Medical Devices and Delivery Methods

Abstract

A medical device and delivery method are provided that can easily deliver a substance to be delivered to a gap between biological tissues. [Solution] The medical device (1) comprises a first holding part (2b) and a second holding part (2c) that sandwich and hold a delivery target (3) in a sandwiching direction perpendicular to the front-to-rear direction, the first holding part having a first holding part main body (2b1) and a first sliding body (2b2) ​​that performs a first sliding movement in which the tip part (2a) of the first holding part performs a first sliding movement in the front-to-rear direction relative to the first holding part main body toward the outer surface while holding the delivery target, and the second holding part having a second holding part main body (2c1) and a second sliding body (2c2) that performs a second sliding movement in which the tip part performs a second sliding movement in which the tip part performs a second sliding movement in which the tip part performs a second sliding movement in which the tip part performs a second sliding movement in the front-to-rear direction relative to the second holding part main body while holding the delivery target, and the medical device has a delivery part that delivers the delivery target to a gap between biological tissues formed by the tip part of the delivery part (2) by the first sliding movement and the second sliding movement.

Description

[Technical Field]

[0001] The present disclosure relates to medical devices and delivery methods. [Background technology]

[0002] BACKGROUND ART Medical devices that deliver a target substance to a treatment site in a living body are known (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2023 / 277045 Summary of the Invention [Problem to be solved by the invention]

[0004] An object of the present disclosure is to provide a medical device and a delivery method that can easily deliver a target substance to a gap between biological tissues. [Means for solving the problem]

[0005] One aspect of the present disclosure is as follows.

[0006] [1] A medical device comprising: a delivery unit extending in a front-to-rear direction and having a tip portion at a front, the delivery unit comprising a first holding unit and a second holding unit that sandwich and hold an object to be delivered in a sandwiching direction perpendicular to the front-to-rear direction, the first holding unit and the second holding unit each having an inner surface located on the side of the object to be delivered in the sandwiching direction and an outer surface located opposite the inner surface, the first holding unit having a first holding unit main body and a first sliding body that performs a first sliding movement in which the tip portion folds back in the front-to-rear direction from the inner surface side toward the outer surface side relative to the first holding unit main body while holding the object to be delivered, and the second holding unit having a second holding unit main body and a second sliding body that folds back at the tip portion in the front-to-rear direction from the inner surface side toward the outer surface side relative to the second holding unit main body while holding the object to be delivered, and the delivery unit delivers the object to a gap between biological tissues formed by the tip portion of the delivery unit by both or either of the first sliding movement and the second sliding movement.

[0007] [2] The medical device described in [1], wherein the tip portion of the delivery portion is tapered.

[0008] [3] The medical device according to [1] or [2], wherein the first sliding body is provided integrally with the second sliding body.

[0009] [4] The medical device according to any one of [1] to [3], wherein the object to be delivered is a transplant.

[0010] [5] A delivery method using the medical device according to any one of [1] to [4], a gap portion forming step of forming the gap portion between the biological tissues by inserting the tip end portion of the delivery unit between the biological tissues; and a delivery step of delivering the object to be delivered to the gap portion between the biological tissues by both or either one of the first sliding and the second sliding.

[0011] [6] The delivery method described in [5], wherein in the gap portion forming step, the tip portion of the delivery section is inserted between the biological tissues while the first sliding and the second sliding are generated.

[0012] [7] The delivery method according to [5] or [6], wherein the gap portion forming step includes an advancing step of advancing the tip portion of the delivery unit between the biological tissues, and a retracting step of forming the gap portion between the biological tissues by retracting the tip portion of the delivery unit between the biological tissues.

