Device for delivering medicament

Abstract

A device for delivering a medicament, comprising a pressure regulating component, which includes a pressure regulating chamber and an outlet chamber. The pressure regulating inlet of the pressure regulating chamber is connected to a catheter, and the included angle between the chamber wall of the pressure regulating outlet and the axis of the pressure regulating chamber is 10°-12.5°; the outlet inlet of the outlet chamber is assembled with the pressure regulating outlet, and the included angle between the chamber wall of the outlet outlet and the axis of the outlet chamber is 5°-6°. The device provided by the present invention can deliver the medicament in the container in a more stable, continuous and balanced propulsion manner and in a more gentle form, effectively avoiding the sudden release of pressure, so that the medicament is affected by the reaction of the target tissue and fills the endoscopic field of view, making the administration (such as: hemostatic agent) more accurate. At the same time, the continuity of endoscopic surgery is improved, the hemostatic effect is enhanced, and the operation time of the surgery is shortened.

Description

Technical Field

[0001] The present invention relates to a drug delivery container, and particularly to a device that is driven by a pressure source to deliver a medicament to a target tissue, so as to facilitate the medicament to play a therapeutic role in the target tissue. Background Art

[0002] Currently, for traumatic bleeding caused by trauma or surgery, regardless of the hemostatic technique used, the conventional method of "compression hemostasis" is indispensable. Common ones include: band-aids for external trauma, and hemostatic sponges, hemostatic microspheres, hemostatic medical membranes, and hemostatic gauzes made by non-woven processes used in various surgeries. Although these hemostatic techniques have effectively improved the hemostatic efficiency, external force must be removed after compression for a period of time, and it is necessary to observe whether there are still bleeding points at the trauma site. If there is still bleeding, hemostatic agents need to be used continuously and compressed again until hemostasis is achieved. The operation is not only complicated and relies on human judgment, but it is difficult to accurately operate for hemostasis of deep parenchymal organs and deep wounds in cavities, resulting in difficult hemostasis. Especially for these parts or tissues, local compression for a long time is required for hemostasis, which is not conducive to the late healing of the trauma. For example, for the sinuses or nasal cavity, an inflatable hemostatic sponge is usually used at present, and hemostasis is not easy to be complete. It is necessary to observe no bleeding after compression for 24 hours and then remove the hemostatic sponge. The patient's nasal swelling and respiratory tract obstruction also cause difficulties in timely hemostasis during the operation, the patient's quality of life is poor, and observation for 24 hours and the need for a second removal increase the workload of medical staff.

[0003] The emergence of hemostatic gels has improved traumatic hemostasis. However, for wounds with a large amount of bleeding, it is difficult for the hemostatic gel to adhere to the wound in a short time, otherwise it is difficult to achieve the purpose of timely hemostasis.

[0004] In the market, there are also products that spray medicaments on the wound in a spray manner. The purpose of this spray method is to evenly spray powders, which is not a hemostatic method. For example, Yunnan Baiyao aerosol is mainly used for sprains. For contusions and knife wounds, it is still necessary to use powders for hemostasis, and the method of compression hemostasis must also be used (according to the aerosol instruction manual).

[0005] Chinese Utility Model Patent ZL201420372934.3 discloses a hemostatic device for trauma and its components, including a container for holding a hemostatic agent, a valve for controlling the connection or disconnection between an external pressure source and the container, an action catheter with one end bent to form a bent portion, and a tee joint communicating with the container, the valve and the action catheter respectively. This device can quickly stop bleeding from the target tissue. However, due to the instantaneous pressure relief at the moment of opening the valve - which causes the pressure of the ejected fluid to rise instantaneously, making the hemostatic powder that impacts the tissue instantaneously under the drive of pressure generate a reaction force on the acting part, causing the hemostatic powder to cover the field of view and making it impossible to continue observing. At the same time, the surgical laparoscope is also adhered by the hemostatic powder, resulting in the inability to observe, affecting the timely observation of the hemostatic effect of the hemostatic agent on the tissue and also affecting the continuity of the endoscopic surgical operation. Summary of the Invention

[0006] One object of the present invention is to provide a device for delivering a medicament, which is driven by a pressure source to deliver the medicament to a target tissue, so as to facilitate the medicament to exert a therapeutic effect on the target tissue.

