CN109938810A - Needle Assembly and Balloon Catheter Kit - Google Patents

Abstract

The embodiment of the invention discloses a kind of puncture needle component and balloon catheter kits, wherein puncture needle component includes puncture needle and epitheca, and the puncture needle includes needle core and needle core base, and one end of the needle core is fixedly connected on the needle core base；Epitheca includes that sheath and epitheca are done, and one end of the sheath is fixedly connected on the epitheca seat, and the needle core can be inserted into the sheath, and the needle core base is snapped connection with the epitheca seat.Needle core base and the epitheca seat are snapped connection needle core when not only can prevent from being punctured using puncture needle component and retreated；And when puncture is completed to exit needle core, it can prevent needle core from driving epitheca in tissue because torsion is subjected to displacement, so that puncture needle component is to tissue and neural injury when reducing puncture and exiting needle core.

Description

Needle Assembly and Balloon Catheter Kit

technical field

The invention relates to the technical field of medical devices, in particular to a puncture needle assembly and a balloon catheter kit.

Background technique

Trigeminal neuralgia is a very painful condition. It is mainly manifested as brief, recurrent lightning-like pain in the distribution area of the facial trigeminal nerve. From the etiology, it is divided into primary trigeminal neuralgia and secondary trigeminal neuralgia.

Percutaneous trigeminal meniscus balloon compression was first used in clinical treatment of trigeminal neuralgia by Mulla and Lichtor in 1978 and published in 1983. This technique was originally intended to relieve trigeminal neuralgia that could not be controlled due to the failure of other techniques. In recent years, this technique has been widely used in the treatment of various trigeminal neuralgias due to its ease of operation and its safety.

At present, the puncture used for percutaneous trigeminal nerve meniscus balloon compression in the treatment of various trigeminal neuralgias causes too much damage to the human body.

SUMMARY OF THE INVENTION

The main technical problem to be solved by the present invention is how to reduce the damage to the human body caused by the puncture used for percutaneous trigeminal nerve meniscus balloon compression to treat various trigeminal neuralgias.

A technical solution adopted in the present invention is to provide a puncture needle assembly that can be used for percutaneous trigeminal nerve meniscus balloon compression to treat various trigeminal neuralgias, including:

a puncture needle, comprising a needle core and a needle core seat, one end of the needle core is fixedly connected to the needle core seat;

The outer sheath includes a sheath body and an outer sheath, one end of the sheath body is fixedly connected to the outer sheath seat, the needle core can be inserted into the sheath body, and the needle core seat and the outer sheath seat are buckled connect.

In some embodiments, the needle core holder is provided with a snap portion; the outer sheath comprises a base portion, a connecting portion, a grip portion and a snap portion, and the grip portion is connected to the base portion through the connecting portion In a fixed connection, one end of the sheath body is fixedly connected to the base portion, the snap portion is fixedly connected to one end of the grip portion, and the snap portion is connected to the snap portion.

In some embodiments, there are two latching parts in total, and the two latching parts are respectively located on two sides of the needle core holder; both the holding part and the latching part have two, and The two engaging portions are opposite to each other.

In some embodiments, the length of one end of the gripping portion is smaller than the length of the other end of the gripping portion.

The present invention also provides a balloon catheter kit that can be used for percutaneous trigeminal nerve meniscus balloon compression to treat various trigeminal neuralgias, comprising: the above-mentioned puncture needle assembly and the balloon catheter.

In some embodiments, the balloon catheter comprises a balloon, a catheter and a connecting seat, the balloon is arranged at one end of the catheter, the connecting seat is arranged at the other end of the catheter, and the connecting seat passes through The catheter is in communication with the balloon.

In some embodiments, one end of the guide is semi-spherical or conical, and the other end communicates with one end of the catheter; a side wall of the guide is provided with an air outlet, and the balloon is sleeved on the The outer side wall of the guide piece is communicated with the guide piece through the air outlet hole.

In some embodiments, the balloon catheter further includes a imaging pressure ring, the imaging pressure ring is fixed on one end of the catheter and is close to the balloon.

