阅读说明：本技术 一种高压椎体扩张球囊及其制备方法 (High-pressure vertebral body expansion balloon and preparation method thereof ) 是由 王兴娅 顾海军 于 2019-09-29 设计创作，主要内容包括：本发明提供了一种高压椎体扩张球囊及其制备方法,包括：基础球囊,用于接收膨胀流体,以抬升椎体至生理高度；纤维套,所述纤维套附在所述基础球囊的表面,用于防止所述基础球囊过度膨胀且能够增加球囊的耐压性；第二球囊,所述第二球囊套设在所述基础球囊上,所述第二球囊用于阻隔基础球囊与骨水泥反应；通过在基础球囊外设计纤维套以及第二球囊的组合,使得该球囊在椎体中不与骨水泥反应,以便于球囊管在椎体内移动,同时也可以根据需要调整椎体的高度,便于骨水泥的填充,不会出现因球囊撤出后塌陷或者空腔回填的现象,也不会造成骨水泥灌注时受阻或者骨水泥泄漏的这种情况发生,也不用另外向椎体内放入外物,可以有效避免额外的治疗风险。(The invention provides a high-pressure vertebral body expansion balloon and a preparation method thereof, wherein the high-pressure vertebral body expansion balloon comprises the following steps: a basal balloon for receiving inflation fluid to elevate the vertebral body to a physiological height; the fiber sleeve is attached to the surface of the basic balloon and used for preventing the basic balloon from over-expansion and increasing the pressure resistance of the balloon; the second balloon is sleeved on the base balloon and used for blocking the reaction of the base balloon and bone cement; through the combination of the outer meter fibre cover of basis sacculus and second sacculus for this sacculus does not react with bone cement in the centrum, so that the sacculus pipe removes in the centrum, also can adjust the height of centrum as required simultaneously, be convenient for the packing of bone cement, the phenomenon of collapsing or cavity backfill can not appear because of the sacculus is withdrawn from the back, this kind of condition that obstructed or bone cement leaked when also can not causing bone cement to pour into takes place, also need not put into the foreign object in addition to the centrum, can effectively avoid extra treatment risk.)

1. A high pressure vertebral dilation balloon, comprising:

a basal balloon for receiving inflation fluid to elevate the vertebral body to a physiological height;

the fiber sleeve is attached to the surface of the basic balloon and used for preventing the basic balloon from being over-inflated;

and the second balloon is sleeved on the basic balloon and used for blocking the reaction of the basic balloon and the bone cement.

2. The high pressure vertebral dilation balloon of claim 1, wherein: further comprising:

an outer catheter in conductive connection with the base balloon for delivering inflation fluid to a lumen within the base balloon;

the inner catheter is arranged in the outer catheter and used for placing a supporting guide wire.

3. The high pressure vertebral dilation balloon of claim 1 or 2, wherein: the connector is in conduction connection with the outer conduit.

4. The high pressure vertebral dilation balloon of claim 1 or 2, wherein: and the outer wall of the second balloon is provided with a hole for communicating with the outside of the second balloon.

5. The high pressure vertebral dilation balloon of claim 1 or 2, wherein: the balloon distal end of the base balloon is connected with the balloon distal end neck of the second balloon by a fastener.

6. The high pressure vertebral dilation balloon of claim 1 or 2, wherein:

the base balloon is a compliant, semi-compliant or non-compliant material and the second balloon is made of a non-compliant or semi-compliant material.

7. The high pressure vertebral dilation balloon of claim 1 or 2, wherein:

the second balloon is made of a polyamide polymer.

8. A preparation method of a high-pressure vertebral body expansion balloon is characterized by comprising the following steps:

s10, adhering a layer of fiber sleeve on the surface of the basic balloon;

s20, forming a small hole in the outer wall of the second balloon;

and S30, sleeving the second balloon on the basic balloon attached with the fiber sleeve, and fixing the open end of the second balloon and the basic balloon together.

9. The method for preparing a high pressure centrum expansion balloon according to claim 6, wherein: the surface of the basic balloon is coated with adhesive substances, and then the high-strength fibers are adhered to the surface of the basic balloon to form a fiber sleeve.

