BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diagram showing an embodiment of a device of the present invention.
FIG. 2 is a diagram showing a branch indwelling needle in the device of FIG. 1.
FIG. 3 is a diagram showing a cord tissue holder in the device of FIG. 1.
FIG. 4 is a diagram showing a puncture of a cord using the device of FIG. 1.
FIG. 5 is a diagram showing that the angle can be changed in the device of FIG. 1.
FIG. 6 is a diagram showing a modification of the branch indwelling needle of FIG. 2.
FIG. 7 is a diagram showing another embodiment different from the device of FIG. 1.
FIG. 8 is a diagram showing a branch indwelling needle in the device of FIG. 7.
FIG. 9 is a diagram showing a cord tissue holder in the device of FIG. 7.
FIG. 10 is a diagram showing that the angle can be changed in the device of FIG. 7.
FIG. 11 is a diagram showing still another embodiment different from the devices of FIGS. 1 and 7.
FIG. 12 is a diagram showing an embodiment further including a blood bag in the device of FIG. 1.
1 branch indwelling needle
2 cord tissue holder
3 connecting means
4 blood bag
5 tube
11 distal end side
12 proximal end side
13 inner needle
14 liquid outflow tube portion
21 holding portion
22 base portion
23 connection aid
61 communication piece
62 liquid flow control means
111 outer cylinder needle
121 inner needle drawing tube portion
311 cylindrical body
312 grasping portion
313 groove
321 spherical body
322 grasping body
331 stepwise angle changing means
X cord
DETAILED DESCRIPTION OF THE INVENTION
The present invention will be described inbelow with reference to the accompanying drawings.
FIG. 1 is a schematic diagram of the cord blood correcting device of the present invention. The cord blood correcting device of the present invention includes a branch indwelling needle 1, a cord tissue holder 2, and angle changing means 3. The cord tissue holder 2 is connected to the branch indwelling needle 1.
FIG. 2 shows the details of the branch indwelling needle 1 shown in FIG. 1. The branch indwelling needle 1 of the present invention is a device constituted such that a tissue is punctured with a metal inner needle and then a plastic outer cylinder needle is left in the blood vessel of the cord by pulling out the metal inner needle. Specifically, the branch indwelling needle 1 includes an outer cylinder needle 111 provided on the distal end side 11, an inner needle drawing tube portion 121 provided on the proximal end side 12, an inner needle 13 provided inside the inner needle drawing tube portion 121, and a liquid outflow tube portion 14 which branches off from the inner needle drawing tube portion 121. In the present invention, the direction (shown by an arrow “a” in FIG. 2) from the proximal end side 12 to the distal end side 11 of the branch indwelling needle 1 is designated as a “puncture direction”,
The basic structure of the branch indwelling needle 1 is the same as that of a commercially available branch indwelling needle. The outer cylinder needle 111, the inner needle drawing tube portion 121, and the liquid outflow tube portion 14 are made of plastic, and the inner needle 13 is made of metal such as stainless steel, aluminum, aluminum alloy, titanium, or titanium alloy. The above plastic is preferably a soft resin having excellent biocompatibility, antibiotic properties, and flexibility, such as polyurethane or ethylene-polytetrafluoroethylene copolymer, but the present invention is not limited to these. Since the outer cylinder needle 111 is made of plastic, the blood vessel is not damaged by the blood correcting operation and precious cord blood does not spatter. A metal needle is commonly used in the technical field in which cord blood is corrected from a cord tissue, and a branch indwelling needle is not used in the general medical field. The inventors of the present invention have found a problem in that a metal needle penetrates or rips the blood vessel by an impulse from a blood flow or during blood correcting operation, and have solved this problem.
