阅读说明：本技术 生物组织的切割辅具、切割套组及其用途 (Cutting aid for biological tissue, cutting set and use thereof ) 是由 魏肇怡 许旻慧 黄宪瑜 赵朝钦 谢达仁 于 2018-08-08 设计创作，主要内容包括：本发明是关于一种于活体外用以切割一生物组织的切割辅具、切割套组及其用途。所述切割辅具包含设有一进刀口的一中空套管,其中该进刀口用以使一刀片伸入,藉以切割该生物组织；一第一推杆及一第二推杆,其中该第一推杆及该第二推杆可分别滑移入该中空套管的两个端口。所述切割套组包含该切割辅具及一刀片。本发明还包含一种用以于活体外切割一生物组织的方法。该方法包含将该生物组织置入该中空套管中,藉由在该中空套管中,滑移该第一推杆及/或该第二推杆以移动该生物组织,直到其被定位于该进刀口处下方为止,接着将该刀片一或多次伸入该进刀口,以切割该生物组织成一或多片切片,最后取出该切割后的生物组织。(The present invention relates to a cutting aid for cutting a biological tissue for in vitro use, a cutting kit and use thereof. The cutting aid comprises a hollow sleeve provided with a knife inlet, wherein the knife inlet is used for enabling a blade to extend into the hollow sleeve so as to cut the biological tissue; a first push rod and a second push rod, wherein the first push rod and the second push rod can respectively slide into the two ports of the hollow sleeve. The cutting kit comprises the cutting aid and a blade. The invention also includes a method for cutting a biological tissue in vitro. The method comprises placing the biological tissue into the hollow sleeve, moving the biological tissue by sliding the first push rod and/or the second push rod in the hollow sleeve until the biological tissue is positioned below the cutting inlet, then inserting the blade into the cutting inlet one or more times to cut the biological tissue into one or more slices, and finally taking out the cut biological tissue.)

1. A cutting aid for use in extracorporeal cutting of a biological tissue, comprising:

a hollow sleeve with openings at both ends and an inlet knife edge on the tube body;

a first push rod which can slide into one port of the hollow sleeve; and

a second push rod, which can slide into the other end of the hollow sleeve.

2. A cutting aid for use in extracorporeal cutting of a biological tissue, comprising:

a hollow sleeve with openings at both ends and a sampling port on the tube body;

a first push rod which can slide into one port of the hollow sleeve;

a second push rod which can slide into the other end of the hollow sleeve; and

a cover body which can be opened and closed and covers the sampling opening, wherein the cover body is provided with an inlet knife edge.

3. The cutting aid of claim 1 or 2, wherein the hollow sleeve, the first push rod, the second push rod and/or the cover are made of a transparent or translucent material.

4. The cutting aid of claim 1 or 2, wherein the first push rod and/or the second push rod is made of an opaque material.

5. The cutting aid according to claim 1 or 2, wherein the surface of the hollow sleeve, the first push rod and/or the second push rod is provided with a scale.

6. The cutting aid of claim 1 or 2, further comprising a first fixing member and a second fixing member, wherein the first fixing member and the second fixing member penetrate the hollow sleeve, respectively, to fix the first pushing rod and the second pushing rod.

7. The cutting aid of claim 6, wherein the fastener is a bolt, screw, or pin.

8. The cutting aid of claim 1 or 2, wherein the biological tissue is a porcine corneal specimen.

9. A cutting kit for cutting a biological tissue in vitro, comprising: a cutting aid as claimed in any one of claims 1 to 8; and a blade, wherein the blade can extend into the cutting opening to cut the biological tissue.

10. A method for cutting an in vitro biological tissue, comprising the steps of:

(1) placing the biological tissue into the hollow cannula of the cutting kit of claim 9;

(2) moving the biological tissue by sliding the first push rod and/or the second push rod in the hollow cannula until it is positioned below the access port;

(3) the blade is extended into the cutting opening one or more times to cut the biological tissue.

Technical Field

The present invention relates to a cutting tool and a cutting method for a biological tissue, and more particularly, to a cutting tool and a cutting method for a biological tissue capable of assisting in positioning a cutting site.

