Arrangement for Transferring An Ovum From A Follicle

• US 20100081989A1
• Filed: 10/23/2009
• Published: 04/01/2010
• Est. Priority Date: 04/24/2007
• Status: Active Grant

• Current Assignee: Gynotec Co.
• Original Assignee: Gynotec Co.
• Inventors: Berbers, Josephus E.J.M.
• Granted Patent: US 8,696,615 B2
• Time in Patent Office: Days
• US Class Current: 604/44
• CPC Class Codes: A61B 17/435 for embryo or ova transplantation
• CPC Class Codes: Y10T 29/4987 Elastic joining of parts

Abstract

An apparatus for transferring an ovum from a follicle with a double lumen needle having at the distal needle end an aspiration lumen for removing an ovum from a follicle and a flushing lumen, the double lumen needle comprising an outer tube with an internally located inner tube that extends over at least part of the length of the outer tube, one of the lumens being bounded by the inner surface of the inner tube and the other of the two lumens by the space between the outer surface of the inner tube and the inner surface of the outer tube, and a connector having an outlet at a second connector end for discharging the flushing fluid with possibly an ovum to the exterior and having a channel means that connects the outlet with the aspiration lumen and a flushing inlet for supplying the flushing fluid, wherein the two fluid pathways within the connector and the double lumen needle are separated from each other, and the inner tube comprises a deformable material. The lumen of the inner tube is the aspiration lumen and the inner tube comprises a depressible portion that is depressible under the influence of a pressure difference between the aspiration lumen and the flushing lumen and the flushing lumen is the space between the interior surface of the outer tube and the exterior surface of the depressible portion.

Claims

1. An apparatus for transferring an ovum from a follicle with a technique of simultaneous flushing and aspiration, which apparatus comprises:

a double lumen needle having at the distal needle end to be inserted into the follicle an aspiration lumen for removing an ovum from a follicle and a flushing lumen for inserting a flushing fluid into the follicle,

the double lumen needle comprising an outer tube with an internally located inner tube that extends over at least part of the length of the outer tube,

one of the lumens being bounded by the inner surface of the inner tube and the other of the two lumens by the space between the outer surface of the inner tube and the inner surface of the outer tube, and

a connector having a connector body which at a first distal connector end is connected to the proximal needle end remote from the distal needle end, having an outlet at a second connector end for discharging the flushing fluid with possibly an ovum to the exterior and having a channel means that connects the outlet with the aspiration lumen and defines a first fluid pathway for aspirating an ovum and having a flushing inlet between the two ends of the connector body for supplying the flushing fluid and, in fluid communication with the flushing lumen, for defining a second fluid pathway for flushing a follicle,

wherein the two fluid pathways within the connector and the double lumen needle are separated from each other, and

wherein the inner tube comprises a deformable material, and wherein;

the lumen of the inner tube is the aspiration lumen of the double lumen needle,

viewed in cross section, the inner tube comprises at least over part of its circumference a depressible part that is depressible as a result of a pressure difference which occurs during normal use between the aspiration lumen and the flushing lumen, and

the flushing lumen, at least during flushing, consists of a space between the inner surface of the outer tube and the outer surface of said depressible part of the inner tube.

2. An apparatus according to claim 1, wherein the outside diameter of the inner tube in the non-depressed state is substantially the same as the inside diameter of the outer tube.

3. An apparatus according to claim 1, wherein the inner tube has a variable wall thickness where, viewed cross sectionally, a thicker portion is followed by a thinner portion, with said depressible part being provided at the thinner portion.

4. An apparatus according to claim 1, wherein the depressible part of the inner tube is manufactured in a different material than the remaining part of the inner tube.

5. An apparatus according to claim 1, wherein that the inner tube has an inner surface that is made of a biocompatible material.

6. An apparatus according to claim 5, wherein the entire inner tube is made of a biocompatible plastic.

7. An apparatus according to claim 1, wherein the inner tube is manufactured by means of coextrusion, in two different plastic materials.

8. An apparatus according to claim 1, wherein the depressible part is visibly distinguishable from the remaining part of the inner tube.

9. An apparatus according to claim 1, wherein the entire inner tube is made of elastic material and the depressible part is elastically deformable.