[0007] Another object of the present invention is to provide a device for delivering a medicament, which applies a stable pressure to the medicament in the device to avoid causing damage to the target tissue due to impact.

[0008] Another object of the present invention is to provide a device for delivering a medicament, which is driven by a pressure source to accurately deliver the hemostatic agent to the bleeding tissue, avoiding repeated hemostasis of the bleeding tissue and facilitating an appropriate amount of hemostatic agent to exert a hemostatic effect on the bleeding tissue.

[0009] Another object of the present invention is to provide a device for delivering a medicament, which avoids the medicament delivered to the target tissue from generating impact and reaction force on this part and the tissue, causing atomization in the visual field area and making the hemostatic powder adhere to the surface of the instrument (such as the laparoscope mirror surface), thus affecting the observation.

[0010] Another object of the present invention is to provide a device for delivering a medicament, which fixes components such as a catheter to the device or integrally forms them with the device, avoiding the medicament delivered to the target tissue from impacting the tissue and affecting endoscopic observation, so as to facilitate the progress of endoscopic surgery.

[0011] A device for delivering a medicament, comprising

[0012] a container for containing the medicament;

[0013] a cavity, which includes a cavity channel, a cavity inlet and a cavity outlet, and the cavity outlet faces the bottom of the container;

[0014] a valve, which includes a first through hole and a valve body, the first through hole communicates with the cavity inlet and the cavity outlet respectively, and the valve body divides the cavity channel into a pressure relief cavity channel and a pressure - receiving cavity channel.

[0015] Another device, comprising

[0016] a container for containing a medicament;

[0017] an interface for connecting to a pressure source;

[0018] a cavity, which includes a channel, a cavity inlet, and a cavity outlet. The cavity inlet is in communication with the interface, and the cavity outlet faces the bottom of the container;

[0019] a valve, which includes a first through hole and a valve body. The first through hole is in communication with the cavity inlet and the cavity outlet respectively, and the valve body divides the channel into a pressure relief channel and a pressure receiving channel.

[0020] The device provided by the present invention further includes a cover body, which is assembled with the first through hole to close the first through hole.

[0021] In the device provided by the present invention, the valve body causes the fluid moving in the channel to change direction by 90° once.

[0022] In the device provided by the present invention, the pressure source provides a fluid of a desired pressure, such as: gas or liquid, and gas is preferably selected, such as: but not limited to air, N2, O2, CO2, or inert gas, etc.

[0023] Another device further includes a medicament, which is placed in the container and is in powder form. The particle size of more than 90% of the powder particles ≤ 100μm, such as: the particle size of more than 90% of the powder particles ≤ 50μm.

[0024] The medicament is affected by the substance flowing out of the cavity outlet and is discharged from the outlet of the container.

[0025] In the device provided by the present invention, the inner cavity volume of the container is 10 cm 3 ~250 cm 3 . For ease of operation (such as: hand-held), 10 cm 3 ~70 cm 3 is preferably selected, especially 10 cm 3 ~30 cm 3 , such as: but not limited to 10 cm 3 , 11 cm 3 , 12 cm 3 , 13 cm 3 , 14 cm 3 , 15 cm 3 , 16 cm 3 , 17 cm 3 , 18 cm 3 , 19 cm 3 , 20 cm 3 , 21 cm 3 , 22 cm 3 , 23 cm3 , 24 cm 3 , 25 cm 3 , 26 cm 3 , 27 cm 3 , 28 cm 3 , 29 cm 3 and 30 cm 3 .

[0026] To facilitate the direct action of the medicament on the target tissue, a catheter is also provided at the outlet of the container to form the device for delivering the medicament provided by the present invention. By installing the catheter to guide the delivery path of the medicament, it is also beneficial to act on the target tissue when the medicament is close to the target tissue.

