阅读说明：本技术 获取人类卵子的针 (Needle for obtaining human ovum ) 是由 大卫·格林宁 于 2019-05-29 设计创作，主要内容包括：一种用于获取人类卵子的针组件(10),所述针组件(10)包括：外套管(20)；空心内针(30),其可滑动地设置在所述空心外套管(20)内。所述空心内针(30)具有：远端区域(33),其被构造为限定弯曲部(35)；远端(32),其具有尖锐斜面(34)；缩回位置,其中,所述远端区域(33)设置在所述外套管(20)内；和伸出位置,其中,所述空心内针(30)的所述远端(32)远离所述外套管(20)的远端(11),并且所述远端区域(33)至少部分地在所述外套管(20)的外部。所述针组件(10)还包括控制器(40),所述控制器(40)被构造成使所述空心内针(30)在所述缩回位置和所述伸出位置之间移动。(A needle assembly (10) for obtaining a human ovum, the needle assembly (10) comprising: an outer sleeve (20); a hollow inner needle (30) slidably disposed within the hollow outer cannula (20). The hollow inner needle (30) has: a distal region (33) configured to define a bend (35); a distal end (32) having a sharp bevel (34); a retracted position, wherein the distal end region (33) is disposed within the outer cannula (20); and an extended position, wherein the distal end (32) of the hollow inner needle (30) is distal to the distal end (11) of the outer cannula (20) and the distal region (33) is at least partially external to the outer cannula (20). The needle assembly (10) further includes a controller (40), the controller (40) being configured to move the hollow inner needle (30) between the retracted position and the extended position.)

1. A needle assembly for obtaining a human ovum, the needle assembly comprising:

an outer cannula having a proximal end and a distal end;

a hollow inner needle slidably disposed within the hollow outer cannula, the hollow inner needle having:

a distal region configured to define a bend;

a distal end having a sharp bevel;

a retracted position in which the distal end region is disposed within the outer sheath; and

an extended position in which the distal end of the hollow inner needle is distal to the distal end of the outer cannula and the distal region is at least partially outside of the outer cannula; and

a controller configured to move the hollow inner needle between the retracted position and the extended position,

wherein:

the distal end region conforms to the outer cannula when the hollow inner needle is in the retracted position; and is

The distal region defines the bend when the hollow inner needle is in the extended position.

2. The needle assembly of claim 1, wherein the distal end of the outer cannula has a sharp bevel.

3. The needle assembly of claim 2, wherein the sharp bevel of the outer cannula and the sharp bevel of the hollow inner needle are substantially aligned to form a bevel when the hollow inner needle is in the retracted position.

4. The needle assembly of claim 1, wherein the distal end of the hollow inner needle protrudes from the distal end of the outer cannula when the hollow inner needle is in the retracted position.

5. The needle assembly of any one of claims 1 to 4, wherein the bend defined by the distal region is a one-way bend.

6. The needle assembly of any one of claims 1 to 5, wherein the distal region is configured to extend to a maximum angle of 90 ° relative to the outer cannula.

7. The needle assembly of any one of claims 1 to 6, wherein:

moving the hollow inner needle from the retracted position to the extended position by distally advancing the hollow inner needle relative to the outer cannula; and is

The hollow inner needle is moved from the extended position to the retracted position by proximally retracting the hollow inner needle relative to the outer cannula.

8. The needle assembly of claim 7, wherein the radius of the bend is 2.5cm when the hollow inner needle is advanced distally 4cm relative to the outer cannula.

9. The needle assembly of any one of claims 1 to 8, wherein the distal region is made of an elastic alloy.

10. The needle assembly of any one of claims 1 to 9, wherein the hollow inner needle is made of an elastic alloy.

11. The needle assembly of claim 9 or 10, wherein the resilient alloy is a nickel titanium alloy.

12. The needle assembly according to any one of claims 1 to 11, wherein the outer cannula is a needle.

13. The needle assembly according to any one of claims 1 to 11, wherein the outer cannula is a 16g or 17g needle.

14. The needle assembly of any one of claims 1 to 13, wherein the hollow inner needle is a 19g needle.

15. The needle assembly of any one of claims 1 to 14, wherein:

a region near or at the distal end of the outer cannula is radiopaque; and/or

A region near or at the distal end of the hollow inner needle is radiopaque.

16. The needle assembly of any one of claims 1 to 15, wherein the hollow inner needle is restricted from rotating within the outer cannula when the hollow inner needle is in the retracted position or the extended position.

17. The needle assembly of any one of claims 1 to 16, wherein the controller is configured to releasably retain the hollow inner needle in the retracted position or the extended position.

18. The needle assembly of any one of claims 1 to 17, wherein the controller comprises:

a first portion connected to the hollow outer sleeve; and

a second portion connected to the hollow inner needle,

wherein moving the second portion relative to the first portion moves the hollow inner needle between the retracted position and the extended position.

19. The needle assembly of claim 18, wherein:

the first portion has a first slot and a second slot; and is

The second portion having a flange configured to be received in the first slot or the second slot,

wherein the hollow inner needle is retained in the retracted position by the flange being disposed in the first slot, and the hollow inner needle is retained in the extended position by the flange being disposed in the second slot.

20. The needle assembly of claim 19, wherein the flange and the bend extend in the same direction.

21. The needle assembly of any one of claims 1 to 20, wherein the hollow inner needle is configured to be connected in fluid communication with a vacuum source configured to generate negative pressure in the hollow inner needle to obtain a human ovum.

22. The needle assembly of any one of claims 1 to 21, wherein the hollow inner needle is in fluid communication with a receptacle for collecting a human ovum extracted through the hollow inner needle.

23. The needle assembly of claim 22, further comprising a stopcock valve in fluid communication with the hollow inner needle, the container, and the vacuum source, the stopcock valve being movable between a first configuration and a second configuration,

in the first configuration, the hollow inner needle is in fluid communication with the container and the vacuum source to obtain and collect a human ovum;

in the second configuration, the hollow inner needle is in fluid communication with an irrigation fluid for irrigating the hollow inner needle.

24. A method for harvesting a human ovum, the method comprising:

inserting the distal end of the outer cannula of the needle assembly of any one of claims 1 to 17 into an ovary through a vaginal wall of a subject with a hollow inner needle in a retracted position;

positioning the distal end of the outer cannula adjacent to a follicle; and

and obtaining the ovum through the hollow inner needle.

25. The method of claim 24, further comprising:

moving the hollow inner needle to the extended position; and

positioning the distal end of the hollow inner needle adjacent an egg to obtain the egg.

26. The method of claim 25, further comprising the steps of:

moving the hollow inner needle to the retracted position;

rotating the needle assembly to reposition the overtube in the ovary;

moving the hollow inner needle to the extended position; and

positioning the distal end of the hollow inner needle adjacent to a follicle to obtain an ovum.

Technical Field

The present technology relates to needles and needle assemblies for collection or extraction of eggs in connection with In Vitro Fertilization (IVF) and Assisted Reproductive Therapy (ART).

Background

IVF involves the fertilization of a female oocyte (a cell in the ovary that may undergo meiosis to form an ovum) or an ovum in vitro (i.e., outside the uterus).

Basic IVF needles have changed little over the years of improvement. Typically, a needle having a 330mm, cm 16/17 gauge needle shaft and a 19/20 gauge needle tip is generally used.

