Drug delivery device and medical instrument

Abstract

Even if the posture of the drug delivery device is inclined, medical powder contained in a container can be stably dispersed to a target site. This drug delivery device is provided with: a container that has an outlet through which a medical powder is discharged, and that has a space in which the medical powder can be accommodated; a protruding part that protrudes from a surface facing the outlet in the container toward the outlet toward the space, and that has an opening part on a side surface of the protruding part; and an ejection part that ejects the gas into the space from the opening part from the side opposite to the tip of the protruding part through an inlet of the protruding part that communicates with the opening part.

Description

Technical Field

[0001] The present invention relates to a drug delivery device and a medical appliance technology for delivering medical powder. Background Art

[0002] Devices for administering medical powders to a patient's affected area are known for the purpose of preventing adhesion, stopping bleeding, or swelling of tissue, for example (Patent Documents 1 to 4).

[0003] For example, adhesion-preventing materials are used to prevent adhesion between a postoperative wound site and surrounding tissues with the potential for adhesion. Adhesion, for example, occurs when exudate containing fibrin precipitates and deposits on the tissue surface of the wound site, causing the tissue surface to connect or fuse with the surrounding tissue surface. The adhesion-preventing material is applied or affixed between the wound site and the surrounding tissue with the potential for adhesion, functioning as a physical barrier to prevent connection or fusion between the tissues. Patent Document 5 discloses a powdered adhesion-preventing material.

[0004] Prior art literature Patent Literature Patent Document 1: International Publication No. 2003 / 070110 Patent Document 2: International Publication No. 2005 / 089472 Patent Document 3: International Publication No. 2005 / 072700 Patent Document 4: International Publication No. 2010 / 074949 Patent Document 5: International Publication No. 2015 / 115609 Summary of the Invention The doctor applies the medical powder to the affected area by, for example, operating a medication device having a container containing the medical powder. The operator operates the medication device to spread the medical powder contained in the container to the target area of ​​the patient.

[0005] However, depending on the surgical procedure and the location of the wound, the procedure may require the patient to be positioned vertically upward or laterally, while lying in bed. Depending on the operator's relative posture with the medication delivery device, there is a concern that the required amount of medical powder may not be dispensed, or that the powder may be unevenly dispensed, potentially preventing the operator from performing the intended treatment. In medication delivery devices, stable dispensing of medical powder, such as anti-adhesion material, to the target site is required regardless of the tilt of the container containing the medical powder. The present invention aims to provide a medication delivery device that can stably dispense the medical powder contained in the container to the target site, even when the operator is tilted.

[0006] The present inventors conducted in-depth research and discovered that a drug delivery device for containing medical powder can solve the above-mentioned problems by adopting the following structure. Specifically, a drug delivery device according to one embodiment includes a protrusion that protrudes into a container having a space capable of containing medical powder such as an adhesion preventing material. Furthermore, an opening is provided on the side of the protrusion of the drug delivery device, and the opening is connected to a discharge unit that discharges gas into the space of the container containing the medical powder. Thus, the drug delivery device can discharge the gas discharged from the discharge unit into the space of the container containing the medical powder through the opening provided on the side of the protrusion. The gas discharged into the container through the opening can cause the contained medical powder to fly, and at the same time, together with the medical powder, forms a flow toward the outlet of the drug delivery device.

[0007] The more detailed structure is as follows. [1] A drug delivery device, which is a drug delivery device for medical powder, comprising: a container having an outlet for ejecting the medical powder and a space capable of accommodating the medical powder; a protrusion that protrudes from a surface opposite to the outlet toward the outlet in the container toward the space, and has an opening on a side surface of the protruding portion; and The ejection portion ejects gas from the opening into the space from the side opposite to the front end of the protrusion through the inlet of the protrusion communicating with the opening. [2] The medication administering device according to [1], wherein the protrusion is axially symmetrical, and the opening is open in a circumferential direction relative to the axial direction on a side surface near the front end. [3] The medication administering device according to [1] or [2], wherein the protrusion has a pyramidal, conical, prism-like, or cylindrical shape. [4] The medication administering device according to any one of [1] to [3], wherein the protruding end of the protrusion is closed. [5] The medication administering device according to any one of [1] to [4], wherein, in the distance from the opposite surface of the outlet in the container to the inner surface of the outlet side, the opening portion opens at a position separated from the opposite surface of the outlet in the direction of the outlet by more than one-third. [6] The medication administering device according to any one of [1] to [5], further comprising a hook portion for hooking a finger when a user holds the medication administering device. [7] The medication administering device according to any one of [1] to [6], wherein the ejection unit is a press pump. [8] The medication administering device according to any one of [1] to [7], wherein the opening is opened at equal intervals at a plurality of locations in the circumferential direction relative to the axial direction on the side surface near the distal end. [9] The medication delivery device according to any one of [1] to [8], wherein the hole area of ​​the opening is 1 mm per hole. 2 the following.

