The present invention generally relates to a device configured to perform tissue collection quantitatively (a device configured to collect a predetermined amount of tissue without relying on manual operation).
Regenerative medical products are obtained by performing a process such as cultivation for human cells using a human tissue or the like as a raw material. In order to produce regenerative medical products, it is necessary to secure a certain amount of tissue for the regenerative medical product. The human body is thus incised by a scalpel or the like to collect the tissue. However, this type of method is relatively high in invasiveness and has a relatively large impact on the human body.
A tissue collection needle for biopsy or the like is available as a relatively low invasive means. However, the tissue collection needle or the like is for collecting a (relatively) very small amount of tissue for inspection, and it is necessary to use such a needle as described above multiple times in the human body in order to secure an amount of tissue necessary for a regenerative medical product.
For example, Japanese Patent Application Publication No. 2000-60859 discloses a cell tissue collector that includes a tubular body having a distal portion formed in a shape of a needle of a syringe and a brush bar that possesses a distal portion formed in a shape of a needle and has brush hair provided in a projecting manner in the proximity of the distal portion. The brush bar of this cell tissue collector fits into the tubular body such that the brush hair and the distal needle are moved into and out of the tubular body to collect cells from a wide range in an internal organ. The cell tissue collector has a problem, however, in being relatively high in invasiveness or the like in the human body.
Japanese Patent Application Publication No. 2012-235878 discloses a biopsy device that includes a tube shaped sheath and a core shaft configuring a needle main body having a spiral groove at a distal portion of the needle main body. According to this biopsy device, the core shaft is moved into and out of the sheath to collect tissue into the spiral groove. However, this biopsy device has a relatively small collection amount because the core shaft occupies the volume in the sheath.
Japanese Patent Application Publication No. 2015-85141 discloses a puncture needle that includes a sheath member, a needle tube, and a needle member having a rotary blade. Graduations are provided on a needle member operation unit and a needle tube operation unit. The puncture needle is configured so that the operator adjusts the length over which the needle member projects while viewing the graduations. However, since such adjustment relies upon the manipulation of the operator, such a problem that tissue cannot be collected quantitatively or the like is concerned.
The inventor of the present invention has identified problems such as a conventional biopsy device that collects tissue through back and forth movement of a needle member cannot secure a sufficient amount of tissue by a single operation, that there is a difference in collection amount depending upon the manipulation of the operator, and so forth. The device of this application may help address these problems by collecting tissue quantitatively (i.e., of a predetermined amount) by a simple operation.
The inventor has conducted intensive research in order to develop a device with which any person can quantitatively collect tissue by a simple operation while preventing differences in collection amounts due to different manipulations by the operator (i.e., a device that requires manual operation to control the amount of tissue collected may result in differing amounts of tissue collected in separate uses). The inventor has found that tissue can be collected quantitatively by controlling forward and backward movement of a tissue collection device by a threaded engagement mechanism.
In particular, the tissue collection device disclosed in this application relates to the following.
In one aspect, the disclosure relates to a tissue collection device including a sheath member that has a first threaded portion on the inner surface of the sheath member and a puncture tube positionable in the interior of the sheath member. The puncture tube is axially movable in distal and proximal directions relative to the sheath member. The puncture tube has a second threaded portion on the outer surface of the puncture tube that threadedly engages with the first threaded portion when the puncture tube is within the interior of the sheath member. At least one of the distal end of the sheath member and the distal end of the puncture tube includes a blade to incise tissue from a living body.