In other fields, needle assemblies exist that use needles to remove samples and/or apply aids, but these needle assemblies are generally not suitable for retrieval of eggs.

The IVF needle is introduced into the vagina along a vaginal probe with a needle guide to maintain the orientation of the needle. At the proximal end, the needle is connected to a flexible tube and aspirates the human ovum to collect it in a test tube.

Current egg removal procedures require multiple insertions into the vaginal wall to remove multiple eggs, which can be painful and can also lead to bleeding.

Ideally, having a needle assembly that can be used in an outpatient setting would reduce the cost of the patient. Safer, less laborious collection of eggs will reduce IVF costs by allowing collection of eggs in clinics rather than hospitals, and potentially significantly increase IVF cycles and birth rates.

US 6,592,559 discloses a needle assembly comprising a needle cannula made of a superelastic material such as nitinol. The needle cannula is cold worked or heat annealed to produce a pre-formed bend that can be straightened within the passageway of the coaxial outer cannula for introduction into the patient. When deployed from the outer cannula, the needle cannula is returned substantially to the pre-fabricated configuration to introduce or withdraw material in a lateral region of the access path of the needle assembly. The needle assembly can include a plurality of needle cannulae that can be variably arranged or configured for obtaining a desired infusion pattern.

However, for a number of reasons, needle assemblies, in particular, would no longer be suitable for egg retrieval. Since the outer cannula does not include a beveled tip, it is necessary to work with the introducer trocar to insert the outer cannula into the body. The trocar is then removed and the infusion needle is inserted into its place.

The present inventors have developed an improved needle assembly for harvesting human ova.

Disclosure of Invention

In a first aspect, the present invention provides a needle assembly for obtaining a human ovum, the needle assembly comprising:

an outer cannula having a proximal end and a distal end;

a hollow inner needle slidably disposed within the hollow outer cannula, the hollow inner needle having:

a distal region configured to define a bend;

a distal end having a sharp bevel;

a retracted position wherein the distal end region is disposed within the outer sheath; and

an extended position in which the distal end of the hollow inner needle is distal to the distal end of the outer cannula and the distal end region is at least partially outside the outer cannula; and

a controller configured to move the hollow inner needle between a retracted position and an extended position, wherein;

the distal end region conforms to the outer cannula when the hollow inner needle is in the retracted position; and is

The distal region defines a bend when the hollow inner needle is in the extended position.

In an embodiment, the distal end of the outer cannula has a sharp bevel.

In an embodiment, the sharp bevel of the outer cannula and the sharp bevel of the hollow inner needle are substantially aligned and form a bevel when the hollow inner needle is in the retracted position.

In an embodiment, the distal end of the hollow inner needle protrudes from the distal end of the outer cannula when the hollow inner needle is in the retracted position.

In an embodiment, the bend defined by the distal region is a one-way bend.

In an embodiment, the distal region is configured to extend to a maximum angle of about 90 ° relative to the outer cannula.

In the examples:

moving the hollow inner needle from the retracted position to the extended position by advancing the hollow inner needle distally relative to the outer cannula; and is

The hollow inner needle is moved from the extended position to the retracted position by proximally retracting the hollow inner needle relative to the outer cannula.

In an embodiment, the radius of the bend is about 25mm when the hollow inner needle is advanced distally 40mm relative to the outer cannula.

In an embodiment, the distal region of the hollow inner needle is formed of a resilient alloy.

In an embodiment, the hollow inner needle is formed of an elastic alloy.

In an embodiment, the elastic alloy is a nickel titanium alloy.

In an embodiment, the distal region of the hollow inner needle is formed from a thermoplastic polymer.

In an embodiment, the distal end region of the hollow inner needle is formed by a helical spring.

In an embodiment, the helical spring is covered by an elastic material.

In an embodiment, the distal end region of the hollow inner needle is formed of an elastomer.

In embodiments, the elastomer is polyethylene or nylon.

In an embodiment, the distal region of the hollow inner needle is formed of a smart polymer.

In an embodiment, the outer cannula is a needle.

In embodiments, the outer cannula is a 16g or 17g needle.

In an embodiment, the hollow inner needle is a 19g needle.

In an embodiment, the hollow inner needle has a length of about 350 mm.

In an embodiment, the distal region of the hollow inner needle is capable of withstanding the flexing forces necessary to puncture a follicle to withdraw multiple ova.

In an embodiment, the deflection force is about 20,000 mN.

In an embodiment, the hollow inner needle and the outer cannula are coreless.

In an embodiment, the distal end of the hollow inner needle and/or the distal end of the outer cannula are three-sided.

In an embodiment, a region near or at the distal end of the outer sleeve is radiopaque.

In an embodiment, the region near or at the distal end of the hollow inner needle is radiopaque.

In an embodiment, the region near or at the distal end of the outer cannula is radiopaque and the region near or at the distal end of the hollow inner needle is radiopaque.

In an embodiment, the length of the radiopaque region is about 10 mm.

The radiopaque region of the distal end of the hollow inner needle and/or outer cannula allows the location of the needle assembly in the subject to be identified by ultrasound or X-ray.

In an embodiment, the hollow inner needle is restricted from rotating within the outer cannula when the hollow inner needle is in the extended position.

In an embodiment, the hollow inner needle is restricted from rotating within the outer cannula when the hollow inner needle is in the retracted position or in the extended position.

In an embodiment, the controller is configured to releasably retain the hollow inner needle in the retracted position or the extended position.

In an embodiment, the controller comprises:

a first portion connected to the outer sleeve; and

a second portion connected to the hollow inner needle,

wherein moving the second portion relative to the first portion moves the hollow inner needle between the retracted position and the extended position.

In the examples:

the first portion has a first slot and a second slot; and is

The second portion having a flange configured to be received in the first slot or the second slot,

wherein the hollow inner needle is retained in the retracted position by the flange being disposed in the first slot, and the hollow inner needle is retained in the extended position by the flange being disposed in the second slot.

In an embodiment, the flange and the bend extend in the same direction.

In an embodiment, the tubing is connected to a hollow inner needle.

In an embodiment, the proximal end of the hollow inner needle is connected to a tubing system.

In an embodiment, the hollow inner needle is configured to be connected in fluid communication with a vacuum source configured to generate negative pressure in the hollow inner needle to obtain a human ovum.

In an embodiment, the hollow inner needle is in fluid communication with a container for obtaining human egg cells extracted through the hollow inner needle.

In embodiments, the needle assembly further comprises a stopcock in fluid communication with the hollow inner needle, the container and the vacuum source, the stopcock being movable between a first configuration and a second configuration:

in the first configuration, the hollow inner needle is in fluid communication with a container and a vacuum source to obtain and collect a human ovum;

in the second configuration, the hollow inner needle is in fluid communication with an irrigation fluid for irrigating the hollow inner needle.

Also disclosed is an egg retrieval system, comprising:

a needle assembly according to the first aspect of the invention;

a tubing in fluid communication with the hollow inner needle;

a negative pressure pump in fluid communication with the tubing system for removing the ovum through the needle assembly; and

a container in fluid communication with the conduit system for containing the harvested eggs.

