CN115844601A - Double-cavity balloon catheter for nucleus pulposus repair - Google Patents

Abstract

The invention relates to a double-lumen balloon catheter for nucleus pulposus repair, which is used for implanting artificial spinal implants, comprising: an outer capsule extending to one end with an opening through which the artificial nucleus pulposus prosthesis is injected. The outer capsule is filled to form a spinal implant; the inner capsule is sheathed inside the outer capsule and is used to contain the contrast agent to locate the insertion position of the outer capsule; the contrast agent infusion tube is connected to the outer capsule The inner capsule communicates with the inner capsule and is used to inject a contrast agent into the inner capsule; the outer sleeve and the inner sleeve communicate with the outer capsule; one end of the outer sleeve and the inner sleeve located in the same direction is the first end , the other end is the second end, the first end is used to fix the outer capsule, wherein there is a first cavity between the inner surface of the outer sleeve and the outer surface of the inner sleeve, the outer capsule The opening of the body is located in the first cavity, and the outer sleeve and the inner sleeve simultaneously press the opening of the outer capsule toward the direction of the first cavity.

Description

A double-lumen balloon catheter for nucleus pulposus repair

technical field

The invention belongs to the technical field of medical devices, and in particular relates to a double-lumen balloon catheter for nucleus pulposus repair.

Background technique

Degenerative disc disease of the spine is a common and frequently-occurring disease, and the main treatment methods include physical therapy and surgery. The main surgical methods of surgical treatment are divided into spinal fusion and non-fusion. Non-fusion of the spine can avoid the secondary degeneration of the adjacent segment caused by fusion and preserve the physiological function of the operative segment as much as possible. Therefore, it is getting more and more attention. It is widely used and has a good development prospect. Existing spinal non-fusion surgery mainly includes elastic fixation technology, artificial disc replacement and artificial nucleus pulposus replacement. Among them, artificial nucleus pulposus replacement can maintain the integrity of the fibrous annulus, effectively maintain the height of the intervertebral disc, restore the basic motion function of the spine, and reduce the adjacent joints. Advantages such as the possibility of segmental degeneration are more suitable for patients with early and middle stages of intervertebral disc degeneration. At present, artificial nucleus pulposus replacement is in the development stage and can be used for minimally invasive or open surgery to treat disc herniation or lumbar discogenic low back pain.

Among them, the main complications of artificial nucleus pulposus prosthesis replacement are damage to the fibrous annulus, which can easily lead to implant displacement, cartilage endplate wear, and implant subsidence. The probability of postoperative displacement and bulging of the artificial nucleus pulposus is high. It has been reported that the probability of successful implantation of the artificial nucleus pulposus prosthesis (raymedica, Minneapolis, Mn) is between 77% and 90%. Implant displacement occurred in 26% of cases after surgery.

Therefore, the problems that need to be solved for artificial spinal implants at this stage include: possible cartilage endplate damage and prosthetic subsidence; implants may be displaced or squeezed out; intervertebral height is difficult to maintain for a long time; The range of motion of the spine at the implanted segment is reduced, and movement in all directions is limited.

Contents of the invention

The technical problems to be solved by the present invention are: artificial spinal implants at the present stage may cause cartilage endplate damage and prosthesis subsidence; implants may be displaced or squeezed out; intervertebral height is difficult to maintain for a long time; The range of motion of the spine at the implanted segment is reduced, and movement in all directions is limited.

The invention is a double-cavity balloon catheter for nucleus pulposus repair, used for implanting artificial spinal implants, comprising:

The outer capsule has an opening extending toward one end, through which the artificial nucleus pulposus prosthesis is injected to fill the outer capsule to form a spinal implant;

The inner capsule is sheathed inside the outer capsule, and is used for accommodating a contrast agent so as to locate the insertion position of the outer capsule;

A contrast agent infusion tube, which communicates with the inner capsule and is used for injecting a contrast agent into the inner capsule;

An outer sleeve and an inner sleeve, the inner sleeve communicates with the outer capsule; the outer sleeve and the inner sleeve are located in the same direction, one end is the first end, and the other end is the second end, and the first end is used for Fixing the outer capsule, wherein there is a first cavity between the inner surface of the outer sleeve and the outer surface of the inner sleeve, the opening of the outer capsule is located in the first cavity, the outer sleeve and the outer sleeve The inner sleeve simultaneously presses the opening of the outer capsule in the direction of the first cavity, so that the opening of the outer capsule is fixed in the first cavity; the extrusion of the opening is released The exosomes are then released.

In some embodiments of the present application, the inner sleeve extends into the outer capsule, so that the inner sleeve communicates with the outer capsule, and is used for injecting the artificial nucleus pulposus prosthesis into the outer capsule through the inner sleeve.

Preferably, the artificial nucleus pulposus prosthesis is self-curing silica gel or hydrogel, and the artificial nucleus pulposus prosthesis is solidified and fixed after entering the outer capsule to replace the function of the nucleus pulposus.

Preferably, the inner sleeve is sleeved on the outside of the contrast medium infusion tube, and the outer sleeve is sleeved on the outside of the inner sleeve. The contrast agent enters the inner capsule through the contrast agent infusion tube, and the artificial nucleus pulposus enters the outer capsule through the inner cannula. The paths of the contrast agent and the artificial nucleus pulposus are different to prevent inconsistent injection into the outer capsule or the inner capsule. The liquid and contrast agent residues affect the artificial nucleus pulposus prosthesis.

Preferably, a handle is provided, sheathed on the second end of the outer sleeve, for stabilizing the cooperation between the outer sleeve and the inner sleeve, and the handle is fixedly connected to the outer sleeve.