10. The method for preparing a high pressure centrum expansion balloon according to claim 6, wherein: and coating a layer of adhesive substance on the surface of the basic balloon, putting the woven fiber sleeve into a hollow tool with the same shape as the basic balloon, closing the tool, and pressing the fiber sleeve on the surface of the basic balloon.

Technical Field

The invention relates to the field of medical instruments, in particular to a high-pressure vertebral body expansion balloon and a preparation method thereof.

Background

The Percutaneous Kyphoplasty (PKP) is an improvement and development of percutaneous vertebroplasty, and in 1999, the american Berkeley orthopedist Mark Reiley developed an expandable Bone-expanding balloon (KyphXTM, Inflatable Bone Tamp), which reduced the thrust required for injecting Bone cement by using a percutaneous puncture vertebral body balloon expansion method to reposition the vertebral body and form a space inside the vertebral body, and the Bone cement was not easy to flow when being injected into the vertebral body. Compared with the conventional mode, the mode has no difference in biomechanical properties, and clinical application shows that the pain symptom can be relieved or relieved, the height of the compressed vertebral body can be obviously recovered, the rigidity and the strength of the vertebral body are increased, the physiological curvature of the spine is recovered, the volume of the pleuroperitoneal cavity can be increased, the function of organs is improved, and the life quality of a patient is improved.

After the balloon is clinically used for expansion, the restoration of the vertebral body and the cavity expanded by the balloon are not perfect like theoretical analysis, in most clinics, the cavity expanded by the balloon is backfilled after the balloon is decompressed and taken out to a certain extent and continues to collapse, so that bone cement is blocked or even leaked during bone cement perfusion, and if the balloon is not withdrawn from the interior of the vertebral body, the angle of the balloon can be properly adjusted to enable the bone cement to be filled more fully. As most of the existing vertebral body balloon materials are compliant Thermoplastic Polyurethane (TPU), and the materials can react with monomer Methyl Methacrylate (MMA) for preparing bone cement polymethyl methacrylate (PMMA), the balloon must be withdrawn after the inflation is finished to fill the bone cement.

Disclosure of Invention

In order to solve the defects of the prior art, the high-pressure vertebral body expansion balloon and the preparation method thereof provided by the invention can realize that the balloon is continuously remained in the vertebral body to maintain the supporting function after the vertebral body is expanded, and is gradually taken out in the process of injecting bone cement, so that the expansion space of the vertebral body is fully ensured.

The technical scheme provided by the invention is as follows:

a high pressure vertebral dilation balloon comprising:

a basal balloon for receiving inflation fluid to elevate the vertebral body to a physiological height;

a fiber sleeve attached to a surface of the base balloon for preventing over-inflation of the base balloon;

and the second balloon is sleeved on the basic balloon and used for blocking the reaction of the basic balloon and the bone cement.

In this technical scheme, through having the fibre cover at basic sacculus overcoat subsides, can be high pressure resistant with guaranteeing inside basic sacculus, when the inflation fluid is received to basic sacculus, just can not make basic sacculus break because of high-pressure fluid's existence, basic sacculus inflation back, the fibre cover can expand thereupon, the second sacculus also can expand thereupon this moment, attached on the fibre cover, can be high pressure resistant, can completely cut off bone cement again, so that the sacculus pipe is nimble to be removed between the centrum, conveniently fill bone cement, make that bone cement can fill target in place very much.

Preferably, the method further comprises the following steps: the outer catheter is in conduction connection with the basic balloon and is used for conveying inflation fluid to the inner cavity of the basic balloon; an inner catheter disposed within the outer catheter for placement of a support guidewire.

Preferably, the device further comprises a connector which is in conduction connection with the outer conduit.

Preferably, the outer wall of the second balloon is provided with a hole for communicating with the outside of the second balloon.

In this technical scheme, the hole of seting up can make the better attached on the fibre cover of second sacculus to the inflation of basic sacculus including fibre cover and parcel plays the constraint effect, plays withstand voltage effect.