In another aspect, the disclosure involves a tissue collection device for collecting tissue in a living body. The tissue collection device includes a sheath member comprising a main body and a first threaded portion. The sheath member extends in an axial direction from a distal end to a proximal end. The first threaded portion of the sheath member is proximal to the main body. The sheath member is a tubular body with the distal and proximal ends being open. The first threaded portion is on the inner surface of the sheath member. The sheath member possesses an outer surface, an inner surface and an inner diameter. A puncture tube is positionable in the sheath member, the puncture tube extending in the axial direction from a distal end to a proximal end. The puncture tube includes a blade at the distal end of the puncture tube and a second threaded portion proximal to the blade. The second threaded portion is on the outer surface of the puncture tube. The puncture tube possesses an outer surface, an inner surface and an outer diameter. The second threaded portion on the outer surface of the puncture tube is configured to threadedly engage the first threaded portion on the inner surface of the sheath member when the puncture tube is positioned in the sheath member so that relative rotation between the sheath member and the puncture tube in one rotational direction axially moves the blade into the tissue in the living body to incise an amount of tissue, and so that relative rotation between the sheath member and the puncture tube in the opposite rotation direction axially moves the blade out of the living body with the incised tissue held at the distal end of the puncture tube. The inner diameter of the main body of the sheath member is smaller than the outer diameter of the second threaded portion of the puncture tube, such that the second threaded portion of the puncture tube is prevented from moving distally into the main body of the sheath member.
In yet another aspect, the disclosure involves a method for extracting a predetermined amount of tissue from a living body. The method includes contacting the living body with a distal end of a sheath member and axially moving a puncture tube positioned inside the sheath member in a distal direction relative to the sheath member to cause a distal end of the puncture tube to contact the tissue in the living body. The axially moving of the puncture tube relative to the sheath member occurring by virtue of a threaded portion of the puncture tube threadedly engaging a threaded portion of the sheath member. The method includes incising the predetermined amount of the tissue in the living body while axially moving the puncture tube in the distal direction and automatically stopping the axial movement of the puncture tube relative to the sheath member in the distal direction after the predetermined amount of the tissue has been incised. The method includes extracting the predetermined amount of the tissue from the living body.
[4] The tissue collection device according to any one of aforesaid [1] to [3], in which the puncture tube includes an outer side tubular body and an inner side tubular body fitted for back and forth movement in the outer side tubular body.
[5] The tissue collection device according to aforesaid [4], in which the inner side tubular body has a groove extending in an axial direction thereof.
[6] The tissue collection device according to any one of aforesaid [1] to [5], further including:
a vessel for accommodating the puncture tube, the vessel having a third threaded portion for threaded engaging with the second threaded portion.
[7] The tissue collection device according to any one of aforesaid [1] to [6], in which at least part is configured from an optically transparent material.
The device of this application can quantitatively collect tissue by a simple operation. Further, by using the device disclosed here, tissue can be quantitatively collected by a single time operation without depending upon the manipulation of the operator, and therefore, relatively low invasiveness in the living body (i.e., patient) can be achieved.
Set forth below with reference to the accompanying drawings is a detailed description of embodiments of a tissue collection device and a method of tissue collection representing examples of the inventive tissue collection device and method disclosed here. Note that the size of each member (i.e., component) in the figures is suitably emphasized for illustration purposes and does not necessarily correlate to an actual ratio or magnitude. In the following description, the term “proximal portion” and “proximal end” signifies an end portion or end of the device on the operator side, and the term “distal portion” and “distal end” signifies an end portion or end of the device on the tissue side (i.e., in the living body during tissue collection).
A first embodiment of a device disclosed in this application is first described in relation to
A spiral blade 3 is provided in a projecting manner on the inner face at a distal portion 22 of the puncture tube 2 (i.e., the spiral blade 3 extends radially inward from the inner surface of the puncture tube 2 at a distal portion 22 of the puncture tube 2). An operation unit 24 (e.g., a plunger) is provided at a proximal portion 23 of the puncture tube 2. The outer diameter of the proximal side of the sheath member 1 on which the first threaded portion 11 is provided is greater than the outer diameter of the sheath member 1 distal to the first threaded portion 11. A stopper 13 is formed by this offset (i.e., difference) between the outer diameters as shown in
The puncture tube 2 is then inserted into the sheath member 1 until the second threaded portion 21 of the puncture tube 2 and the first threaded portion 11 of the sheath member 1 are threadedly engaged with each other and the operation unit 24 is operated (i.e., rotated) to rotate the puncture tube 2 (as shown in
The threaded engagement of the puncture tube 2 is stopped in the middle (i.e., in a fully engaged position between the first and second threaded portions 11, 21) as shown in
As described above, a problem that the puncture tube 2 inadvertently enters the application region of the living body (i.e., puncture site) or a similar problem is less likely to occur because the disclosed device controls the movement of the puncture tube 2 in the distal and proximal directions using threaded engagement (i.e., via the first and second threaded portions 11, 21) with the sheath member 1. Further, since the distance of the back and forth movement of the puncture tube 2 depends upon the distance of rotation of the operation unit 24, for example, the collection amount of tissue can be adjusted quantitatively by the number of rotations of the operation unit 24. In other words, a predetermined amount of tissue may be collected based on a predetermined number of rotations of the operation unit 24. The stopper 13 on the outer face of the sheath member 1 may make the sheath member 1 inadvertently entering the application region (or a similar problem) relatively less likely to occur when the sheath member 1 punctures the application region of the living body.