In a second aspect, the present invention provides a method for obtaining a human ovum, the method comprising:

inserting the distal end of the outer cannula of the needle assembly according to the first aspect of the invention through the vaginal wall of the subject and into the ovary with the hollow inner needle in the retracted position;

positioning a distal end of the outer cannula adjacent the follicle; and

the ova are obtained from the follicles by means of a hollow internal needle.

In an embodiment, the method further comprises:

moving the hollow inner needle to an extended position; and

the distal end of the hollow inner needle is positioned near the follicle to obtain the ovum.

In an embodiment, the method further comprises:

moving the hollow inner needle to a retracted position;

rotating the needle assembly to reposition the overtube in the ovary;

moving the hollow inner needle to an extended position; and

the distal end of the hollow inner needle is positioned near the follicle to obtain the ovum.

Also disclosed is a method of obtaining a human ovum, the method comprising:

introducing the distal end of the outer cannula of the needle assembly according to the first aspect of the invention into the ovary through the vaginal wall;

moving the hollow inner needle to an extended position; and

one or more ova are obtained through a hollow inner needle.

In an embodiment, a plurality of eggs are obtained from a single inlet at the distal end of the outer cannula of the needle assembly.

Throughout this specification, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

Any discussion of documents, acts, materials, devices or articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this specification.

Drawings

Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

FIG. 1 is a side view of a needle assembly according to an embodiment of the present invention;

FIG. 2 is a top view of the needle assembly of FIG. 1;

FIG. 3 is a perspective view of the distal end of the needle assembly of FIG. 1;

FIG. 4 is a perspective view of the needle assembly of FIG. 1;

FIG. 5 is a cross-sectional side view of the needle assembly of FIG. 1;

FIG. 6 is a cross-sectional side view of the distal end of the needle assembly of FIG. 1;

FIG. 7 is a cross-sectional side view of the distal end of the needle assembly of FIG. 1 with the hollow inner needle slightly extended;

FIG. 8 is a perspective view of the needle assembly of FIG. 1 with the hollow inner needle slightly extended;

FIG. 9 is a perspective view of the needle assembly of FIG. 1 with the hollow inner needle slightly extended;

FIG. 10 is a cross-sectional side view of the needle assembly of FIG. 1 with the hollow inner needle slightly extended;

FIG. 11 is a side elevational view of the needle assembly of FIG. 1 with the hollow inner needle slightly extended;

FIGS. 12-14 show sequential steps in extending the hollow inner needle of the needle assembly of FIG. 1 to its fully extended position (FIG. 14) relative to the outer cannula;

FIG. 15 is a top view of the needle assembly of FIG. 1, with the hollow inner needle fully extended and illustrating the one-way nature of the bend defined by the distal end region of the hollow inner needle;

FIG. 16 is a perspective view of the needle assembly of FIG. 1 with the hollow inner needle fully extended;

FIG. 17 is a cross-sectional side view of the distal end of the needle assembly of FIG. 1 with the hollow inner needle fully extended;

FIG. 18 shows the needle assembly of FIG. 1 with the hollow inner needle fully extended;

FIG. 19 is a perspective view of the distal end region of the hollow inner needle of the needle assembly of FIG. 1, according to another embodiment;

FIG. 20 is a perspective view of a controller for use with the needle assembly of FIG. 1;

FIG. 21 shows the controller of FIG. 20 holding the hollow inner needle of the needle assembly of FIG. 1 in a retracted position;

FIG. 22 shows the controller of FIG. 20 holding the hollow inner needle of the needle assembly of FIG. 1 in an extended position;

FIG. 23 shows a first portion and a second portion of the controller of FIG. 20;

FIGS. 24 and 25 illustrate another controller for use with the needle assembly of FIG. 1; and

FIG. 26 is a perspective view of an egg retrieval system according to an embodiment of the present invention.

Detailed Description

The drawings illustrate a needle assembly 10 for obtaining a human ovum, in accordance with an embodiment of the present invention. Needle assembly 10 has a distal end 11 and a proximal end 12. Distal end 11 of needle assembly 10 has a bevel 13.

Needle assembly 10 includes an outer cannula 20 in the form of a needle and a hollow inner needle 30 slidably positioned within outer cannula 20. Outer sleeve 20 has a proximal end 21 and a distal end 22. The distal end 22 has a sharp bevel 23. The hollow inner needle 30 has a proximal end 31, a distal end 32 and a distal end region 33. The distal end 32 of the hollow inner needle 30 has a sharp bevel 34.

The hollow inner needle 30 has a retracted position (see, e.g., fig. 1) and an extended position (see, e.g., fig. 14). In the retracted position, the distal end region 33 of the hollow inner needle 30 is disposed within the outer sleeve 20. In the extended position, the distal end 32 of the hollow inner needle 30 is distal to the distal end 22 of the outer cannula 20, and the distal end region 33 of the hollow inner needle 30 is outside of the outer cannula 20. It should be understood that hollow inner needle 30 may extend at any position between the retracted position and the extended position. With the hollow inner needle 30 extended to a position between the retracted and extended positions, it will be appreciated that the distal end 32 of the hollow inner needle 30 will be distal to the distal end 22 of the outer cannula 20 and the distal end region 33 of the hollow inner needle 30 will be at least partially outside the outer cannula 20. Preferably, as shown in fig. 6, the distal end region 33 of the hollow inner needle 30 conforms to the shape of the outer cannula 20 when the hollow inner needle 30 is in the retracted position. It will be appreciated that the distal end region 33 of the hollow inner needle 30 is substantially straight within the outer cannula 20 when the hollow inner needle 30 is in the retracted position.

Referring to fig. 14, when the hollow inner needle 30 is in the extended position, the distal end region 33 of the hollow inner needle 30 defines a bend 35. Most preferably, as shown in fig. 15, the bend 35 is a one-way bend (i.e., the bend 35 extends in a fixed plane). Fig. 11 to 14 show the gradual change of the hollow inner needle 30 from the retracted position to the extended position. As can be seen in these figures, hollow inner needle 30 is moved from the retracted position to the extended position by advancing hollow inner needle 30 distally relative to outer cannula 20. Thus, it will be appreciated that hollow inner needle 30 is moved from the extended position to the retracted position by proximally retracting hollow inner needle 30 relative to outer cannula 20.

Referring to fig. 20-23, the needle assembly 10 further includes a controller 40, the controller 40 for moving the hollow inner needle 30 between the retracted position and the extended position.

During the aspiration procedure, the distal end 11 of the needle assembly 10 is inserted into the pelvic cavity of the subject and then directed to the follicle using laparoscopy or ultrasound or X-ray guidance. Needle assembly 10 can be inserted laparoscopically for visualization or vaginally under ultrasound or X-ray guidance. Once it is determined that the distal end 11 of the needle assembly 10 is in the region of the follicle, the distal end 11 of the needle assembly 10 is gently inserted into the follicle. Immediately after the distal end 11 of the needle assembly 10 enters the follicle, negative pressure (i.e., a vacuum source) is applied to the needle assembly 10 to aspirate the oocyte and any follicular fluid.

Outer sleeve

Outer cannula 20 may be a 16g needle or a 17g needle, with distal end 22 of outer cannula 20 being a 17g needle. Describing the gauge of the needle, the larger the number, the smaller the diameter.

