1. Field of the Invention
This invention relates to a bone marrow harvesting needle which is kept indwelling a bone to be used for, for example, harvesting bone marrow, in particular, to a bone marrow harvesting needle used for drilling a hard bone, such as long bone; and a bone marrow harvesting set for harvesting bone marrow cells aseptically using the needle in combination.
2. Description of the Related Art
Bone marrow has been harvested using a bone marrow puncture needle, such as Thomas needle, to puncture ilium. The bone marrow puncture needle is constructed in such a manner as to insert and fit an inner needle into a tubular mantle while allowing the tip of the inner needle to project from the mantle. The bone marrow puncture needle, which is equipped with a handle, percutaneously punctures ilium, and once the tip of the needle reaches bone marrow, the inner needle alone is drawn out and the mantle is kept indwelling the bone marrow to be subsequently used.
As a method for harvesting bone marrow using this bone marrow puncture needle, typically, an aspiration method is employed. The aspiration method is such that the mantle of the bone marrow puncture needle is connected to a syringe to collect bone marrow by virtue of the aspiration force. In this method, however, since the quantity of bone marrow harvested from one site of a bone is as small as several ml, collecting a sufficient quantity of bone marrow requires a number of sites to be punctured; consequently, the method carries a high risk of allowing peripheral blood T cells to mix into the harvested bone marrow, and hence of causing GVHD, which necessitates immunosuppression.
Under these circumstances, a bone marrow perfusion method, as a method for overcoming the above problems, has been developed. The bone marrow perfusion method is such that two bone marrow harvesting needles are kept indwelling respective ends of a long bone, such as humerus, with one of the needles connected to an injection syringe and the other connected to a centrifugal tube for harvesting bone marrow via a collection tube, so as to perfuse bone marrow with a medium such as sterilized and heparinized phosphate-buffered physical saline, and thereby a required quantity of bone marrow is harvested into a collection container at a time by injecting the medium slowly into the bone marrow in such a manner as to wash away the bone marrow.
The conventionally employed method in which a bone marrow puncture needle, equipped with a handle, is pressed into a bone by turning the handle by hand is not suitably applied to the bone marrow perfusion method, because the method using a handle does not easily allow the tip of the needle to reach the cavity accommodating bone marrow.
Thus a method has been desired in which a long bone or the like is drilled with a bone marrow harvesting needle equipped with a drill which is capable of providing a more powerful rotational power than a handle.
This invention has been made in light of the above described problems. Accordingly, the primary object of the invention is to provide a bone marrow harvesting set capable of harvesting bone marrow with minimized exposure to a non-aseptic environment.
The second object of the invention is to provide a bone marrow harvesting needle capable of harvesting bone marrow safely and quickly from a donor by the bone marrow perfusion method.
In order to accomplish the primary object, a bone marrow harvesting set is provided which includes: a centrifuge container for harvesting bone marrow; a cap with an collection inlet through which bone marrow is collected; and a collection tube with connectors attached to its respective ends, the bone marrow harvesting set being constructed in such a manner as to put the cap on the centrifuge container; fit one of the connectors, attached to one end of the collecting tube, closely into the collection inlet of the cap; and fit the other connector, attached to the other end of the collecting tube, snugly into the collection inlet of the cap; and fit the other connector, fitted to the other end of the collecting tube, snugly into the mantle of a bone marrow harvesting needle to be kept indwelling in bone marrow, so as to collect bone marrow.
Desirably, the cap is provided with an air vent to equalize the internal and external pressures of the centrifuge container and the air vent is mounted with a filter.
In order to accomplish the second object, a bone marrow harvesting needle is provided which includes: a tubular mantle; and an inner needle, the inner needle being inserted into and detachably attached to the mantle with its tip allowed to project from the mantle, and the bone marrow harvesting needle is characterized in that the inner needle has a drilling edge formed at its tip and the mantle has a cutting edge at its tip.
Preferably a helical groove is formed on the periphery of the inner needle.
Preferably the face of the cutting edge is constructed in such a manner that it slopes upward from the inner periphery toward the outer periphery of the cutting edge so that fine cut pieces of a bone are gathered onto the inner needle along the cutting edge and discharged into the upper portion along the helical groove.
Preferably co-rotation preventive mechanism is provided for preventing the mantle from co-rotating with the inner needle.
