Surgical hemostasis and leakage-proof combined capsule and packaging structure and using method thereof

Abstract

The invention relates to a surgical hemostasis and leakage-proof combined capsule and a packaging structure and a using method thereof. The surgical hemostasis and leakage-proof combined capsule comprises a capsule shell, two cavities are formed in the capsule shell, and the two cavities are further filled with alpha-cyanoacrylate n-butyl ester and implant-grade fluid gelatin respectively; the internal pressure value of the chamber filled with the alpha-cyanoacrylate n-butyl ester is normal pressure, and the internal pressure value of the chamber filled with the implant-grade fluid gelatin is positive pressure; the capsule further comprises an aluminum bubble cap and a certain amount of xanthan gum filled in the aluminum bubble cap, and the capsule shell is arranged in the aluminum bubble cap; the device is accurate and controllable in dosage and accurate and errorless in positioning, is more effective, reliable and convenient than a traditional needle cylinder and long needle head injection spraying method, can prevent glue from being splashed to the brain surface, cerebrospinal fluid and important nerve and blood vessels irrelevant to an operation, and can prevent the glue from staining surgical instruments by mistake, so that the waste of the glue is greatly reduced, and the cost is reduced. And the operation precision can be obviously improved to be suitable for a plurality of operation scenes of neurosurgery.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a surgical hemostatic and leak-proof combined capsule and a packaging structure and a use method thereof. Background Art

[0002] In the surgical field, especially in neurosurgery, some deep operations are often encountered, such as craniocerebral trauma, skull base fracture combined with epidural hematoma. After the hematoma was removed, it was found that the dura mater had been peeled off from the skull base bone surface, and a dead space was formed between the meninges and the inner plate. If not handled properly, it is easy to form a hematoma again after surgery and require another operation. At this time, the dura mater suspension method alone will not solve the problem. The best way is to use medical glue to glue the dura mater layer by layer from the inside to the outside to eliminate the dead space.

[0003] Traditional glue delivery methods are very difficult to perform during deep operations. The plastic straw that comes with it is too short to complete long-distance delivery. If a long needle is used for injection with a syringe, the needle will easily become clogged and the injection thrust is difficult to control. In addition, glue can easily get on to surgical instruments and, if not careful, it can get on to the suction tube and cause it to become clogged.

[0004] In transnasal endoscopic surgery, we often encounter bleeding from the cavernous sinus, repair after destruction of the sellar floor, cerebrospinal fluid leakage from congenital defects of the lateral recess of the sphenoid sinus, and cerebrospinal fluid leakage after traumatic sphenoethmoid sinus fracture, which require hemostasis and skull base reconstruction to prevent or repair cerebrospinal fluid leakage. Similarly, these problems also require the use of a syringe with a special long needle to locally inject fluid gelatin and medical glue. Since the hemostatic material and medical glue are relatively viscous, the syringe push force is difficult to control, and it is difficult to achieve long-distance and precise operations.

[0005] In some skull base surgeries, such as skull base tumor and intracranial aneurysm surgery, which requires grinding of the anterior and posterior clinoid processes, acoustic tumor surgery, which requires grinding of the posterior wall of the internal auditory canal, and microvascular surgery, which sometimes requires grinding of overly protruding petrous bone surfaces, glue is needed to seal the skull defect surface after grinding off the inner plate to prevent postoperative cerebrospinal fluid leakage. How to control the amount of glue used, deliver it to the site accurately without accidentally dripping into the brain tissue or cerebrospinal fluid, and prevent operating instruments such as electrocoagulation forceps and suction tubes from being contaminated with glue have always been difficult problems encountered by clinicians.

[0006] In addition, during microvascular decompression surgery, it is often difficult to move the responsible blood vessels away from the REZ area. At this time, medical glue is often needed to suspend the responsible blood vessels on the surrounding petrous bone surface. This application scenario has particularly high requirements for the delivery of glue to the target area. If you are not careful, the glue will be scattered all over the surgical area, making the operation impossible to proceed smoothly. Summary of the invention

[0007] In view of the current status of the above-mentioned prior art, the technical problem to be solved by the present invention is to provide a surgical hemostatic and leak-proof combination capsule with precise and controllable dosage and accurate positioning, which is more effective, reliable and convenient than the traditional syringe long needle injection and spraying method. It can not only prevent glue from being spilled on the brain surface, cerebrospinal fluid and important nerves and blood vessels that are not related to the operation, but also prevent glue from accidentally sticking to surgical instruments, thereby greatly reducing the waste of glue and significantly improving the surgical accuracy, so as to be suitable for multiple surgical scenarios in neurosurgery, and its packaging structure and use method.