Outer sleeve 20 may be formed from one or more materials selected from stainless steel, carbon fiber, hard plastic, ceramic, and glass. Particularly preferred materials include stainless steels selected from AISI 304, AISI 316, SIS2346 and SIS 2543. The most preferred material is AISI 304 stainless steel.

The distal end 22 of the outer cannula 20 is configured to pierce the pelvic cavity of the subject. The sharp bevel 23 of the outer cannula 20 and the sharp bevel 34 of the hollow inner needle 30 may be three-sided and coreless. The distal end 22 of the outer cannula 20 may be radiopaque, allowing for ultrasound or X-ray identification. For example, the outer surface of the distal end 22 of the outer sleeve 20 may be provided with one or more grooves. This is particularly useful during laparoscopic surgery and/or when using ultrasound to guide the insertion of the needle assembly 10. The length of the radiopaque distal end 22 of the outer cannula 20 may be about 10mm, and the distal end 22 is integral with the outer needle 20.

Possible needle designs that can be used for outer cannula 20 can have the following dimensions:

generally, outer cannula 20 may be about 40mm shorter than hollow inner needle 30 to allow hollow inner needle 30 to impart motion relative to outer cannula 20, depending on the particular application. The distal region 33 of the hollow inner needle 30 occupies a length difference of about 40mm between the inner needle 30 and the outer cannula 20.

The inner diameter of the outer cannula 20 is configured to allow relative movement of the hollow inner needle 30 within the outer cannula 20.

Most 16 or 17g needles are available, for example, from Cook Medical Inc (Bloomington, ind., USA), Smiths Medical International (Watford, UK), and Gynetics Medical Products n.v. (Achel, Belgium). An 18g needle (1.27mm OD) is available from Smiths Medical International.

In an alternative embodiment, outer sleeve 20 does not include a sharp bevel 23. In this condition, when hollow inner needle 30 is in the retracted position, distal end 32 of hollow inner needle 30 protrudes from distal end 22 of outer cannula 20. In this configuration, the needle assembly 10 relies on the sharp bevel 34 of the hollow inner needle 30 to pierce the pelvic cavity and follicle of the subject.

Hollow inner needle

Hollow inner needle 30 is configured to be slidably positioned within outer cannula 20 and movable relative to outer cannula 20. Referring to fig. 6, when hollow inner needle 30 is in the retracted position, sharp bevel 34 of hollow inner needle 30 and sharp bevel 23 of outer cannula 20 are aligned and form bevel 13. Bevel 13 is adapted for insertion into the pelvic cavity, vaginal wall and ovarian follicles of a subject.

The distal end 32 of the hollow inner needle 30 may be radiopaque to allow identification by ultrasound or X-ray. For example, the outer surface of the distal end 32 of the hollow inner needle 30 may be provided with one or more grooves. This is particularly useful during laparoscopic surgery and/or when using ultrasound to guide the insertion of the needle assembly 10. The radiopaque distal end 32 of the hollow inner needle 30 is approximately 10mm in length, and this distal end 32 is connected to a distal region 33 of the hollow inner needle 30 (see, e.g., fig. 17). It is contemplated that only distal end 32 of hollow inner needle 30 will be radiopaque, or that both distal end 32 of hollow inner needle 30 and distal end 22 of outer cannula 20 will be radiopaque.

According to embodiments in which the hollow inner needle 30 is not of unitary construction, it is contemplated that the distal end 32 of the hollow inner needle 30 can be brazed or welded to the distal region 33, wherein the distal region 33 is also brazed or welded to the shaft 36 of the hollow inner needle 30 (see, e.g., fig. 17). However, the attachment method may require consideration of the radiopaque nature of the distal end 32 of the hollow inner needle 30. The method of connecting the distal end 32, the distal end region 33, and the shaft portion 36 of the hollow inner needle 30 also requires consideration of the tight tolerances required to allow the distal end 32 and the distal end region 33 of the hollow inner needle 30 to extend and retract within the outer cannula 20 without becoming caught or causing friction. The attachment method used to attach distal end 32 to distal region 33 must ensure that distal end 32 does not break and lodge within the bleb during the aspiration process. Desirably, the hollow inner needle 30 is manufactured straight to ensure that tolerances and manufacturing processes are controlled, wherein a bend 35 is formed in the distal region 33 of the hollow inner needle 30 after the hollow inner needle 30 is assembled.

Hollow inner needle 30 may be a 19g needle, which is a needle having a smaller diameter than that used for outer cannula 20, such that hollow inner needle 30 is able to slide within outer cannula 20.

The proximal end 31 of the hollow inner needle 30 is configured to be in fluid communication with a tubing system 70 to allow for removal and collection of ova from within the follicle. A negative pressure pump (not shown) is in fluid communication with the tubing 70 such that it is in fluid communication with the hollow inner needle 30. The negative pressure pump is configured to generate a negative pressure in the hollow inner needle 30 to remove an oocyte egg from the subject. It should be appreciated that any suitable vacuum source known in the art may be used to create a negative pressure in hollow inner needle 30.

In one embodiment, hollow inner needle 30 is longer than outer cannula 20. The distal end region 33 of the hollow inner needle 30 accounts for the difference in length between the hollow inner needle 30 and the outer sleeve 20. In a particular embodiment, hollow inner needle 30 may be about 39mm longer than outer cannula 20. In other words, the distal region 33 of the hollow inner needle 30 is about 39 mm. In this embodiment, the radius of curvature of the curved portion 35 is about 25mm when the hollow inner needle 30 is in the extended position. Referring to fig. 18, when the hollow inner needle 30 is in the extended position, the bend 35 defined by the distal region 33 of the hollow inner needle 30 follows an arc of 1/4 turns, and the distal end 32 of the hollow inner needle 30 is disposed about 25mm away from the distal end 22 of the outer cannula 20, and the distal end 32 of the hollow inner needle 30 is about 25mm from the longitudinal axis of the outer cannula 20. Since the distal region 33 is 39mm long in this embodiment, the total arc length of the bend 35 defined by the distal region 33 is 39mm when the hollow inner needle 30 is in the extended position. In another embodiment, the bend 35 defined by the distal region 33 of the hollow inner needle 30 has a radius of 25mm when the hollow inner needle 30 is advanced distally 40mm relative to the outer cannula 20. In yet another embodiment, the length of the hollow inner needle 30 may be 350mm, however, the length will depend on a number of factors, including the source of the needle, the bending force characteristics (as described below), and the insertion depth necessary during the procedure.

Referring to fig. 11-17, when the hollow inner needle 30 is in the retracted position, the distal end region 33 of the hollow inner needle 30 conforms to the shape of the outer cannula 20 such that the distal end region 33 is straight when the distal end region 33 is disposed/confined within the outer cannula 20. As best shown in fig. 11-14, as the hollow inner needle 30 is advanced from the retracted position to the extended position, the distal region 33 begins to define the bend 35 as the distal region 33 moves outside of the outer cannula 20 an increasing amount. It will be appreciated that when the hollow inner needle 30 has been advanced to the extended position, the distal end region 33 of the hollow inner needle 30 will define a bend 35.