Preferably the co-rotation preventive mechanism is constructed in such a manner that a rotational power produced by an independent rotation driving source is transmitted to the concentrically positioned inner needle and mantle and that the inner needle and the mantle are rotated at different angular velocities.
Preferably the co-rotation preventive mechanism comprises a speed reduction mechanism in which the mantle is rotated at a reduced speed by transmitting the rotation of the inner needle.
Preferably the inner needle is provided with a holder, which is to be gripped by chuck claws of a drill, and at the rear end of the holder a fitting portion is formed for fitting a handle.
The invention provides the following advantages.
The use of the bone marrow harvesting needle of the invention may realize the bone marrow collection by the bone marrow perfusion method quickly, because the inner needle and the mantle have a drilling edge and a cutting edge at their respective tips, allowing a hole to be drilled in a bone by just rotating them without undue force, unlike the use of the bone marrow puncture needle, and allowing the bone marrow harvesting needle to indwell even in a hard and thick bone, such as long bone, quickly and easily. Further, the use of the needle of the invention ensures the safety of donors and makes bone marrow collection less invasive, which may increase donors' cooperation.
The use of the bone marrow harvesting set of the invention may minimize the exposure of the harvested bone marrow to a non-aseptic environment and avoid chances of recipients' suffering from infectious diseases, because, when harvesting bone marrow, the cap is put on the centrifuge container, one of the connectors, fitted to one end of the collecting tube, is closely fitted into the inlet of the cap, and the other connector, fitted to the other end of the collecting tube, is closely fitted into the mantle of the bone marrow harvesting needle.
Thus, according to the invention, bone marrow cells may be harvested in a safe manner and in large quantities, and the bone marrow harvesting needle and the drill may also be used for intra-bone marrow—bone marrow transplantation (IBM-BMT) in which bone marrow cells are transplanted directly into the bone marrow cavity. Further, the invention may contribute not only to bone marrow transplantation, but also to organ transplantation (using bone marrow transplantation in combination), and to study of human mesenchymal stem cell and the regenerative medicine using the same.
If a helical groove is formed in the periphery of the inner needle, fine cutting pieces of a bone produced by drilling the bone may be discharged along the helical groove, resulting in improvement of bone drilling efficiency.
If co-rotation preventive mechanism for preventing the mantle from co-rotating with the inner needle is provided, discharging fine cutting pieces of a bone maybe further ensured on the conveyance principle of a screw conveyer.
The other features of the invention will become more apparent from the following detailed description of preferred embodiments of the invention with reference to the drawings.
In the accompanying drawings,
FIGS. 6(a) and 6(b) illustrate a method for harvesting bone marrow using a guide needle;
FIGS. 14(a) and 14(b) are graphs showing the measured results of cutting force.
In the following the embodiments of the invention will be described with reference to the accompanying drawings.
As shown in FIGS. 1(a) to 1(d), a bone marrow harvesting needle 1 consists of a mantle (outer needle) 2 and an inner needle 3 to be fitted into the mantle 2.
The inner needle 3 includes an inner needle body 4 and a holder 5, between the inner needle body 4 and the holder 5 an external flange 6 is formed, and on the external flange 6 a pair of pins 7 project to prevent free rotation of the mantle 2.
The inner needle body 4 forms a drill cutter having a cutting edge 4a at its tip. A helical groove 4c is formed throughout the full length of the inner needle body 4, and the tip of the inner needle body has a sharp cutting edge.
The mantle 2 includes a mantle body 2a and a fitting portion 9a, and the fitting portion 9a (e.g. lure lock type) is provided with a pair of pin holes 9b.
The mantle body 2a is cylindrically formed as shown in
When the inner needle 3 is fit into the mantle 2, the inner needle body 4 is inserted into the mantle body 2a in such a manner as to fit the pins 7 into the pin holes 9b and allow the tip portion of the inner needle body 4 to project from the tip of the mantle body 2a, as shown in FIGS. 1(c) and 1(d).
