Patch with pain relieving and fever relieving functions for minimally invasive cardiac surgery

Abstract

The invention relates to the technical field of postoperative medical supplies, and provides a patch with pain relieving and fever relieving functions for minimally invasive cardiac surgery. The patch comprises a backing layer and a medicine matrix layer, the backing layer is configured to have an in-vitro shape memory function and an in-vivo degradation function and is used for being attached to the surface of an intercostal incision, an adhesive face is formed on the surface of one side of the medicine matrix layer and is attached to the backing layer, and the medicine matrix layer is attached to the medicine matrix layer. And the surface of the other side of the medicine matrix layer is adhered with medicine particles for relieving pain and relieving fever. According to the patch with the pain relieving and antipyretic functions for the minimally invasive cardiac surgery, a local administration mode is adopted, the effects of relieving heat, relieving pain and antipyretic can be effectively achieved, the effect of the medicine particles can be kept till the state of an operation is stable until a patient can orally take the pain relieving and antipyretic medicine, the back lining layer can be directly degraded in a body, and the pain relieving and antipyretic effects are achieved. The pain of a patient is relieved, and meanwhile the addiction side effect caused by repeated injection is avoided to a certain degree.

Description

Technical Field

[0001] This application relates to the technical field of postoperative medical supplies, and particularly to a patch with pain relief and antipyretic functions for minimally invasive cardiac surgery. Background Art

[0002] Cardiac surgery is a relatively young discipline among the branches of the surgical field, mainly treating heart diseases through surgery. With the development of medical science, the application of minimally invasive techniques in the field of cardiac surgery has become increasingly widespread, making cardiac surgery develop in the direction of less trauma and greater safety.

[0003] Most of the incisions for minimally invasive cardiac surgery are small axillary incisions, that is, the third or fourth intercostal space is the surgical approach for entering the chest. Conventionally, a thoracic drainage tube needs to be placed through the sixth intercostal space after surgery. Since the intercostal space contains rich intercostal nerves and blood vessels, near the surgical wound and drainage opening, patients have very painful symptoms, and often have low fever symptoms due to the absorption heat of the bleeding after surgery.

[0004] However, due to general anesthesia and tracheal intubation after surgery, postoperative patients are unable to take pain relief and antipyretic tablets orally. Sometimes, they have to be given pain relief and antipyretic injections, or even narcotic pain relief injections, which not only increases inconvenience but also increases the side effect of addiction to repeated injections. Summary of the Invention

[0005] In order to solve the above technical problems or at least partially solve the above technical problems, this application provides a patch with pain relief and antipyretic functions for minimally invasive cardiac surgery.

[0006] This application provides a patch with pain relief and antipyretic functions for minimally invasive cardiac surgery, including a backing layer and a drug matrix layer. The backing layer is configured to have an in vitro shape memory function and an in vivo degradation function, and is used to attach to the surface of the intercostal incision. One surface of the drug matrix layer is formed as an adhesive surface, and the adhesive surface is attached to the backing layer. The other surface of the drug matrix layer is attached with drug particles for pain relief and antipyretic.

[0007] Optionally, the backing layer is a thin film layer made of polycaprolactone by electrospinning.

[0008] Optionally, the backing layer is configured to have adhesiveness, and the viscosity increases with the increase of temperature;

[0009] And / or, the backing layer is configured to have elasticity, and the elasticity increases with the increase of temperature.

[0010] Optionally, the drug matrix layer is configured to have an in vivo degradation function.

[0011] Optionally, the drug matrix layer is a gel-like structure made of silk fibroin.

[0012] Optionally, on the other surface of the drug matrix layer away from the adhesive surface, nano-scale micropores and / or pits are provided, and the drug particles are attached to the surfaces of the micropores and / or the pits.

[0013] Optionally, the diameter of the drug matrix layer is greater than or equal to 10 nm and less than or equal to 500 nm;

[0014] And / or, the diameter of the drug particles is greater than or equal to 10 nm and less than or equal to 500 nm.

[0015] Optionally, the drug particles are solid colloidal ibuprofen sustained-release particles.

[0016] Optionally, a hemostatic sponge is further provided on the backing layer, and the hemostatic sponge surrounds the outside of the drug matrix layer.