10. An apparatus according to claim 9, wherein

the inner tube consists of a material that can be elastically stretched in the axial direction such as to simultaneously elastically reduce the outside diameter to a reduced outside diameter that is smaller than the inside diameter of the outer tube, and

the inner tube, exerts an elastic radial pressure on the interior surface of the outer tube.

11. A method for the manufacture of an apparatus in accordance with claim 10, wherein the method comprises the steps of:

providing an outer tube,

providing an inner tube made of elastic material, whose outside diameter in the axially non-depressed state is larger than the inside diameter of the outer tube,

applying opposing axial forces to the opposite ends of the inner tube to axially stretch the inner tube, causing the simultaneous radial reduction of the outside diameter to a stretched condition where the reduced outside diameter of the inner tube is smaller than the inside diameter of the outer tube, and

in said stretched condition fitting the inner tube into the outer tube and cancelling said axial forces, allowing the simultaneous radial expansion of the inner tube and causing the inner tube to radially jam inside the outer tube.

12. An apparatus according to claim 1, wherein

the connector is provided around the outer tube by injection moulding,

the outer tube is provided inside the connector with a through opening in the wall near the flushing lumen and, while being outwardly hermetically sealed, is in fluid communication with a flushing inlet extending to the outside of the connector.

13. An apparatus according to claim 12, wherein

the inner tube consist of elastic material and is at the distal end elastically folded back over a particular foldback length L over the outside of the proximal end of the outer tube,

over the foldback portion of the inner tube at the outside over a particular application length (A), a distal end of a flexible aspiration tube having an aspiration lumen is provided, such that at least part of the foldback portion of the inner tube is located at said application length (A) between the exterior wall of the proximal end of the outer tube and the interior wall of the distal end of the flexible aspiration tube,

the proximal end of the outer tube extends over an axial portion (B), which is shorter than said folded back length (L) of the foldback portion of the inner tube to beyond the connector, such that a portion (C) of the foldback portion is inside the connector, and

the distal end of the flexible aspiration tube is provided over an injected portion (D) inside the connector, where it provides an outwardly hermetically sealed fluid connection between the aspiration lumen of the inner tube and the aspiration lumen of the flexible aspiration tube.

14. A method for the manufacture of the apparatus in accordance with claim 13, wherein the method comprises the steps of:

providing a flexible aspiration tube having an aspiration lumen for connecting to a double lumen needle of the apparatus according to the invention,

at its proximal end elastically folding back a portion of the inner tube made of elastic material over a certain folded back length (L) over the outside of the proximal end of the outer tube,

providing over the foldback portion of the inner tube at the outside over a particular application length (A) a distal end of a flexible aspiration tube having an aspiration lumen, such that at least part of the foldback portion (L) of the inner tube is located at said application length (A) between the exterior wall of the proximal end of the outer tube and the interior wall of the distal end of the flexible aspiration tube,

placing the proximal end of the outer tube, the proximal end of the inner tube and the distal end of the flexible aspiration tube into an injection mould having a mould cavity for forming the connector by injection moulding, wherein the proximal end of the outer tube extends over an axial portion (B) that is shorter than said folded back length (L) of the foldback portion of the inner tube to beyond the mould cavity, such that a portion (C) of said folded back length (L) of the inner tube is inside the mould cavity, and

injecting liquid plastic into the mould cavity, and after curing the injected plastic, removing the apparatus with the injected connector from the mould cavity,

such that the distal end of the flexible aspiration tube is positioned over an injected portion (D) inside the connector providing an outwardly hermetically sealed fluid connection between the aspiration lumen of the inner tube and the aspiration lumen of the flexible aspiration tube.

15. The method of claim 14, wherein the method additionally comprises the steps of:

providing a through opening in the wall of the outer tube, located some distance from the proximal end of the double lumen needle and inside the connector to be formed,

placing an axially movable pin against the outer tube into the mould cavity at the through opening so as to substantially form a seal to liquid plastic, and

after curing the injected plastic, axially withdrawing said pin, whereby from the outside of the connector a flushing inlet is formed which, via the through opening through the outer tube, is in fluid communication with the flushing lumen of the apparatus.