Background

With the development and application of biotechnology, the demand for the operation and treatment of biological tissues is increasing day by day. In terms of cutting wet tissue of a living body, a scalpel generally used in a surgical operation is common, or further, a percutaneous cutting device (hereinafter referred to as a hernia cutting device) which is, for example, inserted into a patient to cut tissue such as a degenerated intervertebral disc or a hernia, such as a hernia cutting device shown in U.S. patent publication No. 4,246,902, 5,106,364, or 5,997,560, or the like. However, the same problem exists in both the surgical knife and the hernia cutting device, i.e. the cutting site of the tissue to be cut cannot be positioned according to the requirement of the user, so that the tissue with a specific volume size required by the user cannot be obtained for the subsequent development. In addition, referring to taiwan patent publication No. 200411047, a tool for cutting cells and tissue mass is disclosed, and although the tool is used as a cutting blade module for cutting cells and tissue mass, which can cut the cells and tissue mass into at least one (several or tens) small mass(s) at the same time, the tool still faces the same problem as the above-mentioned scalpel or hernia cutting device, that is, the cutting site cannot be positioned according to the user's requirement, so that tissue with a specific volume size as the user wants cannot be obtained for subsequent use.

One of skill in the art is familiar with the method by which the size of the volume of tissue cut can be controlled by cutting the biological tissue with a tissue microtome. However, before cutting with a microtome, the biological tissue needs to be subjected to relevant pre-treatments, such as fixing, dehydration, infiltration, embedding, etc. necessary for preparing paraffin sections, or procedures of low-degree fixing and frozen embedding for preparing frozen sections, which may damage the biological tissue to different degrees, and is not favorable for subsequent utilization of the biological tissue. In addition, a microtome is used to cut biological tissue, which has a maximum cutting thickness of 100 μm and can cut only from one end of the biological tissue, but cannot cut at any point on the biological tissue as desired by a user (e.g., cannot cut from the middle of the biological tissue). In view of the foregoing, there is a need in the art for a cutting tool that can assist in locating a cutting site of a biological tissue for cutting the biological tissue.

Disclosure of Invention

Drawings

The disclosure and other features, embodiments and advantages will become more apparent upon consideration of the following detailed description, claims and accompanying drawings, in which:

FIG. 1 is a schematic view of an embodiment of a cutting aid of the present disclosure;

FIG. 2A is a perspective view of a cutting kit of the present disclosure;

FIG. 2B is a cross-sectional view of a cutting kit of the present disclosure;

FIG. 3 is a schematic view of another embodiment of a cutting aid of the present disclosure;

FIG. 4 is a schematic view of another embodiment of a cutting aid of the present disclosure;

FIG. 5 is a schematic view of another embodiment of a cutting aid of the present disclosure;

FIG. 6A is a rear perspective view of FIG. 5;

FIG. 6B is an exploded view of the back view of FIG. 5;

FIG. 7 is a schematic view of another embodiment of a cutting aid of the present disclosure; and

fig. 8 is a schematic view of another embodiment of a cutting aid of the present disclosure.

The various features and elements of the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the particular features and elements of the invention in order to best explain the principles of the invention. Moreover, the same or similar reference numbers are used throughout the different drawings to refer to similar components/features.

[ notation ] to show

100. 200, 300, 400, 500, 600 cutting assistive device

110. 210, 310, 410, 510, 610 hollow sleeve

112. 212, 312, 412, 512, 612 feed ports

120. 220, 320, 420, 520, 620 first push rod

130. 230, 330, 430, 530, 630 second push rod

140 blade

414. 514 cover body

616 first fixing piece

618 second fixing piece

T biological tissue

P perforation

Detailed Description

In order to make the description of the present disclosure more complete and complete, the following description is given for illustrative purposes with respect to the embodiments and specific examples of the present invention; it is not intended to be the only form in which the embodiments of the invention may be practiced or utilized. The embodiments are intended to cover the features of the various embodiments as well as the method steps and sequences for constructing and operating the embodiments. However, other embodiments may be utilized to achieve the same or equivalent functions and step sequences.

Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Furthermore, as used herein, the singular tense of a noun, unless otherwise conflicting with context, encompasses the plural form of that noun; the use of plural nouns also covers the singular form of such nouns.

Although numerical ranges and parameters setting forth the broad scope of the invention are approximate, the values set forth in the specific examples are presented as precisely as possible. Any numerical value, however, inherently contains certain standard deviations found in their respective testing measurements. As used herein, "about" generally means that the actual value is within plus or minus 10%, 5%, 1%, or 0.5% of a particular value or range. Alternatively, the term "about" means that the actual value falls within the acceptable standard error of the mean, subject to consideration by those of ordinary skill in the art. Except in the experimental examples, or where otherwise expressly indicated, it is understood that all ranges, amounts, values and percentages herein used (e.g., to describe amounts of materials, length of time, temperature, operating conditions, quantitative ratios, and the like) are modified by the term "about". Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, these numerical parameters are to be understood as meaning the number of significant digits recited and the number resulting from applying ordinary carry notation.