In some embodiments of the present application, the outer capsule is a cavity structure with an open end, and the outer capsule has a deforming force, and after being injected with the artificial nucleus pulposus prosthesis, the outer capsule is filled and deformed to fill the original nucleus pulposus. space. The outer capsule after being implanted in the human body can replace the function of the nucleus pulposus.

Preferably, the outer capsule in the standby state is a flat bag-like structure; the outer capsule in the filled state extends to one end with an opening, wherein the extended part is a tubular structure, and the tubular structure is sleeved on the inner sleeve outside, located within the first cavity. In the state of use, the tubular structure is located in the first cavity between the outer sleeve and the inner sleeve, and the outer sleeve and the inner sleeve squeeze the tubular structure at the same time, and the tubular structure is squeezed by the outer sleeve and the inner sleeve, so that the outer capsule The body is clamped and fixed, and the outer capsule can be released by releasing the extrusion of the tubular structure by the outer sleeve and the inner sleeve.

In some embodiments of the present application, a clamping tube 1 is provided at the first end of the outer sleeve, and the clamping tube 1 is integrally connected with the outer sleeve. The first end of the inner sleeve is provided with a clamping tube two, which is integrally connected with the inner sleeve, and the inner diameter of the second clamping tube is smaller than that of the inner sleeve. inner diameter, the inner casing and the clamping tube two are transitionally connected through the transition tube two; in the use state, the transition tube one and the transition tube two are misaligned, so that the clamping tube one and the inner sleeve jointly squeeze the outer capsule Open your mouth. The principle of fixing the opening of the outer capsule is: there is an opening first cavity capable of accommodating the outer capsule between the first clamping tube and the inner sleeve. When the transition tube one and the second transition tube are misaligned, the position of the clamping tube one Corresponding to the first end of the inner sleeve, the clamping tube one and the inner sleeve jointly squeeze the opening, thereby fixing the outer capsule.

In some embodiments of the present application, the direction moving toward the first end is defined as the first direction, and the direction moving toward the second end is defined as the second direction. This definition is only for the convenience of the following description and has no limiting effect.

Preferably, when the transition tube moves in the second direction, the opening of the outer capsule is squeezed; when the transition tube moves in the first direction, the extrusion of the opening of the outer capsule is released. When the exocyst is squeezed, it will be fixed, which is convenient for the operator to hold; if the extrusion of the exocyst is released, the exocyst can be released, so that the exocyst can be inserted into the intervertebral disc to replace the function of the nucleus pulposus. The principle of fixing the opening of the outer capsule is: there is a first cavity between the first clamping tube and the inner sleeve that can accommodate the opening of the outer capsule. The position corresponds to the first end of the inner sleeve, and the clamping tube one and the inner sleeve jointly squeeze the opening to fix the outer capsule.

As a preference, the sectional surface of the transition pipe 1 is an inclined surface inclined upward from the first direction to the second direction, and the sectional surface of the transition pipe 2 is an inclined surface inclined upward from the first direction to the second direction; The inner diameter from the inner diameter of the clamping tube 1 becomes smaller, so that the clamping tube 1 and the inner sleeve jointly squeeze the opening of the outer capsule, and the inner diameter of the inner sleeve to the inner diameter of the clamping tube 2 becomes smaller, so that the clamping tube 2 stretches Into the opening of the outer capsule so that the inner sleeve communicates with the outer capsule.

In some embodiments of the present application, an injection part is provided, and the injection part is detachably fixedly connected with the handle, which is used to facilitate the operator to inject the artificial nucleus pulposus prosthesis into the outer capsule and inject the radiography into the inner capsule respectively. agent.

Preferably, the injection part is a multi-channel tubular structure, the injection part includes pipes communicating with the inner cannula and the contrast medium infusion tube respectively, and the inside of the injection part is fixedly connected with the contrast medium infusion tube.

Preferably, the injection part is a Y-shaped pipe, including a first pipe and a second pipe, the first pipe communicates with the inner sleeve, so that the first pipe communicates with the outer capsule, and the second pipe communicates with the inner sleeve. The contrast agent infusion tube is connected, so that the second pipeline communicates with the inner capsule; during use, the artificial nucleus pulposus is injected into the outer capsule through the first pipeline and the inner sleeve, and the artificial nucleus pulposus is injected through the second pipeline, the contrast agent The infusion tube injects contrast medium into the inner capsule. Since the inner capsule and the outer capsule need to be injected with different substances, it is necessary to ensure that the two are not connected. The above-mentioned first pipeline and the second pipeline realize the independence of the inner capsule and the outer capsule.

Preferably, one end of the second pipeline in the first direction is the first end, and one end in the second direction is the second end, the second end of the second pipeline is provided with a connecting piece, and the connecting piece and the second pipeline are detachable A type of fixed connection, the connecting piece is used to connect the syringe to inject contrast medium into the second pipeline.

Preferably, the connector includes a connecting pipe one extending into the second pipeline, and a connecting pipe two communicating with the syringe, the connecting pipe one communicating with the second pipeline, the connecting pipe one communicating with the connecting pipe two, and the connecting pipe one communicating with the second pipeline. It is integrally formed with the connecting pipe two. When in use, the syringe is connected to the second connecting pipe, and the contrast agent in the syringe is injected into the second connecting pipe, and then the contrast agent flows through the first connecting pipe and the second pipe in turn, and enters the inner capsule.