FIG. 3 shows an example of the details of the cord tissue holder 2 shown in FIG. 1. The cord tissue holder 2 of the present invention includes a base portion 21 which is directly or indirectly connected to the branch indwelling needle 1 and a holding portion 22 for holding a cord tissue. The cord tissue holder 2 is a device for holding the branch indwelling needle 1 in the cord tissue so that the branch indwelling needle 1 does not slip out from the cord tissue while the cord blood is corrected. The structure of the holding portion 22 of the cord tissue holder 2 is not particularly limited as long as it has holding force with which the branch indwelling needle 1 does not slip out from the cord tissue and the blood vessel of the cord is not crushed. Although the cord tissue may be sandwiched, grasped, bit or held, it is preferably sandwiched as shown in FIG. 3 from the viewpoints of easiness in manufacture and low costs. In the present invention, the direction (shown by an arrow “b” in FIG. 3) from the base portion 21 to the holding portion 22 which is parallel to a straight line having the shortest distance between the base portion 21 and the holding portion 22 of the cord tissue holder 2 is designated as a “holding direction”.
The branch indwelling needle 1 and the cord tissue holder 2 are interconnected by connecting means 3. For instance, connection is effected by engaging the cylindrical body 311 of the branch indwelling needle 1 shown in FIG. 2 with a grasping portion 312 provided in the base portion 21 of the cord tissue holder 2 shown in FIG. 3. The structure of the connecting means 3 is such that connection is effected directly by engagement, fitting, welding, sandwiching, holding, biting, or grasping between the member of the branch indwelling needle 1 and the member of the cord tissue holder 2, or indirectly by means of a member for interconnecting the branch indwelling needle 1 and the cord tissue holder 2. The structure of the connecting means is not particularly limited since it can be suitably designed by the person skilled in the art.
For example, FIGS. 7 to 9 show a modifications which are different from the connecting means 3 shown in FIGS. 1 to 3 in structure. The branch indwelling needle 1 of FIG. 8 has a spherical body 321 on the side wall of the inner needle drawing tube portion 121. Meanwhile, the cord tissue holder 2 of FIG. 9 includes a grasping body 322 which has a structure for grasping the spherical body 321, and the branch indwelling needle 1 and the cord tissue holder 2 are interconnected by allowing the grasping body 322 to be held in the spherical body 321 of the branch indwelling needle 1.
Further, as shown in FIG. 11, there is a modification which further includes a connection aid 33 for indirectly interconnecting the branch indwelling needle 1 and the cord tissue holder 2.
The connecting means 3 may be provided on the proximal end side 12 or the liquid outflow tube portion 14 of the branch indwelling needle 1 and/or any position on the cord tissue holder 2. It is preferably provided on the proximal end side 12 of the branch indwelling needle 1 as it is easy to puncture the cord tissue, or on the base portion 22 of the cord tissue holder 2 as it is easy to hold the cord tissue. The cord tissue holder 2 may be detachable from the branch indwelling needle 1.
The connecting means 3 has a structure for changing the angle between the branch indwelling needle 1 and the cord tissue holder 2. Specifically, it has a structure for changing the angle between the puncture direction and the holding direction as well as the direction of puncturing the cord tissue with the branch indwelling needle 1. With this structure, after the insertion and indwelling of the outer cylinder needle 111 in the blood vessel of the cord, the outer cylinder needle 111 is fixed to the cord by using the cord tissue holder 2 on the puncture direction “a” side as shown in FIG. 4-1. After that, the branch indwelling needle 1 is turned 180° by the connecting means 3 to change its direction as shown in FIG. 4-2. Accordingly, the outer cylinder needle 111 is inserted deep into the blood vessel of the cord by a distance C, with the result that the leakage of the cord blood from the base portion of the outer cylinder needle 111 can be prevented. When the outer cylinder needle 111 becomes thicker from its end toward its base, it has a larger effect of preventing the leakage of the cord blood. If the side wall of the blood vessel of the cord tissue blocks the mouth portion of the outer cylinder needle 111 of the branch indwelling needle 1, the cord blood can be corrected more efficiently by changing the puncture direction into the cord tissue by means of the connecting means 3.
