Rectal biopsy assisting tool
The rectal biopsy aid with a through-hole and display features addresses the challenges of inaccurate and costly existing methods by enabling precise and safe mucosal tissue collection in pediatric patients.
Patent Information
- Application Number
- JP2024005812
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-01-18
- Publication Date
- 2025-07-31
AI Technical Summary
Existing rectal biopsy methods face challenges such as difficulty in accurately collecting mucosal tissue due to poor visibility and unknown sampling position, especially in pediatric patients, with methods like biopsy forceps and suction biopsy having limitations in precision and cost.
A rectal biopsy aid with a cylindrical main body, a through-hole, a protrusion amount display, and a biopsy position display, designed to facilitate accurate and safe mucosal tissue collection by indicating the appropriate protrusion amount and position.
Enables simple and precise mucosal tissue collection in a predetermined region by ensuring the correct protrusion amount and position, reducing patient discomfort and operational complexity.
Smart Images
Figure 2025111895000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a rectal biopsy aid used for collecting rectal mucosal tissue in rectal biopsy.
Background Art
[0002] Conventionally, for patients with intestinal diseases, biopsy of intestinal mucosa has been performed. For example, for diseases such as Hirschsprung's disease, rectal mucosal biopsy is performed for its diagnosis. In addition, since Hirschsprung's disease is a congenital disease, transanal rectal mucosal biopsy is often performed in infancy.
[0003] As methods for tissue collection for transanal rectal mucosal biopsy, mainly, a method of collecting with biopsy forceps while directly observing with an anoscope, a method of collecting using a dedicated instrument for suction biopsy (for example, Rbi2 Suction Rectal Biopsy System manufactured by Aus systems), etc. are available. In the method using biopsy forceps, since an examiner such as a doctor collects tissue while directly observing the rectal mucosa, it is possible to accurately collect tissue at an appropriate depth. However, there are problems such as the sampling operation becoming difficult when the visual field becomes poor due to the influence of bleeding, feces, etc., and it is difficult to know the distance from the anus.
[0004] In addition, although suction biopsy can easily collect tissue, since the tip of the suction device is blindly inserted from the anus and the rectal mucosa is suctioned for tissue collection, the sampling site is not observed, the sampling position is unknown, and the possibility of failure is relatively high at about 10 to 30%, and there are problems such as the dedicated instrument used for suction biopsy being expensive.
[0005] In response to the above problems, the K-PUNCH method has been developed as a simple and highly successful tissue sampling method (Non-Patent Document 1). In the K-PUNCH method, a rectal biopsy aid with a through-hole formed near the tip of a cylindrical blood collection tube with a hemispherical tip is used. Specifically, the rectal biopsy aid is inserted through the patient's anus. When the inserted rectal biopsy aid expands the rectum, the rectal mucosa protrudes into the interior of the rectal biopsy aid through the through-hole. An examiner such as a doctor holds the rectal mucosa protruding inside with forceps and rotates the cylindrical rectal biopsy aid around the central axis to excise and collect the rectal mucosal tissue.
[0006] According to the K-PUNCH method, since the rectal biopsy aid, which is a cylindrical blood collection tube, is rotated to collect the rectal mucosal tissue, it is possible to compress the tissue sampling site of the expanded rectum against the outer surface of the rectal biopsy aid to stop bleeding. Therefore, it is possible to collect mucosal tissue from multiple locations in a short time without causing poor visibility due to bleeding at the tissue sampling site.
Prior Art Documents
Non-Patent Documents
[0007]
Non-Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0008] In the K-PUNCH method of Non-Patent Document 1, each time a biopsy is performed, the examiner forms a through-hole in the blood collection tube to create the instrument. Therefore, the position, shape, etc. of the through-hole are not constant, and it is difficult to accurately collect tissue in areas necessary for biopsy such as size and depth.
[0009] The present invention has been made in view of the above circumstances, and an object thereof is to provide a rectal biopsy assisting tool that can simply and accurately collect mucosal tissue in a predetermined region.
Means for Solving the Problems
[0010] To achieve the above object, a rectal biopsy assisting tool according to the present invention includes a cylindrical main body portion that is inserted into the rectum of a patient and has a closed tip portion on the insertion side and an open base end portion on the side opposite to the tip portion, a through hole formed in the wall portion of the main body portion, and a protruding amount display portion that protrudes near the insertion side of the through hole on the inner wall of the main body portion and indicates an appropriate protruding amount of the biopsy site.
