JP2023034853A - Medical apparatus and method for delivery of medical delivery object to target portion - Google Patents

Abstract

To provide a medical apparatus for delivering a medical delivery object to a target portion while keeping its shape, with a simple mechanism and a simple operation.SOLUTION: A medical apparatus 1 for delivery of a medical delivery object S to a target portion comprises a hollow body 2 having a placing part 21 for placing the medical delivery object S. The placing part 21 is configured to be movable vertically so as to be displaced between an exposure position to be exposed on the surface of the body and a non-exposure position to be sunk in the inside of the body.SELECTED DRAWING: Figure 1

Description

The present invention relates to medical devices and methods for delivering a medical delivery to a target site.

In recent years, attempts have been made to transplant various cells in order to repair damaged tissues and the like. For example, use of fetal myocardial cells, skeletal myoblasts, mesenchymal stem cells, cardiac stem cells, ES cells, iPS cells, etc. for the repair of myocardial tissue damaged by ischemic heart diseases such as angina pectoris and myocardial infarction. has been attempted (Non-Patent Document 1).

As part of such attempts, a cell structure formed using a scaffold and a sheet-like cell culture in which cells are formed into a sheet have been developed (Non-Patent Document 2).
Regarding application of sheet cell culture to treatment, use of cultured epidermal sheet for skin damage due to burns, use of corneal epithelial sheet cell culture for corneal damage, oral mucosa sheet for endoscopic resection of esophageal cancer Studies on the use of morphogenetic cell cultures are underway, and some of them have entered the stage of clinical application.

Regarding surgical methods for administering sheet-like cell cultures to target sites, endoscopic surgery is widely used as a minimally invasive surgical method for the human body. Various instruments have been proposed for
For example, the transporting and administering device described in Patent Document 1 has a sheet supporting member formed into a cylinder and stored in an outer cylinder, thereby reducing the degree of invasiveness to the human body and allowing the sheet-shaped therapeutic substance to reach the implantation site. can be transported.

The sheet sticking device described in Patent Document 2 moves a rod-shaped member arranged along the surface of the sheet supporting portion along the surface of the sheet supporting portion to peel off the sheet-like substance, thereby attaching the sheet-like substance to the target site. can be affixed to
The delivery device described in Patent Document 3 is a sheet detachable device capable of applying a negative pressure to the sheet support to adsorb and hold the sheet-shaped therapeutic substance and a positive pressure to release the sheet-shaped therapeutic substance from the sheet support. The sheet can be administered by means.
The transfer device described in Patent Document 4 includes a displacement body that is displaceably provided with respect to a main body, and a belt that is wound so as to cover the displacement body and is connected to the main body. By displacing it, the biological implant placed on the belt can be transported.

Japanese Patent Application Laid-Open No. 2009-511 JP 2016-187601 A JP 2008-173333 A JP 2012-30045 A

Haraguchi et al., Stem Cells Transl Med. 2012 Feb;1(2):136-41 Sawa et al., Surg Today. 2012 Jan;42(2):181-4

The inventors of the present invention have faced problems such as difficulty in efficiently delivering the medical delivery product to the target site while maintaining the shape of the medical delivery product as described above. Accordingly, an object of the present invention is to solve such problems and to realize a medical device for delivering a medical delivery product to a target site while maintaining its shape with a simple mechanism and a simple operation. do.

In order to solve the above problems, the inventors of the present invention have made intensive research and found that a hollow main body having a mounting portion is used to move the mounting portion up and down with respect to the main body. It was found for the first time that it can be efficiently delivered to the target site while maintaining its shape, and as a result of further research based on such findings, the present invention was completed.

That is, the present invention relates to the following.
[1] A medical device for delivering a medical delivery product to a target site, comprising a hollow main body having a mounting portion for placing the medical delivery product, the mounting portion being provided on the surface of the main body. The medical device is configured to be movable up and down so as to be displaced between an exposed position where it is exposed and a non-exposed position where it is sunk inside the main body.
[2] Further including a sliding body that slides back and forth within the main body, and by moving the sliding body back and forth between a contact position where it contacts the mounting portion and a non-contact position where it does not contact the mounting portion, The medical device according to [1], wherein the placing section can be raised and lowered.
[3] The medical device according to [2], which has an operation part for raising and lowering the placing part at the base end of the sliding body.
[4] The medical device according to any one of [1] to [3], further including a cover body capable of covering the placing section.