In some embodiments, the balloon catheter further comprises a round head for guiding the catheter to be smoothly inserted into the puncture needle assembly, the round head is fixed on the end face of one end of the catheter, and the balloon is located in the puncture needle assembly. between the round head and the developing pressure ring.

In some embodiments, the maximum outer diameter of the round head is larger than the outer diameter of the developing pressure ring.

In some embodiments, the catheter is provided with a scale, and the depth of the catheter entering the puncture needle assembly can be known by reading the scale.

In some embodiments, the balloon catheter further comprises an inner core and a cap, the cap is mounted on the connecting seat by a screw connection, and the inner core is fixed on the connecting seat by the threads of the connecting seat and the cap inside the catheter.

The beneficial effects of the embodiments of the present invention are: different from the situation in the prior art, in the embodiments of the present invention, the puncture needle assembly includes a puncture needle and an outer sheath, the puncture needle includes a needle core and a needle core seat, and one end of the needle core fixedly connected to the needle core seat; the outer sheath is made of a sheath body and an outer sheath, one end of the sheath body is fixedly connected to the outer sheath seat, the needle core can be inserted into the sheath body, the needle core seat It is snap-connected with the outer sheath seat. The snap connection between the needle core seat and the outer sheath seat can not only prevent the needle core from retreating when the puncture needle assembly is used for puncturing, but also prevent the needle core from driving the outer sheath to displace in human tissue due to torsion when the needle core is withdrawn from the puncture needle assembly, thereby reducing the It avoids the damage to human tissue and nerves caused by the puncture needle assembly when puncturing and withdrawing the needle core.

Description of drawings

1 is a schematic structural diagram of a balloon catheter kit in an embodiment of the present invention;

2 is a side view of a balloon catheter in a balloon catheter kit according to an embodiment of the present invention;

3 is a perspective view of a puncture needle assembly in a balloon catheter kit according to an embodiment of the present invention;

4 is an exploded view of the puncture needle assembly in the balloon catheter kit according to the embodiment of the present invention;

5 is a perspective view of a needle hub seat in a puncture needle assembly according to an embodiment of the present invention;

6 is a perspective view of an outer sheath seat in a puncture needle assembly according to an embodiment of the present invention;

7 is a cross-sectional view of a puncture needle assembly according to an embodiment of the present invention.

Detailed ways

In order to facilitate understanding of the present invention, the present invention will be described in more detail below with reference to the accompanying drawings and specific embodiments. It should be noted that when an element is referred to as being "fixed to" another element, it can be directly on the other element, or one or more intervening elements may be present therebetween. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or one or more intervening elements may be present therebetween. The terms "vertical", "horizontal", "left", "right" and similar expressions used in this specification are for illustrative purposes only.

Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the technical field of the present invention. The terms used in the description of the present invention in this specification are only for the purpose of describing specific embodiments, and are not used to limit the present invention. As used in this specification, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The present invention provides a balloon catheter kit that can be used for percutaneous trigeminal nerve meniscus balloon compression to treat various trigeminal neuralgias. Please refer to FIG. 1 . The balloon catheter kit 100 provided by the embodiment of the present invention includes: a balloon The catheter 10 and the puncture needle assembly 20, the balloon catheter 10 is used to compress the trigeminal nerve meniscus, and the puncture needle assembly 20 is used to puncture human tissue, and guide the balloon catheter 10 into a predetermined position in the human tissue, and puncture the human tissue. Trigeminal nerve meniscus compression. Doctors can use the balloon catheter 10 and the puncture needle assembly 20 together to complete percutaneous trigeminal meniscus balloon compression to treat various trigeminal neuralgias.