[0011] Further, the peripheral edge portion of the through hole may be inclined so as to become thinner from the outer wall side toward the inner wall side. This may also be the case.
[0012] Further, the main body portion may be transparent or translucent. This may also be the case.
[0013] Further, the outer shape of the tip portion may be a sharp dome shape. This may also be the case.
[0014] Further, the main body portion may be provided with a biopsy position display portion formed on the outer wall and representing the distance from the center of the through hole. This may also be the case.
[0015] Further, the outer diameter of the main body portion may be 10 mm or more and 14 mm or less. This may also be the case.
Effects of the Invention
[0016] Since the rectal biopsy aid of the present invention is provided with a protrusion amount display portion protruding in the vicinity of the insertion side of the through hole on the inner wall of the cylindrical main body portion, it is possible to easily determine whether or not the protrusion amount of the biopsy site is appropriate. Therefore, it is possible to simply and accurately collect mucosal tissue in a predetermined region.
Brief Description of the Drawings
[0017]
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
Figure 8
Embodiments for Carrying Out the Invention
[0018] Hereinafter, a rectal biopsy aid according to the present invention will be described with reference to the drawings. In the present embodiment, a rectal biopsy aid 1 used for rectal mucosal biopsy of children will be described as an example.
[0019] The rectal biopsy aid 1 is an aid that is inserted into the rectum of a patient and used for collecting rectal mucosal tissue. As shown in FIGS. 1 and 2, the rectal biopsy aid 1 includes a cylindrical main body 11 having a closed tip 111 and an open base end 112. From the viewpoints of safety, manufacturing cost, etc., the material of the rectal biopsy aid 1 is preferably a resin, for example, a transparent or translucent resin such as polypropylene or polyethylene that is widely used in medical instruments. By making the rectal biopsy aid 1 of a transparent or translucent resin, the light irradiated by a penlight or the like from the open base end 112 outside the body is guided by the main body 11. Therefore, since the rectal mucosa, which is the tissue collection area, and the lumen of the rectal biopsy aid 1 can be observed directly by visual recognition, it is possible to perform tissue collection safely and reliably.
[0020] The size of the main body 11 may be determined based on the size of the body of the target patient, etc. For example, when targeting pediatric patients, it is preferable that the outer diameter of the main body 11 be 10 mm or more and 14 mm or less. Thereby, the rectum of pediatric patients can be moderately expanded. The rectal biopsy aid 1 according to the present embodiment has a length of 80 mm, an outer diameter of 12 mm, an inner diameter of 10 mm, and a thickness of 1 mm in the central axis direction of the main body 11.
[0021] The tip 111 is the closed end on the side where the rectal biopsy aid 1 is inserted from the anus into the rectum (hereinafter, also simply referred to as the insertion side). The outer shape of the tip 111 is a sharp dome shape. Thereby, compared with the case where the tip is flat or the case where it is a hemispherical dome shape like a blood collection tube, the resistance when inserting the rectal biopsy aid 1 into the anus is reduced, and the burden on the patient can be reduced.
[0022] The proximal end portion 112 is an open end portion on the side opposite to the distal end portion 111 of the rectal biopsy assisting device 1 (hereinafter, also simply referred to as the proximal end side). A flange-shaped stopper 112a is integrally formed on the proximal end portion 112. Thereby, it is possible to prevent the entire rectal biopsy assisting device 1 from entering the rectum. The outer dimensions of the stopper 112a are not particularly limited and may be determined in consideration of the magnitude of the resistance when passing through the anus, the ease of operation of the examiner, the manufacturing cost, and the like. For example, the outer diameter of the stopper 112a may be set to be about 2 to 8 mm larger than the outer diameter of the main body portion 11. In the present embodiment, the flange width of the stopper 112a is 1 mm and the outer diameter of the stopper 112a is 14 mm.
[0023] Also, as shown in FIGS. 1 and 2, the rectal biopsy assisting device 1 includes a through hole 12, a protrusion amount display portion 13, and a biopsy position display portion 14.