[10] A medical device comprising the medical powder contained in the container of the medication administering device according to any one of [1] to [9].

[11] The medical device according to

[10] , wherein the medical powder is an anti-adhesion material.

[12] The medical device according to

[10] or

[11] further includes a tubular applicator.

[13] A surgical method using the medical device described in

[12] , comprising: inserting at least the front end portion of the applicator connected to the outlet into a living body; and Gas is ejected from the distal end portion to disperse the medical powder together with the gas toward a target site in the living body.

[14] The surgical method according to

[13] , wherein the surgery is an open surgery or a laparoscopic surgery.

[15] The surgical method according to

[13] or

[14] , wherein the target site is the peritoneum. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a diagram showing an example of the configuration of a medication administering device according to an embodiment.

[0024] Figure 2 These are diagrams illustrating a state related to use of the medication administering device according to the embodiment.

[0025] Figure 3 This is a diagram illustrating an operating posture of a medication administering device containing medical powder.

[0026] Figure 4 These are diagrams illustrating the structure of a protruding portion of a medication administering device according to an embodiment.

[0027] Figure 5 These are diagrams illustrating another configuration of the protruding portion of the medication administering device according to the embodiment.

[0028] Figure 6 This is a diagram illustrating a dispersion test when the tilt angle of the medication administering device according to the embodiment is 0 degrees.

[0029] Figure 7 This is a diagram illustrating a dispersion test when the medication administering device according to the embodiment has an inclination angle of 25 degrees.

[0030] Figure 8 This is a diagram illustrating a dispersion test when the medication administering device according to the embodiment has an inclination angle of 40 degrees. DETAILED DESCRIPTION

[0031] A medication delivery device according to one embodiment of the present invention (hereinafter also referred to as one embodiment or an embodiment) will be described below with reference to the accompanying drawings. The configuration of the embodiment described below is merely illustrative, and the medication delivery device is not limited to the configuration of the embodiment. Furthermore, the dimensions, materials, shapes, and relative placement of the components disclosed in this embodiment are not intended to limit the technical scope of the invention to these dimensions, unless otherwise specified.

[0032] According to the present invention, it is possible to provide a medication administering device that can stably distribute the medical powder contained in a container to a target site even when the device is tilted.

[0033] In the following description, medical powder refers to powder used for medical purposes. Medical powders include materials used during surgical procedures, such as adhesion prevention materials, hemostatic materials, tissue swelling materials, and wound dressing materials. Examples of adhesion prevention materials and tissue swelling materials include the cross-linked acidic polysaccharide disclosed in Patent Document 5 (e.g., cross-linked chondroitin sulfate). Examples of hemostatic materials include oxidized cellulose, fibrinogen, collagen, and gelatin. Examples of wound dressing materials include alginic acid and carboxymethyl cellulose. It should be noted that medical powders are not limited to the substances listed above.

[0034] The particle size (diameter) of the medical powder is preferably such that at least 95% of the total particles, calculated on a mass basis, are less than 1 mm, and more preferably at least 95% of the total particles, calculated on a mass basis, are less than 0.5 mm. The particle size of the medical powder is measured according to "3.04 Particle Size Determination Methods - Second Method - Sieve Method" of the Eighteenth Revision of the Japanese Pharmacopoeia.

[0035] (Medical powder delivery device) First, use Figure 1 and Figure 2The medication administering device according to this embodiment will be described. Figure 1 This is a diagram showing an example of the configuration of the medication administering device 1 according to this embodiment. Figure 1 (a) illustrates a side view of the overall structure of the medication administering device 1 as viewed from the side. Figure 1 (b) shows a side view of the ejection portion 15 in a state where the ejection portion 15 is compressed in the axial direction. Figure 1 In (a) and (b), the dashed line represents the central axis ZS1 of the medication administering device 1, and the direction in which the central axis ZS1 extends is referred to as the axial direction. Figure 1 , the axial direction is the left-right direction facing the drawing. Figure 2 These are diagrams for explaining a state related to use of the medication administering device 1 according to this embodiment. Figure 2 (a) is a perspective view illustrating the operation of the medication administering device 1. Figure 2 (b) shows a diagram illustrating the mechanism of action of the anti-adhesion material 90 dispersed as medical powder.

[0036] like Figure 1 As shown in Figures (a) and (b), medication delivery device 1 comprises a protrusion 10, a container 11, an outlet 12, a connecting portion 13, a hook 14, and a discharge portion 15. These are integrally assembled in the axial direction, forming a generally syringe-shaped device. In the following description, the direction in which the outlet 12 of medication delivery device 1 is disposed is referred to as the distal end direction, and the direction in which the discharge portion 15 is disposed is referred to as the proximal end direction.