[0027] To facilitate the performance of endoscopic surgery and avoid the counteraction of the medicament delivered to the target tissue on the tissue, which causes the medicament to cover the entire endoscopic field of view and affect endoscopic observation, the device of the present invention further includes a pressure regulating component, including a pressure regulating chamber, one end of which is open and connected to the catheter, and the included angle between the chamber wall at the other end opening and the axial direction of the pressure regulating chamber is 3° to 10°.

[0028] The medicament exits from the other end opening and directly acts on the target tissue.

[0029] To further improve the pressure acting on the target tissue, another pressure regulating component includes

[0030] a pressure regulating chamber, the pressure regulating inlet of which is connected to the catheter, and the included angle between the chamber wall at the pressure regulating outlet and the axial direction of the pressure regulating chamber is 10° to 12.5°;

[0031] an exit chamber, the exit inlet of which is assembled with the pressure regulating outlet, and the included angle between the chamber wall at the exit outlet and the axial direction of the exit chamber is 5° to 6°.

[0032] Along the radial direction of the pressure regulating chamber, a plurality of grooves are provided on the chamber wall of the pressure regulating chamber.

[0033] The caliber of the exit inlet is the same as that of the pressure regulating outlet. Between the exit inlet and the exit outlet, a buffer chamber is also provided, and its axial length is 0.5 mm to 2 mm, especially 0.5 mm to 1.5 mm.

[0034] The medicament exits from the other end opening and directly acts on the target tissue.

[0035] The device provided by the present invention is assembled by the container, the catheter and the pressure regulating component for the delivery of the medicament. Or the container, the catheter and the pressure regulating component are integrally formed by 3D printing or molding for the delivery of the medicament. These devices are all disposable medical consumables, which are convenient for manufacturing and use.

[0036] The beneficial effects brought by the present invention are:

[0037] After being connected to a pressure source, the device provided by the present invention can achieve a more gentle delivery of the medicament in the container in a more stable and continuously balanced propulsion manner, effectively avoiding the medicament being affected by the reaction of the target tissue and filling the endoscope field of view, or adhering to the surface of the endoscope, resulting in the inability to timely observe the effect of the medicament on the target tissue (especially the hemostasis situation of the hemostatic agent on the target tissue), and improving the continuity of the endoscopic surgery.

[0038] The device provided by the present invention, in cooperation with a pressure regulating component, enables the medicament driven by the pressure source to act more concentratedly on the target tissue. Especially for bleeding tissues, the control of the hemostatic administration area is more precise, and more than 75% of the medicament can be restricted within an area with a radius of 0.5 cm to 1.5 cm.

[0039] The device provided by the present invention enables the medicament driven by the pressure source to act more concentratedly on the target tissue. Especially for bleeding tissues, more medicament acts on the bleeding wound surface, and hemostasis can be achieved within 20 seconds under the action of the medicament, significantly shortening the hemostasis time.

[0040] Compared with the technical solution disclosed in Chinese Utility Model Patent ZL201420372934.3, the device provided by the present invention transports the hemostatic powder to the bleeding tissue, avoiding the atomization of the hemostatic agent powder in the endoscope field of view area due to the reaction and not adhering to the mirror surface of the endoscope, facilitating the progress of endoscopic surgery operations, enabling more intuitive and precise hemostatic measures to be implemented on the bleeding tissue, and shortening the operation time. Brief Description of the Drawings

[0041] Figure 1 It is a schematic structural diagram of an embodiment of the device for transporting the medicament of the present invention;

[0042] Figure 2 For Figure 1 A schematic cross-sectional view of the device shown at an angle;

[0043] Figure 3 It is a schematic cross-sectional view of an embodiment of a catheter with a pressure regulating component assembled at one end;

[0044] Figure 4 It is a schematic cross-sectional view of an embodiment of the pressure regulating component;

[0045] Figure 5 It is a schematic diagram of an embodiment of the action area formed by using the existing device to transport the medicament on the target tissue;

[0046] Figure 6 It is a schematic diagram of an embodiment of the action area formed by the component of the present invention transporting the medicament on the target tissue. Detailed Description of the Embodiment

[0047] The technical solution of the present invention will be described in detail below with reference to the accompanying drawings. The embodiments of the present invention are only used to illustrate the technical solution of the present invention and not to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solution of the present invention can be modified or equivalently replaced without departing from the spirit and scope of the technical solution of the present invention, and all of them should be covered by the scope of the claims of the present invention.