The distal end region 33 of the hollow inner needle 30 may be made of a super-elastic alloy such as nickel titanium alloy (Ni-Ti). Nitinol is an alloy characterized by a martensite to austenite phase transition at a temperature below the operating temperature of needle assembly 10. The bend 35 defined by the distal region 33 of the hollow inner needle 30 can be formed by heat setting a permanent bend into the distal region 33 such that the distal region 33 retains the permanent bend once it is extended from the outer cannula 20.

Alternatively, the distal end region 33 of the hollow inner needle may be made of a thermoplastic polymer such as nylon or polyethylene. Alternatively, the distal end region 33 of the hollow inner needle 30 may be made of a helical spring (see fig. 19) covered with an elastomeric material such as polyethylene.

For example, using 16g or 17g outer cannula 20 and 19g hollow inner needle 30 to form needle assembly 10 may result in a stiffer, stronger needle, and less flexibility when used together. As described below, rigidity and strength are necessary for insertion (during laparoscopic or ultrasound guided procedures) into the pelvic cavity and follicles of a subject.

Possible needle designs that can be used for the hollow inner needle 30 may have the following dimensions:

it should be understood that outer cannula 20 and hollow inner needle 30 may have different gauges than described above, so long as hollow inner needle 30 is slidably disposed within outer cannula 20.

In an alternative embodiment of needle assembly 10, hollow inner needle 30 is formed from a superelastic alloy. That is, the entire hollow inner needle 30 is formed of a single material such as nitinol. In this embodiment, a connecting process of connecting the distal end 32 to the distal end region 33 and the distal end region 33 to the shaft portion 36 is not required, so that the manufacturing time of the hollow inner needle 30 can be reduced.

In an alternative embodiment of needle assembly 10, distal region 33 and distal end 32 of hollow inner needle 30 are formed from a superelastic alloy, such as nitinol. In this embodiment, the super-elastic alloy forming the distal region 33 of the hollow inner needle 30 can be welded or connected to the shaft portion 36 of the hollow inner needle 30 that slides within the outer sleeve 20. In this embodiment, the stem portion 36 may be formed of stainless steel. The superelastic alloy forming the distal end 32 of the hollow inner needle 30 is then machined to produce the sharp bevel 34 as desired.

In another alternative embodiment, the distal end region 33 of the hollow inner needle 30 is formed from a super-elastic alloy, such as nitinol. In this embodiment, the shaft portion 36 and distal end 32 of the hollow inner needle 30 may be formed of stainless steel, with only the distal region 33 of the hollow inner needle 30 being formed of a superelastic alloy (e.g., nitinol). It will be appreciated that in this embodiment, a connection process will be required to connect the distal end 32 to the distal end region 33 and the distal end region 33 to the stem portion 36.

Distal region of hollow inner needle

As briefly mentioned above, the distal end region 33 of the hollow inner needle 30 may be made of:

superelastic alloys, such as nickel titanium alloys;

a thermoplastic polymer;

a coil spring (covered with an elastic material);

an elastomer; or

Smart polymers (Flex-2 future research project).

When the distal end region 33 of the hollow inner needle 30 is retracted inside the outer cannula 20, it has to be straightened out, but when the distal end region 33 of the hollow inner needle 30 is extended from the distal end 22 of the outer cannula 20, it has to be bent back and define the bend 35. Based on a simplified tube bending mechanism, the minimum radius of curvature (R) that can be elastically maintained is given by:

R＝r/εγ

where r is the radius of the inner needle and ε γ is the material yield strain of the material forming the distal region 33 of the hollow inner needle 30.

The following table gives an example of the minimum needle curvature for a 16g needle (r ═ 0.66 mm):

when considering the selection of suitable materials for hollow inner needle 30 and outer cannula 20, the following design considerations must be taken into account. The hollow inner needle 30 must maintain sufficient bending stiffness when moved to the extended position to allow for the pressure applied by the operator. The orientation of hollow inner needle 30 and outer cannula 20 of needle assembly 10 must be controlled so that sharp bevel 23 of outer cannula 20 and sharp bevel 34 of hollow inner needle 30 remain substantially aligned when hollow inner needle 30 is in the retracted position. Needle assembly 10 should have increased bending stiffness when hollow inner needle 30 is in the retracted position, as compared to outer cannula 20 itself.

Superelastic alloys such as nitinol can be reversibly strained to 10% so that they will be considered suitable for use as the distal end region 33 of the hollow inner needle 30.

Final approval of the pre-curved superelastic alloy forming the distal end region 33 of the hollow inner needle 30 requires consideration of the following factors:

the bending stiffness of the distal region 33 when the hollow inner needle 30 is in the extended position;

resistance to buckling of the distal region 33 when the hollow inner needle 30 is in the retracted position.

Most polymers are able to withstand strains of 4% or more without buckling. As a preliminary proof of concept, the polymer tube has been heat set into a pre-curved shape and has been shown to be reversibly extendable and retractable from a 15g needle. Three different polymer tubes of different compositions and diameters were tried. The pre-bending radius range is 6 mm-20 mm.

Final considerations for the pre-bent polymer forming the distal region 33 of the hollow inner needle 30 will include:

long term performance, ensuring that the curvature is not lost during storage when the distal end region 33 remains straight in the outer cannula 20 when the hollow inner needle 30 is in the retracted position;

the bending stiffness of the distal region 33 when the hollow inner needle 30 is in the extended position;

resistance to buckling of the distal region 33 when the hollow inner needle 30 is in the retracted position; and

a method of connecting the polymer tube forming the distal region 33 to the shaft 36 of the hollow inner needle 30, which hollow inner needle 30 may be formed from a stainless steel tube.

An elastomeric tube can be used for the distal region 33, which is molded to define the bend 35, and then reversibly straightened and re-bent by moving the hollow inner needle 30 between the retracted and extended positions. The main problems of forming elastomeric tubes of the distal region 33 include:

supporting sufficient bending stiffness when the hollow inner needle 30 is in the extended position; and

friction with outer cannula 20 causes difficulty in moving hollow inner needle 30 between the retracted position and the extended position.

The coil spring can be heat set into a pre-bent shape, and a bendable tube having high elasticity can be formed by covering the spring with an elastomeric material that can be used for the distal end region 33 of the hollow inner needle 30. Fig. 19 shows an uncovered coil spring that has been heat set into a curved shape.

The amount of lateral bending must also be considered in view of the precise nature of inserting the distal end 32 of the hollow inner needle 30 into an egg. The distal end 32 of the hollow inner needle 30 should ideally enter the ovum at the equatorial plane (equator).

In an alternative embodiment, the distal end of distal region 33 integrally includes distal end 32 with a sharp bevel 34. That is, rather than connecting distal end 32 with sharp bevel 34 to distal end region 33, sharp bevel 34 is interrupted with distal end region 33.

Details of manufacture of hollow inner needle

The following are general manufacturing methods that can be used to manufacture hollow inner needle 30, including the selection of design variations. All designs are based on the use of nitinol to form the distal end region 33 of the hollow inner needle 30.

Nitinol is an alloy consisting of approximately equal components of nickel and titanium that can be drawn into a thin wire or tube. The essential property of nitinol for this invention is "superelasticity," which allows it to be highly deformed (stretched, bent, twisted) and to have sufficient recovery capacity.

At least three designs that can achieve the desired function of the hollow inner needle 30:

the entire hollow inner needle 30 made of nitinol;

a stainless steel needle forming shaft portion 36, a nickel titanium alloy forming distal region 33 and distal end 32;

stainless steel forms the shaft portion 36 and distal end 32, and nitinol forms the distal region 33.