[0037] In the medication device 1 of the present embodiment, the protrusion 10 is hollow and is configured to protrude into a container 11 having a space capable of accommodating medical powder. The protrusion 10 protrudes toward the outlet from the opposite surface of the outlet portion 12 in the container 11, and an opening portion connected to the ejection portion 15 is circumferentially provided on the side surface near the front end. Furthermore, the protrusion 10 of the medication device 1 ejects the gas ejected through the ejection portion 15 through the opening portion into the space of the container 11 containing the medical powder, and the ejection portion 15 is compressed by a pressing operation of an operator such as a user. The gas ejected into the container 11 through the opening portion stirs the contained medical powder, and together with the medical powder, it moves toward the outlet portion 12 and is ejected to the target part of the patient through the applicator 20 engaged with the outlet portion. It should be noted that when using Figure 4 、 Figure 5 The protrusion 10 will be described in detail.

[0038] The container 11 is a cylindrical member with a space for storing medical powder. An outlet 12 is provided at the distal end of the container 11, and a connection portion 13 is provided at the proximal end. The container 11 can be of various shapes and sizes, depending on the type and material of the medical powder to be stored. The material of the container 11 is not particularly limited; any material used to form components of known containers, such as glass and resin, can be used. If the container 11 is made of a synthetic resin, it can be formed into any desired shape through injection molding, extrusion molding, or other methods.

[0039] The outlet 12 communicates with the space in the container 11 and has an internal path for discharging the medical powder contained therein, along with gas, toward the outlet. The proximal end of the outlet 12 is formed into a roughly frustoconical shape that can engage with the container 11, while the distal end is formed into a cylindrical shape that can engage with the applicator (a tubular or tube-shaped needle) 20 used to dispense the medical powder to a target site. The outlet of the outlet 12 communicates with the interior of the tube of the applicator 20. The proximal end of the outlet 12 can be shaped in any manner as long as it can engage with the container 11. The same applies to the distal end of the outlet 12. In other words, the distal end can be shaped in any manner as long as it can engage with the applicator 20. The proximal end of the outlet 12 can be engaged with the container 11, and the distal end of the outlet 12 can be engaged with the applicator 20 using known methods such as threaded fastening and interference fit, depending on the material, shape, and size of the respective materials. For example, threads are formed on the outer peripheral surface of the distal end side of the outlet portion 12, and thread grooves are formed on the inner peripheral surface of the proximal end side of the applicator 20 to be threadedly engaged with the threads of the distal end side of the outlet portion 12, thereby enabling fitting engagement.

[0040] The material of the outlet portion 12 is also not particularly limited, and known materials such as resin materials can be appropriately adopted. It should be noted that if the outlet portion 12 is made of the same synthetic resin material as the container 11, the outlet portion 12 and the container 11 can be integrally formed by injection molding, extrusion molding, or the like. Furthermore, the structure of the applicator 20 is not particularly limited as long as it can spray the medical powder contained in the container 11 together with the gas to the target area. From the perspective of ease of distribution to the target area and low invasiveness, it is preferably formed from a member made of an elastic resin.

[0041] The inner diameter (diameter) of the tube of the applicator 20 is not particularly limited as long as it is a size through which the medical powder can pass, but is preferably greater than 1 mm and less than 5 mm, and more preferably greater than 2 mm and less than 3.5 mm.

[0042] The connection portion 13 is a member that connects the container 11 and the discharge portion 15. For example, the distal end of the connection portion 13 is formed to engage with the proximal end of the container 11, and the proximal end is formed to engage with the distal end of the discharge portion 15. The connection between the distal end of the connection portion 13 and the container 11, and the connection between the proximal end of the connection portion 13 and the discharge portion 15, can be achieved by using known engagement methods such as threaded connection and interference fit, depending on the material, shape, and size of each. The material of the connection portion 13 is not particularly limited, and known materials such as resin materials can be used as appropriate.

[0043] The outer peripheral surface of the connection portion 13 is opened with a gas suction hole 13c that communicates with the interior of the ejection portion 15. The gas suction hole 13c is, for example, formed in the ejection portion 15 ( Figure 1 (b) state) returns to the state before the pressing operation ( Figure 1 In the case of (a), the opening hole allows gas (air) to flow into the inside of the ejection portion 15 which is under negative pressure.

[0044] The opening for allowing gas (air) to flow into the compressed, negatively pressurized discharge section 15 can be provided, for example, at the end 15a of the discharge section 15. For example, the operator can block the opening provided at the end 15a while pressing, compressing the discharge section 15 and causing the gas within the discharge section to be ejected into the container 11 through the protrusion 10. Alternatively, the operator can open the blocked opening to restore the compressed discharge section 15 to its pre-pressing state, allowing gas (air) to flow into the negatively pressurized discharge section 15. By adopting this configuration, a drug delivery device 1 for ejecting medical powder to a target site can be provided that can be operated with a simpler structure.