2 is a side view of a balloon catheter in a balloon catheter kit according to an embodiment of the present invention. As shown in FIG. 2 , the balloon catheter 10 in the embodiment of the present invention includes a balloon 11 , a catheter 12 , a round head 13 , a developing pressure ring 14 , a connecting seat 15 , an inner core (not shown) and a cap 17 . The balloon 11 is disposed at one end of the catheter 12 and communicates with the catheter 12 . The round head 13 is disposed on one end face of the conduit 12 . The developing pressure ring 14 is disposed at one end of the catheter 12 , and the balloon 11 is located between the round head 13 and the developing pressure ring 14 . The connecting seat 15 is disposed on the other end of the conduit 12 and communicates with the conduit 12 . The inner core is fixedly installed in the conduit 12 . The cap 17 is mounted on the connecting seat 15 .

Specifically, the balloon 11 is compliant or semi-compliant. Compliance refers to the ease with which an elastomer deforms under the action of an external force. The balloon 11 can be made of thermoplastic elastomer plastics such as latex, nylon, silicone, TPU or TPE. The shape of the expanded balloon 11 can be spherical, elliptical, pear-shaped, capsule-shaped or peanut-shaped.

The catheter 12 is a solid-colored tube body with transparent color strips, which is helpful for doctors to observe the state of the liquid in the catheter 12 and adjust the operation method. The solid-colored portion of the catheter is added with a developer (eg, barium sulfate, strontium sulfate, magnesium carbonate, etc.), which can be visualized in human tissue, so that the doctor can determine the specific position of the catheter 12 in the human tissue. The conduit 12 can be made of thermoplastic resin materials with toughness and strength such as PA, PVC, PE, FEP, Pebax polyether block elastomer, etc., so that it has certain toughness and rigidity, and is not easy to bend, which is beneficial to the conduit 12 Insert into the puncture needle assembly 20 . In order for the doctor to know the depth of the catheter 12 entering into the puncture needle assembly 20, a scale is provided on the catheter 12, and the scale is related to the total length of the puncture needle assembly 20. By reading the scale, it is known that the catheter 12 has entered the puncture needle assembly 20. Depth within needle assembly 20.

In one specific embodiment, one end of the catheter 12 connected to the balloon 11 is made of elastic metal material, the other end is made of medical polymer material, and the two ends are connected by bonding or heat sealing process.

The round head 13 is fixed on the end face of one end of the catheter 12 , which is made of stainless steel, tantalum, platinum-iridium alloy, platinum, gold, nickel-titanium, iron or other metals and alloys with certain rigidity and developing function. The round head 13 is used to guide the catheter 12 to be inserted into the puncture needle assembly 20 smoothly. The shape of the round head 13 may be a semi-circle head, an elliptical head or a cone head with a certain arc, and its maximum outer diameter is slightly larger than the outer diameter of the developing pressure ring 14 to prevent the developing pressure ring 14 from coming out.

The developing pressure ring 14 is fixed on one end of the catheter 12 and is close to the balloon 11, and is made of stainless steel, tantalum, platinum-iridium alloy, platinum, gold, nickel-titanium, iron or other metals, Made of alloy material. The doctor can locate the specific position of the developing pressure ring 14 in the human tissue by X-ray, so as to locate the specific position of the balloon catheter 10 in the human tissue.

The connecting seat 15 is disposed at the other end of the conduit 12 and communicates with the conduit 12 . The connecting seat 15 is provided with a Luer taper and a standard thread, which is convenient for connecting with other medical instruments.

The connecting seat 15 has an inner cavity, and the inner cavity can be single cavity, Y-shaped double cavity, T-shaped double cavity, three cavity or four cavity, and is made of medical polymer materials such as PP, PE, PC, ABC, POM, etc. . The connecting seat 15 can be connected with a syringe, and the developer is injected into it by the syringe, enters the catheter 12, and then flows into the balloon 11, so that the balloon 11 expands; on the contrary, when the liquid is withdrawn, the balloon 11 contracts.

The inner core penetrates into the conduit 12 . The cap 17 is mounted on the connecting seat 15 through a screw connection. The inner core is fixed in the conduit 12 through the threads of the connecting seat 15 and the cap 17 . The inside of the cap 17 is provided with a Luer taper and a standard thread, which can be screwed tightly with the connecting seat 15 to keep the inner core from moving in the conduit 12 . The outside of the cap 17 is provided with anti-skid patterns to prevent slipping when grasping.