Since the puncture tube 2 of the present invention is a tubular body, a sufficient amount of tissue can be collected into the inner side of the puncture tube 2. Further, the puncture tube 2 can advance while rotating in the application region and can shred the tissue because the spiral blade 3 is provided in a projecting manner on the inner surface of the puncture tube 2. The spiral blade 3 achieves a function of a lid (i.e., acts as a collecting member to collect the living body tissue) at the distal portion 22 of the puncture tube 2. That is, when the sheath member 1 and/or the puncture tube 2 are to be pulled out from the living body in a state in which tissue is collected in the puncture tube 2, the spiral blade 3 can help prevent the tissue from falling from (i.e., out of) the distal portion 22 of the puncture tube 2.
The device according to the first embodiment can thereby collect tissue quantitatively (i.e., by a set or predetermined amount) by a single time operation without depending upon the manipulation of the operator (i.e., manual operation to draw a certain or desired amount of tissue), and therefore, relatively low invasiveness of the living body can be achieved.
The sheath member 1 of the disclosed tissue collective device is not limited to that of the first embodiment but can assume various modifications. For example, the stopper 13 of the sheath member 1 is not limited to such a stopper that utilizes an offset as described above. For example, a flange portion may be provided which can be fixed to an outer face of the sheath member 1 but is slidably movable in the axial direction of the sheath member 1. This flange portion may allow quantitative tissue collection to be achieved by slidably moving the flange portion with reference to such graduations on the outer face of the sheath member 1 in a similar manner to that described above.
The spiral pitch of the spiral blade 3 may be made equal to the thread pitch between the first and second threaded portions 11, 21 of the puncture tube 2 and the sheath member 1. Consequently, it is possible to minimize destruction of the tissue by the spiral blade 3 and advance the spiral blade 3 smoothly into the tissue. The angle of the two plate-shaped members 32 configuring the spiral blade 3 as viewed from the axial direction is not limited to 90 degrees and can be set freely within the range of 1 to 360 degrees or exceeding 360 degrees. In particular, the spiral blade 3 may be a blade in the form of a string, a sectoral blade or a spiral blade of 360 degrees or more. Also the number of such plate-shaped members 32 is not limited to two but can be set freely, for example, from one plate-shaped member to ten or more plate-shaped members. The projection height of the spiral blade 3 in the center direction (i.e., the extension length of the spiral blade 3 inward from the inner surface of the puncture tube 2) may be greater than the radius of the puncture tube 2 to increase the cutting away effect of the tissue.
Now, a second embodiment of a tissue collection device is described in relation to
In the embodiment shown in
A grasping unit 51 is provided on the proximal side of the inner side tubular body 5. The outer diameter of the grasping unit 51 is greater than the inner diameter of the outer side tubular body 4 so that the grasping unit 51 is prevented from entering the interior of the outer side tubular body 4. Although an operator can grip the grasping unit 51 to slidably move the inner side tubular body 5 in the outer side tubular body 4 (and relative to the outer side tubular body 4), the advancement of the grasping unit 51 is stopped on the proximal side of the outer side tubular body 4. The grasping unit 51 can be removably fixed to an operation unit 44 of the outer side tubular body 4, so that the outer side tubular body 4 and the inner side tubular body 5 can be rotated integrally.