Preferably, the connector further includes a threaded pipe provided with an internal thread, the threaded pipe is sleeved on the outside of the connecting pipe one, the threaded pipe is integrally connected with the connecting pipe one, and the inner surface of the threaded pipe is connected to the outer surface of the connecting pipe one There is a cavity between them that allows the second pipeline to extend in, the second pipeline is provided with external threads, and threaded pipe one is threadedly connected with the second pipeline. In use, the second end of the second pipe is inserted into the cavity between the threaded pipe and the connecting pipe one, and the threaded pipe and the second pipe are screwed tightly so that the connecting piece is fastened on the second pipe.

Preferably, a cap is provided for closing the two connecting pipes, and the cap is detachably fixedly connected to the two connecting pipes. In the standby state, installing the sealing cap on the second connecting pipe can seal the connecting piece and the second pipe to play a protective and dustproof role.

Preferably, the sealing cap includes a sealing tube and a threaded cylinder, the sealing tube extends into the second connecting pipe, the threaded cylinder is integrally connected with the sealing tube, the second connecting pipe has external threads, and the threaded cylinder is threadedly connected with the second connecting pipe. When in use, the sealing pipe extends into the second connecting pipe so that the second connecting pipe is sealed, and the sealing cap is fixed on the second connecting pipe through the threaded cylinder.

Preferably, the first end of the second pipe is detachably fixedly connected to the handle. Two parts for easy assembly and disassembly.

Preferably, the first end of the second pipeline has an external thread, the handle has a channel allowing the first end to extend into the channel, and an internal thread matching the external thread of the first end is provided in the channel, and the second pipeline is threadedly connected to the handle , making the Y-shaped tube and the handle detachable.

In some embodiments of the present application, the inner capsule is sealed and connected to one end of the contrast medium infusion tube, and the other end of the contrast medium infusion tube is connected to the second connecting tube. A tube runs through the inner sleeve and the second conduit. When in use, the syringe containing the contrast agent is connected to the second connecting tube, and the contrast agent is injected into the second end of the connecting tube. The positions of the capsule and the external capsule are positioned so that the doctor can make adjustments and find the best placement of the artificial nucleus pulposus prosthesis.

Preferably, the length of the contrast medium infusion tube is greater than the length of the inner sleeve, and the contrast medium infusion tube extends from the second end of the inner sleeve; the length of the inner sleeve is greater than the length of the outer sleeve, and the inner sleeve extends from the second end of the inner sleeve. The second end of the outer sleeve protrudes.

Preferably, the contrast medium infusion tube is connected to the interior of the connecting piece through a seal, so that there is no liquid leakage between the contrast medium infusion tube and the connecting piece, preventing the contrast medium from leaking out.

Preferably, the sealing member is a tubular structure, the sealing member communicates with the first connecting pipe, and the sealing member communicates with the second connecting pipe, the contrast medium infusion tube is glued to the sealing member, and the sealing member is glued to the inner wall of the connecting member. catch.

Preferably, the handle has a channel allowing the outer sleeve to enter, and the channel communicates with the hole.

Preferably, the outer wall of the handle is provided with a handle for easy grasping, and the handle is integrally connected with the handle.

The usage method of the present invention:

Preparation stage: set the inner cannula outside the contrast medium infusion tube, then set the opening of the outer capsule on the first end of the inner cannula, and set the outer cannula from the second end of the inner cannula to the inner cannula Outside the casing, move the outer casing to the first direction, so that the outer casing and the inner casing squeeze the opening of the outer capsule tightly, thereby fixing the outer capsule; then, set the channel of the handle on the outer casing from the second end Outside the tube, the handle and the outer tube are relatively fixed, and the handle can drive the outer tube to move; finally, the injection tube is connected to the handle.

Use process: hold the handle, insert the outer capsule into the intervertebral disc, install a connector on the second tube of the injection tube, inject contrast agent into the second tube through the connector, and the contrast agent flows through the contrast medium infusion tube into the inner capsule , rays cannot pass through the contrast agent. Since the inner capsule is inside the outer capsule, the position of the inner capsule can indicate the position of the outer capsule, and guide the doctor to find the most suitable release position of the outer capsule; after determining the position, pass The second pipeline draws out the contrast medium inside the inner capsule, measures the volume of the contrast medium, holds the connector and pulls out the contrast medium infusion tube and the inner capsule, tightens the cap onto the second connecting tube, and then injects The first tube of the tube is injected with an artificial nucleus pulposus prosthesis equal to the volume of the contrast agent, such as self-curing silica gel or hydrogel, so that the external capsule is filled to an appropriate level. After being filled with liquid silica gel or hydrogel, under the action of pressure, the external capsule will expand and deform until it fills the space of the protonucleus pulpus. During this process, the external capsule has sufficient deformation capacity to ensure that it will not be damaged.

Withdrawing the instrument: hold the injection tube, unscrew the thread between the injection tube and the handle, pull the injection tube in the second direction, so that the clamping tube 2 of the inner cannula moves to the position corresponding to the clamping tube 1 of the outer cannula. The distance between the clamping tube one and the clamping tube two is relatively large, so the opening of the outer capsule is decompressed and the outer capsule is released.

Insert the intervertebral disc; hold the infusion tube and continue to pull the inner cannula in the second direction to withdraw the inner cannula from the patient. Then hold the handle and move back for a certain distance, rotate the angle slightly and push forward to cut off the tail of the injected liquid support, then take out the handle together with the outer sleeve, and the remaining liquid support in the outer sleeve will be taken out at the same time. Pull out the outer cannula to complete the insertion.

Beneficial effects of the present invention:

(1) Minimally invasive implantation, less damage to the fibrous annulus, and preserve the structure of the intervertebral disc as much as possible.

(2) By injecting contrast agent into the inner capsule for positioning, the exact insertion position and the required amount of prosthesis can be determined.