[0045] It should be noted that the connection portion 13 may also be provided with a mechanism, such as a two-way valve, that restricts the gas flow to a single direction. Such a mechanism for restricting the gas flow to a single direction is, for example, configured to block the path between the gas intake hole and the interior of the discharge portion 15 when the compressed discharge portion 15 is discharged through the protrusion 10 into the container 11. Various known structures, such as a diaphragm type, a ball type, and a disc type, can be employed as such a mechanism.

[0046] The hooking parts 14 are a pair of members for hooking fingers when holding the medication device 1. The hooking parts 14 are each formed in a ring shape and are arranged at opposite positions on the outer peripheral surface of the container 11. Figure 2As shown in (a) of FIGURE 1 , an operator using the medication delivery device 1 inserts their index finger Z2 and middle finger Z3, respectively, through a pair of loop-shaped hooks 14, gripping the container 11 of the medication delivery device 1 from opposing positions. Furthermore, when compressing the discharge portion 15, the operator places their thumb Z1 in contact with the end 15a and presses it toward the distal end. Inserting the operator's index finger Z2 and middle finger Z3 through the loop-shaped hooks 14 improves gripping reliability of the medication delivery device 1. Furthermore, the dispensing portion 15 can be compressed toward the distal end using the pressing force between the index finger Z2 and middle finger Z3 and the thumb Z1, making the pressing operation easier. Since the medication delivery device 1 can be gripped using the index finger Z2 and middle finger Z3 inserted through the loop-shaped hooks 14, the compression can be released by releasing the thumb Z1 from contact with the end 15a to return the compressed discharge portion 15 to its pre-pressing state. The hook portion 14 may have any shape as long as it allows the operator to hook the hook with their fingers and pinch the container 11 from the facing position, and may be a flat plate or an arc shape.

[0047] Regarding the placement of the hook portion 14, for example, a pair of notches for retaining the hook portion 14 are formed at opposing positions on the outer circumference of the connecting portion 13 that engages with the proximal end of the container 11, and a retaining protrusion extending toward the proximal end is formed on the hook portion 14. Furthermore, by engaging the retaining protrusions formed on the hook portion 14 with retaining grooves formed on the outer circumference of the connecting portion 13, a pair of hook portions 14 can be placed at opposing positions on the outer circumference of the container 11. The retaining method for the hook portion 14 can be appropriately adopted by any known retaining method. Alternatively, the hook portion 14 can be adhesively fixed to opposing positions on the outer circumference of the container 11. The material of the hook portion 14 is not particularly limited; any known material, such as a resin material, can be used. Furthermore, if the hook portion 14 is made of the same synthetic resin material as the connecting portion 13, the hook portion 14 and the connecting portion 13 can be integrally formed by injection molding, extrusion molding, or the like.

[0048] The ejection portion 15 has a bellows-shaped cylindrical shape and is a member that can be expanded and contracted in the axial direction. The end portion 15a on the base end side of the ejection portion 15 is closed, and the front end side engaged with the connection portion 13 is configured so that when compressed, the compressed gas can be ejected into the container 11 through the protrusion 10. The ejection portion 15 is formed into a bellows shape to be able to expand and contract in the axial direction. For example, the ejection portion 15 is expanded and contracted when a pressure is applied to the end portion 15a. Figure 1 When the state shown in (a) is compressed to the state shown in (b), the gas in the bellows is ejected into the container 11 through the protrusion 10. In addition, the ejection portion 15 is released from the end portion 15a when the pressing force applied to the end portion 15a is released. Figure 1When the state shown in (b) is extended to the state shown in (a), gas (air) flows from the gas intake hole 13c into the negative pressure bellows. The ejection portion 15 functions as a pressure pump by repeatedly changing its state: compression toward the distal end due to the pressing force, and expansion (restoration) toward the proximal end due to the release of the pressing force. This serves as a gas supply source for the compressed gas into the container 11. Hereinafter, the gas supplied from the ejection portion 15 will also be referred to as pressurized gas.

[0049] As the ejection unit, in addition to a bellows pump, a push pump such as a rubber ball, a gas cylinder, an air pump, etc. can be used. When a gas cylinder is used as the ejection unit, it is preferable to provide an air pressure regulating valve.

[0050] When a press pump is used as the discharge unit 15, its material can be appropriately selected from known materials such as polyolefin. When the discharge unit 15 is a bellows pump, its material is preferably polyester or polyolefin, more preferably polyolefin, and even more preferably polyethylene. The discharge unit 15 can be appropriately shaped, sized, etc. depending on the material and other factors.

[0051] The medication delivery device 1, which contains medical powder in a container 11, is engaged with an applicator 20 and functions as a medical device. At least the distal end of the applicator 20 is inserted into a living body. The operator grips the medication delivery device 1 by hooking the fingers of the operator's hand onto a pair of hook portions 14, and presses the end 15a of the bellows-shaped discharge portion 15 toward the distal end. The discharge portion 15 is compressed toward the distal end by the pressing force applied to the end 15a, and the gas in the bellows is discharged into the container 11 through the opening formed in the protrusion 10. The pressurized gas discharged into the container 11 stirs the contained medical powder and flows into the applicator 20 engaged with the outlet portion 12 together with the medical powder. The medical powder contained in the container 11 is discharged to the target site through the conduit-shaped applicator 20 together with the pressurized gas.