[5] A method for delivering a medical delivery product to a target site, comprising: providing the medical device according to any one of [1] to [4]; displacing the rest to an unexposed position; approximating the medical device to the target site; and displacing the rest to the exposed position.
[6] The method according to [5], wherein the medical device further includes a cover capable of covering the mounting section, and the target site is approached while the mounting section is covered with the cover.
[7] The method of [5] or [6] for transperitoneally inserting a medical delivery product into a body cavity and delivering it to a target site.

According to the present invention, it is possible to efficiently deliver a medical delivery product to a target site while maintaining its shape with a simple mechanism and simple operation, so there are great advantages in terms of workability and manufacturing cost. be.

FIG. 1 is a conceptual diagram showing a medical device according to a first embodiment of the invention. FIG. 2 is a conceptual diagram showing two aspects of the main body 2 according to the first embodiment of the invention.

In the present invention, the term “medical delivery product” means pharmaceuticals, regenerative medicine products, medical devices, etc. that are delivered to a living body and used for treatment or the like. Pharmaceuticals include tissue adhesives, local anesthetics, and the like. Regenerative medicine products include grafts, cell cultures, and the like. Medical devices include adhesion barriers, hemostats, wound dressings, and the like. Medical deliverables include sheet-like deliverables that are difficult to transport while maintaining their shape, such as film-like and membranous (highly viscous substances).
In the present invention, the term "graft" means a structure for transplantation into a living body, and particularly means a structure for transplantation containing living cells as a constituent. Examples of the graft of the present invention include, but are not limited to, sheet-like cell cultures, spheroids, cell aggregates, etc., preferably sheet-like cell cultures or spheroids, more preferably sheet-like cells. It is a culture.

In the present invention, the term "sheet-like cell culture" refers to a sheet-like cell culture formed by connecting cells to each other. Cells may be connected to each other directly (including through cellular elements such as adhesion molecules) and/or through intermediaries. The intervening substance is not particularly limited as long as it is a substance capable of at least physically (mechanically) connecting cells to each other, and examples thereof include an extracellular matrix. The mediator is preferably of cell origin, in particular of cells that make up the cell culture. The cells are at least physically (mechanically) linked, but may also be functionally linked, eg chemically, electrically. Sheet-like cell cultures may be composed of one cell layer (single layer) or composed of two or more cell layers (laminated (multilayered) body, e.g., two layers, three layers, 4 layers, 5 layers, 6 layers, etc.). Moreover, the sheet-like cell culture may have a three-dimensional structure in which the cells do not exhibit a clear layered structure and have a thickness exceeding the thickness of a single cell. For example, in a vertical cross section of a sheet-like cell culture, the cells may be nonuniformly arranged (for example, in a mosaic pattern) without being evenly aligned in the horizontal direction.

The sheet-like cell culture preferably does not contain a scaffold (support). Scaffolds are sometimes used in the art to attach cells onto and/or into their surfaces and maintain the physical integrity of sheet-like cell cultures. The sheet-like cell culture of the present invention can maintain its physical integrity without such a scaffold. In addition, the sheet-like cell culture of the present invention can be coated with fibrin or the like to reinforce its physical strength.

Cells constituting the sheet-like cell culture are not particularly limited as long as they can form the sheet-like cell culture, and include, for example, adherent cells (adherent cells). Adherent cells include, for example, adherent somatic cells (e.g., cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, kidney cells, adrenal cells, periodontal ligament cells, gingival cells, periosteal cells, skin cells, synovial cells, chondrocytes, etc.) and stem cells (e.g., myoblasts, tissue stem cells such as cardiac stem cells, embryonic stem cells, pluripotent stem cells such as iPS (induced pluripotent stem) cells, mesenchymal stem cells, etc.) and so on. Somatic cells may be stem cells, particularly those differentiated from iPS cells (iPS cell-derived adherent cells). Non-limiting examples of cells that make up the sheet-like cell culture include myoblasts (e.g., skeletal myoblasts), mesenchymal stem cells (e.g., bone marrow, adipose tissue, peripheral blood, skin, hair roots, muscle tissue, endometrium, placenta, umbilical cord blood-derived, etc.), cardiomyocytes, fibroblasts, cardiac stem cells, embryonic stem cells, iPS cells, synovial cells, chondrocytes, epithelial cells (e.g., oral mucosal epithelial cells) , retinal pigment epithelial cells, nasal mucosal epithelial cells, etc.), endothelial cells (e.g., vascular endothelial cells, etc.), hepatocytes (e.g., liver parenchymal cells, etc.), pancreatic cells (e.g., pancreatic islet cells, etc.), renal cells, adrenal cells , periodontal ligament cells, gingival cells, periosteal cells, skin cells, and the like. Non-limiting examples of iPS cell-derived adhesive cells include iPS cell-derived cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, renal cells, adrenal cells, periodontal ligament cells, gingival cells, and periosteal cells. , skin cells, synovial cells, chondrocytes, and the like.