[0008] The technical solution adopted by the present invention to solve the above technical problems is: a surgical hemostatic and leak-proof combined capsule, characterized in that it includes a capsule shell, wherein two chambers are formed inside the capsule shell, and the two chambers are respectively filled with α-cyanoacrylate n-butyl ester and implant-grade fluid gelatin;

[0009] The internal pressure of the chamber filled with n-butyl α-cyanoacrylate is normal pressure, and the internal pressure of the chamber filled with implantable fluid gelatin is positive pressure, thereby ensuring that the capsule shell is first broken from the side of the chamber filled with fluid gelatin;

[0010] The capsule shell is made of gelatin and glycerin to reduce its melting point to 15° C., so that it can be quickly dissolved at normal body temperature.

[0011] A packaging structure of a surgical hemostatic and leak-proof combination capsule, comprising the surgical hemostatic and leak-proof combination capsule as claimed in claim 1, characterized in that it also includes an aluminum blister and a certain amount of xanthan gum filled inside the aluminum blister, wherein the capsule shell is arranged inside the aluminum blister.

[0012] A surgical hemostatic and leak-proof combined capsule and a method for using the packaging structure thereof, characterized in that the method comprises the following steps:

[0013] S1: Before use, open the seal of the aluminum blister and place it with the opened seal facing upwards, then drip a small amount of saline into the inside of the aluminum blister. After the xanthan gum comes into contact with the saline, it will gradually become viscous and adhere to the outside of the capsule shell;

[0014] S2: Use a disc-shaped microstrip to move the capsule shell with sticky xanthan gum to the surgical target area and stick it to the lesion. Since the temperature of the lesion is higher than the melting point of the capsule shell, the capsule shell wall will rupture:

[0015] S3: Since the filling pressure of n-butyl α-cyanoacrylate is normal pressure, and the filling pressure of implant-grade fluid gelatin is positive pressure, a chamber filled with implant-grade fluid gelatin will rupture first and release the implant-grade fluid gelatin to cover the lesion;

[0016] S4: Subsequently, a chamber containing n-butyl α-cyanoacrylate will also rupture and release n-butyl α-cyanoacrylate. The released n-butyl α-cyanoacrylate undergoes anionic polymerization reaction with water vapor to generate poly-α-cyanoacrylate. When the poly-α-cyanoacrylate is mixed with implant-grade fluid gelatin, a tougher and denser bonding repair material will be generated.

[0017] Compared with the prior art, the advantages of the present invention are as follows: the present invention packs α-cyanoacrylate n-butyl ester and implant-grade fluid gelatin for bonding and repair into two chambers in a capsule shell, and the capsule shell filled with α-cyanoacrylate n-butyl ester and implant-grade fluid gelatin is packaged into an aluminum blister filled with a certain amount of xanthan gum after low-temperature sterilization; before surgery, the aluminum blister is opened and a small amount of physiological saline is dripped into the capsule shell to make the xanthan gum sticky and adhere to the capsule shell; during surgery, the capsule shell can be accurately delivered to the surgical target area with the help of a disc-shaped microstripper and adhered to the lesion site by using the stickiness of the xanthan gum; finally, the capsule shell is ruptured by heat. The implant-grade fluid gelatin and α-butyl cyanoacrylate are released successively. The poly α-cyanoacrylate generated by the reaction of α-butyl cyanoacrylate with water vapor will react with the implant-grade fluid gelatin to form a tougher and denser bonding repair material. The dosage is precisely controllable and the positioning is accurate. It is more effective, reliable and convenient than the traditional syringe long needle injection spraying method. It can prevent glue from spilling on the brain surface, cerebrospinal fluid and important nerves and blood vessels that are not related to the operation, and prevent glue from accidentally sticking to surgical instruments. This greatly reduces the waste of glue and significantly improves the surgical precision to be suitable for multiple surgical scenarios in neurosurgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a cross-sectional structural diagram of the surgical hemostasis and leakage prevention combined capsule of the present invention;

[0019] Figure 2 It is a cross-sectional structural diagram of the packaging structure of the surgical hemostatic and leak-proof combination capsule of the present invention. DETAILED DESCRIPTION

[0020] Unless otherwise defined, the technical terms or scientific terms used in the present invention should be understood by people with ordinary skills in the field to which the present invention belongs. The words "first", "second" and similar words used in the present invention do not indicate any order, quantity or importance, but are only used to distinguish different components. "Include" or "comprise" and similar words mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Connect" or "connected" and similar words are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0021] In order to keep the following description of the embodiments of the present invention clear and concise, detailed descriptions of well-known functions and well-known components are omitted.