[0052] The mechanism of action of the medical powder sprayed to the target site is explained by taking the adhesion prevention material described in Patent Document 5 as an example. The adhesion prevention material is a pharmaceutical composition used to prevent adhesion between the wound site after surgery and the surrounding tissues with the possibility of adhesion. It is believed that adhesion is caused by, for example, the precipitation and deposition of exudate containing fibrin on the tissue surface of the wound site, and the connection or fusion of the tissue surface with the surrounding tissue surface. For example, during open surgery, if the intestinal tract in the abdominal cavity adheres to the abdominal wall or the intestinal tracts each other, the fluidity of the intestinal tract is impaired, sometimes causing intestinal obstruction (adhesive ileus). For the purpose of preventing such adhesions, such as Figure 2As shown in (b), the anti-adhesion material 90, a medical powder contained in the medication delivery device 1, is sprayed by the applicator 20 between the wound site in the organ Z5 within the abdominal cavity and the abdominal wall Z4, where adhesion is possible. The anti-adhesion material 90 sprayed from the applicator 20 spreads over the surface of the wound site in the organ Z5 and the surface of the abdominal wall Z4, such as the peritoneum.

[0053] The applied anti-adhesion material 90 absorbs water around the wound site of organ Z5 and swells. The swollen anti-adhesion material 90 isolates the surface tissue of the wound site of organ Z5 from the surface tissue of the abdominal wall Z4, which could potentially cause adhesion, functioning as a physical barrier to prevent adhesion between the two tissues. The swollen anti-adhesion material 90 then becomes a solution and is gradually absorbed or decomposed, thus preventing adhesion between the tissues.

[0054] Figure 3 This is a diagram for explaining an operating posture of the medication administering device 1 containing the anti-adhesion material 90 . Figure 3 (a) is a schematic diagram illustrating an operating posture of the medication administering device 1 during laparotomy. Figure 3 (b) shows a schematic diagram illustrating the operating posture of the medication device 1 during laparoscopic surgery. Figure 3 As shown in (a), the adhesion prevention material 90 during laparotomy is spread to a target site such as the peritoneum through the applicator 20. The operator, for example, makes the drug delivery device 1 containing the adhesion prevention material 90 into a horizontal state and starts spreading to the target site (blowing out surround A1). Here, the horizontal state refers to a state in which the axial direction of the central axis ZS1 of the drug delivery device 1 is parallel to the horizontal direction. The operator gradually lifts the drug delivery device 1 with the front end of the applicator 20 facing opposite to the target site as the center, while spreading the adhesion prevention material 90 (blowing out surround A2). The posture of the drug delivery device 1 is tilted in a manner that the relative angle with respect to the horizontal direction gradually increases. Then, as the adhesion prevention material 90 contained in the container 11 decreases, the posture of the drug delivery device 1 is tilted in a direction in which the relative angle with respect to the horizontal direction increases, while ending the spreading (blowing out surround A3).

[0055] Regarding the distribution of the adhesion-preventing material 90, the posture of the medication delivery device 1 changes similarly during laparoscopic surgery. It should be noted that the distribution of the adhesion-preventing material 90 during laparoscopic surgery is performed using an applicator 21 inserted into the abdominal cavity Z6 of a living body using a trocar system. The applicator 21 is a catheter-like needle used in laparoscopic surgery, with a curved tip 21a. For example, while visually observing an image of the abdominal cavity Z6 captured via a laparoscope, the operator manipulates the medication delivery device 1, with the applicator 21 engaged, to align the tip 21a with the distribution surface Z7, such as the peritoneum, which is the target site of the living body. The operator then tilts the medication delivery device 1 while pressing, distributing the adhesion-preventing material 90 contained in the container 11 to the target site. The relative tilt of the medication delivery device 1 with respect to the horizontal direction from the start to the end of distribution also varies within an angle range of approximately 0° to 90° during laparoscopic surgery.

[0056] (Protrusion structure) Next, refer to Figure 4 、 Figure 5 The structure of the protrusion 10 of this embodiment will be described. Figure 4 is a perspective view illustrating the structure of the protruding portion 10. Figure 5 It is a perspective view illustrating another structure of the protruding portion 10 . Figure 4 (a) and (b) Figure 5 (a) and (b) respectively illustrate different structural modes of the protrusion 10 .