It can be understood that, in other embodiments, in order to simplify the structure of the balloon catheter 10, the round head 13, the developing pressure ring 14, the inner core 16 and the cap 17 in the above-mentioned balloon catheter 10 can be omitted. The balloon 11 is disposed at one end of the catheter 12 , the connecting seat 15 is disposed at the other end of the catheter 12 , and the connecting seat 15 communicates with the balloon 11 through the catheter 12 .

As shown in FIGS. 3 and 4 , in the embodiment of the present invention, the puncture needle assembly 20 includes a puncture needle 21 and an outer sheath 22 , and the puncture needle 21 can be inserted into the outer sheath 22 . The puncture needle 21 includes a needle core 211 and a needle core seat 212 , and one end of the needle core 211 is fixedly connected to the needle core seat 212 . The outer sheath 22 includes a sheath body 221 and an outer sheath seat 222 , and one end of the sheath body 221 is fixedly connected to the outer sheath seat 222 . The needle core 211 can be inserted into the sheath body 221 , and the needle core seat 212 is snap-connected with the outer sheath seat 222 .

Specifically, one end of the needle core 211 is a needle tail, which is fixedly connected to the needle core seat 212; the other end of the needle core 211 is a needle head, which can be a round head, a pointed head, a semicircular head, or an oval head Or a conical head with a certain radian, etc.

As shown in FIG. 5 , the needle core seat 212 is cylindrical, one end of which is closed and the other end has an opening. A fixing portion 2121 for fixedly connecting with the needle core 211 is provided in the needle core seat 212 . A buckle portion 2122 is provided on the outer side of the other end of the needle core holder 212 . In this embodiment, there are two latching portions 2122 , which are located on two opposite sides of the needle core holder 212 respectively.

The sheath body 221 is made of thin and tough material, which can be specifically made of stainless steel, alloy, or thermoplastic elastomer plastics such as PP, PEP, or TPU/TPE that are pre-processed and tearable. The thickness of the side wall of the sheath body 221 can be as low as 0.1 mm, so that the insertion diameter of the sheath body 221 can be greatly reduced. The matching gap between the needle core 211 and the sheath body 221 is between 0.05 mm and 0.2 mm, and the matching degree is excellent, which can effectively reduce the puncture resistance caused by capillary action during the puncture process and reduce bleeding.

As shown in FIG. 6 , the outer sheath 222 includes a base portion 2221 , a connecting portion 2223 , a grip portion 2224 and a clamping portion 2225 . One end of the base portion 2221 is cylindrical and the other end is conical. A through hole 2222 is provided along its axis. One end of the sheath body 221 passes through the through hole 2222 and is fixedly connected to the base 2221 through the through hole 2222 . The gripping portion 2224 is in the shape of a long flat plate. The side surface of the gripping portion 2224 is fixedly connected to the base portion 2221 through the connecting portion 2223 , and the gripping portion 2224 is disposed along the axis of the base portion 2221 . The engaging portion 2225 is fixedly connected to one end of the holding portion 2224 , and the engaging portion 2225 is located on the surface of the holding portion 2224 facing the base portion 2221 . There are two holding parts 2224 and two clamping parts 2225 , and the two clamping parts 2225 are opposite to each other.

As shown in FIG. 7 , the snap portion 2122 and the snap portion 2225 cooperate with each other. In this embodiment, the specific structure of the snap portion 2122 is a bump, and the specific structure of the snap portion 2225 Also bumps. In another embodiment, the specific structure of the latching portion 2122 is a groove, and the specific structure of the latching portion 2225 is a convex block. In yet another embodiment, the specific structure of the latching portion 2122 is a bump, and the specific structure of the latching portion 2225 is a groove.