As shown in
As shown in FIGS. 3(a) and 3(b), the bone marrow harvesting needle 1 is fitted into a handle B. A fitting portion 10 for fitting the needle into the handle B is formed at the back end of the holder 5 of the inner needle 3, as shown in
An average size of the bone marrow harvesting needle 1 will be shown below as an example. In actuality, however, a set of several kinds of bone marrow harvesting needles different in length are prepared, since the distance from the skin surface to the periosteal surface differs from person to person. As to long needles, in order to maintain their mechanical strength, a balance of length and thickness shall be kept by making the outside diameters larger.
Average size of bone marrow harvesting needle 1 as an example:
As for recipients, who are the subjects of bone marrow transplantation, organ transplantation, regenerative medicine, etc., their immunological functions are significantly lowered due to the pretreatment such as X-ray irradiation. Therefore, avoiding chances of their suffering from infectious diseases as much as possible is indispensable to treatments involving transplantation. In such a situation, the use of a bone marrow harvesting set, which will be described below, in the harvest of bone marrow may minimize the exposure of harvested bone marrow to a non-aseptic environment.
The bone marrow harvesting set includes: a rigid plastic centrifuge container E(with a volume of, for example, 60 ml); a cap H with an air vent H2, into which a filter H1 (made of, for example, sintered resin) is fitted, an collection inlet H3; and an collection tube F with connectors G fixed to both of its ends. The connector G provided at one end of the collection tube F is fitted into the collection inlet H3 of the cap H and the connector G provided at the other end of the collection tube F is fitted into the fitting portion 9a of the mantle 2 of the bone marrow harvesting needle 1.
For the harvest of bone marrow, a guide needle 12 shown in
In the following, a method will be described for harvesting bone marrow from a long bone C, such as humerus, using the above described needle and set.
First, as shown in
Further, if the positional relation between the guide needle 12 and the long bone C is checked by CT scan etc. in advance, decision of the site where the bone marrow harvesting needle 1 indwells becomes easy, and moreover, the record can be reserved.
Then, the shaft needle 16 of the guide needle 12 is drawn out from the guide cylinder 14 while leaving the guide cylinder 14 indwelling. Next, the bone marrow harvesting needle 1 having been fitted to the electric drill A is inserted into the guide cylinder 14.
The electric drill A is then rotated, while pressing the bone marrow harvesting needle 1, so as to drill a hole in the long bone C by the use of the inner needle 3 and the cutting edges 21 of the mantle 2. After the tip of the bone marrow harvesting needle 1 reaches bone marrow, the electric drill A is pulled toward a surgeon to draw the inner needle 3 out from the mantle 2 while leaving the mantle 2 indwelling at one end of the long bone C, as shown in
Then, as shown in
Bone marrow is collected into the centrifuge container E through the collection tube F by injecting heparinized saline solution slowly into the long bone C from the injection syringe D, or the parenteral fluid pump or the parenteral fluid pack positioned at a regulated hight. After completing the collection of bone marrow, the connectors G of the collection tube F are detached. The centrifuge container E is capped with a sterilized cap (not shown in the figure). Immediately after this, the collected bone marrow is centrifuged to recover bone marrow cell fractions. Such a through process using the bone marrow harvesting set can minimize the exposure of harvested bone marrow to a non-aseptic environment.
FIGS. 8 to 13 illustrate a bone marrow harvesting set and a bone marrow harvesting needle of embodiment 2. The bone marrow harvesting needle 1 includes: a mantle 2, an inner needle 3 and co-rotation preventive mechanism 17.
As shown in
The inner needle body 4 of the inner needle 3 is constructed as described above. As shown in
The mantle body 2a of the mantle 2 is constructed as described above. As shown in
The lower housing 18 includes a base portion 18b. The base portion 18b is provided with a central hole. From the peripheral portion of the central hole a cylinder portion 18d is extends downward. On the internal circumference side of the cylinder portion 18d, a tapered bearing bore 18a is formed. On the upper surface of the base portion 18b a circular circumference wall 18c is raised. Outside the circumference wall 18c, four hooked portions 18j are provided. These hooked portions 18j are arranged in the circumferential direction of the circumference wall 18c at intervals of 90 degrees.
