CN211271097U

CN211271097U - Double-layer vertebral body expansion balloon

Info

Publication number: CN211271097U
Application number: CN201921629419.8U
Authority: CN
Inventors: 王兴娅; 顾海军
Original assignee: Shanghai Kinetic Medical Co Ltd
Current assignee: Shanghai Kinetic Medical Co Ltd
Priority date: 2019-09-27
Filing date: 2019-09-27
Publication date: 2020-08-18
Anticipated expiration: 2029-09-27

Abstract

The utility model provides a double-deck centrum expansion sacculus, including having withstand voltage basis sacculus for after receiving inflation fluid, in order to support the centrum. The second balloon is sleeved on the base balloon, and the inner wall of the opening end of the second balloon is connected with the outer wall of the base balloon and used for blocking the reaction of the base balloon and bone cement; the basic sacculus after strutting is with centrum lifting, the supporting role that plays that can be better, according to the change of filling the bone cement position, constantly adjusts the position and the angle of this double-deck sacculus to reach and fill up the cavity after strutting, the cover is established the basic sacculus of second sacculus separation outside and is reacted with bone cement, just so can fill the limit and remove, can reach better packing, can not appear because of the sacculus withdraws from the back and subsides or the phenomenon that the cavity was backfilled.

Description

Double-layer vertebral body expansion balloon

Technical Field

The utility model relates to the field of medical equipment, indicate a double-deck centrum expansion sacculus especially.

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.

The prior art is through establishing an expansion support at the sacculus overcoat, drives the support through the sacculus expansion and struts, and the sacculus pressure release back is withdrawn from the sacculus, and the support is stayed in the vertebra, but if the support is too soft then play the effect of support, can cause the damage to the centrum too hard, if the support can not be accurate and firm fixed in the vertebra, in case the shift position probably damages nerve. In addition, once the support is propped up and the balloon is withdrawn, the support angle cannot be flexibly changed, and bone cement cannot be fully and accurately filled into a vertebral body, so that the double-layer vertebral body expansion balloon is provided.

SUMMERY OF THE UTILITY MODEL

The utility model discloses to solve among the prior art sacculus after strutting the centrum, can not stay in the cavity that struts to and the technical problem who reacts with bone cement, provide a double-deck centrum expansion sacculus.

The utility model provides a technical scheme as follows:

a double-layered vertebral expansion balloon comprising:

a base balloon having a pressure resistance for receiving an inflation fluid;

the second sacculus, the second sacculus cover is established on the basis sacculus, just the open end inner wall and the basic sacculus outer wall of second sacculus are connected for keep apart basic sacculus and bone cement reaction.

In this technical scheme, establish a second sacculus through at basic gasbag overcoat, make second sacculus and basic sacculus synchronous expansion, the basic sacculus after strutting is with centrum lifting, form the cavity, be used for filling bone cement, when filling bone cement, according to the change of filling the bone cement position, constantly adjust the position and the angle of this double-deck sacculus, in order to reach the cavity that fills up after strutting, the second sacculus separation basic sacculus of cover establishing in the outside reacts with bone cement, just so can fill the limit and remove, can reach better filling, the phenomenon of collapsing or cavity backfill after withdrawing from because of the sacculus can not appear, this kind of condition emergence of hindering or bone cement leakage when also can not making bone cement pour into takes place.

Preferably, the inflatable balloon catheter further comprises an outer catheter and an inner catheter, wherein the inner catheter is arranged in the outer catheter and is used for providing a supporting guide wire channel, and the outer catheter is in communication connection with the basic balloon and is used for conveying inflation fluid to the basic balloon.

Preferably, the open end of the second balloon is connected to the base balloon.

Preferably, the open end of the second balloon is connected to the outer wall of the base balloon by means of a first snap or adhesive.

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

Preferably, the base balloon is made of a compliant material.

In the technical scheme, the basic balloon made of the material which is compliant and does not generate rejection reaction with the action body does not generate any rejection reaction with a human body on one hand, and can resist high pressure on the other hand so as to receive the expansion fluid to prop open the vertebral body to form a cavity.

Preferably, the second balloon is made of an elastic material, and the elasticity of the material for manufacturing the second balloon is equal to or better than that of the material for manufacturing the base balloon.

In this technical scheme, the elasticity of preparation second sacculus material equals or because preparation basis sacculus elasticity, does benefit to when the expansion of inflation fluid is received to the basis sacculus, and the second sacculus can expand with basic sacculus synchronous, can not appear breaking.

Preferably, the second balloon is made of high-elasticity rubber materials such as natural rubber latex and silica gel.

Preferably, the balloon fixing device further comprises a second buckle, and one end, far away from the opening end, of the second balloon is fixed with the base balloon through the second buckle.