[0013] [8] [7] The delivery method according to [7], wherein in the retracting step, the tip portion of the delivery unit is retracted between the biological tissues while preventing sliding of the first sliding body and the second sliding body relative to the first holding unit body and the second holding unit body. [Effects of the Invention]

[0014] According to the present disclosure, it is possible to provide a medical device and a delivery method that can easily deliver a target substance to a gap between biological tissues. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a cross-sectional view showing a state during an approaching step in a delivery method using a medical device according to a first embodiment of the present disclosure. FIG. [Figure 2] 2 is a cross-sectional view showing a state when an entry step is completed from the state shown in FIG. 1. FIG. [Figure 3] 3 is a cross-sectional view showing a state when a retreat step is completed from the state shown in FIG. 2. FIG. [Figure 4] 4 is a cross-sectional view showing the state when the delivery step is completed from the state shown in FIG. 3. FIG. [Figure 5] FIG. 2 is a top view of the medical device shown in FIG. 1. [Figure 6] FIG. 2 is a plan view showing the inside of the medical device shown in FIG. 1 in an open state. [Figure 7]FIG. 10 is a cross-sectional view showing a state during an approaching step in a delivery method using a medical device according to a second embodiment of the present disclosure. [Figure 8] 8 is a cross-sectional view showing a state when the entry step is completed from the state shown in FIG. 7. FIG. [Figure 9] 9 is a cross-sectional view showing a state when a retreat step is completed from the state shown in FIG. 8. FIG. [Figure 10] 10 is a cross-sectional view showing the state when the delivery step is completed from the state shown in FIG. 9. FIG. [Figure 11] FIG. 8 is a plan view showing the inside of the medical device shown in FIG. 7 in an open state. [Figure 12] FIG. 10 is a cross-sectional view showing a state during a delivery method using a medical device according to a third embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings.

[0017] As shown in FIGS. 1 to 6, the medical device 1 according to the first embodiment of the present disclosure is a delivery section 2 that extends in the front-rear direction and has a tip 2a at the front D3, and is composed of a first holding section 2b and a second holding section 2c that sandwich and hold the object to be delivered 3 in a sandwiching direction perpendicular to the front-rear direction, and the first holding section 2b and the second holding section 2c each have an inner surface located on the side of the object to be delivered 3 in the sandwiching direction and an outer surface located opposite the inner surface, and the first holding section 2b is a first holding section main body 2b1 and is configured to hold the object to be delivered 3 while being attached to the first holding section main body 2b1. The delivery unit 2 includes a first sliding body 2b2 that performs a first sliding movement from the inner surface side to the outer surface side at the tip end 2a, folding back in the front-rear direction at the tip end 2a, relative to the second holding unit 2c, while holding the delivery target 3. The delivery unit 2 includes a second holding unit main body 2c1 and a second sliding body 2c2 that performs a second sliding movement from the inner surface side to the outer surface side at the tip end 2a, folding back in the front-rear direction at the tip end 2a, relative to the second holding unit main body 2c1, relative to the second holding unit 2c, while holding the delivery target 3. The delivery unit 2 delivers the delivery target 3 to a gap 4a between biological tissues 4 of a human or the like, formed by the tip end 2a of the delivery unit 2, by the first sliding movement and the second sliding movement. In this embodiment, the direction from the inner surface side to the outer surface side of the first holding unit 2b along the clamping direction (vertical direction) is referred to as a first direction D1 (upward), and the opposite direction is referred to as a second direction D2 (downward). The direction perpendicular to the front-rear direction and the clamping direction is referred to as a left-right direction.

[0018] The distal end 2a of the delivery unit 2 is tapered, and in this embodiment, it is tapered all the way to the distal end. The first holding unit main body 2b1 extends in the front-rear direction and has a first distal end 2b3 at the front D3. The outer surface of the first distal end 2b3 is tapered, inclining in the second direction D2 toward the front D3. The first distal end 2b3 has a rounded distal end when viewed in the left-right direction. The second holding unit main body 2c1 extends in the front-rear direction and has a second distal end 2c3 at the front D3. The outer surface of the second distal end 2c3 is tapered, inclining in the first direction D1 toward the front D3. The second distal end 2c3 has a rounded distal end when viewed in the left-right direction. This configuration makes it easier to form a gap 4a between biological tissues 4. The gap 4a between biological tissues 4 is formed, for example, by incising the biological tissue with the distal end 2a of the delivery unit 2. Furthermore, the roundness of the first tip portion 2b3 allows for smooth first sliding, and the roundness of the second tip portion 2c3 allows for smooth second sliding.