For example, the cylindrical body 311 may be provided at an angle from the puncture direction like the branch indwelling needle 1 shown in FIG. 2. The cylindrical body 311 can change the angle between the puncture direction “a” and the holding direction “b” by turning the branch indwelling needle 1 while it engages with the grasping portion 312 of the cord tissue holder 2 shown in FIG. 3 (FIG. 5). The angle between the puncture direction “a” and the holding direction “b” is fixed by friction resistance between the cylindrical body 311 and the grasping portion 312 as long as artificial force is not applied. This makes possible the stable correcting of the cord blood. Although the angle of the cylindrical body 311 is not particularly limited, it is about 5 to 45°, preferably about 10 to 30° from the viewpoint of the easiness in manufacture of the cylindrical body 311. That is, when the angle of the cylindrical body is 50, the angle between the puncture direction and the holding direction becomes 80 to 95°. When the angle of the cylindrical body is 300, the angle between the puncture direction and the holding direction becomes 60 to 120°. When the angle of the cylindrical body is 45°, the angle between the puncture direction and the holding direction becomes 45 to 135°.
Changing the angle between the puncture direction and the holding direction by means of a groove 313 shown in FIG. 6 and not by means of the cylindrical body 311 shown in FIG. 2 could have been easily realized by the person skilled in the art.
Further, in the structure of the connecting means 3 shown in FIGS. 7 to 9, the angle between the puncture direction and the holding direction can be changed by engaging the spherical body 321 of the branch indwelling needle 1 shown in FIG. 8 with the grasping body 322 of the cord tissue holder 2 shown in FIG. 9 (FIG. 10). The angle between the puncture direction and the holding direction is fixed by friction resistance between the spherical body 321 and the grasping body 322 as long as artificial force is not applied. This makes possible the stable correcting of the cord blood.
In addition, in the structure of the connecting means 3 shown in FIG. 11, the angle between the puncture direction and the holding direction can be changed by a stepwise angle changing structure 331 provided in the connection aid 33. The angle between the puncture direction and the holding direction is fixed by the stepwise angle changing means 331 as long as artificial force is not applied. This makes possible the stable correcting of the cord blood.
Preferably, the cord blood correcting device of the present invention further includes a blood bag 4 as shown in FIG. 12. The blood bag 4 is connected to the liquid outflow tube portion 14 of the branch indwelling needle 1 in advance. Therefore, after the cord tissue is punctured, cord blood can be introduced into the blood bag aseptically. The term “connection” in the present invention means internal communication, generally, connection by means of a tube 5. The tube 5 may be made of the same material as that of a general-purpose medical tube, for example, a polyvinyl chloride tube. The material of the blood bag may be the same as that of a known blood bag, such as polyethylene or polyvinyl chloride. The capacity of the above blood bag 4 is about 100 to 400 ml, preferably about 150 to 250 ml when the following is taken into consideration: the amount of the corrected cord blood during the delivery of a premature baby is about 40 to 150 ml in the case of vaginal delivery; and a drug solution which will be described later is pre-stored in the blood bag 4 and mixed with the corrected cord blood.
Further, the above blood bag may contain a drug solution suitable for the preservation of the blood. Examples of the drug solution include whole blood preparation (Japan standard commodity classification No: 876341), erythrocyte preservative solution (also called “biological product standard blood preservative solution A”, Japan standard commodity classification No: 873339), and blood component preparation (Japan standard commodity classification No: 876342) which can be used discriminately according to its purpose. The amount of the drug solution is about 10 to 60 ml, preferably about 20 to 30 ml from the viewpoint of its influence upon the human body at the time of blood transfusion. The tube 5 may be provided with liquid flow control means 6 such as a communication piece and/or a clamp. Since these means related to the connection of the blood bag can be suitably designed by the person skilled in the art, they are not particularly limited.
EXAMPLE
The method of correcting cord blood with the cord blood correcting device shown in FIG. 12 of the present invention will be described hereinbelow. However, the present invention is not limited to this.
EXAMPLE 1
Correcting of Cord Blood
In this example, the approval of the ethical committee of an insurance medical care facility and substantial informed consent from the guardian of a patient are necessary. The term “informed consent” in the present invention means that a sufficient explanation of autologous cord blood transfusion treatment has been given to the guardian of a patient and a consent has been obtained through self-decision of the guardian with satisfaction. Thus an ethical problem has been solved.