The whole nickel-titanium alloy inner needle:

in this case, since the entire hollow inner needle 30 is nitinol, a coupling process of coupling the distal end region 33 to the shaft portion 36 and the distal end 32 is not required. The sharp bevel 34 can be formed by cutting the nitinol forming the distal end 32.

Stainless steel + tip with nitinol flexibility:

as described above, the nitinol section can be welded or connected to the stainless steel shaft 36. The nitinol section is then machined to the desired distal end 32 with a sharp bevel 34. This can be achieved by conventional machining methods, but the invention may be more suitable for non-conventional machining methods such as laser cutting.

Stainless steel rod and tip + nickel titanium alloy flexibility:

this design enables the use of an existing stainless steel needle to provide the shaft portion 36 and distal end 32 with a sharp bevel 34. The nitinol section (distal region 33) can then be connected at one end to the shaft 36 and at the other end to the distal end 32 to form the hollow inner needle 30. The nitinol distal region 33 can be connected to stainless steel using methods such as welding, as is commonly used for making other medical devices using nitinol. A typical solder alloy for use with nitinol has a composition of 96.5% Sn 3.5% Ag and a melting temperature of 221 ℃. Other joining methods may also be used to join the nitinol to stainless steel, and include welding, use of epoxy or adhesive, or mechanical methods known in the art. Depending on the method used, some finishing process may be required to make the seam burr or blemish free.

Turning now to the fabrication process of the other components, the hollow inner needle 30 may have a radiopaque tip for visualization under X-ray or ultrasound. For designs in which distal end 32 is formed of stainless steel, distal end 32 can be derived from an existing satisfactory needle. For both designs where the distal end 32 is formed of a nickel titanium alloy, the nickel titanium alloy has similar radiopaque properties as stainless steel, which may be sufficient to be identified using ultrasound or X-ray. However, the visibility of distal end 32 can depend on the final geometry of distal end 32 and the application environment. If enhanced radiopacity is desired, the distal end 32 can be coated with gold or other radiopaque material or use an alloying element such as platinum. These materials are commonly used with stents made of nitinol.

Once the hollow inner needle 30 is manufactured, the hollow inner needle 30 will then need to be "trained" into the desired curved shape to ensure that the curve 35 defined by the distal region 33 will be predictable in a unidirectional direction when the hollow inner needle 30 is in the extended position. To perform this training, the assembled hollow inner needle 30 may be placed in a forming jig that holds the hollow inner needle 30 in a desired shape. The exact temperature and time of this last step may vary depending on the composition and final geometry of the hollow inner needle 30, however, in medical devices it is conventional practice to hold the device at 500 ℃ for about 15-20 minutes before cooling it in a forming jig for several hours. Because other processing methods may alter the heat treatment of the nickel titanium alloy, the "training" or heat setting of the desired shape of the bend 35 defined by the distal region 33 should be the final step when manufacturing the hollow inner needle 30. The heating step is most commonly carried out using an oven, but can also be accomplished using joule heating.

Once the "training" or heat setting process is complete, needle assembly 10, including outer cannula 20 and hollow inner needle 30, may be assembled, with hollow inner needle 30 inserted into outer cannula 20 and connected to any desired tubing 70.

Controller

Referring to fig. 20-23, needle assembly 10 includes a controller 40 to move hollow inner needle 30 between a retracted position and an extended position. Controller 40 has a first portion 41 connected to outer cannula 20 and a second portion 42 connected to hollow inner needle 30. The second portion 42a is slidable within the first portion 41 a.

The first portion includes a first slot 43 having a closed end 44 and a second slot 45 having a closed end 46. Second portion 42 includes a flange 47 having a distal end 48. The flange 47 is configured to be received in either the first slot 43 or the second slot 45. The second portion 42 is connected to the hollow inner needle 30 such that the flange 47 and the bend 35 extend in the same direction when the hollow inner needle 30 is in the extended position. Thus, it will be appreciated that the flange 47 indicates to the operator the direction in which the distal region 33 of the hollow inner needle 30 will bend to define the bend 35.

Fig. 20 and 21 show the flange 47, the flange 47 being received in the first slot 43 such that the distal end 48 of the flange 47 abuts the closed end 44 of the first slot 43. When flange 47 is in this position, hollow inner needle 30 is in the retracted position, and sharp bevel 23 of outer cannula 20 and sharp bevel 34 of hollow inner needle 30 are aligned and form bevel 13 for passage through the vaginal wall of the subject and into the ovary. The retracted position will also be used to withdraw the needle assembly 10 from the subject.

Fig. 22 shows the flange 47, the flange 47 being received in the second slot 45 such that a distal end 48 of the flange 47 abuts the closed end 46 of the second slot 45. When the flange 47 is in this position, the hollow inner needle 30 is in the extended position.

Moving the hollow inner needle 30 from the retracted position to the extended position comprises:

proximally retracting the hollow inner needle 30 and removing the flange 47 from the first slot 43;

inserting the distal end 48 of the flange 47 into the second slot 45; and

the hollow inner needle 30 is advanced distally such that the flange 47 slides within the second slot 45 until the distal end 48 of the flange 47 abuts the closed end 46 of the second slot 45.

It will be appreciated that for certain applications, the hollow inner needle 30 need not be advanced until the distal end 48 of the flange 47 abuts the closed end 46 of the second slot 45, but rather the hollow inner needle 30 can be advanced such that the distal end 48 of the flange 47 is placed anywhere along the second slot 45.

Moving the hollow inner needle 30 from the extended position to the retracted position comprises:

proximally retracting the hollow inner needle 30 and removing the flange 47 from the second slot 45;

inserting the distal end 48 of the flange 47 into the first slot 43; and

the hollow inner needle 30 is advanced distally such that the flange 47 slides within the first slot 43 until the distal end 48 of the flange 47 abuts the closed end 44 of the first slot 43.

The controller 40 is configured to maintain the hollow inner needle 30 in a retracted position or an extended position. When the flange 47 is received in the first slot 43 or the second slot 45 and/or slides in the first slot 43 or the second slot 45, the controller 40 limits the hollow inner needle 30 from rotating within the outer cannula 20.

Fig. 24 and 25 show another control 40a that can be used to move the hollow inner needle 30 between the retracted position and the extended position. Controller 40a has a first portion 41a to be connected to outer cannula 20 and a second portion 42a to be connected to hollow inner needle 30.

The first portion 41a has a pinion 43a and the second portion 42a has a rack 44 a. The rack 44a and the pinion 43a are operatively associated such that the second portion 42a is linearly moved by rotating the pinion 43 a. The pinion 43a rotates in a plane aligned with the plane in which the curved portion 35 extends when the hollow inner needle 30 is in the extended position. Thus, it will be appreciated that the pinion gear 43a indicates to the operator the direction in which the distal region 33 of the hollow inner needle 30 will bend to define the bend 35. It should also be appreciated that the interaction of the rack 44a and pinion 43a limits the rotation of the hollow inner needle 30 within the outer cannula 20.