The term "subject" refers to a source of biological tissue that can be cut using the cutting aids, cutting kits, and cutting methods of the present disclosure. In certain embodiments, the source subject is a mammal. The term "subject" means both male and female unless one sex is specified. Exemplary "individuals" include, but are not limited to, humans, rats, mice, guinea pigs, monkeys, pigs, goats, cattle, horses, dogs, cats, birds, and chickens. In a specific embodiment, the subject is a pig.

"biological tissue" includes tissue from a component (e.g., an organ) of an individual, including, but not limited to, integumentary tissue (e.g., a portion of the skin), oral tissue (e.g., mouth, tongue, jaw, gum), respiratory tissue (e.g., pharynx, larynx, trachea, bronchi, lung, diaphragm), gastrointestinal tissue (e.g., esophagus, stomach, liver, gall bladder, pancreas, intestine, colon, rectum, and anus), cardiovascular tissue (e.g., heart, blood vessels), endocrine tissue (e.g., hypothalamus, pituitary, pineal or pineal gland, thyroid, parathyroid, adrenal gland), and genitourinary tissue (e.g., kidney, ureter, bladder, urethra, ovary, fallopian tube, uterus, vagina, breast, testis, vas deferens, seminal vesicles, prostate, penis), muscle tissue, neural tissue (e.g., brain, spinal cord, nerve), Cartilage tissue (e.g., cartilage, ligaments, tendons) and the eye. The biological sample can be any type of biological tissue, including both healthy tissue and diseased tissue (e.g., cancer, malignancy, necrosis, etc.). In one embodiment, the biological tissue is the cornea of an eye.

As mentioned above, the instruments for cutting biological tissues known to those skilled in the art are not limited to the cutting tools known in the art, such as scalpels, hernia cutting devices, or microtomes, but these cutting tools do not allow the user to arbitrarily position the desired cutting site according to his/her needs, so that the desired volume of the cut tissue cannot be obtained. Therefore, an object of the present invention is to provide a cutting aid for assisting a user in locating a cutting site of a biological tissue, and a cutting kit including the cutting aid. The cutting aid and the cutting set can enable a user to cut the biological tissue into a desired size according to the requirement, so that the subsequent utilization is facilitated. To illustrate the usage of the cutting aid and the cutting kit of the present invention, the present invention also provides a method for cutting biological tissue by using the cutting kit, so that a user can use the cutting aid and the cutting kit to obtain a desired cut biological tissue. The cutting aid and the cutting sleeve set are novel, low in cost, easy to operate, easy to produce in large scale and suitable for wide popularization and application.

Fig. 1 is a schematic view of an embodiment of a cutting aid (i.e., cutting aid 100) of the present disclosure. The cutting aid 100 for assisting in cutting biological tissue according to the present disclosure includes a hollow sleeve 110, a first push rod 120 and a second push rod 130, wherein both ends of the hollow sleeve 110 are respectively provided with an opening and a cutting edge 112 is further provided on a wall of one side of the hollow sleeve. Structurally, the first push rod 120 slidably extends into one port of the hollow sleeve 110, and the second push rod 130 slidably extends into the other port of the hollow sleeve 110.

Fig. 2A and 2B are a perspective view and a cross-sectional view, respectively, of a cutting kit of the present disclosure, including the cutting aid 100 of the present disclosure and a blade 140. As shown, in a non-limiting embodiment, when cutting biological tissue T (e.g., a porcine corneal specimen) originating from a body using the cutting aid 100 of the present disclosure, the biological tissue T is first placed within the hollow cannula 110. Then, the first push rod 120 and the second push rod 130 slide in the hollow sleeve 110, so as to push the biological tissue T to a position below the incision 112, and the biological tissue T is clamped and fixed at a specific position by the first push rod 120 and the second push rod 130, respectively (fig. 2B). Thereafter, the blade 140 is inserted into the incision 112 to cut the biological tissue T; the excised biological tissue is then removed. In other embodiments, the above steps may be repeated according to the actual needs of the user, i.e., after each cutting, the position of the biological tissue T is adjusted to be located below the incision point, and the blade 140 is used again to cut the biological tissue T until the desired number of slices of the biological tissue T are obtained.

