JP6906252B2 - Medical equipment - Google Patents

Description

The present invention relates to a medical device in which a resin layer that emits red or near-infrared fluorescence is adhered to a fingertip.

Endoscopy is used to diagnose cancers and the like that have developed in the mucous membranes of tubular human tissues such as the rectum. Palpation, in which the operator's finger is inserted into the body, is also used for diagnosis. Therefore, it has been proposed to attach an imaging device to the tip of the finger cot and to provide the finger cot with a window opening for palpation (Patent Document 1).

Japanese Unexamined Patent Publication No. 2002-291746

By attaching the finger cot described in Patent Document 1 to a finger and inserting the finger into a tubular human tissue such as the rectum, the surface condition of the tubular human tissue on the mucosal side can be observed and the mucosal tissue can be palpated. Furthermore, when a treatment for removing the cancer is required, it is possible to perform a puncture treatment while observing the affected area.

On the other hand, when surgically excising the cancer that has developed on the mucous membrane of the tubular human tissue, it is necessary to identify the position of the cancer from the serosal side of the tubular human tissue. However, even if the finger cot described in Patent Document 1 is used, the position of the cancer cannot be specified from the serosal side. Therefore, for example, when rectal cancer is diagnosed by endoscopy or palpation, it is standard to excise the area where the diagnosed cancer has a margin of about 2 cm in the anterior-posterior direction. This may remove the anus for which the presence of cancer has not been confirmed and may require an artificial anus.

On the other hand, the present invention makes it possible to identify the position of the affected area from the serosa side of the tubular human tissue when the doctor identifies the position of the affected area by palpating the mucous membrane of the tubular human tissue such as the rectum. Is the subject.

The present inventor adheres a resin layer that emits red fluorescence or near-infrared fluorescence to the tip of a finger to be palpated, and by observing the fluorescence emitted by the resin layer from the serosa side, the mucosal side is palpated. The present invention was completed with the idea that the position of the affected area identified in 1 can be specified from the serosal side.

That is, the present invention provides a medical device in which a resin layer that emits red fluorescence or near-infrared fluorescence is adhered to a fingertip.

According to the present invention, a resin layer that emits red fluorescence or near-infrared fluorescence can be adhered to the fingertips. Therefore, by observing the fluorescence emitted by the resin layer, the affected area identified by palpation on the mucosal side It is possible to specify the position of the resin from the serosa side. Therefore, when surgically excising the affected area identified by palpation on the mucosal side, the margin of the excision range required because the location of the affected area cannot be accurately determined should be significantly reduced or eliminated. And the excision range can be minimized. Therefore, for example, it becomes possible to preserve the anus that was previously unnecessarily excised, and the burden on the patient is reduced.

Further, according to the present invention, since palpation is possible, it is possible to accurately diagnose the size of cancer from the hardness of the mucous membrane.

FIG. 1 is a front view of the medical device 1A having a finger cot shape. FIG. 2A is an explanatory diagram of the position of the affected part in the body when the affected part is in the rectum. FIG. 2B is an explanatory diagram of a method of identifying the position of the affected portion in the rectum with the medical device 1A of the embodiment. FIG. 3 is a perspective view of the medical device 1B of the embodiment. FIG. 4 is a perspective view of the medical device 1C of the embodiment. FIG. 5 is a perspective view of the medical device 1D of the embodiment. FIG. 6 is a perspective view of the medical device 1E of the embodiment. FIG. 7 is a perspective view of the medical device 1F of the embodiment. FIG. 8A is a perspective view of the medical device 1G of the embodiment. FIG. 8B is a perspective view of the medical device 1G of the embodiment attached to the glove. FIG. 9A is a perspective view of the medical device 1H of the embodiment. FIG. 9B is a perspective view of the medical device 1H of the embodiment attached to the glove. FIG. 10A is an image of the medical device 1A of the embodiment taken by a digital color camera under white illumination. FIG. 10B is an image of the front surface of the medical device 1A of the embodiment placed behind the silicone sheet when the front surface of the silicone sheet is photographed by a digital color camera under white illumination. FIG. 10C is an image of the front surface of the medical device 1A of the embodiment placed behind the silicone sheet, the front surface of the silicone sheet is irradiated with excitation light, and the front surface thereof is photographed by a near-infrared color system.

Hereinafter, the present invention will be described in detail with reference to the drawings. In each figure, the same reference numerals represent the same or equivalent components.

