Pressure relief device implant kit and method of use thereof

Abstract

The present invention discloses a pressure relief device implantation kit and a method for using the same. The pressure relief device implantation kit comprises: a cannula, wherein the interior of the cannula is a hollow structure, and a cannula seat is provided at the proximal end of the cannula, a positioning sheath is provided on the inner wall of the cannula seat, and the distal end of the cannula is open; a puncture needle, wherein the puncture needle is sharp at the distal end and can extend further distally from the distal end of the cannula; a solid needle, wherein the distal end of the solid needle is smooth and blunt; a delivery needle, and a pressure relief device. The proximal ends of the puncture needle, the solid needle, and the delivery needle all have needle seats, and each needle seat is provided with a positioning groove that cooperates with the positioning sheath. The puncture needle, the solid needle, and the delivery needle are all configured to be inserted into the cannula. According to the present invention, craniotomy is not required for the patient during treatment, which reduces the difficulty of the operation, the labor intensity of the operator, and the time of the operation. The incision is small, which reduces the burden and pain of the patient, and the pressure relief device can be accurately delivered to the target site.

Description

Technical Field

[0001] The present invention relates to a medical device, and in particular to a decompression component implantation kit and a use method thereof. Background Art

[0002] The trigeminal nerve is one of the largest nerves in the head. When spontaneous pain occurs, it can severely impact a patient's daily life. According to statistics, the primary cause of trigeminal neuralgia is compression of the trigeminal nerve root by tortuous blood vessels in the Meckel's capsule. The pulsation of these vessels repeatedly stimulates and compresses the trigeminal nerve, causing pain.

[0003] Currently, clinical treatment usually involves using magnetic resonance imaging (MRI) and computed tomography (CT) to determine the cause of trigeminal neuralgia. If the pain is confirmed to be caused by compression of the trigeminal nerve by blood vessels, microvascular decompression surgery is often used for treatment.

[0004] The current microvascular decompression procedure involves drilling a small hole in the skull behind the ear. This hole directly connects to the Meckel's capsule, where the trigeminal nerve root is located. The nerve is then carefully separated from the blood vessels, and a pressure-reducing pad is placed between them to absorb the vibrations from the blood vessels. This procedure is effective in alleviating pain, has a low recurrence rate, and few side effects.

[0005] However, this surgery involves a craniotomy, which is time-consuming and laborious, places a heavy physical strain on the patient, and carries the risk of damaging nerves, blood vessels, and the adjacent brainstem. Furthermore, there is the risk of postoperative discomfort such as edema, facial numbness, headache, and vomiting.

[0006] In addition, in recent years, surgical methods for treating trigeminal neuralgia by percutaneous puncture with radiofrequency ablation or percutaneous puncture with balloons have been increasingly developed. This percutaneous puncture method has the advantages of convenient operation, low burden on the patient's body, and low risk. However, percutaneous puncture with radiofrequency ablation achieves the effect of blocking pain by causing a certain degree of damage to the trigeminal nerve, so it is prone to sequelae such as facial numbness and neuromuscular disorders. Percutaneous puncture with balloons uses the expansion force of the balloon to separate the blood vessels and nerves, which requires precise control of the balloon's expansion force, and there is also the risk of damaging or over-compressing the nerves. Moreover, during the balloon implantation process, there is also the undesirable situation that the balloon cannot be accurately placed in the target position. Summary of the Invention

[0007] The present invention is proposed based on the problems existing in the above-mentioned prior art, and its purpose is to provide a decompression device implant kit that uses the decompression device to separate blood vessels and nerves. It is simple to operate, puts little burden on the patient's body, does not cause irreversible damage to the nerves, and can accurately deliver the decompression device to the target site.

[0008] In order to achieve the above-mentioned purpose, the present invention adopts the following technical means.

[0009] (1) A pressure relief device implantation kit, comprising:

[0010] A cannula, wherein the interior of the cannula is a hollow structure, a cannula seat is provided at the proximal end of the cannula, a positioning sheath is provided on the inner wall of the cannula seat, and the distal end of the cannula is open;

[0011] a puncture needle having a sharp distal end and capable of extending further distally from the distal end of the cannula;

[0012] A solid needle, wherein the distal end of the solid needle is smooth and blunt;

[0013] delivery needle; and

[0014] Pressure relief parts;

[0015] The proximal ends of the puncture needle, the solid needle and the delivery needle are each provided with a needle seat, and each needle seat is provided with a positioning groove that cooperates with the positioning sheath;

[0016] The puncture needle, the solid needle, and the delivery needle are all configured to be inserted into the cannula.