Fig. 3 is a schematic view of another embodiment of a cutting aid (i.e., cutting aid 200) of the present disclosure. The cutting aid 200 is similar in structure to the cutting aid 100 of fig. 1, and also includes a hollow sleeve 210 having an inlet 212; a first push rod 220 and a second push rod 230 are configured in a manner similar to that of the cutting aid 100 of fig. 1, and are not described herein again. The cutting aid 200 is different from the cutting aid 100 shown in fig. 1 in that the wall surface of the hollow sleeve 210 of the cutting aid 200 is provided with a scale, so that a user can more precisely adjust the fixing position and the cutting thickness of the biological tissue, thereby controlling the cutting size or improving the cutting accuracy.

It should be noted that the surface scale of the hollow sleeve 210 is disposed on both sides of the cutting edge 212, and is continuously disposed toward the other end with any end of the hollow sleeve 210 as an origin, and covers the position of the cutting edge 212, or continuously disposed toward the other side of the cutting edge 212 with one side of the cutting edge 212 as an origin, and covers the position of the cutting edge 212, so that the user can conveniently position the cutting site and adjust the cutting volume of the biological tissue T.

Fig. 4 is a schematic view of another embodiment of a cutting aid (i.e., cutting aid 300) of the present disclosure. The cutting aid 300 has a similar structure and configuration to the cutting aid 100, except that the hollow sleeve 310 of the cutting aid 300 includes a plurality of cutting edges 312, so that when the biological tissue T to be cut is cut for a plurality of times at multiple fixed points, the cutting can be directly performed for a plurality of times, and the biological tissue T can be omitted from being repositioned for a plurality of times, thereby achieving the effect of saving time. In some embodiments, the gap between adjacent inlet edges is about 1-10 mm, for example, about 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 mm. Preferably, the gap is about 2-5 mm, e.g., about 2, 2.5, 3, 3.5, 4, 4.5, 5 mm. More preferably, the gap is about 2 mm.

Fig. 5, 6A and 6B illustrate a cutting aid according to another embodiment of the present disclosure, wherein fig. 5 is an external view of the cutting aid 400, and fig. 6A and 6B are a back perspective view and a back exploded view thereof, respectively. As shown in the drawings, the cutting aid 400 has a similar structure and configuration to the cutting aid 100, except that a sampling opening is dug on one side of the wall of the hollow sleeve 410 of the cutting aid 400, and an openable cover 414 covers the sampling opening. One end of the cover 414 is coupled to the hollow sleeve 410, and the cover 414 is rotatably opened (fig. 6A and 6B). Alternatively, the connection between the cap 414 and the hollow sleeve 410 can be adjusted or changed by a person skilled in the art by using a snap-fit method or according to actual usage and general experience. In one embodiment, the cover 414 is provided with an inlet 412, so that the cut biological tissue T can be conveniently taken out by opening the cover 414 upwards after the biological tissue T is cut.

Fig. 7 is a schematic view of another embodiment of a cutting aid (i.e., cutting aid 500) of the present disclosure. The cutting aid 500 has a similar structure to the cutting aid 400, but the difference between the cutting aid 400 and the cutting aid 500 is that only one cutting inlet 412 is disposed on the cover 414, and a plurality of cutting inlets 512 are disposed on the cover 514 of the cutting aid 500.

Fig. 8 is a schematic view of another embodiment of a cutting aid (i.e., cutting aid 600) of the present disclosure. The cutting aid 600 has a similar structure to the cutting aid 100, except that the cutting aid 600 further comprises a first fixing member 616 and a second fixing member 618, wherein the first fixing member 616 and the second fixing member 618 respectively penetrate the hollow sleeve 610 through the through hole P (as shown by the arrow) to fix the first pushing rod 620 and the second pushing rod 630, so as to prevent the first pushing rod 620 and/or the second pushing rod 630 and the hollow sleeve 610 from generating relative displacement during cutting, so that the cutting aid cannot be positioned on the biological tissue T or cannot cut at a desired cutting site. The first and second fixing members 616 and 618 may be coupled to the hollow sleeve 610 by, for example, locking or inserting (e.g., bolts, screws, or pins). Alternatively, one skilled in the art may adjust or change the operation according to the actual usage and general experience. Optionally, the first push rod 620 and/or the second push rod 630 may be further provided with scales on the surface thereof. The scale is continuously provided from one end of the first push rod 620 and/or the second push rod 630 to the other end. Or, the scale is set at one end of the first push rod 620 and/or the second push rod 630 sliding into the hollow sleeve 610 or not sliding into the hollow sleeve 610, so as to assist the user in positioning the cutting site and adjusting the volume of the biological tissue T to be cut, thereby controlling the cutting size or improving the cutting accuracy.