A preparation method of a high-pressure vertebral body expansion balloon comprises the following steps:

s10, adhering a layer of fiber sleeve on the surface of the basic balloon;

s20, forming a small hole in the outer wall of the second balloon;

and S30, sleeving the second balloon on the basic balloon attached with the fiber sleeve, and fixing the open end of the second balloon and the basic balloon together.

Preferably, the surface of the base balloon is coated with an adhesive substance, and then the high-strength fibers are adhered to the surface of the base balloon to form a fiber sleeve.

Preferably, a layer of adhesive substance is coated on the surface of the basic balloon, the woven fiber sleeve is placed into a hollow tool with the same shape as the basic balloon, the tool is closed, and the fiber sleeve is pressed on the surface of the basic balloon.

Preferably, the base balloon is a compliant, semi-compliant or non-compliant material and the second balloon is made of a non-compliant or semi-compliant material.

In the technical scheme, the basic saccule is made of nylon, polyethylene terephthalate (PET), polyurethane, polyether block amide copolymer (PEBA) or a mixture polymer thereof, and the second saccule is made of a polyamide polymer material.

Preferably, the fiber sleeve is made of any one of high-strength fiber materials of polyethylene and polyimide.

Compared with the prior art, the high-pressure vertebral body expansion balloon and the preparation method thereof provided by the invention have the following beneficial effects:

1. according to the invention, through the combination of the basic balloon, the fiber sleeve and the second balloon, the device does not react with bone cement in the vertebral body, so that the balloon tube can move in the vertebral body, the position of the balloon tube can be moved as required, meanwhile, the height of the vertebral body can be adjusted as required, the bone cement can be conveniently filled, the phenomenon of collapse or cavity backfill after the balloon is withdrawn can not occur, the condition of blocking or bone cement leakage during bone cement infusion can not occur, and no foreign object is required to be additionally placed into the vertebral body, so that the additional treatment risk can be effectively avoided.

2. According to the invention, the fiber sleeve is attached to the outer wall of the basic balloon, the second balloon is sleeved outside the fiber sleeve, the fiber sleeve can play a role in restraining the basic balloon, and the second balloon is provided with the holes, so that the second balloon can be better attached outside the fiber sleeve, better pressure resistance can be ensured, and due to the existence of the fiber sleeve and the second balloon, the basic balloon does not need to be harsh on material selection, and only the elastomer can be expanded.

3. The invention solves the problems that the conventional basic balloon cannot be prepared by adopting a non-compliant or semi-compliant material, the material selection of the basic balloon is wider due to the combination of the fiber sleeve, the second balloon and the basic balloon in the application document, and the basic balloon is not easy to break when the balloon tube is moved during the filling of bone cement, so that the filling state can be maintained, and the phenomenon of cavity collapse in the ruptured vertebral body of the balloon can be avoided.

Drawings

The above features, technical features, advantages and modes of realisation of a hyperbaric corpus vertebrae dilatation balloon and a method of producing the same will be further described in the following preferred embodiments in a clearly understandable manner with reference to the accompanying drawings.

FIG. 1 is a schematic view of a basic balloon structure of a high pressure vertebral dilation balloon of the present invention;

FIG. 2 is a schematic structural view of a high-pressure centrum-dilating balloon filament-winding balloon according to the present invention;

FIG. 3 is a schematic structural view of a second balloon of the high pressure vertebral dilation balloon of the present invention;

FIG. 4 is a schematic view of a second balloon with holes of the high pressure vertebral expansion balloon of the present invention;

FIG. 5 is a schematic view of a double-layered balloon structure of a high-pressure vertebral dilatation balloon according to the present invention;

FIG. 6 is a schematic view of the overall structure of a high pressure vertebral dilation balloon of the present invention;

fig. 7 is a schematic view of the operation of the high-pressure vertebral body expansion balloon of the invention.

The reference numbers illustrate: the device comprises a basic balloon 1, a balloon distal end neck 2, a balloon proximal end neck 3, a balloon body 4, a fiber sleeve 5, a second balloon 6, a second balloon distal end 7, a second balloon proximal end 8, a hole 9, an outer catheter 10, a connector 11, a first channel 12, a second channel 13, bone cement 14, a working balloon 15, an intra-vertebral cavity 16 and an inner catheter 17.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

For the sake of simplicity, the drawings only schematically show the parts relevant to the present invention, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".