[0057] like Figure 4 As shown in (a), the protrusion 10 has a cylindrical structure extending from the base end side to the front end side in the container 11 and protruding toward the space capable of accommodating the medical powder. Figure 1 The protrusion 10 is formed axially symmetrical with the center axis ZS1 shown in (a) and (b) as the center. The front end side, that is, the protrusion end 10b, is closed, and on the side, the opening 10a is open in the circumferential direction relative to the axial direction. The opening 10a is formed to communicate with the space 10c formed in the protrusion 10. The space 10c formed in the protrusion 10 has an inlet on the connecting portion 13 side and is inserted into the connecting space 13a in the connecting portion 13. Furthermore, the connecting space 13a in the connecting portion 13 is inserted into the bellows of the ejection portion 15. By having such a structure, the protrusion 10 can eject the pressurized gas accompanied by the compression of the ejection portion 15 into the space in the container 11 containing the medical powder through the opening 10a, as shown by the dotted arrow.

[0058] The material of the protrusion 10 is not limited, and any known material such as glass or resin can be used, but preferably the same resin as the connection portion 13. When the protrusion 10 is made of a synthetic resin material, it can be formed into any shape by injection molding, extrusion molding, etc.

[0059] The opening portion 10a opened on the side of the protrusion 10 may be one or more than two. In the case of one, the gas compressed by the compression of the ejection portion 15 can be ejected to the area on the bottom side of the medical powder collection contained in the container in a relatively increased pressing force. In the case where the opening portion 10a is provided at multiple locations along the axial direction, the compressed gas can be ejected to multiple areas on the bottom side of the medical powder collection contained in the container. The medical powder collected on the bottom side of the container 11 is caused to fly in the container 11 by the ejected pressurized gas. The flying medical powder diffuses in the container 11 and is ejected to the outlet portion 12 together with the pressurized gas. In addition, as Figure 4 (b) Figure 5 As shown in (a) and (b), when the openings 10 a are provided at multiple locations in the circumferential direction relative to the axial direction, a uniform flow of pressurized gas can be formed so that the medical powder stirred and flying in the container 11 flows along the inner circumferential surface of the container 11 toward the outlet 12.

[0060] The hole area (area per hole) of the opening 10a can be adjusted according to the particle size of the medical powder, and is preferably 1 mm. 2 Below, more preferably 0.5mm 2 The hole area of ​​the opening 10a (the area per hole) is preferably 0.01 mm, for example. 2 More than 0.1 mm 2 The shape of the opening 10a is not particularly limited, and may be, for example, circular, square, or semicircular.

[0061] In the space within the container 11, the proximal end of the protrusion 10 is the proximal end, and the outlet 12 is the distal end. The space within the container 11 extends from the inner surface of the proximal end (i.e., the surface facing the outlet 12) to the inner surface of the distal end (the inner surface on the outlet 12 side). In this space within the container 11, the opening 10a of the protrusion 10 preferably opens at a position at least one-third of the distance from the surface facing the outlet 12 toward the outlet 12. This allows the opening 10a of the protrusion 10 to open relatively close to the outlet 12 within the container 11. This makes it easier for the medical powder contained in the container 11 to be ejected from the outlet 12 than if the opening were located at the proximal end. Even if the medication delivery device 1 is tilted, the medical powder contained in the container 11 can be stably dispersed.

[0062] The protrusion 10 may be integrally formed with the container 11 or the connection portion 13 or may be configured as a separate body. By configuring the protrusion 10 as a separate body, for example, the protrusion 10 can be provided so as to be replaceable depending on the type and material of the medical powder contained in the container 11.

[0063] Figure 4 (b) illustrates an example of a separate configuration of the protrusion 10. While this configuration describes an engagement method based on an interference fit, known engagement methods such as threaded engagement can also be employed. The separate protrusion 10 can be made of any known material, but preferably, a resin material capable of injection molding, extrusion molding, or other methods is employed. The number, size, and shape of the openings 10a formed in the protrusion 10 can be appropriately selected based on the type and material of the medical powder contained in the container 11.

[0064] The protrusion 10, which is constructed as a separate body, has an engagement portion 10d formed to be engageable with the connection portion 13, and is formed into an axisymmetric cylindrical shape with the protrusion end 10b on the front end side closed. A plurality of openings 10a are opened in the circumferential direction relative to the axial direction on the side surface of the protrusion 10, and each opening 10a is connected to a space 10c formed in the protrusion 10. An engagement hole 13b is opened in the connection portion 13, which is formed to be engageable with the engagement portion 10d of the protrusion 10. The engagement hole 13b is inserted into the connection space 13a of the connection portion 13. By fitting the engagement portion 10d of the protrusion 10 into the engagement hole 13b of the connection portion 13, the protrusion 10, which is constructed as a separate body, and the connection portion 13 are fastened together. Through the engagement, the space 10c formed in the protrusion 10 and the connection space 13a are connected. Even with this configuration, the pressurized gas compressed by the ejection portion 15 can be ejected through the connection space 13a communicating with the bellows of the ejection portion 15 through the opening 10a into the space in the container 11 containing the medical powder.