[0017] Optionally, a cover sheet is detachably pasted on the backing layer, and the cover sheet covers the drug matrix layer.

[0018] The technical solution provided by the embodiment of the present application has the following advantages compared with the prior art:

[0019] The patch with pain-relieving and antipyretic functions for minimally invasive cardiac surgery provided by the present application includes a backing layer and a drug matrix layer. The backing layer is configured to have an in vitro shape memory function and an in vivo degradation function, that is, the backing layer can maintain a certain shape in vitro to facilitate sending the backing layer to the incision position for attachment to the surface of the intercostal incision. One surface of the drug matrix layer is formed as an adhesive surface, and the adhesive surface is pasted on the backing layer. In this way, the drug matrix layer can be directionally transported to the surface area of the intercostal incision following the backing layer. The other surface of the drug matrix layer is attached with drug particles for pain relief and antipyretic, and the drug particles act on the surface of the intercostal incision. By adopting the local drug delivery method, the antipyretic and pain-relieving effects can be effectively exerted, and the efficacy of the drug particles can be maintained until the patient's condition is stable after the operation. After the tracheal intubation is removed, the patient can take oral painkillers, which can play a bridging role. The backing layer does not need to be taken out in the patient's body and can be directly degraded in the body, reducing the patient's pain and avoiding the side effect of addiction caused by repeated injections to a certain extent. It can be clinically applied to reduce the pain and fever symptoms of patients after minimally invasive cardiac surgery. Description of the Drawings

[0020] The drawings here are incorporated into the specification and constitute a part of this specification, showing the embodiments in line with the present application and used together with the specification to explain the principles of the present application.

[0021] To more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0022] Figure 1 Stereoscopic structure diagram of a patch with pain-relieving and antipyretic functions according to an embodiment of the present application;

[0023] Figure 2 Structure diagram of a patch with pain-relieving and antipyretic functions according to an embodiment of the present application;

[0024] Figure 3 Shape memory schematic diagram in vitro of a patch with pain-relieving and antipyretic functions according to an embodiment of the present application;

[0025] Figure 4 Top view of a patch with pain-relieving and antipyretic functions according to an embodiment of the present application;

[0026] Figure 5 Exploded schematic diagram of a patch with pain-relieving and antipyretic functions according to an embodiment of the present application.

[0027] In the figure: 1. Backing layer; 2. Drug matrix layer; 3. Drug particles; 4. Coagulation sponge; 5. Cover sheet. Detailed implementation manners

[0028] In order to more clearly understand the above-mentioned objects, features and advantages of the present application, the following will further describe the solutions of the present application. It should be noted that, without conflict, the embodiments of the present application and the features in the embodiments can be combined with each other.

[0029] Many specific details are set forth in the following description in order to fully understand the present application, but the present application can also be implemented in other ways different from those described herein; obviously, the embodiments in the specification are only a part of the embodiments of the present application, rather than all the embodiments.

[0030] The following will specifically describe the patch with pain-relieving and antipyretic functions used in minimally invasive cardiac surgery through specific embodiments:

[0031] Referring to Figures 1 to 5 As shown, a patch with pain-relieving and antipyretic functions provided by some embodiments of the present application includes a backing layer 1 and a drug matrix layer 2.

[0032] Among them, the backing layer 1 is configured to have an in vitro shape memory function and an in vivo degradation function, that is, the backing layer 1 can maintain a certain shape in vitro to facilitate the delivery of the backing layer 1 to the incision position for attachment to the surface of the intercostal incision. One side surface of the drug matrix layer 2 is formed as an adhesive surface, and the adhesive surface is attached to the backing layer 1. In this way, the drug matrix layer 2 can be directionally transported to the surface area of the intercostal incision following the backing layer 1, and drug particles 3 for relieving pain and reducing fever are attached to the other side surface of the drug matrix layer 2.