[0024] The through hole 12 is formed so as to penetrate the wall portion of the main body portion 11. The position of the through hole 12 is not particularly limited, but by setting it at a position close to the distal end portion 111, the insertion amount of the rectal biopsy assisting device 1 can be reduced, so that the operation of tissue collection becomes easy and the physical burden on the patient is reduced, which is preferable.
[0025] The size of the through hole 12 is not particularly limited, but it is preferably a size that can collect the target tissue for biopsy at an appropriate depth. For example, when performing a rectal mucosa biopsy for Hirschsprung's disease, it is preferably circular or elliptical with a diameter of 6 mm or more and 9 mm or less so that ganglion cells in the submucosa can be collected. The through hole 12 according to the present embodiment is an ellipse having a major axis of 8 mm in the central axis direction (insertion direction) of the rectal biopsy assisting device 1 and a minor axis of 7 mm in the circumferential direction orthogonal to the central axis direction. Thereby, when the outer diameter of the rectal biopsy assisting device 1 is 12 mm, a part of the rectum expanded by the rectal biopsy assisting device 1 protrudes into the inside of the rectal biopsy assisting device 1 (hereinafter, also referred to as the lumen) with an appropriate protrusion amount. Note that since the rectal biopsy assisting device 1 according to the present embodiment is intended for pediatric patients, if the patient is an adult, the outer diameter of the rectal biopsy assisting device 1 and the diameter of the through hole 12 may be increased and adjusted.
[0026] Also, as shown in FIGS. 1 and 2, the peripheral edge of the through-hole 12 is inclined so as to become thinner from the outer wall side toward the inner wall side. The degree of inclination in the present embodiment is equivalent to chamfering of 45 degrees. Thereby, due to the contraction force of the rectum expanded by inserting the rectal biopsy assisting tool 1, the rectal mucosa easily protrudes into the lumen of the rectal biopsy assisting tool 1. Further, since the inner wall side is thinner, it becomes easier to excise the rectal mucosa by rotating the rectal biopsy assisting tool 1 around the central axis. Therefore, mucosal tissue can be collected without excessively damaging the patient's rectum.
[0027] The protrusion amount display portion 13 is a substantially hemispherical convex portion integrally formed in the vicinity of the through-hole 12 on the inner wall of the main body portion 11, and is not limited to one. As shown in the cross-sectional view of FIG. 2, the position of the protrusion amount display portion 13 is preferably located in the vicinity of the tip side of the through-hole 12 on the inner wall of the main body portion 11. The protrusion amount display portion 13 protrudes so as to have a height of about 1 mm from the inner wall of the main body portion 11. When the rectal biopsy assisting tool 1 is inserted into the patient's rectum, the protrusion amount display portion 13 is hidden by the rectal mucosa protruding from the through-hole 12 into the lumen of the rectal biopsy assisting tool 1. The examiner can easily determine whether mucosal tissue can be collected at an appropriate depth by observing the lumen of the rectal biopsy assisting tool 1 from the proximal end portion 112 and checking whether the protrusion amount display portion 13 is hidden by the rectal mucosa.
[0028] Also, the protrusion amount display portion 13 is preferably formed about 1 mm on the tip side from the edge of the through-hole 12. Thereby, when looking into the lumen from the proximal end portion 112, it becomes easier to focus on both the protruding rectal mucosa and the protrusion amount display portion 13, so that the operation of tissue collection can be facilitated.
[0029] The biopsy position display unit 14 is formed on the outer wall of the main body unit 11 and is a scale indicating the distance from the center of the through hole 12. As shown in FIG. 1, the biopsy position display unit 14 includes numbers indicating the distance from the center of the through hole 12 and lines formed in the circumferential direction for each such distance. The distance from the center of the through hole 12 displayed as the biopsy position display unit 14 is, for example, 30 mm, 40 mm, 50 mm, etc. Thereby, the examiner can easily grasp the distance from the anus to the through hole 12, that is, the distance from the anus to the tissue sampling position.
[0030] The biopsy position display unit 14 is integrally formed as a convex portion or a concave portion in the rectal biopsy assistive device 1 made of resin. Also, in the present embodiment, the number arranged at the circumferential center of the biopsy position display unit 14 is formed coaxially with the center of the through hole 12 in the central axis direction of the rectal biopsy assistive device 1. Thereby, since the position in the rotational direction of the through hole 12 can be grasped without looking into the inner cavity of the rectal biopsy assistive device 1, it is possible to more easily collect mucosal tissue.