Compared with the prior art, the utility model provides a pair of double-deck centrum expansion sacculus has following beneficial effect:

1. the utility model has the advantages that the second balloon is sleeved outside the basic balloon, the second balloon and the basic balloon are synchronously expanded, the expanded basic balloon lifts the vertebral body, the supporting effect can be better realized, the vertebral body is not damaged, the lifted vertebral body forms a cavity and is used for filling bone cement, when the bone cement is filled, the position and the angle of the double-layer balloon are continuously adjusted according to the change of the position of the filled bone cement so as to fill the expanded cavity in time, the second balloon sleeved outside blocks the basic balloon from reacting with the bone cement, so that the filling and the moving can be realized while the filling are carried out, the phenomena of collapse or cavity backfilling caused by the withdrawal of the balloon can be avoided, the phenomenon of blocking or bone cement leakage during the bone cement filling can not be caused, and no foreign object is additionally arranged in the vertebral body, additional treatment risks can be effectively avoided.

2. The utility model discloses in the second sacculus of the big material preparation of elasticity, use the basic sacculus of compliance material preparation simultaneously, the elasticity that makes preparation second sacculus material is greater than the elasticity of preparation basic sacculus material to guarantee that the second sacculus can be along with basic sacculus together expands when the basic sacculus receives inflation fluid.

Drawings

The foregoing features, technical features, advantages and implementations of a double layer vertebral expansion balloon will be further described in the following detailed description of the preferred embodiments in a clearly understandable manner in conjunction with the accompanying drawings.

Fig. 1 is a schematic structural view of a double-layer vertebral body expansion balloon basic balloon of the present invention;

fig. 2 is a schematic structural view of the double-layer vertebral body expansion balloon of the present invention;

fig. 3 is a schematic view of the folding structure of the double-layer vertebral body expansion balloon of the present invention;

fig. 4 is a schematic view of the expansion structure of the double-layer centrum expansion balloon of the present invention;

fig. 5 is a schematic view of a working scene of the double-layer vertebral body expansion balloon of the present invention;

fig. 6 is a schematic structural view of another embodiment of the double-layered vertebral body expansion balloon of the present invention.

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

Detailed Description

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

For the sake of simplicity, only the parts relevant to the present invention are schematically shown in the drawings, 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, a double-layered vertebral body expansion balloon comprises a pressure-resistant base balloon 1, as shown in fig. 1, for receiving an inflation fluid;

in specific implementation, the basic balloon 1 is prepared by using a die forming or balloon mold blank method, the basic balloon 1 is composed of a distal neck 2, a balloon body 4 and a proximal neck 3, and when the proximal neck 3 of the basic balloon 1 is connected with one end of the external catheter 6, the proximal neck 3 of the basic balloon 1 is connected with one end of the external catheter 6 by adopting an adhesive bonding, welding or heat sealing process, so that the connection between the proximal neck 3 of the basic balloon 1 and one end of the external catheter 6 is firmer;

as shown in fig. 2, the second balloon 5 is sleeved on the base balloon 1, and the inner wall of the opening end of the second balloon 5 is connected with the outer wall of the base balloon 1 for blocking the reaction between the base balloon 1 and bone cement.

In the embodiment, the base balloon 1 is folded to be in a folded state, the second balloon 5 is sleeved on the base balloon 1 along the balloon distal neck 2 of the base balloon 1, then the open end of the second balloon 5 is connected with the proximal neck 3 of the base balloon 1, the shape of the second balloon 5 is the same as that of the base balloon 1, after the base balloon 1 is expanded, the second balloon 5 can be attached to the base balloon 1, on one hand, the reaction between the base balloon 1 and bone cement can be blocked, on the other hand, after the second balloon 5 is attached to the base balloon 1, according to the acting force and the reacting force, when the inner cavity of the base balloon 1 is filled with the inflation fluid, the inner wall of the base balloon 1 is continuously expanded to apply force to the inner wall of the second balloon 5, and simultaneously, the inner wall of the second balloon 5 also applies force to the outer wall of the base balloon 1, so that the expansion of the base, so as to achieve the function of compression resistance and ensure that the double-layer saccule has the effect of high pressure resistance.

In another embodiment of the present invention, as shown in fig. 3, the open end of the second balloon 5 is connected with the base balloon 1; the open end of second sacculus 5 passes through first buckle to be connected on the outer wall of basic sacculus 1, also can directly connect on the outer wall of basic sacculus 1 through the mode of bonding. In specific implementation, in order to better connect the base balloon 1 and the second layer balloon 5 together, the base balloon 1 and the second layer balloon 5 may be processed by adhesion, and then clamped together by the first clamp, the first clamp is made of a metal material capable of adapting to a biological phase, as long as the second balloon 5 and the base balloon 1 can be clamped together, the first clamp may be in a ring shape, and the second balloon 5 and the base balloon 1 are clamped together by pressing deformation, and the shape thereof is not described in detail in this embodiment.

After the proximal neck 3 of the base balloon 1 is connected with the outer catheter 6 described below, the open end of the second balloon 5 and the proximal neck 3 of the base balloon 1 are clamped together by the first clamp 8, so that the effect that the second balloon 5 and the base balloon 1 can be synchronously expanded is ensured.