When using the puncture needle assembly 20 , the needle of the needle core 211 is aligned with the sheath body 221 , and the needle core 211 is gradually inserted into the sheath body 221 . When the needle core 211 is aligned with the sheath body 221 , the two snap parts 2122 on the needle core seat 212 are respectively engaged with the two snap parts on the outer sheath seat 222 Section 2225 is aligned. During the process of inserting the needle core 211 into the sheath body 221 , the latching portion 2225 and the latching portion 2122 cooperate with each other, so that the needle core seat 212 and the outer sheath seat 222 are fully locked. connect.

In the process of using the puncture needle assembly 20, the needle core 211 and the sheath body 221 are both inserted into the patient's body tissue. The needle core seat 212 and the outer sheath seat 222 are connected by the above-mentioned snap connection. When the needle core 211 is withdrawn from the patient's body tissue, the needle core seat 212 and the The connection of the outer sheath seat 222 is disconnected, and then the needle core seat 212 is held and pulled away. Obviously, compared with other connection methods (for example, screw connection), the snap connection can make the needle hub 212 and the outer sheath 222 separate more quickly, and the above snap connection The needle core seat 212 and the outer sheath seat 222 are prevented from rotating relative to each other during the separation process, thereby preventing the needle core 211 from rotating relative to the sheath body 221 . If the needle core 211 and the sheath body 221 rotate relative to each other, the needle core 211 will rotate in the human tissue, thereby increasing the damage to the human tissue.

It can be understood that, in other embodiments, in order to facilitate the alignment of the two snap portions 2122 on the needle hub 212 with the two snap portions 2225 on the outer sheath seat 222, The needle hub 212 is provided with a first guide portion, the outer sheath seat 222 is provided with a second guide portion, and the first guide portion and the second guide portion cooperate with each other to guide the needle on the needle hub 212. The two snap portions 2122 are respectively aligned with the two snap portions 2225 on the outer sheath 222 . The specific structure of the first guide portion may be a guide groove, and the guide groove may be opened on the inner side wall of the needle core seat 212 . The specific structure of the second guide portion may be a guide block, and the guide block is provided on the outer side surface of the base portion 2221 . One end of the guide groove facing the needle head of the needle core 211 is provided with an opening, and the opening is trumpet-shaped or V-shaped.

When the puncture assembly 20 is used to complete the puncture work, the puncture needle 21 needs to be pulled out from the outer sheath 22 . Since the structure of the gripping portion 2224 and the engaging portion 2225 is similar to a seesaw, when the other end of the gripping portion 2224 is pressed down, one end of the gripping portion 224 is lifted, causing the engaging portion 2225 The needle core seat 212 and the outer sheath seat 222 are separated from each other by being staggered from the buckle portion 2122 , so that the puncture needle 21 is pulled out from the outer sheath 22 . In order to facilitate the user to easily press down the other end of the holding portion 2224 , the length of one end of the holding portion 2224 is smaller than the length of the other end of the holding portion 2224 .

The specific use method of the balloon catheter kit 100 in the embodiment of the present invention: the patient is placed in a supine position after general anesthesia, and the under-shoulder pad is wrapped with a cloth roll at an appropriate height to ensure a slight extension of the neck. In the X-ray environment, the puncture needle assembly 20 is used to puncture the side of the patient, and the puncture point is selected about 2.5 cm beside the corner of the patient's side mouth. Guide the needle assembly 20 into the foramen ovale through the X-ray positioning and the scale on the sheath body 221, but do not pierce the upper edge of the foramen ovale. Unlock the needle hub 212 and the outer sheath 222, pull out the puncture needle 21, and leave the outer sheath 22 in the human tissue. The balloon catheter 10 is inserted along the outer sheath 22 , and the insertion depth is determined by the X-ray positioning and the graduation line on the catheter 12 . After the balloon 11 enters the meniscus of the trigeminal nerve in Meckle's cavity, the dilute contrast agent is injected through the connecting seat 15 to inflate the balloon 11, and the filling status of the balloon 11 is monitored by X-ray images. Continue to inject the diluted contrast agent until the balloon 11 just fills the Meckle's cavity, and monitor the filling shape of the balloon 11 to be an ideal pear-shaped appearance by X-ray imaging. Keep the balloon 11 inflated and compress the trigeminal meniscus for 1 minute, then withdraw the contrast agent, withdraw the balloon catheter 10 and the outer sheath 22, press the puncture point for several minutes to stop the bleeding, and the operation is completed.