In some embodiments, the hollow sleeve 210 of fig. 3, the first push rod 620 and the second push rod 630 of fig. 8 can be alternatively exchanged or combined with other hollow sleeves, first push rods and second push rods of the present disclosure, so that the user can easily position the cutting site and adjust the cutting volume of the biological tissue T according to his/her needs by using calibration to control the cutting size or improve the cutting accuracy. Therefore, the method of using the cutting aid of the present disclosure to assist cutting or using the cutting kit of the present disclosure to cut a biological tissue T further includes controlling the cutting thickness of the biological tissue T by using the surface scale of the hollow sleeve 210, the first push rod 620 and/or the second push rod 630. In a particular embodiment, the hollow sleeve has a cover, the surface of which may be provided with a scale.

In certain embodiments, the hollow cannula has a length of about 3 to 20 centimeters, for example, about 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, or 20 centimeters. Preferably, the hollow sleeve has a length of about 5-10 cm, for example, about 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 cm. More preferably, the hollow cannula is about 7 centimeters in length.

In certain embodiments, the hollow casing has a tube diameter of about 0.5 to 5 centimeters, e.g., about 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, or 5.0 centimeters. Preferably, the hollow conduit has an internal tube diameter of about 1-4 cm, for example, about 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0 cm. More preferably, the internal diameter of the hollow pipe is about 1.3 cm.

In certain embodiments, the feed opening width is about 0.1 to 2 millimeters, e.g., about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 millimeters. Preferably, the width of the feed opening is about 1 mm.

In some embodiments, the cutting area of the blade at the cutting inlet is about 5% to 99% of the cross-sectional area of the inner tube of the hollow cannula, e.g., about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99%. Preferably, the cut area is about 50% -95% of the cross-sectional area of the inner tube of the hollow cannula, e.g., about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94% or 95%. More preferably, the cut area is about 70% -90% of the cross-sectional area of the inner tube of the hollow cannula, e.g., about 70%, 75%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89% or 90%. In one embodiment, the cutting area is about 50% of the cross-sectional area of the inner tube of the hollow cannula. In other embodiments, the cut area is about 75% of the cross-sectional area of the inner tube of the hollow cannula. In a specific embodiment, the cutting area is about 99% of the cross-sectional area of the inner tube of the hollow sleeve.

In addition, the structure of the outer tubular wall near the entry edge may be reinforced with a reinforcing material without affecting the extension of the blade into the entry edge, exemplary reinforcing materials include, but are not limited to, support sheets, clays, resins, synthetic plastics, and combinations thereof. For example, a layer of reinforcing material may be coated on the side of the outer tube wall near the cutting inlet to stabilize the structure of the hollow sleeve.

In a non-limiting embodiment, the first push rod and/or the second push rod has a length greater than that of the hollow sleeve, so that the first push rod and/or the second push rod can move relative to the hollow sleeve, thereby facilitating the extraction of the cut biological tissue. Additionally or alternatively, the shape of the end of the first and/or second push rod contacting the biological tissue T (e.g. a plane or a concave arc) can be adjusted according to the original curvature of the biological tissue T to be cut, so as to ensure that the biological tissue T does not deflect to any side of the tube wall during operation.

In optional embodiments, in order to facilitate the positioning of the cutting site of the biological tissue T when the biological tissue T is placed in the hollow sleeve, the first push rod, the second push rod and/or the cover body can be made of a transparent or translucent material. For example, the transparent or translucent material is glass or synthetic plastic, including, but not limited to, Polyethylene Terephthalate (PET), High Density Polyethylene (HDPE), polyvinyl chloride (PVC), Low Density Polyethylene (LDPE), Polypropylene (PP), Polystyrene (PS), Polycarbonate (PC), polylactic Acid (PLA), Acrylonitrile Butadiene Styrene (ABS), polymethyl methacrylate (PMMA), or a combination thereof. Alternatively, the first push rod and the second push rod may be made of opaque materials, such as wood, bamboo, opaque rigid plastic, rubber, rigid silica gel, composite materials or steel. In some embodiments, in order to facilitate the cutting operation and improve the accuracy of identifying the position, the hollow sleeve, the first push rod and/or the second push rod and the biological tissue may have a color difference contrast, that is, the hollow sleeve, the first push rod and/or the second push rod may use two or more colors with distinct contrast so as to be clearly identified by naked eyes.

While specific embodiments of the present disclosure have been disclosed in the foregoing specification, various changes and modifications may be suggested to one skilled in the art. The above specification, examples and experimental data provide a complete description of the disclosure as to structure and use in exemplary embodiments. Although various embodiments of the present disclosure have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this disclosure.