(3) The outer capsule is squeezed and fixed by the outer sleeve and the inner sleeve, and the extrusion can be quickly released, so that the outer capsule can be released quickly, and the insertion of the outer capsule can be completed efficiently.

(4) The artificial nucleus pulposus prosthesis with self-curing silica gel or hydrogel is used for implantation. When the prosthesis is in liquid state, it is implanted through the cannula, which is simple and can ensure the full filling of the prosthesis; it can replace the nucleus pulposus after curing. Function, and not easy to come out.

(5) The outer capsule filled with self-curing silica gel or hydrogel can well adapt to the anatomical structure of the patient's nucleus pulposus, replace the function of the nucleus pulposus, preserve the function of the diseased segment, and avoid degeneration of adjacent segments.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following will briefly introduce the accompanying drawings of the embodiments. Obviously, the accompanying drawings in the following description only relate to some embodiments of the present disclosure, rather than limiting the present disclosure , for those skilled in the art, other drawings can also be obtained according to these drawings on the premise of not paying creative work.

Fig. 1 is a kind of overall structure schematic diagram of realizing the present invention;

Fig. 2 is the cross-sectional structure schematic diagram of Fig. 1;

Fig. 3 is the schematic diagram that outer sleeve and inner sleeve fix the outer capsule;

Fig. 4 is a schematic perspective view of an outer sleeve, an inner sleeve, an outer capsule, and an inner capsule in use;

Fig. 5 is the enlarged schematic view of the first end of the inner casing and the outer casing;

Fig. 6 is a structural schematic diagram of a first end of the inner sleeve provided with an expansion tube;

Fig. 7 is a cross-sectional view of the injection pipe and the handle in use;

Fig. 8 is a cross-sectional enlarged structural schematic diagram of a contrast medium infusion tube and a sealing member;

Fig. 9 is a schematic cross-sectional structural view of the handle;

Fig. 10 is a schematic cross-sectional structural view of the outer cannula, the inner cannula, the contrast agent infusion tube and the handle.

In the figure, 1. Outer tube; 11. Clamping tube one; 2. Inner tube; 21. Clamping tube two; 22. Expansion tube; 3. Outer capsule; 4. Inner capsule; 41. Contrast agent Infusion tube; 5, injection tube; 51, first pipeline; 52, second pipeline; 6, handle; 61, passage; 62, gripper; 63, hole; 7, connector; 71, connecting pipe one; 72 , connecting pipe two; 73, threaded pipe; 74, seal; 8, sealing cap; 81, sealing pipe; 82, threaded barrel.

Detailed ways

The technical solutions in the embodiments of the present invention are clearly and completely described below through specific specific embodiments. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all embodiments. Those skilled in the art can learn from this Other advantages and functions of the present invention can be easily understood from the contents disclosed in the specification. The present invention can also be implemented or applied through other different specific implementation modes. In the case of no conflict, the following embodiments and the features in the embodiments can be combined with each other. Based on the embodiments of the present invention, those of ordinary skill in the art will All other embodiments obtained under the premise of no creative work belong to the protection scope of the present invention.

Embodiments and examples of the present disclosure will be described in detail below in conjunction with the accompanying drawings.

Fig. 1 is a schematic view of the overall structure of the present invention, and Fig. 2 is a schematic view of the overall sectional structure of the present invention, as described in Fig. 1-2, this specific embodiment provides a double-lumen balloon catheter for nucleus pulposus repair, Used to place artificial spinal implants, including:

The outer capsule 3 has an opening extending toward one end, through which the artificial nucleus pulposus prosthesis is injected to fill the outer capsule 3 to form a spinal implant;

The inner capsule 4 is sheathed inside the outer capsule 3, and is used for accommodating a contrast agent to locate the insertion position of the outer capsule 3;

Contrast agent infusion tube 41, communicated with the inner capsule 4, for injecting contrast agent into the inner capsule 4;

The outer sleeve 1 and the inner sleeve 2, the inner sleeve 2 communicates with the outer capsule 3; the outer sleeve 1 and the inner sleeve 2 are all located in the same direction, one end is the first end, and the other end is the second end, so The first end is used to fix the outer capsule 3, wherein there is a first cavity between the inner surface of the outer sleeve 1 and the outer surface of the inner sleeve 2, and the opening of the outer capsule 3 is located at the In the first cavity, the outer sleeve 1 and the inner sleeve 2 simultaneously press the opening of the outer capsule 3 in the direction of the first cavity, so that the opening of the outer capsule 3 is fixed on the In the first cavity; the outer capsule 3 can be released by releasing the extrusion on the opening.

In some embodiments of the present application, the inner sleeve 2 extends into the outer capsule 3, so that the inner sleeve 2 communicates with the outer capsule 3, and is used to inject the artificial nucleus pulposus into the outer capsule 3 through the inner sleeve 2 Prosthesis.

The inner sleeve 2 is sleeved on the outside of the contrast medium infusion tube 41 , and the outer sleeve 1 is sleeved on the outside of the inner sleeve 2 . The contrast agent enters the inner capsule 4 through the contrast agent infusion tube 41, and the artificial nucleus pulposus prosthesis enters the outer capsule 3 through the inner sleeve 2. The paths of the contrast agent and the artificial nucleus pulposus prosthesis are different to prevent the outer capsule 3 or The problem of injecting inconsistent liquid in the inner capsule body 4 .

A handle 6 is provided, sleeved on the second end of the outer sleeve 1 , for stabilizing the cooperation between the outer sleeve 1 and the inner sleeve 2 , and the handle 6 is detachably fixedly connected to the outer sleeve 1 .