[0033] Specifically, when implemented, the drug particles 3 act on the surface of the intercostal incision. By adopting the local administration method, the drug effectively plays the role of relieving heat and pain, and the effect of the drug particles 3 can be maintained until the patient's condition is stable after the operation. After the tracheal intubation is removed, the patient can take oral painkillers, which can play a bridging role. The backing layer 1 does not need to be taken out in the patient's body and can be directly degraded in the body, reducing the patient's pain and, to a certain extent, avoiding the side effect of addiction caused by repeated injections of injections. It can be clinically applied to reduce the pain and fever symptoms of patients after minimally invasive cardiac surgery.

[0034] It can be understood that due to general anesthesia tracheal intubation, postoperative patients are unable to eat and take oral painkillers and antipyretics. Sometimes, they have to be given injection painkillers and antipyretics, and even narcotic painkillers, which not only increases the inconvenience but also increases the side effect of addiction caused by repeated injections. The patch with pain-relieving and antipyretic functions of the present application can be attached to the surface of the intercostal incision of the chest incision and the surface of the intercostal incision of the drainage port before closing the chest after the operation. By adopting the local administration method, the drug particles 3 for relieving pain and reducing fever are slowly released, and the action time is 48 to 72 hours until the tracheal intubation is removed after the operation, and then oral painkillers and antipyretics are taken.

[0035] In some embodiments, the backing layer 1 is a thin film layer made of polycaprolactone by electrospinning. The backing layer 1 can be adhesively attached to the intercostal surface during minimally invasive cardiac surgery, with high adhesion, which can ensure the stability of the directional administration of drug particles and thus effectively play a role at the tissue of the intercostal incision surface.

[0036] It can be understood that polycaprolactone (full English name Polycaprolactone, abbreviated as PCL), as a medical modeling material, has good biocompatibility, good compatibility with organic polymers, and good biodegradability. It can be used as a cell growth support material, can be compatible with a variety of conventional plastics, has good biocompatibility with biological cells in the body, and cells can grow normally on its scaffold and can be degraded into carbon dioxide CO 2 and water H 2O can be completely degraded in 6 - 12 months under natural environmental conditions. In addition, PCL also has good shape - memory thermo - control properties and can be used as a drug carrier for the drug matrix layer 2, which can be fixed and formed under low - temperature conditions. Specifically, it can be frozen in an external refrigerator and then patched through body - temperature induction in the body.

[0037] Specifically, the backing layer 1 is configured to have adhesiveness, and the adhesiveness increases with the increase in temperature. When the external temperature is low, the adhesiveness is low, which is convenient for transportation and can avoid sticking to positions other than the target area during transportation. When the internal body temperature is high, the adhesiveness is high, so that it can adhere to the target position on the surface of the intercostal incision, ensuring the stable release of the drug particles 3 to the intercostal area of the incision. It can be understood that the property that the adhesiveness of the backing layer 1 increases by about 10 times with the increase in temperature (from 20°C to 37°C) can ensure the attachment of the patch, support the dynamic and continuous expansion and contraction of the chest wall, and ensure the attachment stability of the drug particles on the surface of the intercostal incision.

[0038] The backing layer 1 is configured to have elasticity, and the elasticity increases with the increase in temperature. When the external temperature is low, the elasticity is low, and the backing layer 1 can maintain a certain shape, that is, it has a shape - memory function, which is convenient for entering the body and being transported to the position of the intercostal incision. When the internal body temperature is high, the elasticity is high, and it becomes rubber - like in the body, which can wrap the surface of the intercostal incision. At the same time, it can also deform with the dynamic and continuous expansion and contraction of the chest wall to avoid causing secondary trauma to the incision and reducing the pain of the patient.

[0039] Furthermore, the backing layer 1 is also configured to have a high moisture content and excellent plasticity, which can promote the exchange of oxygen and soluble factors and has high air - permeability.

[0040] It should be noted that the film - like backing layer 1 made of polycaprolactone by electrospinning can simultaneously have an external shape - memory function, an in - vivo degradation function, adhesiveness, elasticity, and high water - content. It can facilitate positioning to the target incision position while realizing in - vivo drug delivery, and at the same time, it will not affect the normal functions of the human body, and there is no need to perform a second thoracotomy to remove the backing layer 1.