(Finger cot-shaped medical device)
FIG. 1 is a front view of the medical device 1A according to an embodiment of the present invention having a finger cot shape, and the broken line represents a hand wearing the finger cot-shaped medical device 1A on a finger. As described above, the medical device of the present invention is coated with a resin layer that emits red fluorescence or near-infrared fluorescence around the fingertips, particularly the pad of the finger or the pad of the finger. More specifically, the medical device 1A has a length that covers the first joint of the finger from the fingertip when worn on the finger, and also has a fenestration portion 2 that exposes at least the central portion of the finger pad. Have. The presence of the fenestration 2 allows the operator to easily perform palpation using the pad of the finger exposed from the fenestration 2.

The size of the window opening portion 2 is preferably 5 to 15 mm in width w1 and 5 to 20 mm in length h1 from the viewpoint of enabling palpation. On the other hand, as will be described later, when the window portion of the medical device 1A is applied to the affected part on the mucosal side of the human body tissue and irradiated with excitation light, the resin layer of the medical device 1A fluoresces, so that the fluorescence image is displayed from the serosa side. When observed, the window opening portion 2 is dark, and the circumference of the window opening portion 2 is observed brightly in a ring shape, and the position of the window opening portion, that is, the position of the affected portion can be specified, but the position of the affected portion can be specified more accurately. From the viewpoint of making it possible, it is preferable that the width w1 of the window opening portion 2 is 10 to 15 mm and the length h1 is 10 to 20 mm. On the other hand, if the size of the window opening portion 2 is too small, the light emitting portion observed from the serosa side does not form a ring shape, and the portion corresponding to the window opening portion 2 also appears to emit light. It becomes difficult to accurately identify the position, and conversely, if it is too large, it becomes difficult to identify where the affected area is in the darkly observed part.

(Resin that forms medical devices)
The medical device 1A is made of a resin that emits red fluorescence or near-infrared fluorescence. As the resin that emits red fluorescence or near-infrared fluorescence, for example, a flexible resin in which a fluorescent dye is kneaded can be used. Here, as the flexible resin, one obtained by blending polyurethane, polypropylene, polyethylene, polyvinyl chloride, polyamide, polyamide elastomer or the like with a curing agent, if necessary, can be used. It is preferable that the shore hardness after curing is 30A to 70A. Further, by using a resin having an elongation at the time of cutting of 300% or more, the fit feeling when the finger cot-shaped medical device 1A is fitted to the fingertip is improved.

The preferable thickness of the resin layer forming the finger cot shape is determined according to the emission intensity of the resin layer containing the fluorescent dye, and therefore varies depending on the type and concentration of the fluorescent dye, but is usually 0.1 to 2 mm in thickness. preferable.

(Fluorescent dye)
The fluorescent dye to be kneaded into the flexible resin is preferably one that fluoresces in the red to near infrared wavelength range of 600 to 1400 nm, preferably in the red light or near infrared light wavelength range of 700 to 1100 nm. Light in such a wavelength range is highly permeable to human tissues such as skin, fat, and muscle, and can reach the serosal surface from the mucous membrane of tubular human tissues such as the rectum.

Examples of the fluorescent dye that fluoresces in the above-mentioned wavelength range include riboflavin, thiamine, NADH (nicotinamide adenine dinucleotide), indocyanine green (ICG), an azo-boron complex compound described in JP2011-162445, WO2016 / 132596. Examples thereof include dyes having a fused ring structure described in Japanese Patent Publication No.

The preferable concentration of the fluorescent dye in the resin that emits near-infrared fluorescence is determined according to the type of the fluorescent dye and the resin used as the binder, and is usually preferably 0.001 to 1% by mass.

As a method of incorporating the fluorescent dye into the flexible resin, for example, the fluorescent dye is kneaded into the resin using a twin-screw kneader. After that, it may be formed into a finger cot shape by extrusion molding or injection molding.

(Additive)
A contrast agent such as barium sulfate may be added to the fluorescent resin, if necessary. As a result, even if the medical device 1A is removed from the finger in the living body, the medical device 1A in the living body can be tracked by photographing it with an X-ray.

(How to use medical equipment)
As a method of using the medical device 1A, for example, when the position X of the rectal cancer shown in FIG. 2A can be identified from the serosa side, first, the operator's hand, preferably the operator's hand wearing surgical gloves. A finger cot-shaped medical device 1A is fitted to the finger of the finger as shown in FIG. In this case, the fenestration portion 2 is positioned on the pad of the finger.

Next, as shown in FIG. 2B, a finger fitted with a finger cot-shaped medical device 1A is inserted into the rectum from the anus, the rectum is palpated to identify the position of the cancer, and the finger is exposed from the fenestration 2. Hold the cancer with the pad of your finger. Then, the serosa side of the rectum is irradiated with excitation light for emitting red fluorescence or near-infrared fluorescence from the resin forming the medical device 1A, and the fluorescence emitted by the medical device 1A is observed from the serosa side.