In some embodiments of the present application, the outer capsule 3 is a cavity structure with an open end, and the outer capsule 3 has a deformation force, and the outer capsule 3 is filled and deformed to fill the space of the original nucleus pulposus after being injected with the artificial nucleus pulposus prosthesis . The outer capsule 3 injected with the artificial nucleus pulposus prosthesis can replace the function of the nucleus pulposus. As shown in Figures 3-4, the outer sleeve 1 and the inner sleeve 2 in this embodiment jointly squeeze the opening of the outer capsule 3, so that the outer capsule 3 is clamped between the outer sleeve 1 and the inner sleeve 2. At the first end, at the same time, the handle 6 will stably cooperate the second end of the outer sleeve 1 and the inner sleeve 2, hold the handle 6, move the outer sleeve 1 to move the outer capsule 3; release the extrusion of the outer capsule 3, That is, the outer capsule 3 is released, and the outer capsule 3 is separated from the outer sleeve 1 and the inner sleeve 2, so that the outer capsule 3 is inserted into the intervertebral disc.

In some embodiments of the present application, the outer capsule body 3 is a cavity structure with an open end, and the outer capsule body 3 has deformation force. replace the function of the nucleus pulposus. More specifically, the outer capsule 3 is a soft capsule structure. After being injected with the artificial nucleus pulposus, the outer capsule 3 can evenly disperse stress in the intervertebral disc and avoid damage to a certain part of the intervertebral disc due to excessive load. Specifically, the artificial nucleus pulposus prosthesis is self-curing silica gel or hydrogel. Preferably, the self-curing silica gel is solidified and molded after being injected into the outer capsule 3 to become a spinal implant.

The outer capsule 3 in the standby state is a flat bag-like structure, shaped like an uninflated balloon, with one end inflated, and the other end has an opening; the outer capsule 3 in the filled state extends to one end with an opening, and the extended part is The tubular structure is sleeved on the outside of the inner casing 2 and located in the first cavity. In the state of use, the tubular structure is located in the first cavity between the outer sleeve 1 and the inner sleeve 2, the outer sleeve 1 and the inner sleeve 2 simultaneously squeeze the tubular structure, and the tubular structure is squeezed by the outer sleeve 1 and the inner sleeve 2 tight, so that the outer capsule 3 is clamped and fixed, and the outer capsule 3 can be released by releasing the extrusion of the tubular structure by the outer sleeve 1 and the inner sleeve 2 .

After the outer capsule 3 is filled with a liquid support, under the action of pressure, the outer capsule 3 will expand and deform to fill the space of the original nucleus pulposus, thereby being able to replace the original function of the nucleus pulposus.

As shown in Figure 5, in some embodiments of the present application, the first end of the outer sleeve 1 has a clamping tube 11, which is integrally connected with the outer sleeve 1, and the inner diameter of the clamping tube 11 is smaller than that of the outer sleeve. The inner diameter of the tube 1, the outer tube 1 and the clamping tube one 11 are connected through a transition tube one; the first end of the inner tube 2 has a clamping tube two 21, and the clamping tube two 21 is integrated with the inner tube 2 , the inner diameter of clamping tube 2 21 is smaller than the inner diameter of inner sleeve 2, and the inner sleeve 2 and clamping tube 2 21 are connected through transition tube 2; The tight tube 11 and the inner sleeve 2 squeeze the opening of the outer capsule 3 together. The principle of fixing the opening of the outer capsule 3 is: there is a first cavity between the clamping tube 11 and the inner sleeve 2 that can accommodate the opening of the outer capsule 3. When the transition tube 1 and the transition tube 2 are misaligned, the clamping The position of the tightening tube 11 corresponds to the first end of the inner sleeve 2 , and the clamping tube 11 and the inner sleeve 2 jointly squeeze the opening to fix the outer capsule 3 .

Specifically, the difference between the inner diameter of the first clamping tube 11 and the outer diameter of the inner casing 2 is A, the difference between the inner diameter of the first clamping tube 11 and the outer diameter of the second clamping tube 21 is B, and B≧ 2A, so that the clamping tube 11 and the inner sleeve 2 can squeeze the tubular structure of the outer capsule 3, but the clamping tube 11 and the clamping tube 2 21 do not have the effect of simultaneously squeezing the tubular structure, that is to say, As long as the clamping tube one 11 is moved to a position corresponding to the inner casing 2 and not corresponding to the clamping tube two 21, the tubular structure can be squeezed, and the clamping tube one 11 is moved to a position corresponding to the clamping tube two 21 position, that is, the extrusion of the tubular structure can be released, and the purpose of releasing the outer capsule 3 can be realized. During operation, it is defined that the direction moving to the first end is the first direction, and the direction moving to the second end is the second direction. As soon as the transition tube moves to the second direction, the opening of the outer capsule 3 is squeezed; Moving in the first direction releases the extrusion of the opening of the outer capsule body 3 . When the outer capsule 3 is squeezed, it will be fixed, which is convenient for the operator to hold; if the extrusion of the outer capsule 3 is released, the outer capsule 3 can be released, so that the outer capsule 3 can be inserted into the intervertebral disc to replace the function of the nucleus pulposus. The sectional surface of the transition pipe 1 is an inclined surface inclined upward from the first direction to the second direction, and the sectional surface of the transition pipe 2 is an inclined surface inclined upward from the first direction to the second direction; the inner diameter of the outer sleeve 1 to the clamping The inner diameter of the tube one 11 becomes smaller, so that the clamping tube one 11 and the inner sleeve 2 squeeze the opening of the outer capsule 3 together, and the inner diameter of the inner sleeve 2 to the inner diameter of the clamping tube two 21 becomes smaller, so that the clamping tube Two 21 extend into the opening of the outer capsule 3, so that the inner sleeve 2 communicates with the outer capsule 3.