In the present invention, "medical device" means a machine intended to be used for the diagnosis, treatment or prevention of diseases in humans or animals, or to affect the structure or function of the human or animal body. It refers to equipment, etc.

In the present invention, the term “target site” refers to the portion to which the medical delivery product is applied (pasted). The target site includes, for example, the surface of an organ, a damaged site of an organ, an anastomosis site of an organ, and the like. The target site is typically the heart, the surface of the heart, a damaged site of the heart, an anastomotic site of the heart, or the like. Further, the target site includes a site where damage (wound) exists in a hollow organ, such as a damaged site inside the lumen wall, the opposite side of the lumen wall corresponding to the site where damage exists, and the like. "Hollow organ" means an organ with a lumen enclosed in a body cavity, i.e., an organ with a tubular or bag-like structure, such as the digestive system, circulatory system, urinary system, respiratory system, Reproductive organs and the like can be mentioned.

Gastrointestinal organs include the esophagus, stomach, duodenum, pancreas, gallbladder, bile duct, small intestine, large intestine, rectum, and the like. Among them, the duodenum is most preferable because of its thin luminal wall, high risk of perforation, and its exposure to various digestive juices, which is likely to cause damage to the duodenum.

In one aspect, the medical delivery is immersed in a protective liquid. The term "medical deliverable" is not particularly limited as long as it is a liquid that can maintain the shape and function of the implant. Liquids such as culture media, water, or mixtures thereof.

In the present invention, "delivering the medical delivery product to the target site" means placing the medical delivery product on the mounting portion of the main body and moving the main body to the target site. The proximal side of the body is the side of the operator who operates the medical device, and the distal side of the body is the side opposite to the proximal side, closer to the target site and delivering the medical delivery. .

In the present invention, the "main body" is a hollow body having an opening on the upper surface, and refers to a member capable of holding the mounting section so as to be able to move up and down with respect to the opening. The mounting portion is a plate-like body having a flat surface on which a delivery article having a certain area, such as a sheet-like medical delivery article, can be placed while maintaining its shape. The material of the main body (including the mounting portion) is not particularly limited, and various known materials can be used singly or in combination.

Examples of such materials include metals, soft vinyl chloride resins, polyurethane resins, silicone rubbers, natural rubbers, synthetic rubbers, styrene-ethylene-butylene-styrene copolymers (SEBS), styrene-ethylene-propylene-styrene copolymers. Polymer (SEPS), ethylene vinyl acetate copolymer (EVA), polyamide resin and polyamide elastomer such as nylon, polyester resin and polyester elastomer such as polyethylene terephthalate (PET), olefin resin such as polyethylene, fluororubber, fluororesin etc., and one or more of these may be used in combination.

In the present invention, the "sliding body" is moved forward and backward within the shaft portion of the main body to move between a contact position where the sliding body comes into contact with the mounting section and a non-contact position where the sliding body does not come into contact with the mounting section. A long body that can be cut.
The material of the sliding body is not particularly limited, and various known materials can be used singly or in combination. Examples of such materials include metals, soft vinyl chloride resins, polyurethane resins, silicone rubbers, natural rubbers, synthetic rubbers, styrene-ethylene-butylene-styrene copolymers (SEBS), styrene-ethylene-propylene-styrene copolymers. Polymer (SEPS), ethylene vinyl acetate copolymer (EVA), polyamide resin and polyamide elastomer such as nylon, polyester resin and polyester elastomer such as polyethylene terephthalate (PET), olefin resin such as polyethylene, fluororubber, fluororesin etc., and one or more of these may be used in combination.