[0048] Figure 1 The device for delivering medicament of the present invention Figure 2 is Figure 1 a schematic cross-sectional view of the device at an angle. Figure 1 and Figure 2 As shown, the device of this embodiment includes a container 100 and a cavity 200. The volume of the container is 15 cm 3 . An interface 300 is provided on the container 100 for connecting to a pressure source. In this embodiment, the pressure source provides a fluid with a desired pressure, such as: gas or liquid, preferably gas, such as: but not limited to air, N2, O2, CO2 or inert gas, etc. The interface 300 is also in communication with the cavity 200 to introduce the pressurized fluid into the cavity 200.

[0049] The cavity 200 is in communication with the inner cavity of the container 100 and includes a cavity channel 230, a cavity inlet 210 and a cavity outlet 220. The cavity inlet 210 is in communication with the interface 300, and the cavity outlet 220 faces the bottom of the container. The pressurized fluid is introduced into the cavity channel 230 from the cavity inlet 210, flows in the cavity channel 230, and after flowing out from the cavity outlet 220, acts on the medicament in the container. The medicament is transported towards the container outlet under the pressure of the fluid.

[0050] After the pressure source valve is opened, the fluid from the pressure source enters the cavity 200 and quickly flows out from the cavity outlet 220, so that the medicament at the cavity outlet 220 generates a sudden acting force to drive the medicament to quickly move towards the container outlet 110. When the medicament with a large momentum acts on the target tissue, due to the reaction of the target tissue, the area acted on by the medicament is enlarged (see Figure 5 ), the medicament is dispersed, and the concentration of the medicament in the target tissue is reduced. When used in endoscopic surgery, due to the reaction of the target tissue, the medicament fills the entire field of view, and the surgery cannot continue. It is necessary to take out the endoscope and wipe it before continuing the surgery, which affects the continuity of the surgery and is not conducive to the progress of the surgery.

[0051] To avoid this situation, the device of this embodiment further includes a valve 400, which includes a first through hole 410 and a valve body 420. The first through hole 410 is in communication with the cavity inlet 210 and the cavity outlet 220 respectively, and the valve body 420 divides the cavity channel 230 into a pressure relief channel 231 and a pressure receiving channel 232.

[0052] After the pressure source valve is opened, the fluid from the pressure source enters the cavity 200 through the cavity inlet 210, then passes through the pressure relief channel 231, and is discharged through the first through hole 410. After the fluid flow rate of the pressure source is stable, the first through hole 410 is closed by the cover 500, so that the fluid from the pressure source enters the pressure receiving channel 232 and is discharged through the cavity outlet 220, acting on the medicament placed at the bottom of the container. At this time, the fluid from the pressure source can act on the medicament with a more stable flow rate, making the medicament receive more uniform force. When the medicament acts on the target tissue, the reaction force of the target tissue is reduced, making the medicament more concentrated on the target tissue.

[0053] For endoscopic surgery, the device of this embodiment reduces the reaction force of the medicament acting on the target tissue, and the medicament no longer affects the vision of the endoscope, enabling the surgery to be carried out continuously. The method of closing the first through hole 410 can be selected according to the application scenario. For example: during the surgery, the operator can press the first through hole 410 with the thumb to close the first through hole 410, thereby guiding the fluid from the pressure source into the pressure receiving channel 232 and discharging it through the cavity outlet 220, making the operation of the device more convenient. Another example: for product packaging, a cover (not shown) is used to close the first through hole 410 to maintain the aseptic state during product transportation and storage.

[0054] In order to effectively control the flow rate of the fluid from the pressure source, a flow meter or other device can also be used to adjust the accessed fluid, and the pressure of the fluid can be pre-adjusted by means of a preset flow rate.