Specifically, both the inner sleeve 2 and the outer sleeve 1 are cylindrical tubes.

As shown in FIG. 6, alternatively, in another embodiment of the present application, the outer sleeve 1 is sleeved on the outside of the inner sleeve 2, and the first end of the inner sleeve 2 has a bulge toward the direction of the outer sleeve 1. The expansion tube 22, the expansion tube 22 is inserted into the opening of the outer capsule 3, so that the tubular structure of the outer capsule 3 is sleeved outside the expansion tube 22; the distance between the outer sleeve 1 and the expansion tube 22 is smaller than that of the outer sleeve 1 and the inner sleeve 2, move the outer sleeve 1 in the first direction, so that the outer sleeve 1 and the expansion tube 22 co-extrude the tubular structure, thereby fixing the outer capsule 3; move the outer sleeve 1 in the second direction 1. Misalignment of the outer tube 1 and the expansion tube 22 to release the extrusion on the tubular structure. In this state, the outer capsule 3 can be released. In this embodiment, the diameter of the expansion tube 22 is larger than the diameter of the inner sleeve 2 and smaller than the inner diameter of the outer sleeve 1 to achieve the purpose of extruding the tubular structure to fix the outer capsule 3; the outer capsule 3 can also be quickly released , efficient and time-saving.

In some embodiments of the present application, an injection part is provided, and the injection part is detachably fixedly connected with the handle 6, which is used to facilitate the operator to inject the artificial nucleus pulposus prosthesis into the outer capsule body 3 and inject the artificial nucleus pulposus into the inner capsule body 3 respectively. A contrast agent is injected into the body 4 .

The injection part is a multi-channel tubular structure, and the injection part includes pipes communicating with the inner cannula 2 and the contrast medium infusion tube 41 respectively. The requirements for connection with the handle 6, injection of artificial nucleus pulposus prosthesis and injection of contrast agent are met. The artificial nucleus pulposus prosthesis is self-curing silica gel or hydrogel.

As shown in Figure 7, preferably, the injector is a Y-shaped pipe, including a first pipe 51 and a second pipe 52, the first pipe 51 communicates with the second pipe 52, and the first pipe 51 communicates with the inner pipe 52 through the second pipe 52. The cannula 2 is in communication, and the second pipeline 52 is in communication with the inner capsule 4; during use, the artificial nucleus pulposus is injected into the outer capsule 3 through the first pipeline 51, and the contrast agent is injected into the inner capsule 4 through the second pipeline 52 . In this embodiment, the first pipe 51 is a branch pipe, and the second pipe 52 is a main branch pipe. Since the inner capsule 4 and the outer capsule 3 need to be injected with different substances, it is necessary to ensure that the two are not connected. The first pipe 51 and the second pipe 52 realize the independence of the inner capsule 4 and the outer capsule 3 .

One end of the second pipeline 52 located in the first direction is the first end, and one end located in the second direction is the second end. The second end of the second pipeline 52 is provided with a connecting piece 7, and the connecting piece 7 and the second pipeline 52 are detachable. Type of fixed connection, the connecting piece 7 is used to connect the syringe to inject contrast medium into the second pipeline 52 . The first end of the second tube 52 is glued to the inner sleeve 2, so that the inner sleeve 2 can move synchronously with the second tube, for example, move the connecting part 7 to the second direction, so that the inner sleeve 2 can be withdrawn from the patient's body.

The connector 7 includes a connecting pipe one 71 stretching into the second pipeline 52, and a connecting pipe two 72 communicated with the syringe, the connecting pipe one 71 communicates with the second pipeline 52, the connecting pipe one 71 communicates with the connecting pipe two 72, and the connecting pipe The first 71 and the second connecting pipe 72 are integrally formed. When in use, the syringe is connected to the second connecting pipe 72 , and the contrast agent in the syringe is injected into the second connecting pipe 72 , and then the contrast agent flows through the first connecting pipe 71 and the second pipe 52 to enter the inner capsule 4 .

The connector 7 also includes a threaded pipe 73 provided with an internal thread. The threaded pipe 73 is sleeved on the outside of the connecting pipe 71. The threaded pipe 73 is integrally connected with the connecting pipe 71. There is a cavity between the outer surfaces to allow the second pipe 52 to extend in. The second pipe 52 is provided with external threads, and the threaded pipe 73 is threadedly connected with the second pipe 52 . During use, the second end of the second pipeline 52 is inserted into the cavity between the threaded pipe 73 and the connecting pipe one 71, and the threaded pipe 73 and the second pipe 52 are screwed tightly so that the connector 7 is fastened to the second pipe 52. superior.

A cap 8 is provided for closing the second connecting pipe 72, and the cap 8 is detachably fixedly connected to the second connecting pipe 72. In the standby state, the sealing cap 8 is installed on the connecting pipe 2 72 to seal the connecting piece 7 and the second pipe 52 to protect and prevent dust.

The sealing cap 8 includes a sealing tube 81 and a threaded cylinder 82, the sealing tube 81 extends into the connecting pipe 2 72, the threaded cylinder 82 is integrally connected with the sealing tube 81, the connecting tube 2 72 has external threads, and the threaded cylinder 82 and the connecting pipe 2 72 are threaded connect. During use, the sealing tube 81 extends into the second connecting tube 72 so that the second connecting tube 72 is closed, and the sealing cap 8 is fixed on the second connecting tube 72 through the threaded cylinder 82 .