It should be noted that the description of the present invention and the accompanying drawings provide preferred embodiments of the present invention, however, the present invention can be implemented in many different forms, and is not limited to the embodiments described in this specification. These examples are not intended as additional limitations to the content of the present invention, and are provided for the purpose of providing a more thorough and complete understanding of the present disclosure. In addition, the above technical features continue to be combined with each other to form various embodiments not listed above, which are all regarded as the scope of the description of the present invention; further, for those of ordinary skill in the art, they can be improved or transformed according to the above description. , and all these improvements and transformations should belong to the protection scope of the appended claims of the present invention.

Claims (11)

1. a kind of puncture needle component (20) characterized by comprising

Puncture needle (21), including needle core (211) and needle core base (212), one end of the needle core (211) are fixedly connected on the needle Core print seat (212)；

Epitheca (22), including sheath (221) and epitheca are done (222), and one end of the sheath (221) is fixedly connected on the epitheca Seat (222), the needle core (211) can be inserted into the sheath (221), and the needle core base (212) and the epitheca seat (222) are blocked Button connection.

2. puncture needle component (20) according to claim 1, which is characterized in that

The needle core base (212) is provided with clamping part (2122)；

The epitheca seat (222) includes base portion (2221), interconnecting piece (2223), grip part (2224) and clamping portion (2225), institute It states grip part (2224) to be fixedly connected by the interconnecting piece (2223) with the base portion (2221), the one of the sheath (221) End is fixedly connected on the base portion (2221), and the clamping portion (2225) is fixedly connected on one end of the grip part (2224), The clamping part (2122) and the clamping portion (2225).

3. puncture needle component (20) according to claim 2, which is characterized in that

There are two the clamping part (2122) is total, two clamping parts (2122) are located at the two of the needle core base (212) Side；

The grip part (2224) and the clamping portion (2225) there are two, and two clamping portions (2225) phase each other It is right.

4. puncture needle component (20) according to claim 3, which is characterized in that

The length of described grip part (2224) one end is less than the length of the grip part (2224) other end.

5. a kind of balloon catheter kit (100), which is characterized in that including the puncture needle group as described in any one of claim 1-4 Part (20) and foley's tube (10).

6. balloon catheter kit (100) according to claim 5, which is characterized in that

The foley's tube (10) includes sacculus (11), conduit (12) and attachment base (15), and the sacculus (11) is set to described One end of conduit (12), the attachment base (15) are set to the other end of the conduit (12), and the attachment base (15) passes through institute Conduit (12) is stated to be connected to the sacculus (11).

7. balloon catheter kit (100) according to claim 6, which is characterized in that

The foley's tube (10) further includes development pressure ring (14), and development pressure ring (14) is fixed on the one of the conduit (12) End, and close to the sacculus (11).

8. balloon catheter kit (100) according to claim 7, which is characterized in that

The foley's tube (10) further includes the circle being swimmingly inserted into the puncture needle component (20) for guiding catheter (12) Head (13), the round end (13) are fixed on the end face of the conduit (12) one end, and the sacculus (11) is located at the round end (13) Between the development pressure ring (14).

9. balloon catheter kit (100) according to claim 8, which is characterized in that

The maximum outside diameter of the round end (13) is greater than the outer diameter of development pressure ring (14).

10. balloon catheter kit (100) according to claim 6, which is characterized in that

It is provided with scale on the conduit (12), knows that the conduit (12) enters the puncture needle by reading the scale Depth in component (20).

11. balloon catheter kit (100) according to claim 6, which is characterized in that

The foley's tube (10) further includes inner core (16) and nut cap (17), and the nut cap (17), which is connected through a screw thread, is installed on institute It states attachment base (15), the inner core (16) is threadedly secured in the conduit by the attachment base (15) and the nut cap (17) (12) in.