[0041] In some embodiments, the drug matrix layer 2 is configured to have an in - vivo degradation function. It can be understood that the drug matrix layer 2 enters the body following the backing layer 1 for in - vivo drug delivery. Until after the chest is closed during the operation, the drug matrix layer 2 can be degraded in the body, and there is no need to perform a second thoracotomy to remove the drug matrix layer 2. After the drug particles 3 on the drug matrix layer 2 lose their effectiveness, they will not affect the normal functions of the human body.

[0042] Specifically, the drug matrix layer 2 is a gel-like structure made of silk fibroin. It can be understood that after the gel-like drug matrix layer 2 is formed, it has viscosity and can directly form an adhesive surface to be attached to the backing layer 1, so as to strengthen the connection performance between the drug matrix layer 2 and the backing layer 1 and have relatively stable adhesion performance. Due to its strong bionic potential, silk fibroin hydrogel has adjustable mechanical properties, biocompatibility, low immunotoxicity, controllable biodegradability, and high breathability.

[0043] After the drug matrix layer 2 is implanted into the human body, it will not have an adverse impact on tissues, blood, and the immune system, and the final degradation products can be completely absorbed by the body.

[0044] Furthermore, the mechanical properties of the drug matrix layer 2 can include viscosity and elasticity. When the temperature is relatively low in vitro, the viscosity is relatively low, which is convenient for transportation. When the temperature is relatively high in vivo, the viscosity is relatively high, so that it can adhere to the target position on the surface of the intercostal incision, ensuring the stability of drug administration. At the same time, when the temperature is relatively low in vitro, the elasticity is relatively low, and the drug matrix layer 2 can maintain a certain shape. When the temperature is relatively high in vivo, the elasticity is relatively high, enabling it to deform with the dynamic and continuous expansion and contraction of the thoracic cage.

[0045] In some embodiments, referring to Figure 2 and Figure 3 as shown, on the other surface of the drug matrix layer 2 away from the adhesive surface, nano-scale micropores and / or pits are provided. That is, on the other surface of the drug matrix layer 2 away from the adhesive surface, nano-scale micropores can be provided, or nano-scale pits can be provided, or both nano-scale micropores and pits can be provided. The drug particles 3 adhere to the surface of the micropores and / or pits. In this way, the area for the drug particles 3 to adhere can be enlarged, and then the number of drug particles 3 carried on the drug matrix layer 2 can be increased, ensuring the drug effect of relieving pain and reducing fever.

[0046] It should be noted that the drug particles 3 can also be filled in the micropores or pits, which can ensure the continuous and stable release of the drug particles 3 while being directionally transported to the surface area of the intercostal incision, contributing to the simple application of the patch with the function of relieving pain and reducing fever in the surface area of the intercostal incision.

[0047] In some embodiments, the diameter of the drug matrix layer 2 is greater than or equal to 10 nm and less than or equal to 500 nm, and the diameter of the drug particles 3 provided on the drug matrix layer 2 is greater than or equal to 10 nm and less than or equal to 500 nm. Such a diameter size can ensure that the drug particles 3 are slowly and stably released to the intercostal part of the incision, and can ensure that the drug action time lasts for 48 to 72 hours. After the drug particles 3 lose their effectiveness, by taking oral pain-relieving and antipyretic drugs, the patch with the function of relieving pain and reducing fever in this application can play a bridging role.

[0048] In specific implementation, the drug microparticles 3 are solid colloidal ibuprofen sustained-release microparticles.

[0049] It can be understood that there are many common injectable analgesic and antipyretic drugs. Non-steroidal anti-inflammatory injection drugs are the most commonly used and have the least side effects among postoperative analgesic and antipyretic drugs. Ibuprofen injection is one of the most commonly used non-steroidal anti-inflammatory drugs, mainly used for the antipyretic and analgesic treatment of adults and pediatric patients 6 months and above. It can be used to treat mild to moderate pain; as an adjunct to opioid analgesics, it can be used to treat moderate to severe pain, especially pain of types such as muscle pain, neuralgia, myalgia, postoperative pain, post-traumatic pain, pain after strain or exercise, etc. All can be relieved by this product. Specifically, for analgesia and fever, intravenous drip is used. It can be repeated every 6 hours as needed with a dose of 0.4 g - 0.8 g, or repeated every 4 hours with a dose of 0.1 g - 0.2 g, and the maximum daily dose is 3.2 g.