In some embodiments of the present application, the injection pipe 5 is threadedly connected to the handle 6, wherein the first end of the second pipe 52 has an external thread, and the handle 6 has a channel 63 allowing the first end to extend into the channel 63. The internal thread matched with the external thread of the first end, the second pipe 52 is threadedly connected with the handle 6 , so that the whole Y-shaped pipe is detachably fixed on the handle 6 . See Figure 9.

Alternatively, in other embodiments of the present application, the injection tube 5 is engaged with the handle 6, the first end of the second pipe 52 is provided with a groove, and the handle 6 has a channel 63 that allows the first end to extend into the channel. 63 is provided with an elastic protrusion, and the second pipe 52 is inserted into the hole 63 along the first direction. When the corresponding position is reached, the elastic protrusion falls into the groove, so that the second pipe 52 is clamped with the handle 6 to realize injection. Fixation of tube 5.

In some embodiments of the present application, the inner capsule body 4 is sealingly connected with one end of the contrast medium infusion tube 41, and the other end of the contrast medium infusion tube 41 is communicated with the connecting tube 2 72, and the contrast medium in use state The infusion tube 41 runs through the inner sleeve 2 and the second pipeline 52 . When in use, the syringe containing the contrast agent is connected to the connecting tube 2 72, and the contrast agent is injected into the connecting tube 2 72, and the contrast agent passes through the connecting tube 2 72, the connecting tube 1 71, and the contrast agent infusion tube 41, and enters the inner bag body 4, so as to locate the positions of the inner capsule 4 and the outer capsule 3, so that the doctor can make adjustments to find the best placement position of the artificial nucleus pulposus prosthesis.

Wherein, the contrast medium infusion tube 41 is a cylindrical tube, and the contrast medium infusion tube 41 extends into the connecting tube 2 72 to receive the contrast medium efficiently.

The diameter of the contrast medium infusion tube 41 is smaller than the inner diameter of the inner cannula 2, the length of the contrast medium infusion tube 41 is greater than the length of the inner cannula 2, and the contrast medium infusion tube 41 protrudes from the second end of the inner cannula 2; The length of the inner sleeve 2 is greater than that of the outer sleeve 1 , and the inner sleeve 2 protrudes from the second end of the outer sleeve 1 .

As shown in FIG. 8 , the contrast medium infusion tube 41 is connected to the interior of the connector 7 through a sealing member 74 , so that there is no liquid leakage between the contrast medium infusion tube 41 and the connector 7 , preventing the contrast medium from leaking out.

The sealing member 74 has a tubular structure, and the sealing member 74 communicates with the connecting pipe 1 71, and the sealing member 74 communicates with the connecting pipe 2 72. Inner wall glued.

Preferably, the sealing member 74 is located between the first connecting tube 71 and the second connecting tube 72 , so that the contrast fluid can directly enter the contrast medium infusion tube 41 to reduce the contrast medium loss. Specifically, the inner diameter of the second connecting pipe 72 is greater than the inner diameter of the first connecting pipe 71, so that there is a platform between the first connecting pipe 71 and the second connecting pipe 72 due to the difference in inner diameter, and the sealing member 74 is cut from the second direction to the first direction. , the cut surface is T-shaped, the end of the seal 74 with a larger outer diameter is glued to the platform, and the end with a smaller outer diameter of the seal 74 extends into the connecting pipe 71, so that the seal 74 is fixed on the connecting pipe 71 Between the connecting tube 2 72 ; the contrast medium infusion tube 41 is glued to the sealing member 74 , so that the contrast medium infusion tube 41 can efficiently receive the contrast medium and avoid waste of contrast medium.

As shown in FIGS. 9-10 , in some embodiments of the present application, the handle 6 has a channel 61 allowing the second end of the outer sleeve 1 to enter, and the channel 61 communicates with the hole 63 . The handle 6 is detachably fixedly connected with the outer sleeve 1 . Specifically, the passage 61 is provided with an internal thread, and the second end of the outer sleeve 1 is provided with a matching external thread, the outer sleeve 1 is screwed to the passage 61, and the outer sleeve 1 is rotated to install the outer sleeve 1 in the passage 61 of the handle 6 , so that the outer sleeve 1 is fixed on the handle 6 and can move synchronously with the handle 6 .

Alternatively, in other embodiments of the present application, the handle 6 is clamped with the outer sleeve 1, an elastic ball is arranged in the channel 61, and the second end of the outer sleeve 1 is provided with a dimple matching the elastic ball, and the outer sleeve 1 is inserted into the channel 61 of the handle 6 along the second direction, and when it reaches the corresponding position, the elastic ball falls into the recess, so that the handle 6 and the outer sleeve 1 are relatively fixed, and the outer sleeve 1 and the handle 6 can move synchronously.

Alternatively, the handle 6 is glued to the outer sleeve 1, and the inner surface of the handle 6 is glued to the outer surface of the outer sleeve 1 through adhesive glue.

In some embodiments of the present application, the outer wall of the handle 6 is provided with a handle 62 for easy grasping, and the handle 62 is integrally connected with the handle 6 . The handle 62 is a plate-like structure with a smooth surface and no edges and corners. At least two handles 62 are provided, and the two handles 62 are equally spaced. Anti-slip lines are provided on the outer wall of the handle 6 to prevent the handle 6 from slipping during use.

The above descriptions of the embodiments are only for the understanding of the present invention. It should be pointed out that those skilled in the art can make some improvements to the present invention without departing from the principles of the present invention, and these improvements will also fall within the protection scope of the claims of the present invention.