According to an embodiment of the present invention, as shown in fig. 1, a high pressure vertebral body expansion balloon comprises: a basal balloon 1 for receiving inflation fluid to lift the vertebral body to a physiological height; in specific implementation, the base balloon 1 is made of a polymer of nylon, polyethylene terephthalate (PET), polyurethane, polyether block amide copolymer (PEBA) or a mixture thereof, in this embodiment, the material selected for the base balloon 1 is not described in detail, and in the actual operation process, the base balloon 1 is integrally formed by the balloon proximal neck 103, the balloon body 4 in the middle, and the balloon distal neck 2

As shown in fig. 2, a fiber sleeve 5, the fiber sleeve 5 is attached on the surface of the base balloon 1 for preventing the base balloon 1 from over-inflation; during implementation, a layer of adhesive is coated on the surface of the basic balloon 1, on one hand, fibers can be adhered to the surface of the basic balloon 1 little by little to form a woven fiber sleeve 5, on the other hand, the fiber sleeve 5 can be integrally sleeved on the basic balloon 1 after being woven, the basic balloon 1 sleeved with the fiber sleeve 5 is placed into a hollow tool with the same shape as the basic balloon 1, and then the tool is closed to achieve the purpose of attaching each fiber to the adhesive.

As shown in fig. 3, the second balloon 6 is sleeved on the base balloon 1, the second balloon 6 is used for blocking the base balloon 1 from reacting with bone cement, in the implementation, the second balloon 6 has the same shape as the base balloon 1 and also has a proximal neck and a distal neck, so as to ensure that when the base balloon 1 is inflated, the second balloon 6 can be better matched with the base balloon 1, the base balloon 1 sleeved with the fiber sleeve 5 is folded, then the open end of the second balloon 6 is sleeved on the base balloon 1 along the balloon distal neck 2 of the base balloon 1, the proximal end of the base balloon 1 and the open end of the second balloon 6 can be connected in a bonding, welding or heat sealing manner, in the embodiment, preferably an adhesive is used for connection, which is convenient and fast, in the specific implementation, the second balloon 6 has a second balloon distal end 7 and a second balloon proximal end 8, respectively matched with the balloon far end neck part 2 and the balloon near end neck part 3 of the basic balloon 1.

As shown in fig. 5, in another embodiment of the present invention, the method further includes: the outer catheter 10 is in conductive connection with the basic balloon 1 and is used for conveying inflation fluid to the inner cavity of the basic balloon 1; the outer catheter 10 is connected with the basic balloon 1 in a bonding, welding or heat sealing mode, when the inflatable balloon is used, inflation fluid is conveyed into the basic balloon 1 through the outer catheter 10, the basic balloon 1 is inflated, other spaces in the outer catheter 10 except the inner catheter 17 form a channel for flowing the inflation fluid, and the inner catheter 17 is arranged in the outer catheter 10 and used for placing a supporting guide wire.

The device also comprises a connector 11, wherein the connector 11 is communicated and connected with the outer catheter 10, the connector is of a Y-shaped structure, and a Y-shaped side tube is communicated with the inner catheter 17.

As shown in fig. 4, the outer wall of the second balloon 6 is provided with a hole 9 for communicating with the outside of the second balloon 6, and the second balloon 6 provided with the hole 9 can keep the internal air pressure of the second balloon 6 the same as the external air pressure, when the base balloon 1 is expanded, the second balloon 6 is only attached to the surface of the fiber sleeve 5, so that the base balloon 1 is well bound, the expansion of the base balloon 1 is prevented, and a better pressure-resistant effect is achieved.

In another embodiment of the present invention, a snap fastener is further included for securing the distal end of the second balloon 66 to the balloon distal neck 22 of the base balloon 11 (not shown), in which the snap fastener is a biomass snap ring, and in which the snap fastener is deformed by pressing the snap fastener with physical pressure during installation to secure the distal end of the second balloon 66 to the balloon distal neck 22 of the base balloon 11.