[0019] The first sliding body 2b2 is sheet-shaped and is disposed along the inner and outer surfaces of the first holding unit main body 2b1. The second sliding body 2c2 is sheet-shaped and is disposed along the inner and outer surfaces of the second holding unit main body 2c1. The first sliding body 2b2 and the second sliding body 2c2 each come into contact with the sheet-shaped object to be delivered 3 and sandwich the object to be delivered 3. In this embodiment, the first sliding body 2b2 is provided separately from the second sliding body 2c2.

[0020] 5, the medical device 1 may have an annular elastic member 5. The annular elastic member 5 is wrapped around the outer surface of the delivery unit 2 so as to press the first sliding body 2b2 and the second sliding body 2c2 by the elastic force of the annular elastic member 5 itself, so that the first sliding body 2b2 and the second sliding body 2c2 do not move relative to the first holding unit main body 2b1 and the second holding unit main body 2c1, respectively, in a state in which the first sliding body 2b2 is wrapped around the first holding unit main body 2b1, the second sliding body 2c2 is wrapped around the second holding unit main body 2c1, and the first sliding body 2b2 and the second sliding body 2c2 are in contact with the sheet-like object to be delivered 3 and sandwich the object to be delivered 3 between them. When the first slide body 2b2 and the second slide body 2c2 need to move relative to the first holding part body 2b1 and the second holding part body 2c1, the annular elastic member 5 is removed from the delivery part 2 or partially moved to release the first slide body 2b2 and the second slide body 2c2. The user may also press the first slide body 2b2 and the second slide body 2c2 directly with their hands without using the annular elastic member 5.

[0021] As shown in Figures 5 and 6, the medical device 1 has a hinge unit 6 that rotatably connects the first holding unit body 2b1 and the second holding unit body 2c1 so as to be switchable between a closed state (a state in which the delivery target 3 can be clamped) in which the inner surfaces of the first holding unit body 2b1 and the second holding unit body 2c1 face each other, and an open state that is more open than the closed state. In this embodiment, the hinge unit 6 connects the first holding unit body 2b1 and the second holding unit body 2c1 at their left and right ends. As shown in Figure 11 related to a second embodiment described later, the hinge unit 6 may also be configured to connect the first holding unit body 2b1 and the second holding unit body 2c1 at their rear ends.

[0022] The first retaining portion main body 2b1 has, on its inner surface, a first guide groove 2b4 that guides the first sliding movement of the first sliding body 2b2. The first guide groove 2b4 extends in the front-rear direction. Both left and right side surfaces of the first guide groove 2b4 face both left and right end surfaces of the first sliding body 2b2 and guide the first sliding movement by contacting these end surfaces. The second retaining portion main body 2c1 has, on its inner surface, a second guide groove 2c4 that guides the second sliding movement of the second sliding body 2c2. The second guide groove 2c4 extends in the front-rear direction. Both left and right side surfaces of the second guide groove 2c4 face both left and right end surfaces of the second sliding body 2c2 and guide the second sliding movement by contacting these end surfaces.

[0023] The gap 4a between biological tissues 4 to which the delivery object 3 is delivered is not particularly limited, and is, for example, the gap 4a between the heart and pericardium. The delivery object 3 is not particularly limited as long as it is a medical substance, and is, for example, a therapeutic substance such as a graft or a drug, or a test / diagnostic substance such as a sensor. The cells constituting the graft are not particularly limited, and are, for example, somatic cells or stem cells. The cells are, for example, cardiomyocytes derived from somatic stem cells (adult stem cells), mesenchymal stem cells, or iPS cells (induced pluripotent stem cells). The somatic stem cells are preferably skeletal myoblasts (myoblast cells).