[0065] exist Figure 4 In embodiment (b), openings 10a, openings on the side of protrusion 10, are arranged at regular intervals of 90° along the circumference. As indicated by the dotted arrows, protrusion 10 can eject pressurized gas into the space within container 11 containing the medical powder at intervals of 90° circumferentially centered on protrusion 10. The pressurized gas ejected at intervals of 90° centered on protrusion 10 is expected to improve the uniformity of the flow generated within container 11 toward outlet 12, thereby enhancing the stability of the medical powder ejected along with the pressurized gas.

[0066] It should be noted that the shape of the protrusion 10 protruding into the container 11 may be as follows: Figure 4 The protrusion 10 is cylindrical as shown in (a) and the like, but may be formed in other shapes. For example, the protrusion 10 is axially symmetrical, and as long as the front end is closed and a space 10c is formed to be inserted into the bellows of the ejection part 15, and the opening 10a opened on the side of the protrusion 10 is connected to the space 10c. For example, the protrusion 10 may be formed as Figure 5 The prismatic shape 10h, the pyramidal shape (eg, cone or pyramid), the truncated cone shape (eg, Figure 5 The shape of the protrusion 10 may be a truncated cone 10i or a truncated pyramid as exemplified in (b). The shape may be appropriately selected depending on the material and size of the protrusion 10, the type and material of the medical powder contained in the container 11, the desired amount of dispersion, and the like. Furthermore, the protruding end of the protrusion 10 may be open or closed. A closed end of the protrusion 10 is preferred because it increases the flow rate of the pressurized gas ejected toward the side of the ejection portion.

[0067] (Dispersion test) Next, refer to Figures 6 to 8 , the procedure and results of the dispersion test of the medical powder using the drug delivery device 1 are explained. The dispersion test was carried out by means of the following medical device, in which the medical powder was contained in the container 11 of the drug delivery device 1, and the applicator 20 (cylinder inner diameter 3.2 mm) used in laparotomy, etc. was installed at the outlet portion 12. The medical powder for the dispersion test was an anti-adhesion material 90 (particle size: 95% or more (mass conversion) of particles with a particle size less than 0.5 mm) prepared according to Example 20 of Patent Document 5, and the filling amount contained in the container 11 (content 24 mL) was set to 1 g. In the drug delivery device 1, the number of openings 10a opened in the circumferential direction of the side surface of the protrusion 10 was set to 4 locations arranged at equal intervals of 90 degrees, and the openings were set to have a hole area (per hole) of 0.4 mm 2The dispensing operation was performed while the medication delivery device 1 was tilted at a predetermined angle without changing its posture. The tilt angle of the medication delivery device 1 was set to three states: 0 degrees parallel to the horizontal direction, 25 degrees, and 40 degrees relative to the horizontal direction. In the dispensing test, while maintaining the tilt angle, the bellows portion of the ejection portion 15 was extended and retracted to eject pressurized gas into the container 11. The weight of the medical powder ejected from the applicator 20 along with the pressurized gas was measured. The weight of the medical powder was measured every 10 pump operations, with one reciprocating action of compression and recovery being used as the unit.

[0068] Figure 6 This is a diagram illustrating a dispersion test when the medication delivery device 1 has an inclination angle of 0 degrees. Figure 7 This is a diagram illustrating a dispersion test when the medication administering device 1 is tilted at an angle of 25 degrees. Figure 8 This is a diagram illustrating a dispersion test when the medication administering device 1 is tilted at an angle of 40 degrees. Figures 6 to 8 (a) shows a diagram illustrating the tilt of the posture of the medication administering device 1 in the scattering test. Figures 6 to 8 The single-dot chain line in each (a) indicates the horizontal direction. Figures 6 to 8 In each (b), a graph showing the results of the scattering test is shown. Figure 6 In the graph showing the results of the dispersion test shown in (b), the vertical axis represents the dispersion amount (g) and the horizontal axis represents the number of pump operations. Figure 7 (b) and Figure 8 In the dispersion test with the medication administering device 1 tilted at 0 degrees and 40 degrees, in order to evaluate the dispersion amount of the dispersed medical powder, the medication administering device (medication administering device) without the protrusion 10 was subjected to the same operation and the dispersion amount was measured.

[0069] exist Figure 6 In (b), graph G1 shows the variation in the amount of medical powder dispensed as the number of pump cycles of medication delivery device 1 increases, while graph G2 shows the variation in the amount of medical powder dispensed as the number of pump cycles of a medication delivery device serving as a comparison. As shown in graph G2, when a medication delivery device without protrusion 10 is pressed in a horizontal position, the amount of medical powder dispensed from applicator 20 varies around 0 (g), regardless of the number of pump cycles. On the other hand, as shown in graph G1, in medication delivery device 1 equipped with protrusion 10, a constant amount of medical powder contained in container 11 is dispensed as the discharge unit 15 pumps, ensuring a stable amount of medical powder dispensed even in a horizontal position.