A reduced thickness portion T extending in the axial direction is provided on the inner side tubular body 5. The tissue of the living body can be taken out (i.e., removed or extracted) readily by an operator pulling out the inner side tubular body 5 from the outer side tubular body 4 (i.e., retracting the inner side tubular body 5 in the proximal direction relative to the outer side tubular body 4) and putting a bar-like member or air into the inner side tubular body 5 from the proximal side (or by like means) to push out the tissue to the distal side or dividing (i.e., splitting or opening) the inner side tubular body 5 longitudinally along the reduced thickness portion T. The inner side tubular body 5 is configured from an optically transparent material and has graduations 52 on an outer face of the inner side tubular body 5. Accordingly, the operator can confirm the amount of tissue collected in the inner side tubular body 5 from outside of the inner side tubular body 5. If the tissue collection amount is relatively small (i.e., too small), a sufficient amount of tissue can be taken in by returning the inner side tubular body 5 into the outer side tubular body 4 and rotating the puncture tube 2A in the sheath member 1 again.
Since the device according to the second embodiment can collect tissue quantitatively by a single time operation without depending upon the manipulation of the operator, relatively low invasiveness can be achieved.
The puncture tube 2A is not restricted to the embodiment of
A third embodiment of a tissue collection device is described in relation to
The device illustrated in
The puncture tube 2B is not limited to any particular embodiment, but can assume various modifications. For example, in addition to the blade at the distal portion 22B of the puncture tube 2B, a spiral blade may be provided in a projecting manner on the inner face of the puncture tube 2B (i.e., the blade may extend radially inward from the inner surface of the puncture tube 2B at a distal portion of the puncture tube 2B). The opening 25 may be openable and closeable such that the inside of the puncture tube 2B is enclosed without depending upon the manipulation by the operator. The puncture tube 2B may include a piston member that can be inserted into the opening 25. The piston member can be slidably moved in the puncture tube 2B to draw up tissue taken in the puncture tube 2B to the proximal portion 23 side (i.e., urge the tissue in the proximal direction), or conversely push out the tissue from the distal portion 22 side of the puncture tube 2B (i.e., urge the tissue in the distal direction).
By threadedly engaging the second threaded portion 41 of the puncture tube 2A with the third threaded portion 61 of the vessel 6, it is possible to threadedly engage the puncture tube 2A with certainty in the vessel 6 to place the vessel 6 into an enclosed state. Tissue is taken in the puncture tube 2A (i.e., the puncture tube 2A has previously extracted tissue from a living body and contains the tissue) and is preserved in a state in which the tissue is immersed in the liquid in the vessel 6. The grasping unit 51 of the inner side tubular body 5 of the puncture tube 2A can be gripped to pull out (i.e., retract proximally) the inner side tubular body 5 from the puncture tube 2A to confirm the state of the tissue in the vessel 6. The state of the tissue can be confirmed simply by this operation. Here, the vessel 6 and the outer side tubular body 4 may be configured from an optically transparent material such that the state of the tissue can be confirmed from the outside of the vessel 6.
While the devices according to various embodiments have been described, the present disclosure is not limited to any particular embodiment(s). Those skilled in the art can design a device having a different configuration or shape by suitably combining the components and the shapes of the devices according to the above description. For example, the blade may be provided selectively at the distal end or distal portion of the sheath member 1, at the distal end or distal portion of the puncture tube 2 or at the distal end or distal portion of the plate-shaped member 32 of the puncture tube 2. A blade of a spiral shape as is used in an auger screw may be provided in a projecting manner on the inner face of the puncture tube 2 or a spiral blade may be attached to a support like an auger screw so as to be slidably movable in the axial direction of the puncture tube 2.
In the present invention, it is possible to replace the components with desired components that can exhibit similar functions or to add desired components.
The detailed description above describes a tissue collection device and a method for using a tissue collection device. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.
Number | Date | Country | Kind |
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2016-058142 | Mar 2016 | JP | national |
This application is a continuation of International Application No. PCT/JP2017/011624 filed on Mar. 23, 2017, and claims priority to Japanese Application No. 2016-058142 filed on Mar. 23, 2016, the entire content of both of which is incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2017/011624 | Mar 2017 | US |
Child | 16137792 | US |