[0031] Hereinafter, a method for tissue sampling for biopsy using the rectal biopsy assistive device 1 according to the present embodiment will be described.
[0032] First, an examiner such as a doctor inserts the rectal biopsy assistive device 1 from the anus of a pediatric patient. While confirming the biopsy position display unit 14 of the rectal biopsy assistive device 1, the examiner inserts the rectal biopsy assistive device 1 until the through hole 12 reaches a predetermined position. The examiner stops inserting the rectal biopsy assistive device 1 at the predetermined position.
[0033] Subsequently, the examiner observes from the proximal end portion 112 while illuminating the inner cavity of the rectal biopsy assistive device 1 with a lighting device such as a penlight. Since the outer diameter of the rectal biopsy assistive device 1 is set larger than the normal inner diameter of the patient's rectum, the rectum is expanded as the rectal biopsy assistive device 1 is inserted. Therefore, due to the contraction force of the expanded rectum, the rectal mucosa protrudes into the inner cavity of the rectal biopsy assistive device 1. The examiner confirms whether the protruding rectal mucosa is an appropriate amount using the protrusion amount display unit 13.
[0034] When the height of the protruding rectal mucosa is lower than the top of the protrusion amount display portion 13 and the protrusion amount is insufficient (Fig. 3(A)), the examiner operates the rectal biopsy assisting tool 1 to press the through hole 12 against the rectum. Also, when the height of the protruding rectal mucosa is higher than the protrusion amount display portion 13 and the protrusion amount is excessive (Fig. 3(B)), the examiner operates the rectal biopsy assisting tool 1 in a direction to separate the through hole 12 from the rectum.
[0035] When it can be determined that the height of the protruding rectal mucosa is approximately equal to the height of the top of the protrusion amount display portion 13 and the protrusion amount is appropriate (Fig. 3(C)), the examiner inserts forceps from the proximal end portion 112 and grips the rectal mucosa protruding into the inner cavity of the rectal biopsy assisting tool 1 with the forceps. While gripping the rectal mucosa, the examiner rotates the rectal biopsy assisting tool 1 around the central axis to excise and collect the mucosal tissue at the biopsy site at the edge on the inner wall side of the through hole 12.
[0036] After the tissue is collected, the outer wall portion of the rotated rectal biopsy assisting tool 1 is pressed against the excised portion of the rectal mucosa by the contraction force of the rectum. As a result, the excision site can be hemostatic, so that the collection of mucosal tissue from other sites can be continuously performed. After the necessary tissue collection is completed, the examiner removes the rectal biopsy assisting tool 1 from the patient's anus.
[0037] As described above, the rectal biopsy assisting tool 1 according to the present embodiment is provided with a protrusion amount display portion 13 that protrudes near the insertion side of the through hole 12 on the inner wall of the main body portion 11 and shows an appropriate protrusion amount of the biopsy site, so that it is possible to simply and accurately collect mucosal tissue in a predetermined region.
[0038] Further, the peripheral edge portion of the through hole 12 of the rectal biopsy assisting tool 1 according to the present embodiment is inclined so as to become thinner from the outer wall side toward the inner wall side, so that the rectal mucosa easily protrudes from the through hole 12 to the inner cavity side, and the protruding rectal mucosa is easily excised.
[0039] Further, since the main body portion 11 of the rectal biopsy assisting tool 1 according to the present embodiment is transparent or translucent, the inside of the rectum can be easily visually recognized during tissue collection related to biopsy, and tissue collection can be performed more safely and reliably.
[0040] In addition, since the outer shape of the tip portion 111 of the rectal biopsy aid 1 according to the present embodiment is a pointed dome shape, the resistance when inserting the rectal biopsy aid 1 from the patient's anus is small, and the burden on the patient can be reduced.
[0041] In addition, since the main body portion 11 of the rectal biopsy aid 1 according to the present embodiment is formed on the outer wall and includes a biopsy position display portion 14 that represents the distance from the center of the through hole 12, the examiner can easily grasp the distance from the anus to the through hole 12, that is, the distance from the anus to the tissue sampling position.
[0042] In addition, since the outer diameter of the main body portion 11 of the rectal biopsy aid 1 according to the present embodiment is 10 mm or more and 14 mm or less, the rectum of a pediatric patient can be appropriately expanded, and the rectal mucosa at the biopsy site can be properly protruded into the lumen of the rectal biopsy aid 1.