In the present invention, the term "hole" refers to one or more through-holes provided in the mounting portion for mounting the medical delivery, and the fluid is fed from the opposite side of the surface supporting the medical delivery. By ejecting a fluid through the holes, the medical delivery material can be peeled off from the placing section and attached. It is sufficient that the fluid can be ejected, and if at least one hole is provided in a portion of the mounting portion that contacts the vicinity of the edge of the medical delivery, the medical delivery can be peeled off from the vicinity of the edge. .

It is preferable that a plurality of holes be discretely arranged on the placement part so that the peeling position of the medical delivery can be adjusted. For example, by providing at least one of the plurality of holes near the edge of the medical delivery, peeling the medical delivery from the vicinity of the edge, and then discharging the fluid from the other holes, the medical The delivery can also be peeled off in stages. The arrangement of the plurality of holes can be, for example, a matrix arrangement of rows and columns such as 2×2 to 40×40, 5×5 to 20×20, etc., and the spacing between the holes is, for example, 0.05 mm to 0.05 mm. 10 mm, 0.5 mm to 2 mm, and the diameter of the hole can be, for example, 0.05 mm to 10 mm, 0.3 to 0.6 mm, but not limited to these, anyone skilled in the art For example, it can be freely selected in accordance with the size of the medical delivery product, the degree of adhesion between the medical delivery product and the placement section, and the like. A matrix arrangement of a plurality of holes can also be achieved by making the structure of the mounting portion a mesh structure.

In the present invention, "fluid" is a general term for gases and liquids that can be extruded and peeled off without damaging the medical delivery. The liquid is composed of at least one component, and the component is not particularly limited, and is composed of, for example, liquids such as water, aqueous solutions, non-aqueous solutions, suspensions, emulsions, and the like. The components that constitute the liquid are not particularly limited as long as they have little effect on the medical delivery product. When the medical delivery is a film made of a material derived from a living body, the component that constitutes the liquid must be biocompatible, that is, it does not cause unwanted effects such as inflammatory reactions, immune reactions, and toxic reactions on living tissues and cells. It is preferable to use a material that does not cause such an effect or at least has a small effect.

BEST MODE FOR CARRYING OUT THE INVENTION A medical device according to a preferred embodiment of the present invention will be described in detail below with reference to the drawings. FIG. 1 is a conceptual diagram showing a medical device according to a first embodiment of the invention. FIG. 2 is a conceptual diagram showing two aspects of the main body 2 according to the first embodiment of the invention.
In addition, in each drawing in the present application, the size of each member is appropriately emphasized for ease of explanation, and each member shown does not indicate the actual size.

First Embodiment First, the first embodiment of the present invention will be described.
As shown in FIG. 1a, the medical device 1 according to the first embodiment of the present invention includes a main body 2 and a placement section 21 for placing a medical delivery product S thereon. The mounting portion 21 is a plate-like body having a flat surface on which a delivery article having a certain area, such as a sheet-like medical delivery article S, can be placed while maintaining its shape. As shown in FIG. 1b, the main body 2 is a hollow body having an opening on the upper surface, and can hold the mounting section 21 with respect to the opening so as to be able to move up and down. That is, the medical device 1 of the present invention moves the mounting portion 21 up and down to an exposed position where the mounting portion 21 is exposed on the surface of the main body 2 and a non-exposed position where the mounting portion 21 is sunk inside the main body 2. can be displaced to

A long shaft portion 22 is connected to the main body 2 so that the main body 2 can be delivered to a target site. The shaft portion 22 may be a hollow body and configured to accommodate the sliding body 3 therein. In the medical device 1 of the present invention, the sliding body 3 is advanced and retracted within the shaft portion 22, and has a contact position where the sliding body 3 contacts the mounting portion 21 and a non-contact position where the sliding body 3 does not contact the mounting portion 21. can be moved to That is, when the sliding member 3 is retracted toward the proximal end of the shaft portion 22, it does not contact the mounting portion 21 of the main body 2. 2 is configured to abut on the mounting portion 21 .