[0024] The medical device 1 of this embodiment can be used in, for example, the following delivery method. As shown in Figures 1 to 3, the delivery method of this embodiment includes a gap portion 4a formation step of forming a gap portion 4a between the biological tissues 4 by inserting the tip portion 2a of the delivery section 2 into the biological tissues 4, and a delivery step of delivering the object to be delivered 3 into the gap portion 4a between the biological tissues 4 by first sliding and second sliding, as shown in Figure 4. The first sliding and second sliding are performed synchronously so as not to damage the object to be delivered 3. Preferably, the first sliding and the second sliding are performed at the same timing and by the same movement amount.

[0025] The gap portion 4a forming step includes an advancing step of advancing the tip portion 2a of the delivery unit 2 between the biological tissues 4, as shown in Figures 1 and 2, and a retracting step of retracting the tip portion 2a of the delivery unit 2 between the biological tissues 4, thereby forming the gap portion 4a between the biological tissues 4, as shown in Figures 2 and 3.

[0026] In this embodiment, in the entering step of the gap portion 4a forming step, as shown in Figures 1 and 2, the tip portion 2a of the delivery unit 2 is entered into the space between biological tissues 4 while first sliding and second sliding are generated. According to the above configuration, it is possible to easily enter the tip portion 2a of the delivery unit 2 into the space between biological tissues 4. At this time, it is preferable to advance the object to be delivered 3 to the tip portion 2a of the delivery unit 2 by the first sliding and second sliding, as shown in Figures 1 and 2.

[0027] 2 and 3 , in the retracting step, the tip portion 2a of the delivery unit 2 is retracted between the biological tissues 4 while preventing the first sliding body 2b2 and the second sliding body 2c2 from sliding relative to the first holding unit body 2b1 and the second holding unit body 2c1. According to the above configuration, the object to be delivered 3 can be prevented from retracting within the delivery unit 2 in the retracting step, which makes it easier to deliver the object to be delivered 3 to the gap portion 4a between the biological tissues 4 in the delivery step following the retracting step.

[0028] In this embodiment, the first slide body 2b2 is provided separately from the second slide body 2c2. However, the present invention is not limited to this. For example, as in the second embodiment, the first slide body 2b2 may be configured to be integral with the second slide body 2c2.

[0029] 7 to 11, the rear end of the first sliding body 2b2 located on the inner surface of the first holding part 2b is integrally connected to the rear end of the second sliding body 2c2 located on the inner surface of the second holding part 2c. In this embodiment, the connecting part 2d between the first sliding body 2b2 and the second sliding body 2c2 is adjacent to the rear end of the object to be delivered 3, but is not limited to this, and the connecting part 2d may be provided at a distance D4 rearward from the rear end of the object to be delivered 3. In this embodiment, the hinge part 6 connects the first holding part main body 2b1 and the second holding part main body 2c1 at their rear ends, as shown in FIG.

[0030] 7 to 10, the medical device 1 of the second embodiment can be used in a delivery method similar to the delivery method of the first embodiment. In particular, in the delivery method of the second embodiment, the rear end of the object to be delivered 3 can be pushed out by the connecting part 2d between the first sliding body 2b2 and the second sliding body 2c2 in the delivery step, which makes it easier to deliver the object to be delivered 3 to the gap part 4a between the biological tissues 4. In addition, the object to be delivered 3 can be prevented from moving backward by being received by the connecting part 2d.