[0055] It has been verified that by changing the flow direction of the fluid from the pressure source, it is also possible to better solve the problem that the fluid entering the initial stage of the channel 230 causes an instantaneous high momentum of the medicament during transportation, so that the medicament receives a more stable and continuous force from the pressurized fluid. In the device of this embodiment, a reversing member 421 is provided in the valve body 420 to cause the fluid moving in the pressure receiving channel to change direction by 90° once.

[0056] The medicament acting on the target tissue is in powder form, and the particle size of more than 90% of the powder particles ≤ 100 μm, for example: the particle size of more than 90% of the powder particles ≤ 50 μm. The fluid exits from the cavity outlet 220 and pushes the medicament to move towards the outlet 110 of the container, so that the medicament acts on the target tissue.

[0057] To facilitate the direct action of the medicament on the target tissue, a catheter is also provided at the outlet of the container and combined with the device of this embodiment. By installing the catheter to guide the delivery path of the medicament from the container outlet, it is also beneficial to act on the target tissue when the medicament is close to the target tissue.

[0058] To facilitate the performance of laparoscopic surgery and further avoid the counteraction of the impact of the medicament delivered to the target tissue on the tissue, and to prevent the medicament from covering the entire laparoscopic field of view and affecting laparoscopic observation, this embodiment also provides a pressure regulating component for combined use with the device and catheter of this embodiment.

[0059] Figure 3 Schematic cross-sectional view of an embodiment of a catheter with a pressure regulating component assembled at one end Figure 4 Schematic cross-sectional view of an embodiment of the pressure regulating component. Combining Figure 3 , as Figure 4 shown, the pressure regulating component 700 of this embodiment includes a pressure regulating chamber 710, whose pressure regulating inlet 712 is connected to the catheter 600, and the axial angle b between the chamber wall 714 of the pressure regulating outlet 713 and the axis of the pressure regulating chamber is 10° - 12.5°. Along the radial direction of the pressure regulating chamber 710, a plurality of grooves 715 are provided on the chamber wall of the pressure regulating chamber.

[0060] An exit chamber 720 is also provided at the front part of the pressure regulating chamber 710. Its exit inlet 721 is assembled with the pressure regulating outlet 713, and the axial angle c between the chamber wall of the exit outlet 722 and the axis of the exit chamber is 5° - 6°. The medicament guided by the catheter exits from the opening of the angle c and directly acts on the target tissue. For the action surface formed by the medicament on the target tissue, see Figure 6 .

[0061] In this embodiment, the caliber of the exit inlet 721 is the same as that of the pressure regulating outlet 713. Between the exit inlet and the exit outlet, a buffer chamber 730 is also provided, whose axial length d is 0.5 mm - 2 mm, especially 0.5 mm - 1.5 mm.

[0062] Load the hemostatic medicament (see ZL2015100443818) into the device of this embodiment and conduct a hemostasis test on the bleeding tissue. Connect the interface 300 to the gas source and introduce pressurized gas. Align the catheter 600 with the bleeding target tissue, press the first through hole 410 so that the pressurized gas enters the pressure-receiving chamber 232, changes direction once in the 90° direction, moves towards the chamber outlet, and meets the medicament at the chamber outlet. Under the push of the gas, the medicament at the bottom of the container 100 is discharged from the outlet of the catheter and acts on the bleeding wound surface. Adjust the gas flow rate and observe the hemostasis situation.

[0063] After incising the middle lobe of the rat liver, the bleeding was active. During the process of pressing and stopping bleeding with the hemostatic gauze in the model group, the bleeding phenomenon was still very serious. Except for only one case of complete hemostasis, the rest were all incomplete hemostasis, with relatively large blood loss and long bleeding time. After administering the medicament to the bleeding target tissue using the device of this embodiment, the liver blood loss decreased significantly, showing a significant difference compared with the model group (p < 0.001); the liver bleeding time in this group was significantly reduced compared with the model group (p < 0.01). The results are shown in Table 1.