Here, as a method of illuminating the excitation light, the serosa of the rectum may be exposed by laparotomy and the excitation light may be irradiated there. A surgical endoscope is inserted through a hole made in the abdominal wall and irradiated from the serosa side. You may. The wavelength of the excitation light is shorter than the wavelength of fluorescence, but the wavelength range of the excitation light that emits red fluorescence or near-infrared fluorescence is also highly transparent to human tissue, and the excitation light irradiated to the serous membrane side is the tissue of the rectum or It is absorbed by the medical device 1A on the mucosal side with almost no inhibition of absorption by blood, and the resin layer of the medical device 1A emits red fluorescence or near-infrared fluorescence. Therefore, when the fluorescence is red, it is observed with the naked eye, when the fluorescence is near infrared, it is observed through a known infrared visual conversion glass, or the rectum is photographed from the serosa side, and the near infrared is imaged. By visualizing the fluorescence, the ring-shaped light emission by the medical device 1A can be easily observed from the serosa side, and further, the dark part by the window opening 2 inside the ring-shaped light emitting part is used as the cancer occurrence position. Can be identified. If the position of the cancer can be identified from the serosal side in this way, a mark can be made with an electric knife, and the mark can be used as a guide when excising the affected area.

The application scene of the medical device 1A of the present invention is not limited to specifying the position of the affected part within the reach of the medical device 1A by inserting a finger from the outside of the human body as in the rectum described above. For example, a finger wearing a medical device 1A is inserted into a hole made in the abdominal wall for insertion of a laparoscope or a surgical instrument, and further inserted into the gastric cavity through a hole made in the stomach wall, and the position of the affected part in the gastric mucosa. Can also be used to identify from the gastric serosal side.

The position of the affected area can also be specified by the light emission of the fluorescent dye-containing resin attached to the clip by sandwiching the mucous membrane of the affected area with a metal clip described in Japanese Patent No. 1661096 and observing from the serosa side. However, there is a risk that the metal clip will hit the scalpel during excision of the affected area and the scalpel will be damaged. On the other hand, according to the medical device of the present invention, there is no possibility that the scalpel will be damaged even if the scalpel hits the medical device of the present invention for excision of the affected portion.

(Deformation mode of medical equipment)
The medical device of the present invention can take various aspects. For example, the medical device 1B shown in FIG. 3 has a take-out thread 3 attached to the end of the medical device 1A shown in FIG. 1 by adhesion or welding. Since the medical device 1B is attached with the take-out thread 3, even if the medical device 1B comes off from the fingertip in the body, the medical device 1B can be easily taken out from the body by picking and pulling the take-out thread 3.

In addition, in order to firmly attach the take-out thread 3 to the medical device main body 1, it is preferable to secure a sufficient length of the adhesive region 3a of the take-out thread 3.

The medical device 1C shown in FIG. 4 has a length of the medical device 1A shown in FIG. 1 so as to cover the second joint from the fingertip, and is below the opening portion 2 (that is, the finger insertion opening side). ) With an infrared or near-infrared light opaque resin with scales 4 at predetermined intervals. As a result, when observing the medical device 1C on the mucosal side from the serosa side, the fenestration portion 2 and the scale 4 are observed as dark areas in the finger cot type light emitting region, and this scale is used as a guideline for the excision margin of the affected portion. Can be used.

The medical device 1D shown in FIG. 5 has holes 5 punched out in a scale shape in the medical device 1C shown in FIG. 4 instead of forming the scale with an infrared or near infrared light opaque resin. Infrared or near-infrared light opaque resin layer by attaching the infrared or near-infrared light opaque resin film 6 to the main body 1 of the medical device, printing the infrared or near-infrared light opaque resin layer, etc. Is provided. Since a resin that emits infrared or near-infrared fluorescence is exposed from this hole 5, when the medical device 1D is observed from the serous membrane side by irradiating with excitation light, the fingertip of the medical device 1D fitted to the finger. On the side, the window opening portion 2 is observed as a dark portion in the finger cot type light emitting region, and a scale that emits light in the dark portion region can be observed on the lower side of the window opening portion.

The medical device 1E shown in FIG. 6 has a glove shape, and has a ring-shaped printing layer 8 formed of a resin that emits red or near-infrared fluorescence on the pad of the index finger of the glove 7. .. The ring-shaped printing layer 8 is formed so as to surround the central portion of the pad of the finger.

As the gloves 7, general surgical gloves made of natural rubber or synthetic rubber can be used.

According to the medical device 1E, the position of the affected part is specified by palpation with a fingertip having a ring-shaped printing layer 8 of the hand on which the medical device 1E is fitted. Then, excitation light is irradiated from the serosa side to cause the ring-shaped printing layer 8 to emit red or near-infrared fluorescence, and the fluorescence is observed from the serosa side in the same manner as in the medical device 1A shown in FIG. The affected part can be accurately identified as a dark part inside the ring-shaped light emitting part according to 8.