[0031] The medical device 1 may be configured without the hinge unit 6. In this case, the delivery unit 2 may deliver the delivery target 3 to the gap 4a between the biological tissues 4 formed by the tip end portion 2a of the delivery unit 2 by the first sliding movement and the second sliding movement, or by either the first sliding movement or the second sliding movement. The delivery unit 2 may be configured to have the hinge unit 6, and the first holding unit 2b and the second holding unit 2c are movable relative to each other in the front-rear direction, and to deliver the delivery target 3 to the gap 4a between the biological tissues 4 formed by the tip end portion 2a of the delivery unit 2 by both or either the first sliding movement and the second sliding movement. According to these configurations, in the delivery step, the delivery target 3 can be delivered to the gap 4a between the biological tissues 4 by both or either the first sliding movement and the second sliding movement. 12, for example, in the delivery step, the object to be delivered 3 can be delivered to the gap portion 4a between the biological tissues 4 by the second sliding, which is either the first sliding or the second sliding. According to this type of delivery, when the object to be delivered 3 is delivered to the gap portion 4a between the biological tissues 4 formed in the retraction step, the first holding part 2b can prevent the object to be delivered 3 from contacting the upper biological tissue.

[0032] Although the embodiments of the present disclosure have been described above, the present disclosure is not limited to the above-described embodiments, and the above-described embodiments can be modified in various ways without departing from the gist of the present disclosure. [Explanation of symbols]

[0033] 1. Medical Devices 2 Delivery part 2a Tip 2b 1st holding part 2b1 1st holding part main body 2b2 First sliding body 2b3 1st tip 2b4 First guide groove 2c 2nd holding part 2c1 2nd holding part main body 2c2 Second sliding body 2c3 2nd tip 2c4 Second guide groove 2d connection part 3 Delivered object 4 Between biological tissues 4a Gap part 5. Annular elastic member 6 Hinge part D1 1st direction (upward) D2 2nd direction (downward) D3 forward D4 rear

Claims

1. A medical device comprising: a delivery unit extending in a front-to-rear direction and having a tip portion at the front, the delivery unit comprising a first holding unit and a second holding unit that sandwich and hold an object to be delivered in a sandwiching direction perpendicular to the front-to-rear direction, the first holding unit and the second holding unit each having an inner surface located on the side of the object to be delivered in the sandwiching direction and an outer surface located opposite the inner surface, the first holding unit having a first holding unit main body and a first sliding body that performs a first sliding movement in which the tip portion folds back in the front-to-rear direction from the inner surface side toward the outer surface side relative to the first holding unit main body while holding the object to be delivered, and the second holding unit having a second holding unit main body and a second sliding body that folds back at the tip portion in the front-to-rear direction from the inner surface side toward the outer surface side relative to the second holding unit main body while holding the object to be delivered, and the delivery unit delivers the object to a gap between biological tissues formed by the tip portion of the delivery unit by both or either of the first sliding movement and the second sliding movement.

2. The medical device of claim 1 , wherein the tip of the delivery portion is tapered.

3. The medical device of claim 1 , wherein the first slide is integral with the second slide.

4. The medical device of claim 1 , wherein the object is an implant.

5. 10. A delivery method using the medical device of claim 1, comprising: a gap portion forming step of forming the gap portion between the biological tissues by inserting the tip end portion of the delivery unit between the biological tissues; and a delivery step of delivering the object to be delivered to the gap portion between the biological tissues by both or either one of the first sliding and the second sliding.

6. The delivery method according to claim 5 , wherein in the gap portion forming step, the tip end portion of the delivery unit is inserted between the biological tissues while the first sliding and the second sliding are occurring.

7. 6. The delivery method according to claim 5, wherein the gap portion forming step includes an advancing step of advancing the tip portion of the delivery unit between the biological tissues, and a retracting step of retracting the tip portion of the delivery unit between the biological tissues, thereby forming the gap portion between the biological tissues.

8. 8. The delivery method according to claim 7, wherein in the retracting step, the tip portion of the delivery unit is retracted between the biological tissues while preventing sliding of the first sliding body and the second sliding body relative to the first holding unit body and the second holding unit body.

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