[0022] like Figure 1 As shown, a surgical hemostatic and leak-proof combined capsule comprises a capsule shell 1, wherein two chambers 11 are formed inside the capsule shell 1, and the two chambers 11 are respectively filled with α-butyl cyanoacrylate 2 and implantation-grade fluid gelatin 3;

[0023] The internal pressure value of the chamber 11 filled with α-cyanoacrylate n-butyl ester 2 is normal pressure, and the internal pressure value of the chamber 11 filled with implant grade fluid gelatin 3 is positive pressure. The purpose of such setting is to ensure that the capsule shell 1 is first broken from the side of the chamber 11 filled with fluid gelatin 3;

[0024] The capsule shell 1 is made of gelatin and glycerin to reduce its melting point to 15° C., so that it can be quickly dissolved at normal body temperature.

[0025] Implant-grade fluid gelatin 3 is extracted from pig skin and is suitable for surgical assisted hemostasis of bleeding from capillaries, veins and small arteries when compression, ligation or other traditional methods are ineffective or impractical. Because implant-grade fluid gelatin 3 can achieve submicron particle size through a special process, it can penetrate into the wound gap, thereby quickly solidifying in the body and forming a stable gel-like substance to achieve the purpose of hemostasis; because it is not easy to compress the surrounding nerves, and can be gradually absorbed in the body without leaving foreign matter, it is widely used, especially suitable for uneven wound bleeding.

[0026] α-Butyl cyanoacrylate 2 is a common medical adhesive. When α-butyl cyanoacrylate 2 contacts the adhered object and is exposed to the outside, water vapor will act as its initiator, causing α-butyl cyanoacrylate 2 to undergo anionic polymerization and rapidly solidify. The poly α-cyanoacrylate generated by the reaction has extremely strong cohesive force and adhesive strength to various adherends. When poly α-cyanoacrylate meets implant-grade fluid gelatin 3, it can condense into a tougher and denser solidified material.

[0027] like Figure 2 As shown, this embodiment also provides a packaging structure of the above-mentioned surgical hemostatic and leak-proof combination capsule, which includes the above-mentioned surgical hemostatic and leak-proof combination capsule, and also includes an aluminum blister 4 and a certain amount of xanthan gum 5 filled inside the aluminum blister 4, and the capsule shell 1 is arranged in the aluminum blister 4.

[0028] Xanthan gum 5 is an extracellular acidic heteropolysaccharide produced by the fermentation of Xanthomonas. It will disperse and emulsify into a stable hydrophilic viscous colloid when it comes into contact with water.

[0029] This embodiment also provides a method for using a surgical hemostatic and leak-proof combined capsule and its packaging structure, comprising the following steps:

[0030] S1: before use, the seal of the aluminum blister 4 is opened and placed with the opened seal facing upwards, and then a small amount of physiological saline is dripped into the interior of the aluminum blister 4. After the xanthan gum 5 contacts the physiological saline, it gradually becomes viscous and adheres to the exterior of the capsule shell 1;

[0031] S2: Use a disc-shaped microstrip to move the capsule shell 1 with the sticky xanthan gum 5 to the surgical target area and attach it to the lesion. Since the temperature of the lesion is higher than the melting point of the capsule shell 1 (15° C.), the capsule wall of the capsule shell 1 will rupture:

[0032] S3: Since the filling pressure of α-cyanoacrylate n-butyl ester 2 is normal pressure, and the filling pressure of implant grade fluid gelatin 3 is positive pressure, a chamber 11 filled with implant grade fluid gelatin 3 will rupture first and release the implant grade fluid gelatin 3 and cover the lesion site;

[0033] S4: Subsequently, a chamber 11 containing α-cyanoacrylate 2 will also rupture and release α-cyanoacrylate 2. The released α-cyanoacrylate 2 undergoes anionic polymerization with water vapor to generate poly-α-cyanoacrylate. The poly-α-cyanoacrylate is mixed with implant grade fluid gelatin 3 to generate a tougher and denser bonding repair material.