The lifting and lowering of the mounting section 21 can be realized by using various mechanisms. For example, as shown in FIG. 2a, by rotatably connecting the base end side of the mounting portion 21 to a part of the opening of the main body 2 and rotating the mounting portion 21 by the sliding member 3, Displaceable between an exposed position and a non-exposed position. That is, when the slide member 3 is advanced from the shaft portion 22 into the main body 2 and the leading end of the slide member 3 is brought into contact with the mounting portion 21 , the mounting portion 21 is pushed up by the slide member 3 and the surface of the main body 2 is pushed up. (exposure positions indicated by dashed-dotted lines). Conversely, when the sliding member 3 is retracted from the main body 2 and the leading end of the sliding member 3 is separated from the mounting portion 21, the mounting portion 21 is released from the support by the sliding member 3 and sinks into the main body 2. (non-exposed position). In FIG. 2, the shaft portion 22 is omitted.

As another mechanism, for example, as shown in FIG. The portion 21 is biased toward the opening. At this time, the sliding member 3 is advanced from the shaft portion 22 into the main body 2, and the mounting portion 21 is locked at the tip of the sliding member 3, thereby sinking the mounting portion 21 to the bottom surface position. (non-exposed position). Conversely, when the sliding member 3 is retracted from the main body 2 and the leading end of the sliding member 3 is separated from the mounting portion 21, the mounting portion 21 is pushed up by the spring 24 and exposed inside the main body 2. (exposed position).

By providing an annular gripping portion 23 at the proximal end portion of the main body 2 and gripping the gripping portion 23, the elongated main body 2 can be appropriately held and delivered to the target site. By providing an operation portion 31 adjacent to the grip portion 23 at the proximal end portion of the sliding body 3, the long sliding body 3 can be configured to be operated at hand by the operator. A cover body (not shown) that can slide forward and backward on the opening of the main body 2 to cover the mounting portion 21 can be further included. Further, by further covering the mounting portion 21 sunk to the bottom surface position with a cover body, the medical delivery product S can be protected more appropriately.

When using the medical device 1 of the present invention, first, the placing portion 21 is exposed on the surface of the main body 2 and the medical delivery product S is placed on the placing portion 21 . Next, after displacing the mounting portion 21 to a non-exposed position where it is sunk inside the main body 2, the main body 2 is brought close to the target site. Thereby, the medical delivery article S is protected inside the main body 2 when the medical delivery article S is transperitoneally inserted into the body cavity and delivered to the target site. Then, with the mounting portion 21 exposed on the surface of the main body 2, the medical delivery product S is peeled off from the mounting portion 21 with forceps or the like, and adhered to the target site. By displacing the mounting portion 21 to the exposed position while the main body 2 is in contact with the target site, the medical delivery product S can be pressed (pasted) to the target site.

Use of the medical device of the present invention can be performed sequentially by the following steps.
(1) Providing a medical device (2) Placing a medical delivery product on the placement section (3) Displacing the placement section to a non-exposed position (4) Bringing the medical device closer to the target site (5) Displace the mounting section to the exposed position

In the step (4), the medical deliverable can be more appropriately protected by bringing the sliding body sunk into the bottom surface position close to the target site while being covered with the cover body. In the step (5), the placement section is displaced to the exposed position while the main body is in contact with the target site, thereby pressing the medical delivery placed on the placement section against the target site (sticking). You can also

1 Medical Device 2 Main Body 21 Mounting Part 22 Shaft Part 23 Grasping Part 24 Spring 3 Sliding Body S Medical Deliverable

Claims (7)

A medical device for delivering a medical delivery product to a target site, comprising a hollow main body having a mounting portion for placing the medical delivery product, the mounting portion being exposed on the surface of the main body. and a non-exposed position in which the body is sunk into the main body. Further including a sliding body that slides back and forth within the main body, the sliding body is advanced and retracted between a contact position where it contacts the mounting section and a non-contact position where it does not contact the mounting section. 2. The medical device of claim 1, wherein the can be raised and lowered. 3. The medical device according to claim 2, wherein the base end of the sliding body has an operation part for raising and lowering the placing part. The medical device according to any one of claims 1 to 3, further comprising a cover capable of covering the mounting portion. A method for delivering a medical delivery to a target site, comprising:
providing a medical device according to any one of claims 1-4,
placing the medical delivery product on the placement unit;
displacing the mounting portion to a non-exposed position;
The above method, comprising the steps of: bringing the medical device into close proximity with the target site; and displacing the mounting portion to the exposed position. 6. The method according to claim 5, wherein the medical device further includes a cover capable of covering the mounting portion, and the target site is approached while the mounting portion is covered with the cover. 7. The method according to claim 5 or 6, for transperitoneally inserting a medical delivery product into a body cavity to deliver it to a target site.

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