Fig. 24 shows the position of the second portion 42a relative to the first portion 41a when the hollow inner needle 30 is to be in the retracted position. Fig. 25 shows the position of the second portion 42a relative to the first portion 41a when the hollow inner needle 30 is to be in the extended position. When hollow inner needle 30 is in the retracted position, sharp bevel 23 of outer cannula 20 and sharp bevel 34 of hollow inner needle 30 will align and form bevel 13 for insertion into the ovary through the vaginal wall of the subject. The retracted position will also be used to withdraw the needle assembly 10 from the subject.

It should be understood that other suitable mechanisms can be used as a controller for needle assembly 10, so long as the controller meets the following requirements:

when hollow inner needle 30 is in the retracted position, the controller aligns sharp bevel 23 of outer cannula 20 with sharp bevel 34 of hollow inner needle 30;

the controller limits rotation of the hollow inner needle 30 within the outer cannula 20 when the hollow inner needle 30 is in the retracted position or the extended position; or

The control allows the hollow inner needle 30 to move between a retracted position and an extended position.

Examples of other suitable mechanisms that can be used for the controls of needle assembly 10 include a sliding mechanism or a twisting mechanism, among others.

Pipe system

In an embodiment, tubing 70 is connected in fluid communication to hollow inner needle 30. Tubing 70 provides access from the needle assembly to a container (not shown), such as a test tube, for retrieval of the ovum. Tubing 70 is connected in fluid communication with a negative pressure pump (not shown) to withdraw eggs from within the follicles. Tubing 70 may be standard medical tubing made from medical silicone tubing. The tubing 70 may in turn be connected to a Luer lock fitting, which in turn may be connected to another tubing 70 connected to a negative pressure pump or other suitable vacuum source. The Luer lock may provide the flushing function of the needle assembly 10.

Plug valve

Needle assembly 10 may also include a stopcock valve 50. The stopcock valve 50 is in fluid communication with the hollow inner needle 30, a container for storing an egg, and a negative pressure pump or other suitable vacuum source. The stopcock 50 is movable between a first configuration and a second configuration. In the first configuration, the hollow inner needle 30 is in fluid communication with the reservoir and the negative pressure pump. The first configuration of the stopcock 50 is used to capture and deposit eggs into containers. In the second configuration, the hollow inner needle 30 is in fluid communication with an irrigation fluid to irrigate the hollow inner needle 30. Thus, the stopcock valve 50 allows the hollow inner needle 30 to be flushed and then withdrawn into the container, which may be suitable for patients with low oocytes or difficult oocyte collection. The container may be a standard test tube used in medical laboratories. The stopcock 50 allows the needle assembly 10 to be used as an irrigation needle, thereby adding versatility to the needle assembly 10.

Negative pressure pump

Needle assembly 10 is configured to have minimal clearance between hollow inner needle 30 and outer cannula 20. The hollow inner needle 30 is connected in fluid communication to a negative pressure pump or other suitable vacuum source that is activated and creates a negative pressure in the hollow inner needle 30 once the needle assembly 10 pierces a follicle and removes an ovum. The negative pressure generated in the hollow inner needle 30 by the negative pressure pump causes the ovum to be drawn out of the inside of the follicle through the hollow inner needle 30. These extracted eggs can then be deposited and stored in a container (not shown).

The negative pressure pump may be an off-the-shelf component, such as London pocket at 240V,30W,50 Hz. The negative pressure pump operates at about 102mm Hg (-13.6 kPa) to 120mm Hg (-16 kPa). Pressures of up to 200mmHg may be required if the tubing 70 or needle assembly 10 becomes occluded. The approximate diameter of a human oocyte is 0.1mm to 0.2mm, with cumulus cells (ribbons) surrounding the oocyte, and the diameter of the entire cell mass can be as high as 10mm (Aziz et al, 1993). Thus, the thinner the inner diameter of the hollow inner needle 30, the greater the risk of damaging the oocyte when it is passed through the needle assembly 10. Thus, the use of a thinner needle for the hollow inner needle 30 increases the risk of damaging the oocyte, thereby reducing the likelihood of successful pregnancy resulting from the IVF procedure. In addition, the smaller inner diameter of hollow inner needle 30 requires a negative pressure pump to create a greater negative pressure in needle assembly 10. Accordingly, the standard minimum operating needle size of the hollow inner needle 30 may be 22 g.

Ovum acquisition system

FIG. 26 illustrates an egg retrieval system including the needle assembly 10; stopcock valve 50 connected in fluid communication to proximal end 12 of needle assembly 10 by tubing 70 a; a stopper 60 sealing a container (not shown) for collecting and storing the harvested eggs; stopcock valve 50 is in fluid communication with the container via plug 60 through tubing 70 b; and a negative pressure pump in fluid communication with the container via the plug 60 through the tubing 70 c.

Accordingly, it should be understood that the negative pressure pump is in fluid communication with the container, stopcock 50 and needle assembly 10. As described above, the plug valve 50 is movable between the first configuration and the second configuration.

External member

Needle assembly 10 may be provided as a kit. Such kits may include one or more of the following:

the assembled needle assembly 10;

controls 40, 40a mounted on needle assembly 10;

a plug valve 50;

a container for storing the harvested eggs;

tubing 70 connecting needle assembly 10 in fluid communication with the container, stopcock valve 50 and/or negative pressure pump;

a medical disinfecting sheet;

a lubricant;

a syringe capable of functioning as a negative pressure pump for obtaining a human ovum through needle assembly 10; and/or

A tissue.

Method

One method of obtaining a human ovum using needle assembly 10 is described below:

a) with the hollow inner needle 30 in the retracted position, the needle assembly 10 is inserted into the vaginal wall of the subject and into the ovary;

b) placing the distal end 11 of the needle assembly 10 adjacent an egg;

c) fluidly connecting proximal end 31 of hollow inner needle 30 to a vacuum source;

d) generating a negative pressure in the hollow inner needle 30 using a vacuum source;

e) the ovum is taken out through the hollow inner needle 30; and

f) with hollow inner needle 30 in the retracted position, needle assembly 10 is removed from the subject.

Another method of obtaining a human egg using needle assembly 10 is described below:

a) with the hollow inner needle 30 in the retracted position, the needle assembly 10 is inserted into the vaginal wall of the subject and into the ovary;

b) moving the hollow inner needle to the extended position such that the distal end 32 of the hollow inner needle 30 is adjacent the ovum;

c) fluidly connecting proximal end 31 of hollow inner needle 30 to a vacuum source;

d) generating a negative pressure in the hollow inner needle 30 using a vacuum source;

e) the ovum is taken out through the hollow inner needle 30;

f) moving the hollow inner needle 30 to the retracted position; and

g) with hollow inner needle 30 in the retracted position, needle assembly 10 is removed from the subject.

Another method of obtaining a plurality of human ova using needle assembly 10 is described below:

a) with the hollow inner needle 30 in the retracted position, the needle assembly 10 is inserted into the vaginal wall of the subject and into the ovary;

b) moving the hollow inner needle to the extended position such that the distal end 32 of the hollow inner needle 30 is adjacent the ovum;

c) fluidly connecting proximal end 31 of hollow inner needle 30 to a vacuum source;

d) generating a negative pressure in the hollow inner needle 30 using a vacuum source;

e) the ovum is taken out through the hollow inner needle 30;

f) moving the hollow inner needle 30 to the retracted position;

g) rotating and/or repositioning needle assembly 10 within the subject;

h) moving the hollow inner needle to the extended position such that the distal end 32 of the hollow inner needle 30 is adjacent the ovum;

i) generating a negative pressure in the hollow inner needle 30 using a vacuum source;

j) another ovum is taken out through the hollow inner needle 30;

k) repeating steps f through j if necessary;

l) moving the hollow inner needle 30 to the retracted position; and

m) removing the needle assembly 10 from the subject with the hollow inner needle 30 in the retracted position.

