tubing) 14 First member (first insulating tube) 16 Second member (second insulating tube) 18 Manifold 20 Air supply line 22 Opening 24 connectors 26 Cylindrical body 28 First end 30 second end 32 bore 34 Receptor 36 Engagement element 38 Branching section 40 free end 100 Oocyte Retrieval System 150 Oocyte Retrieval Needle 152 Needle guide 154 Ultrasound Probe 156 Tip 158 Handle end 160 Transfer tube 162 Collection container 164 Stopper 200 Oocyte Retrieval Methods 210 Insertion Step 220 Heating Step 230 Guidance Steps 240 transport steps

Claims

1. a manifold for receiving a supply of heated air; an outer tubing for housing an inner transfer tube that extends between the collection container and the oocyte retrieval needle in use; An oocyte retrieval tubing system comprising: The oocyte retrieval tubing system includes first and second separate insulating tubes connected to each other via the manifold, and the first and second insulating tubes are each configured to be adjustable in length, whereby adjusting their operating lengths relative to each other regulates the flow of heated air within the outer tubing received through the manifold disposed therebetween, thereby maintaining a stable and uniform temperature distribution within the outer tubing for oocyte retrieval.

2. 10. The oocyte retrieval tubing system of claim 1, wherein the internal temperature of the outer tubing is substantially maintained within the range of about 36.8°C to 37.2°C during use.

3. 3. The oocyte retrieval tubing system of claim 1, wherein the manifold comprises a body having a first end and a second end, the first insulating tube being coupled to the manifold proximate the first end, and the second insulating tube being coupled to the manifold proximate the second end.

4. 4. The oocyte retrieval tubing system of claim 3, wherein the body of the manifold has a tapered diameter from a first diameter at the first end to a reduced second diameter at the second end.

5. 5. The oocyte retrieval tubing system of claim 3 or claim 4, wherein the manifold comprises receiving portions extending from the first and second ends of the body, and the first and second tubes are each coupled to the manifold via the receiving portions.

6. The oocyte retrieval tubing system of claim 5 , wherein the receiving portion includes a constant diameter portion that protrudes linearly from each of the first and second ends of the body.

7. 7. An oocyte retrieval tubing system according to any one of claims 1 to 6, wherein each of the first and second insulating tubes is provided with a collapsible concertina-type section for length adjustment.

8. 8. The oocyte retrieval tubing system according to claim 1, wherein the maximum length of the first insulating tube is longer than the maximum length of the second insulating tube.

9. 9. The oocyte retrieval tubing system of claim 8, wherein the working length of the first insulating tube is about four times the working length of the second insulating tube.

10. The oocyte retrieval tubing system according to any one of claims 1 to 9, wherein the working length of the first insulating tube is between about 40 cm and 65 cm.

11. The oocyte retrieval tubing system according to any one of claims 1 to 10, wherein the working length of the second insulating tube is between about 10 cm and 25 cm.

12. The oocyte retrieval tubing system according to any one of claims 1 to 11, wherein the diameter of the first insulating tube is about 20 mm.

13. The oocyte retrieval tubing system according to any one of claims 1 to 12, wherein the diameter of the second insulating tube is about 15 mm.

14. 14. The oocyte retrieval tubing system of any one of claims 3 to 13, wherein the manifold includes an opening for receiving a supply of heated air, the opening being in fluid communication with the first and second ends of the body.

15. 15. The oocyte retrieval tubing system of claim 14, wherein the manifold includes a branched portion extending from the body between the first and second ends thereof, the opening for the supply of heated air being provided by an open end of the branched portion.

16. 16. The oocyte retrieval tubing system of claim 15, wherein the branch portion extends outwardly from the body portion toward the second end.

17. 17. An oocyte retrieval tubing system according to any one of claims 14 to 16, further comprising an air supply line extending from the opening in the manifold to a heat source.

18. 18. The oocyte retrieval tubing system of claim 17, wherein the diameter of the air supply line is smaller than the diameter of the first and second insulating tubes.

19. The oocyte retrieval tubing system of claim 10, further comprising a connector disposed at a free end of the air supply line and configured to connect to the heat source.

20. 20. The oocyte retrieval tubing system of any one of claims 1 to 19, wherein the heated air supply is received through the manifold and enters the outer tubing at a flow rate of about 30-35 liters per minute.

21. 1. An oocyte retrieval system comprising: an oocyte retrieval needle; a transfer tube attached to the retrieval needle and extending from the needle to a collection container; An oocyte retrieval tubing system according to any one of claims 1 to 20; An oocyte recovery system comprising:

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