[0070] Figure 7Graph G3 in (b) shows the change in the amount of medical powder dispensed as the number of pumps of the medication delivery device 1 increases. Even when the medication delivery device 1 is tilted at a 25-degree angle, a constant amount of medical powder contained in the container 11 can be dispensed as the discharge portion 15 pumps, thereby ensuring a stable amount of medical powder dispensed. It should be noted that the change in the amount of medical powder dispensed from the applicator 20 tends to become more gradual around the 60th to 70th pump count. This is presumably because the amount of medical powder in the container 11 tilted at 25 degrees decreases with increasing pump counts, reducing the amount of medical powder agitated by the pressurized gas ejected from the opening 10a of the protrusion 10.

[0071] exist Figure 8 In (b), graph G4 shows the variation in the amount of dispersion as the number of pumps of medication delivery device 1 increases, while graph G5 shows the variation in the amount of dispersion as the number of pumps of a medication delivery device serving as a comparison. At a 40-degree tilt angle, a predetermined amount of medical powder is deflected toward the vicinity of outlet 12. Therefore, even in the comparison configuration without protrusion 10, a certain amount of medical powder can be ejected, allowing the dispersion amount to be measured. However, as shown in graph G5, even after approximately 100 pump cycles, the dispersion amount remains very low. On the other hand, in medication delivery device 1 equipped with protrusion 10, as shown in graph G4, a certain amount of medical powder contained in container 11 can be ejected as the discharge portion 15 pumps, ensuring a stable dispersion amount. Furthermore, although the change in the amount of medical powder to be dispersed tends to be gentle around 60 to 70 pump times, it can be seen that the entire amount of medical powder contained in the container 11 is dispersed at approximately 100 pump times.

[0072] The present invention has been described in conjunction with specific examples and various embodiments, but it will be readily apparent to those skilled in the art that many modifications and applications of the embodiments described herein can be made without departing from the spirit and scope of the present invention.

[0073] This application claims priority based on Japanese Patent Application No. 2023-036835 filed with the Japan Patent Office on March 9, 2023, the contents of which are incorporated herein by reference in their entirety.

[0074] Description of Reference Numerals 1··Medication device, 10··Protrusion, 10a··Opening, 10b··Protruding end, 10c··Space, 10d··Fitting part, 10h··Prism, 10i··Conical shape, 11··Container, 12··Outlet, 13··Connecting part, 13a··Connecting space, 13b··Fitting hole, 13c··Gas suction hole, 14··Hooking part, 15··Ejection part, 15a··End, 20, 21··Applicator, 90··Anti-adhesion material.

Claims

1. A drug delivery device for medical powders, comprising: a container having an outlet for ejecting the medical powder and a space capable of accommodating the medical powder; a protrusion that protrudes from a surface opposite to the outlet toward the outlet in the container toward the space, and has an opening on a side surface of the protruding portion; and The ejection portion ejects gas from the opening into the space from the side opposite to the front end of the protrusion through the inlet of the protrusion communicating with the opening.

2. The drug delivery device according to claim 1, wherein The protrusion is axially symmetrical, and the opening is open in a circumferential direction relative to the axial direction on a side surface near the front end.

3. The drug delivery device according to claim 1 or 2, wherein: The protrusion is in the shape of a pyramid, a cone, a prism or a cylinder.

4. The drug delivery device according to any one of claims 1 to 3, wherein The protruding end of the protrusion is closed.

5. The drug delivery device according to any one of claims 1 to 4, wherein The opening is opened at a position which is at least one-third away from the surface facing the outlet in the container in a direction toward the outlet.

6. The drug delivery device according to any one of claims 1 to 5, wherein: The medication administering device further includes a hook portion that hooks a finger when a user holds the medication administering device.

7. The drug delivery device according to any one of claims 1 to 6, wherein: The ejection unit is a pressure pump.

8. The medication administering device according to any one of claims 1 to 7, wherein The opening portion is opened at equal intervals at a plurality of locations in the circumferential direction relative to the axial direction on the side surface near the front end.

9. The drug delivery device according to any one of claims 1 to 8, wherein The hole area of ​​the opening is 1 mm per hole. 2 the following. 10 . A medical device comprising the medical powder contained in the container of the medication administering device according to claim 1 .

11. The medical device according to claim 10, wherein The medical powder is an anti-adhesion material.

12. The medical device according to claim 10 or 11, wherein The medical device further comprises a tubular applicator.

13. A surgical method using the medical device according to claim 12, comprising: inserting at least the front end portion of the applicator connected to the outlet into a living body; and Gas is ejected from the distal end portion to disperse the medical powder together with the gas toward a target site in the living body.

14. The surgical method according to claim 13, wherein: The surgery is open surgery or laparoscopic surgery.

15. The surgical method according to claim 13 or 14, wherein: The target site is the peritoneum.

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