As shown in
The speed reduction mechanism 19 includes: a driving gear 19a fixed to the holding shaft 5 of the inner needle 3; an inner teeth portion 19b formed throughout the full circumference of the circumference wall 18c of the lower housing 18 provided on the upper end side of the mantle body 2a; and two intermediate gears 19c engaging with each other. One of the two intermediate gears 19c engages the driving gear 19a and the other engages the inner teeth portion 19b. The driving rotation of the inner needle 3 is transmitted to the mantle 2 via the speed reduction mechanism 19, causing the rotational speed of the mantle 2 to be reduced. The gears 19a and 19c are molded products of resin, such as polyacetal. And the lower housing 18 and the upper housing 20 are formed of, for example, ABS resin or polyacetal resin.
The upper housing 20 is in the form of disc, in its center is formed a bearing bore 20a, on its top surface side is formed a pair of mantle holders 20c, and in its bottom surface side are formed two bearing bores 20b.
As shown in
When joining the upper housing 20 and the lower housing 18 together, the inner needle body 3 is inserted into the mantle body 2a, the lower end of the holding shaft 5 of the inner needle 3 is inserted into the bearing bore 18a of the lower housing 18, and the circumference wall 18c of the lower housing 18 is inserted into the ring groove 20d of the upper housing 20. And, after the hook portions 18j of the lower housing 18 is inserted into the entrance grooves 20e of the upper housing 20 as shown by an arrow 100 of
The upper end of the holding shaft 5 of the inner needle 3 is inserted into the bearing bore 20a of the upper housing 20 rotatably. The shaft bodies 19d of the intermediate gears 19c are pressed into the bearing bores 20b of the upper housing 20, and the falling of the intermediate gears 19c from the shaft bodies 19d is prevented by an E ring 19f. To the holding shaft 5 is fitted a slip-off preventive clamp 51. On each shaft body 19d is formed a hemispherical head portion 19e, and the head portions 19e are in contact with the lower housing 18. The gear 19a is also prevented from falling from the holding shaft 5 by the E ring 19f.
When drilling a hole in a long bone C using the bone marrow harvesting needle 1 constructed as above, the holding shaft 5 of the inner needle 3 is attached to an electric drill A as shown in
Accordingly, the inner needle body 4 and the mantle body 2a are allowed to function as a screw and as a trough, respectively. Thus, fine cut pieces of a bone C2 having been cut by the inner needle body 4 and the mantle body 2a, as shown in
The cutting edges 4a and 21 of the inner needle body 4 and the mantle body 2a shown in
After completing the operation, the join of the upper housing 20 and the lower housing 18 is released by holding the lower housing 18 in one hand and the upper housing 20 in the other hand, then the inner needle body 4 is drawn from the mantle 2 by pulling the upper housing 20 up to leave the mantle body 2a indwelling in the bone.
In order to avoid the chances of infections as much as possible, the bone marrow harvesting needle 1 is used only once and thrown away.
[Variation]
In a alternative embodiment, a bone marrow harvesting needle may have the angles θ2 and θ3 of the cutting edge of the mantle body of 0 degree, and the inner needle body and the mantle body may be co-rotated in the same direction at the same speed.
FIGS. 14(a) and 14(b) show the measured results of cutting force when making boring in a material to be subjected to cutting. As a material to be subjected to cutting was used a polyacetal (Juracon) rod, and the rotation ratio of the inner needle 3 of the bone marrow harvesting needle 1 to the mantle body 2 of the same was set to 1:0.5. In another example, the bone marrow harvesting needle of the above-mentioned alternative embodiment was used (the diameter of the needles were both 2 mm). Boring was made while setting the rotational speed of the electric drill to 570 rpm.
As a result, the cutting force of the latter example was 30 N (10 N/mm2) or more at peak, as shown in
These embodiments are intended to illustrate the invention and the invention is not intended to be limited to the specific embodiments. Variations may be made without departing from the spirit of the invention and the scope described in the following claims.
Number | Date | Country | Kind |
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2001-241586 | Aug 2001 | JP | national |
2002-172476 | Jun 2002 | JP | national |
This is a divisional of application Ser. No. 10/485,202 filed Jan. 29, 2004, which is a 371 of PCT/JP02/08101 filed Aug. 8, 2002. The entire disclosures of application Ser. No. 10/485,202 and PCT/JP02/08101 are considered part of the disclosure of the accompanying divisional application and are hereby incorporated by reference.
Number | Date | Country | |
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Parent | 10485202 | Jan 2004 | US |
Child | 11487962 | Jun 2006 | US |