[0064] Table 1

[0065]

[0066] Note: Compared with the model group, "*" indicates p < 0.05, and "***" indicates p < 0.001

[0067] After the femoral artery incision of the rats, the bleeding was active. After the gauze in the model group absorbed blood and was pressed, there was still a large amount of bleeding. Among them, 3 cases failed to stop bleeding, and the rest were incompletely stopped bleeding. The bleeding time in this group was relatively long. After administration with the device of this embodiment, the bleeding volume at the surgical site decreased (p < 0.05), and the bleeding time was significantly reduced. There was a very significant statistical difference compared with the control group (p < 0.001). Most animals in this group had incomplete hemostasis. The results are shown in Table 2.

[0068] Table 2

[0069]

Claims

1. A device, characterized in that Comprising a pressure regulating component, the pressure regulating component includes: A pressure regulating chamber, whose pressure regulating inlet is connected to a conduit, and the angle formed by the chamber wall of the pressure regulating outlet and the axis of the pressure regulating chamber is 10° to 12.5°; An emission chamber, whose emission inlet is assembled with the pressure regulating outlet, and the angle formed by the chamber wall of the emission outlet and the axis of the emission chamber is 5° to 6°; Between the emission inlet and the emission outlet, a buffer chamber is further provided, and its axial length is 0.5 mm to 2 mm; Along the radial direction of the pressure regulating chamber, a plurality of grooves are provided on the chamber wall of the pressure regulating chamber; A conduit is provided at the outlet of the container, and one end of the conduit is assembled with the pressure regulating component.

2. The device according to claim 1, characterized in that The caliber of the emission inlet is the same as that of the pressure regulating outlet.

3. The device according to claim 1, characterized in that Between the emission inlet and the emission outlet, a buffer chamber is further provided, and its axial length is 0.5 mm to 1.5 mm.

4. The device according to claim 1, characterized in that Further comprising A container for containing a medicament; A cavity provided inside the container, including a cavity channel, a cavity inlet and a cavity outlet, and the cavity outlet faces the bottom of the container; A valve including a first through hole and a valve body, the first through hole is respectively communicated with the cavity inlet and the cavity outlet, and the valve body is placed inside the cavity, separating the cavity channel into a pressure relief channel and a pressure receiving channel.

5. The device according to claim 4, characterized in that Further comprising an interface provided on the container for connecting a pressure source, and the cavity inlet is communicated with the interface.

6. The device according to claim 4, characterized in that The valve body further includes a guiding member to make the pressure relief channel and the pressure receiving channel extend and face the first through hole.

7. The device according to claim 4, wherein The valve body causes the fluid moving inside the pressure receiving channel to change direction by 90° once.

8. The device according to claim 4, characterized in that A fluid with pressure flows inside the cavity, and the fluid is a gas or a liquid.

9. The device according to claim 4, characterized in that The medicament is in powder form, and the particle size of more than 90% of the powder particles is ≤100 μm.

10. The device according to claim 4, wherein The medicament is in powder form, and the particle size of more than 90% of the powder particles is ≤50 μm.

11. The device according to claim 4, characterized in that The medicament is a hemostatic agent.

12. The device according to claim 4, wherein Further comprising a conduit provided at the outlet of the container.

13. The device according to claim 4, characterized in that The internal cavity volume of the container is 10 cm 3 ~250 cm 3 .

14. The device according to claim 4, characterized in that The inner cavity volume of the said container is 10 cm 3 to 70 cm 3 .

15. The device according to claim 4, characterized in that The internal cavity volume of the container is 10 cm 3 to 30 cm 3 .

16. The device according to claim 4, characterized in that The internal cavity volume of the described container is 10 cm 3 , 11 cm 3 , 12 cm 3 , 13 cm 3 , 14 cm 3 , 15 cm 3 , 16 cm 3 , 17 cm 3 , 18 cm 3 , 19 cm 3 , 20 cm 3 , 21 cm 3 , 22 cm 3 , 23 cm 3 , 24 cm 3 , 25 cm 3 , 26 cm 3 , 27 cm 3 , 28 cm 3 , 29 cm 3 or 30 cm 3 .

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