(1) Two positions at the end on the corded baby side are clamped before the expulsion of a placenta after the delivery of a baby, and the section between them is cut to take out the baby. In the case of C-section, after the separation of the baby, the placenta is removed without damaging the blood capillary and is transferred to a kidney dish.
- (2) To suppress the risk of the bacterial infection of cord blood, the cord is cleaned with gauze impregnated with external antiseptic (Japan standard commodity classification No: 872612) from the end on the baby side toward the placenta side and then with clean dry gauze similarly.
- (3) The separated placenta and the separated cord are set so that the cord blood can be corrected by its drop. For example, a placenta holder as disclosed in JP 10-108869 A, JP 10-155809 A, JP 11-009576 A, and JP 11-033016 A is preferably used to hang the cord. However, the present invention is not limited to this.
- (4) The vein of the cord is punctured with the branch indwelling needle 1.
- (5) The inner needle 13 is pulled out.
- (6) The branch indwelling needle 1 is turned (by controlling the connecting means 3) to locate the cord tissue holder 2 on the distal end side.
- (7) The cord is fixed by the cord tissue holder 2.
- (8) The branch indwelling needle 1 is turned (by controlling the connecting means 3) to locate the cord tissue holder 2 on the proximal end side and the outer needle 111 is inserted deep into the blood vessel of the cord (blood leakage becomes unlikely to happen).
- (9) The communication piece 61 is bent to start blood correcting.
- (10) The branch indwelling needle 1 is turned (by controlling the connecting means 3) to adjust the angle and find a suitable puncture angle.
- (11) Liquid flow control means 62 is clamped to terminate blood correcting. When a placenta holding apparatus disclosed in JP 11-009576 A and JP 11-033016 A is used at this point, the blood remaining in the placenta can be visually observed with ease, which is convenient. When a dusky-red portion of the placenta is pressed, the cord blood can be corrected without waste.
Test Example 1
Comparison of Amount of Corrected Blood
Cord blood was corrected by using the cord blood correcting device of the present invention. Specifically,
- (1) two positions at the end on the corded baby side were clamped before the expulsion of a placenta after the delivery of a baby, and the section between them was cut to take out the baby. In the case of C-section, after the separation of the baby, the placenta was removed without damaging the blood capillary and was transferred to a kidney dish.
- (2) To suppress the risk of the bacterial infection of cord blood, the cord was cleaned with gauze impregnated with external antiseptic (Japan standard commodity classification No: 872612) from the end on the baby side toward the placenta side and then with clean dry gauze similarly.
- (3) The separated placenta and the separated cord were set so that the cord blood could be corrected by a head drop.
- (4) The vein of the cord was punctured with the branch indwelling needle 1.
- (5) The inner needle 13 was pulled out. (6) The branch indwelling needle 1 was turned (by controlling the connecting means 3) to locate the cord tissue holder 2 on the distal end side.
- (7) The cord was fixed by the cord tissue holder 2.
- (8) The branch indwelling needle 1 was turned (by controlling the connecting means 3) to locate the cord tissue holder 2 on the proximal end side and the outer needle 111 was inserted deep into the blood vessel of the cord (blood leakage becomes unlikely to happen).
- (9) The communication piece 61 was bent to start blood correcting.
- (10) The branch indwelling needle 1 was turned (by controlling the connecting means 3) to find a suitable puncture angle.
- (11) Liquid flow control means 62 was clamped to terminate blood correcting.
It was confirmed that the above blood correcting work could be carried out very stably. The amount of the corrected cord blood was 95.1 ml. This amount was larger than the amount of the conventionally corrected cord blood (70.4 ml, refer to the web site “Jump into medical science of the 21st century, lecture of clinical medicine, lecture of pediatrics”, URL: http://www2.kmu.ac.jp/ann70/tenkai/clin/text8.html). The utility of the present invention has been verified also from this result.
Patent Application
20080082060