The medical device 1F shown in FIG. 7 is the same as the medical device 1E having the glove shape shown in FIG. 6 in place of the ring-shaped printing layer 8 formed of a resin that emits red fluorescence or near-infrared fluorescence. A circular printing layer 9 made of resin is provided. According to the medical device 1F, the affected part can be accurately identified as a circular light emitting part by observing the fluorescent light emitting part from the serosa side as in the medical device 1A shown in FIG.

The medical device 1G shown in FIG. 8A has an adhesive layer on one side of a ring-shaped resin layer 10 formed of a resin that emits red fluorescence or near-infrared fluorescence, similar to the ring-shaped printing layer 8 shown in FIG. Is provided, and the adhesive layer thereof is attached on the release film 11. This is a seal-shaped medical device.

The resin layer 10 of the seal-shaped medical device 1G preferably has a size that can be attached to the inside of the finger pad. Therefore, the medical device 1G is peeled off from the release film 11, and as shown in FIG. 8B, the ring-shaped resin layer 10 is attached to the surgical glove 12, which is abbreviated as the glove-type medical device 1E shown in FIG. A similar configuration can be obtained. According to this medical device 1G, the medical device of the present invention can be constructed at a lower cost by using the surgical gloves 12 that are used on a daily basis. Further, as a method of using the seal-shaped medical device 1G, the ring-shaped resin layer 10 may be directly attached to the pad of the finger, and the surgical gloves 12 may be worn on the ring-shaped resin layer 10. This makes it possible to eliminate the possibility that the ring-shaped resin layer 10 will come off into the body during palpation.

The medical device 1H shown in FIG. 9A is a seal-shaped medical device in which the ring-shaped resin layer 10 is formed on the circular resin layer 13 in the medical device 1G shown in FIG. 8A. This medical device 1H is also peeled off from the release film 11, and by attaching a circular resin layer 13 to the surgical glove 12 as shown in FIG. 9B, the configuration is substantially the same as that of the glove-type medical device 1F shown in FIG. Can be obtained. As a method of using this seal-shaped medical device 1H, the circular resin layer 13 is directly attached to the pad of the finger, and the surgical gloves 12 are worn on the circular resin layer 13 so that the circular resin layer 13 may peel off into the body. It may be resolved.

The features of the medical device of the present invention described above can be appropriately combined, and for example, the take-out thread 3 may be provided on the finger cot-shaped medical devices 1C and 1D shown in FIGS. 4 and 5.

Hereinafter, the present invention will be specifically described based on Examples.
A dye having a condensed ring structure described in WO2016 / 132596 is kneaded with ABS resin to produce a finger cot type medical device 1A having a thickness of 2 mm as shown in FIG. 1, and the medical device 1A is fitted to a finger. rice field. An image of the medical device 1A fitted on the finger taken with white illumination is shown in FIG. 10A.

A medical device fitted on a finger was placed behind a silicone sheet (thickness 3 mm) 14 that imitated human tissue, and was photographed with a digital color camera from the front of the silicone sheet 14 under white lighting. This image is shown in FIG. 10B.

Further, excitation light (wavelength 740 to 760 nm) was irradiated from the front surface of the silicone sheet 14, and the front surface thereof was photographed by a near infrared color camera system (Mizuho Co., Ltd.). This image is shown in FIG. 10C. As shown in FIG. 10C, a dark portion corresponding to the window opening portion 2 could be observed inside the finger cot type light emitting portion. Therefore, it can be seen that the position of the affected portion can be specified from the serosa side by pressing the affected portion on the mucosal side of the body cavity with the pad of the finger exposed from the window opening portion 2 of the medical device 1A and irradiating with excitation light.

1 Medical device body 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H Medical device 2 Opening part 3 Extraction thread 3a Adhesion area of extraction thread 4 Scale 5 Scale-shaped hole 6 Infrared or near infrared Light-impermeable resin film 7 Gloves 8 Ring-shaped printing layer 9 Circular printing layer 10 Ring-shaped resin layer having an adhesive layer on one side 11 Peeling film 12 Surgical gloves 13 Circular resin layer 14 having an adhesive layer on one side Silicone sheet h1 Length w1 Width

Claims (1)

A seal-shaped medical device for palpation that is attached to a fingertip and has a resin layer and an adhesive layer provided on one side thereof. The resin layer emits red fluorescence or near-infrared fluorescence, and the medical device is A medical device for palpation that has a size that can be attached to the inside of a finger pad and has a ring-shaped opening portion having a width of 5 to 15 mm and a length of 5 to 20 mm.

Images