[0050] When the patch with analgesic and antipyretic functions of this application is administered in vivo, it can ensure a drug action time of 48 to 72 hours, without the need for repeated administration, avoiding side effects caused by repeated injections.

[0051] Specifically, the shape of the backing layer 1 can be square, circular, etc., which can be specifically set according to actual needs, as long as it can carry the drug matrix layer 2 and carry a certain amount of drug microparticles 3 on the drug matrix layer 2 to ensure the drug effect.

[0052] In some embodiments, referring to Figure 1 and Figure 4 as shown, a hemostatic sponge 4 is further provided on the backing layer 1, and the hemostatic sponge 4 surrounds the outside of the drug matrix layer 2. With this setting, it can ensure the blood coagulation function of the intercostal incision, avoid the displacement of drug microparticles 3 on the surface of the intercostal incision due to excessive bleeding, and can also ensure the therapeutic effect of analgesia and antipyretic while having a hemostatic effect.

[0053] The hemostatic sponge 4 is configured to have an in-vivo degradation function. It can be understood that the hemostatic sponge 4 enters the body following the backing layer 1 to facilitate the realization of the blood coagulation and hemostasis function. Until the chest is closed after the operation, the hemostatic sponge 4 can degrade in the body, and there is no need to perform a second thoracotomy to remove the hemostatic sponge 4, and the hemostatic sponge 4 will not affect the normal functions of the human body.

[0054] In specific implementation, the thickness of the hemostatic sponge 4 is less than the thickness of the drug matrix layer 2 to ensure the administration effect of the drug microparticles 3 on the drug matrix layer 2.

[0055] In some embodiments, referring to Figure 4 and Figure 5As shown, a cover sheet 5 is detachably attached to the backing layer 1, and the cover sheet 5 covers the drug matrix layer 2. The cover sheet 5 serves as a protective layer to protect the drug particles 3 and increase the service life of the patch, and can be removed before use.

[0056] It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0057] The above is only a specific implementation of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to these embodiments herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A patch with analgesic and antipyretic functions for use in minimally invasive cardiac surgery, characterized in that: The invention comprises a backing layer (1) and a drug matrix layer (2), wherein the backing layer (1) is configured to have an in vitro shape memory function and an in vivo degradation function and is used to be attached to the surface of an intercostal incision, one side surface of the drug matrix layer (2) is formed as an adhesive surface, and the adhesive surface is attached to the backing layer (1), and the other side surface of the drug matrix layer (2) is attached with drug particles (3) for relieving pain and fever.

2. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 1, characterized in that: The backing layer (1) is a film layer made of polycaprolactone by electrostatic spinning.

3. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 2, characterized in that: The backing layer (1) is configured to be viscous, and the viscosity increases with increasing temperature; And / or, the backing layer (1) is configured to have elasticity, and the elasticity increases with increasing temperature.

4. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 1, characterized in that: The drug matrix layer (2) is configured to have an in vivo degradable function.

5. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 4, characterized in that: The drug matrix layer (2) is a gel-like structure made of silk fibroin.

6. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 1, characterized in that: The other side of the drug matrix layer (2) away from the adhesive surface is provided with nano-scale micropores and / or pits, and the drug particles (3) are attached to the surface of the micropores and / or the pits.

7. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 1, characterized in that: The diameter of the drug matrix layer (2) is greater than or equal to 10 nm and less than or equal to 500 nm; And / or, the diameter of the drug particles (3) is greater than or equal to 10 nm and less than or equal to 500 nm.

8. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 1, characterized in that: The drug particles (3) are solid colloidal ibuprofen sustained-release particles.

9. The patch with analgesic and antipyretic functions for use in minimally invasive cardiac surgery according to claim 1, characterized in that: The backing layer (1) is also provided with a blood coagulation sponge (4), and the blood coagulation sponge (4) is arranged around the outside of the drug matrix layer (2).

10. The patch with analgesic and antipyretic functions for minimally invasive cardiac surgery according to claim 1, characterized in that: A cover sheet (5) is detachably attached to the backing layer (1), and the cover sheet (5) covers the drug matrix layer (2).

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