[0034] The above-mentioned bonding repair material can effectively stop bleeding and repair leaks. It can be used to repair skull defects, opened skull air cells and plate barriers during surgery, and to bond the dura mater peeled off from the inner surface of the skull. It can also be used to suspend the responsible blood vessels in microvascular decompression surgery.

[0035] The present invention packs α-cyanoacrylate n-butyl ester 2 and implant grade fluid gelatin 3 for bonding and repairing into two chambers 11 in a capsule shell 1, and packs the capsule shell 1 filled with α-cyanoacrylate n-butyl ester 2 and implant grade fluid gelatin 3 into an aluminum blister 4 filled with a certain amount of xanthan gum 5 after low temperature sterilization. Before the operation, the aluminum blister 4 is opened and a small amount of physiological saline is dripped into the capsule shell 1 to make the xanthan gum 5 sticky and adhere to the capsule shell 1. During the operation, the capsule shell 1 can be accurately delivered to the surgical target area with the help of a disc-shaped microstripper and adhered to the lesion site by using the viscosity of the xanthan gum 5. Finally, the capsule shell 1 is ruptured by heat and Implant-grade fluid gelatin 3 and α-butyl cyanoacrylate 2 are released successively. The poly α-cyanoacrylate generated by the reaction of α-butyl cyanoacrylate 2 with water vapor will react with the implant-grade fluid gelatin 3 to form a tougher and denser bonding repair material. The dosage is precisely controllable and the positioning is accurate. It is more effective, reliable and convenient than the traditional syringe long needle injection spraying method. It can prevent glue from spilling on the brain surface, cerebrospinal fluid and important nerves and blood vessels that are not related to the operation, and prevent glue from accidentally sticking to surgical instruments. This greatly reduces the waste of glue and significantly improves surgical precision to be suitable for multiple surgical scenarios in neurosurgery.

[0036] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A surgical hemostatic and leak-proof combined capsule, characterized in that: The capsule shell comprises two chambers formed inside the capsule shell, and the two chambers are respectively filled with α-cyanoacrylate n-butyl ester and implant grade fluid gelatin; The internal pressure of the chamber filled with n-butyl α-cyanoacrylate is normal pressure, and the internal pressure of the chamber filled with implantable fluid gelatin is positive pressure, thereby ensuring that the capsule shell is first broken from the side of the chamber filled with fluid gelatin; The capsule shell is made of gelatin and glycerin to reduce its melting point to 15° C., so that it can be quickly dissolved at normal body temperature.

2. A packaging structure of a surgical hemostatic and leak-proof combined capsule, comprising the surgical hemostatic and leak-proof combined capsule according to claim 1, characterized in that: It also includes an aluminum blister and a certain amount of xanthan gum filled in the aluminum blister, and the capsule shell is arranged in the aluminum blister.

3. A surgical hemostatic and leak-proof combined capsule and a method for using the packaging structure thereof, characterized in that: The following steps are involved: S1: Before use, open the seal of the aluminum blister and place it with the opened seal facing upwards, then drip a small amount of saline into the inside of the aluminum blister. After the xanthan gum comes into contact with the saline, it will gradually become viscous and adhere to the outside of the capsule shell; S2: Use a disc-shaped microstrip to move the capsule shell with sticky xanthan gum to the surgical target area and stick it to the lesion. Since the temperature of the lesion is higher than the melting point of the capsule shell, the capsule shell wall will rupture: S3: Since the filling pressure of n-butyl α-cyanoacrylate is normal pressure, and the filling pressure of implant-grade fluid gelatin is positive pressure, a chamber filled with implant-grade fluid gelatin will rupture first and release the implant-grade fluid gelatin to cover the lesion; S4: Subsequently, a chamber containing n-butyl α-cyanoacrylate will also rupture and release n-butyl α-cyanoacrylate. The released n-butyl α-cyanoacrylate undergoes anionic polymerization reaction with water vapor to generate poly-α-cyanoacrylate. When the poly-α-cyanoacrylate is mixed with implant-grade fluid gelatin, a tougher and denser bonding repair material will be generated.

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