Claims (10)

1. A dual lumen balloon catheter for nucleus repair for implantation of an artificial spinal implant, comprising:

the outer capsule body is provided with an opening extending towards one end, and the artificial nucleus pulposus prosthesis is injected through the opening to fill the outer capsule body;

the inner bag body is sleeved inside the outer bag body and is used for containing contrast medium so as to position the embedding position of the outer bag body;

a contrast agent infusion tube communicated with the inner capsule body and used for injecting contrast agent into the inner capsule body;

the inner sleeve is communicated with the outer capsule body; one end of the outer sleeve and the other end of the inner sleeve, which are both located in the same direction, is a first end, the other end of the outer sleeve and the other end of the inner sleeve are second ends, the first end is used for fixing the outer balloon, a first cavity is formed between the inner surface of the outer sleeve and the outer surface of the inner sleeve, an opening of the outer balloon is located in the first cavity, and the outer sleeve and the inner sleeve simultaneously press the opening of the outer balloon towards the direction of the first cavity, so that the opening of the outer balloon is fixed in the first cavity; releasing the compression of the opening releases the outer bladder.

2. The double-cavity balloon catheter for nucleus pulposus repair of claim 1, wherein the outer balloon body is a cavity structure with an opening at one end, the outer balloon body has a deformation force, and the outer balloon body after the artificial nucleus pulposus prosthesis is injected is inflated and deformed to be full of the space of the original nucleus pulposus; in the filling state, an opening extends towards one end of the outer bag body, the extending part is of a tubular structure, and the tubular structure is sleeved outside the inner sleeve and is positioned in the first cavity.

3. The double-lumen balloon catheter for nucleus pulposus repair according to claim 1, wherein a handle is provided, which is sleeved on the second end of the outer cannula and is used for stabilizing the matching of the outer cannula and the inner cannula, and the handle is fixedly connected with the outer cannula.

4. The double-cavity balloon catheter for nucleus pulposus repair according to claim 1, wherein a first clamping tube is arranged at the first end of the outer sleeve, the first clamping tube is integrally connected with the outer sleeve, the inner diameter of the first clamping tube is smaller than that of the outer sleeve, and the outer sleeve is in transition connection with the first clamping tube through a transition tube; the first end of the inner sleeve is provided with a second clamping pipe, the second clamping pipe is integrally connected with the inner sleeve, the inner diameter of the second clamping pipe is smaller than that of the inner sleeve, and the inner sleeve is in transition connection with the second clamping pipe through a second transition pipe; in a use state, the first transition pipe and the second transition pipe are staggered, so that the first clamping pipe and the inner sleeve pipe jointly extrude the opening of the outer bag body.

5. The double-lumen balloon catheter for nucleus pulposus repair according to claim 4, wherein the difference between the inner diameter of the first clamping tube and the outer diameter of the inner sleeve is A, and the difference between the inner diameter of the first clamping tube and the outer diameter of the second clamping tube is B, B is larger than or equal to 2A, so that the first clamping tube and the inner sleeve can squeeze the tubular structure of the outer balloon.

6. The dual lumen balloon catheter for nucleus repair of claim 5, defining a direction of movement toward the first end as a first direction and a direction of movement toward the second end as a second direction; the transition tube moves to a second direction, so that the opening of the outer balloon is squeezed; the transition pipe moves to the first direction to release the extrusion to the opening of the outer balloon body;

the section of the first transition pipe is an inclined surface which is inclined upwards from the first direction to the second direction, and the section of the second transition pipe is an inclined surface which is inclined upwards from the first direction to the second direction; the inner diameter of the outer sleeve pipe is reduced to the inner diameter of the first clamping pipe, so that the first clamping pipe and the inner sleeve pipe jointly squeeze the opening of the outer capsule body, the inner diameter of the inner sleeve pipe is reduced to the inner diameter of the second clamping pipe, the second clamping pipe extends into the opening of the outer capsule body, and the inner sleeve pipe is communicated with the outer capsule body.

7. The double-cavity balloon catheter for nucleus pulposus repair according to claim 3, wherein an injection member is arranged, and the injection member is detachably and fixedly connected with the handle and is used for facilitating an operator to respectively inject the artificial nucleus pulposus prosthesis into the outer balloon and inject the contrast agent into the inner balloon.

8. The dual lumen balloon catheter for nucleus repair of claim 7, wherein the injector is a Y-tube comprising a first tube and a second tube, the first tube in communication with the inner cannula through the second tube, the second tube in communication with the inner balloon; in use, the artificial nucleus pulposus prosthesis is injected into the outer balloon body through the first pipeline, and the contrast agent is injected into the inner balloon body through the second pipeline.

9. The double-lumen balloon catheter for nucleus pulposus repair of claim 8, wherein one end of the second conduit in the first direction is a first end, one end of the second conduit in the second direction is a second end, the second end of the second conduit is provided with a connecting piece, the connecting piece is detachably and fixedly connected with the second conduit, and the connecting piece is used for connecting a syringe to inject a contrast medium into the second conduit;

the connecting piece comprises a first connecting pipe extending into the second pipeline and a second connecting pipe communicated with the injector, the first connecting pipe is communicated with the second pipeline and is communicated with the second connecting pipe, and the first connecting pipe and the second connecting pipe are integrally formed.

10. The double-cavity balloon catheter for nucleus pulposus repair of claim 9, wherein the inner balloon body is hermetically connected with one end of the contrast agent infusion tube, the other end of the contrast agent infusion tube is communicated with the second connecting tube, and the contrast agent infusion tube in a use state penetrates through the inner sleeve and the second pipeline.

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