Another method of obtaining a plurality of human ova using needle assembly 10 is described below:

a) with the hollow inner needle 30 in the retracted position, the needle assembly 10 is inserted into the vaginal wall of the subject and into the ovary;

b) placing the distal end 11 of the needle assembly 10 adjacent an egg;

c) fluidly connecting proximal end 31 of hollow inner needle 30 to a vacuum source;

d) generating a negative pressure in the hollow inner needle 30 using a vacuum source;

e) the ovum is taken out through the hollow inner needle 30;

f) rotating and/or repositioning needle assembly 10 within the subject; .

g) Moving the hollow inner needle to the extended position such that the distal end 32 of the hollow inner needle 30 is adjacent to another ovum;

h) generating a negative pressure in the hollow inner needle 30 using a vacuum source;

i) another ovum is taken out through the hollow inner needle 30;

j) repeating steps b to i if necessary;

k) moving the hollow inner needle 30 to the retracted position; and

l) removing the needle assembly 10 from the subject with the hollow inner needle 30 in the retracted position.

Thus, it should be appreciated that needle assembly 10 allows needle assembly 10 to remove multiple eggs from a single entry into a subject.

All needles required to collect multiple ovarian follicles should have a single entry at the ovarian equatorial plane (equator). That is, a single entry through the vaginal wall may be all that is required to remove multiple eggs. The hollow inner needle 30 may extend after initial insertion through the vaginal wall and reach another ovum.

In use, the process of using needle assembly 10 may be more comfortable for the subject since most of the pain comes from the needle entering the vagina and entering the ovarian wall, which may be reduced by using needle assembly 10.

In use, the needle assembly 10 may collect eggs more quickly and reduce procedure time.

The use of needle assembly 10 may reduce potential complications from bleeding, which is typically bleeding from the vaginal entry point or bleeding from the ovarian entry.

Use of needle assembly 10 may reduce the amount of anesthetic or sedative used.

The distal end region 33 of the hollow inner needle 30 may allow reaching inaccessible follicles with less discomfort to the patient.

Force data

Insertion of the needle assembly 10 through the vaginal wall requires considerable loads and forces (which may cause the needle assembly 10 to bend or twist out of alignment), which is necessary for successful ovum retrieval. The ability of hollow inner needle 30 to extend from needle assembly 10 and still maintain its ability to penetrate into the ovary is a significant feature of hollow inner needle 30. In this regard, tests were conducted to determine the force required to puncture the follicle. To determine the appropriate wall thickness design criteria, flexibility of hollow inner needle 30, and appropriate material selection to minimize the fulcrum effect of opening the insertion point through the interior of the follicle, a sample of force and load data has been accumulated.

Sample ovum collection data analysis was performed by a series of experiments. The test is intended to determine the puncture force required to collect an egg using a standard straight needle. The summary is as follows.

Ovum Collection 1

Basic reading 1978mN

Puncture time (in video)	Maximum reading (mN)	Maximum force (mN)
			5:26	3705	1727
5:54	3022	1044
			7:47	2794	816
8:14	3728	1750

Ovum collection 2

Basic reading 2247mN

The most relevant forces reported are listed as "maximum force" in millinewtons (mN). The maximum force of both experiments was 5853 mN. The design of needle assembly 10 can allow a force tolerance of about 3 times this level, i.e., 20,000 mN.

At least two factors are considered in the design of needle assembly 10:

a) aligning sharp bevel 23 of outer cannula 20 with sharp bevel 34 of hollow inner needle 30 and forming bevel 13 of needle assembly 10; and

b) the hollow inner needle 30 is then pushed with the necessary force in order to puncture the follicle. Thus, as mentioned above, the force penetration requirement of the hollow inner needle 30 of 20,000mN is a factor of the material choice of the distal end region 33 of the hollow inner needle 30 and also represents a distinct point of the curved region on existing needles, which generally do not require penetration capability because penetration is performed by larger, stiffer needles, such as described in US 6,592,559.

Needle assembly 10 may allow a single inlet at the equatorial plane of the ovary to evacuate multiple follicles. That is, multiple eggs can be removed by a single entry of the vaginal wall, with the hollow inner needle 30 moving between a retracted position and an extended position to reach additional eggs after initial insertion through the vaginal wall. The bend 35 defined by the distal end region 33 of the hollow inner needle 30 is designed to be straightened when the hollow inner needle 30 is in the retracted position, but when the hollow inner needle 30 is moved to the extended position, the bend 35 maintains suitable stiffness and hardness characteristics so as to be extendable and insertable into a plurality of follicles.

The needle assembly 10 may have all the functions of current needles (e.g., those manufactured by Wallace), such as a coreless needle tip to minimize the risk of occlusion, echogenic marking to the most extreme needle tip for accurate placement under ultrasound guidance, a silicone plug that may be easily and safely mounted on a test tube when the needle assembly 10 is used with the hollow inner needle 30 in a retracted position, enabling continuous or intermittent flushing during oocyte retrieval, and a vacuum pump adapter.

Needle assembly 10 may provide a safer, simpler, and less painful method of oocyte retrieval that may improve IVF by allowing procedures to be performed outside of clinical and hospital settings with anesthetics. This can reduce costs and make IVF more accessible to patients worldwide. Safe, inexpensive IVF can greatly increase the number of IVF cycles worldwide.

Needle assembly 10 may be stiffer, thereby providing a more secure initial insertion of the vagina and ovary. By advancing the distal region 33 of the hollow inner needle 30, aspiration and retrieval of inaccessible follicles is allowed through the needle assembly 10. A single entry point may provide less pain and reduce the risk of bleeding in a subject. The use of needle assembly 10 can potentially reduce the amount of anesthetic required.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

List of reference numerals

10-needle assembly

11-distal end of needle assembly 10

12-proximal end of needle assembly 10

13-bevel of needle Assembly 10

20-outer sleeve

21-proximal end of outer cannula 20

22-distal end of outer cannula 20

23-sharp bevel of distal end 22 of outer cannula 20

30-hollow inner needle

31-proximal end of hollow inner needle 30

32-distal end of hollow inner needle 30

33-distal region of hollow inner needle 30

34-Sharp bevel of distal end 32 of hollow inner needle 30

35-bend part

36-hollow inner needle 30 shaft

40-controller

41-first part of controller 40

42-second part of controller 40

43-first slot of first portion 41 of controller 40

44-closed end of first slot 43

45-second slot of first portion 41 of controller 40

46-closed end of second slot

47-Flange of second portion 42 of controller 40

48-distal end of flange 47

40 a-controller

41 a-first part of controller 40a

42 a-second part of the controller 40a

43 a-pinion of the first part 41a of the controller 40a

44 a-rack of second portion 42a of controller 40a

50-plug valve

60-plug

70-piping system.