[0043] In the present embodiment, the protrusion amount display portion 13 is a substantially hemispherical convex portion, but it is not limited to this. For example, as shown in FIG. 4, the protrusion amount display portion 13 may have a two-step shape with the insertion side being high and the proximal end side being low. Further, as shown in FIG. 5, the protrusion amount display portion 13 may be two convex portions having different heights. In this case, it is preferable that the two convex portions are arranged side by side so that their positions in the central axis direction are the same, or are arranged such that the insertion side is high and the proximal end side is low. Thereby, the protrusion amount display portion 13 can indicate the lower limit standard and the upper limit standard of the protrusion amount. Therefore, it is possible to determine whether the protrusion amount of the mucosal tissue is an appropriate amount between the lower limit standard and the upper limit standard, so that more accurate tissue sampling at a depth can be performed.
[0044] In addition, as shown in FIG. 6, the protrusion amount display portion 13 may be continuously formed from the vicinity of the through hole 12 toward the insertion side in the central axis direction of the rectal biopsy aid 1 to the tip portion 111. Thereby, the undercut can be eliminated, so that it can be mass-produced inexpensively by injection molding without using a 3D printer or the like.
[0045] In addition, although the position of the protrusion amount display unit 13 according to the present embodiment is on the tip side of the hole portion of the through hole 12, it is not limited thereto. Specifically, the position of the protrusion amount display unit 13 may be in the vicinity of the tip side of the through hole 12, that is, as long as the center of the protrusion amount display unit 13 is on the tip side of the center of the through hole 12. For example, as shown in the cross-sectional view of FIG. 7(A) and the side view from the proximal end side of FIG. 7(B), the protrusion amount display unit 13 may be arranged such that the position in the central axis direction is between the center of the through hole 12 and the tip side end of the hole portion of the through hole 12. By setting the position of the protrusion amount display unit 13 in the vicinity of the tip side of the through hole 12, it is possible to prevent interference with the gripping of the mucosal tissue by the forceps.
[0046] In addition, in the present embodiment, it is determined whether the protrusion amount of the mucosal tissue is appropriate based on the height of the vertex of the protrusion amount display unit 13, but it is not limited thereto. For example, as shown in the cross-sectional view of FIG. 8(A) and the side view from the proximal end side of FIG. 8(B), it may be determined whether the protrusion amount is appropriate by comparing the position of the side portion of the substantially hemispherical convex portion with the position of the top of the mucosal tissue protruding from the through hole 12. As a result, it is difficult for the protrusion amount display unit 13 to be hidden by the protruding mucosal tissue, so that the protrusion amount can be evaluated more easily.
Industrial Applicability
[0047] The present invention is suitable for tissue collection related to rectal biopsy. In particular, it is suitable for tissue collection related to rectal biopsy of small pediatric patients such as the rectum and anus.
Explanation of Reference Numerals
[0048] 1 Rectal biopsy assisting device, 11 Main body portion, 111 Tip portion, 112 Base end portion, 112a Stopper, 12 Through hole, 13 Protrusion amount display unit, 14 Biopsy position display unit
Claims
1. a cylindrical main body portion that is inserted into the patient's rectum and has a closed distal end portion on the insertion side and an open proximal end portion on the opposite side to the distal end portion; a through hole formed in a wall of the main body; a protrusion amount indicator provided on the inner wall of the main body portion near the insertion side of the through hole, the protrusion amount indicator indicating an appropriate protrusion amount of the biopsy site. A rectal biopsy aid characterized by:
2. The peripheral edge of the through hole is inclined so as to become thinner from the outer wall side toward the inner wall side.
2. The rectal biopsy aid according to claim 1.
3. The main body is transparent or translucent.
2. The rectal biopsy aid according to claim 1.
4. The outer shape of the tip is a pointed dome shape.
2. The rectal biopsy aid according to claim 1.
5. the main body portion includes a biopsy position indicator formed on an outer wall thereof and indicating a distance from the center of the through-hole; 2. The rectal biopsy aid according to claim 1.
6. The outer diameter of the main body is 10 mm or more and 14 mm or less.
2. The rectal biopsy aid according to claim 1.