Referring again to fig. 3, in another embodiment of the present invention, the present invention further comprises an outer catheter 6 and an inner catheter 14, wherein the inner catheter 14 is disposed inside the outer catheter 6 and is used for providing a supporting guide wire channel, and the outer catheter 6 is in conductive connection with the base balloon 1 and is used for delivering an inflation fluid to the base balloon 1. The outer catheter 6 is made of nylon or polyurethane. The space inside the outer tube 6 other than the inner tube 14 constitutes a passage through which the inflation fluid flows; the device also comprises a connector 7, wherein the connector 7 is communicated and connected with the outer catheter 6, the connector is of a Y-shaped structure, and a Y-shaped side tube is communicated with the inner catheter 14.

In practice, the connector 7 is joined to the outer pipe 6 by means of an adhesive, welding or heat-sealing process. When the connector 7 is used, the connector is connected with an external pressure filling device, contrast agent is pressed into the saccule to fill the saccule, and the height of the vertebral body is raised. The inner catheter is inserted into a support wire to support the balloon.

In another embodiment of the invention, the base balloon 1 is made of a compliant material. The second balloon 5 is made of an elastic material, the elasticity of the material for manufacturing the second balloon 5 is equal to or better than that of the material for manufacturing the base balloon 1, and in the specific implementation, the second balloon 5 is made of one or more of natural latex and silica gel.

When the inflatable balloon catheter is implemented, the base balloon 1 is made of a compliant material, so that the base balloon 1 can resist high pressure, when the inflatable balloon receives inflation fluid, the base balloon 1 cannot be damaged due to overlarge pressure, the second balloon 5 is made of natural latex, rubber, silica gel or a material with higher elasticity, so that the second balloon 5 can be synchronously inflated along with the base balloon 1, and the second balloon enables the inflated balloon catheter to be free from abrasion and damage to the base balloon 1 when the inflated balloon catheter moves.

As shown in fig. 6, in another embodiment of the present invention, the utility model further comprises a second buckle 15, the second buckle 15 fixes the end of the second balloon 5 away from the open end with the basic balloon 1, when implementing specifically, the end of the second balloon 5 away from the open end is fixed with the distal neck 2 of the basic balloon 1 through the second buckle 15, so as to ensure that when inflating into the basic balloon 1, the second balloon 5 and the basic balloon 1 keep synchronous expansion, and when the balloon tube moves in the vertebral body inner cavity 13, the second balloon keeps consistent with the basic balloon direction.

As shown in figure 5, when in use, firstly positioning the vertebral body, finding out the diseased part, then puncturing, establishing a first channel 9, sending the double-layer vertebral body expansion balloon into the first channel and pressurizing, so that the basic balloon 1 reaches the rated pressure, at the moment, the basic balloon 1 can simultaneously prop up the second balloon 5 to obtain a working balloon 12, as shown in figure 5, the double-layer balloon lifts the diseased vertebral body to restore the physiological height, and then the balloon is moved from the second channel 10 as required while injecting bone cement 11(PMMA) into the cavity 13 in the vertebral body, thereby effectively preventing the situation that spongy bone in the vertebral body continues to collapse and backfills the bone cement injection cavity after the balloon is withdrawn in the traditional operation, and overcoming the defect that the bone cement can be injected after the balloon is withdrawn due to the characteristic that polyurethane of the material of the basic balloon 1 reacts with the bone cement in the traditional operation, the movable support of the balloon in the vertebral body in the technical scheme can fully fill bone cement into the vertebral body cavity, so that 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 reaction traces can not appear in the operation time of an operating doctor in the double-layer vertebral body expansion balloon, the operation time of the operating doctor is about 4 minutes generally, 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 16 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, a plurality of 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.

Claims

1. A double-layer vertebral body expansion balloon is characterized in that: comprises that

A base balloon having a pressure resistance for receiving an inflation fluid;

the second sacculus, the second sacculus cover is established on the basis sacculus, just the open end inner wall and the basic sacculus outer wall of second sacculus are connected for separation basis sacculus and bone cement reaction.

2. The double-layered vertebral dilation balloon according to claim 1, further comprising an outer catheter and an inner catheter, wherein the inner catheter is disposed within the outer catheter and is configured to provide a support guidewire channel, and wherein the outer catheter is in fluid communication with the base balloon and is configured to deliver inflation fluid thereto.

3. The double-layered vertebral expansion balloon according to claim 1 or 2, wherein: the open end of the second balloon is connected to the base balloon.

4. The double-layered vertebral expansion balloon of claim 3, wherein: the open end of the second balloon is connected to the outer wall of the base balloon in a first buckling or bonding mode.

5. The double-layered vertebral expansion balloon of claim 2, wherein: the device also comprises a connector which is in conduction connection with the outer catheter.

6. The double-layered vertebral expansion balloon according to claim 1 or 2, wherein: the base balloon is made of a compliant material.

7. The double-layered vertebral expansion balloon according to claim 1 or 2, wherein: the second balloon is made of elastic material, and the elasticity of the material for manufacturing the second balloon is equal to or superior to that of the material for manufacturing the basic balloon.

8. The double-layered vertebral expansion balloon according to claim 1 or 2, wherein the second balloon is made of one or more of natural latex, silica gel and rubber.

9. The double-layered vertebral expansion balloon of claim 1 or 2, further comprising a second clip for fixing an end of the second balloon away from the open end to the base balloon.