A preparation method of a high-pressure vertebral body expansion balloon comprises the following steps:

s10, adhering a fiber sleeve 5 on the surface of the basic balloon 1;

s20, forming a small hole in the outer wall of the second balloon 6;

and S30, sleeving the second balloon 6 on the base balloon 1 attached with the fiber sleeve 5, and fixing the open end of the second balloon 6 and the base balloon 1 together.

When the method is specifically implemented, the basic balloon 1 and the second balloon 6 are manufactured by using a mold, and the fiber sleeve 5 is adhered to the outside of the basic balloon 1, so that the basic balloon 1 cannot shake in the second balloon 6 when the basic balloon 1 is filled with fluid, and the balloon tube can well move in the cavity 16 in the vertebral body.

In another embodiment of the present invention, the surface of the base balloon 1 is coated with an adhesive substance, and then the high-strength fibers are adhered to the surface of the base balloon 1 to form the fiber sheath 5, and in the specific implementation, the surface of the base balloon 1 is coated with a biological adhesive, and then the high-strength fibers are adhered to the surface of the base balloon 1 one by one, so as to ensure that the base balloon 1 can resist high pressure.

In another embodiment of the invention, a layer of adhesive is coated on the surface of the basic balloon 1, the woven fiber sleeve 5 is placed in a hollow tool with the same shape as the basic balloon 1, the tool is closed, the fiber sleeve 5 is pressed on the surface of the basic balloon 1, during the specific implementation, high-strength fibers are woven into the fiber sleeve 5, then a layer of biological adhesive is coated on the surface of the basic balloon 1, the fiber sleeve 5 is placed in a hollow tool similar to the basic balloon 1, and the tool is closed, so that the fiber sleeve 5 and the basic balloon 1 can be adhered together.

In another embodiment of the present invention, the base balloon 1 is a compliant, semi-compliant or non-compliant material, and the base balloon 1 is made of a polymer using nylon, polyethylene terephthalate (PET), polyurethane, polyether block amide copolymer (PEBA), or a mixture thereof.

The second balloon 6 is made of a non-compliant or semi-compliant material to ensure that the second balloon 6 can be inflated properly and is malleable. In particular, the second balloon 6 is made of a polyamide polymer material.

The fiber sheath 5 is made of any one of polyethylene and polyimide to ensure that the fiber sheath 5 can be better expanded when the base balloon 1 is inflated.

As shown in figure 7, when in use, firstly positioning the vertebral body, finding a diseased part, establishing a first channel 12, sending a high-pressure vertebral body expansion balloon into the first channel and pressurizing the balloon to reach a rated pressure to obtain a working balloon 15, as shown in figure 7, lifting the diseased vertebral body by the high-pressure balloon to restore the physiological height, and then injecting bone cement (PMMA)16 into a cavity 16 in the vertebral body from a second channel 13 while moving the balloon as required, thereby effectively preventing the situation that the spongy bone in the vertebral body is continuously collapsed and backfilled into a bone cement injection cavity after the balloon is withdrawn in the traditional operation, overcoming the defect that the bone cement can be injected into the vertebral body after the balloon is withdrawn due to the characteristic that the polyurethane material of the basic balloon 1 reacts with the bone cement in the traditional operation, and the movable support of the balloon in the vertebral body in the technical invention can fully fill the bone cement into the cavity, the treatment effect is better.

When the traditional vertebral body expansion balloon is used, when the vertebral body expansion balloon only provided with the basic balloon 1 is in contact with bone cement in the usable period for less than one minute, obvious reaction traces can appear on the balloon capsule body 4 and the near end of the balloon, the balloon is broken, the double-layer vertebral body expansion balloon can not have reaction traces in the operation time of an operating doctor, the operation time of the doctor is about 4 minutes generally in the operation time, the bone cement on the market generally enters the usable period after being mixed for 3-5 minutes, the operation time is 6-10 minutes, the conventional bone cement can reach the setting period after 9 minutes, and the bone cement with better effect can reach the setting period after 14 minutes.

It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.