[0017] According to the above (1), a puncture needle with a sharp distal end facilitates the operator to perform the puncture operation, while a solid needle with a smooth and blunt distal end can avoid damaging surrounding tissues when inserted into the target site during the operation.

[0018] Moreover, since the positioning sheath and the positioning groove are provided, the needle seat and the sleeve can be better positioned and fixed during operation.

[0019] (2) The decompression device implantation kit according to (1) above is characterized in that:

[0020] The tube wall of the sleeve is provided with a window for inserting the decompression member, and the distal end of the sleeve is provided with a first arc-shaped thin sheet, and the opening directions of the window and the first arc-shaped thin sheet are the same.

[0021] According to the above (2), the operator can insert the decompression member into the interior of the sleeve through the window. Moreover, since the decompression member can be directly delivered to the desired target position through the first arc-shaped sheet, it is less likely to cause the implantation position of the decompression member to deviate.

[0022] (3) The decompression device implantation kit according to (1) or (2) above, characterized in that:

[0023] The solid needle is configured such that, when inserted into the cannula, the distal end of the solid needle is located at the same position as the distal end of the cannula, or the distal end of the solid needle is located slightly more distally than the distal end of the cannula.

[0024] According to the above (3), the solid needle and the cannula cooperate to enable the cannula to smoothly reach the target site without causing damage to the tissues and the like around the path of travel. Moreover, when the distal end of the solid needle reaches the target site, the distal end of the cannula is substantially at the same target site. Thus, when the solid needle is removed and the pressure reducing member is inserted, the pressure reducing member can be accurately delivered to the target site.

[0025] (4) The decompression device implantation kit according to (1) or (2) above, characterized in that:

[0026] The delivery needle is configured such that, when inserted into the cannula, the distal end of the delivery needle and the distal end of the cannula are located at the same position, and

[0027] The delivery needle has a second arc-shaped thin plate at its distal end, wherein the length of the second arc-shaped thin plate is greater than or equal to the length of the window of the cannula, and the length of the second arc-shaped thin plate is greater than or equal to the length of the first arc-shaped thin plate;

[0028] When the delivery needle is inserted into the cannula, the delivery needle is rotatable relative to the cannula so that the second arcuate sheet switches between a position facing the first arcuate sheet and a position overlapping the first arcuate sheet.

[0029] According to the above (4), when the distal end of the cannula is already located at the target site, the pressure relief member inside the cannula can be pushed to the distal end using the delivery needle, so that the pressure relief member is exactly located at the target site for implantation. The length of the second curved sheet is greater than or equal to the length of the cannula window, which can prevent the pressure relief member from being squeezed out of the window when the delivery needle is inserted into the cannula to push the pressure relief member.

[0030] Furthermore, because the delivery needle can rotate relative to the cannula, the pressure relief member located between the first and second curved sheets can be exposed by rotating the needle, allowing it to adhere to the target area. In other words, the cooperation between the first and second curved sheets ensures reliable retention during delivery and allows for release of the pressure relief member after delivery to the target area. Unlike conventional methods, such as those using a pressure relief balloon, this eliminates the need for further decompression by pushing the balloon out of the cannula, allowing precise control of the release position of the pressure relief member.

[0031] (5) The decompression device implantation kit according to (1) above is characterized in that:

[0032] The needle seats of the puncture needle, the solid needle and the delivery needle all have an integrally formed first section and a second section, the diameter of the first section is larger than the diameter of the second section, the second section is configured to be inserted into the cannula seat, and when the second section is inserted into the cannula seat, the first section abuts against the end surface of the proximal side of the cannula seat.

[0033] According to the above (5), the needle hub and the cannula can be easily matched. Moreover, since the first section abuts against the cannula hub when inserted to the specified position, the matching state of the needle hub and the cannula can be easily grasped without observation and confirmation, and the undesirable situation of over-insertion will not occur.

[0034] (6) The decompression device implantation kit according to (5) above is characterized in that:

[0035] The positioning groove includes a straight groove and an annular groove.

[0036] The linear groove is formed along the entire length of the outer wall of the second section.

[0037] The annular groove is formed at one end side of the linear groove located on the first segment side, and is formed within a half circumference along the circumference of the second segment in a manner that one end portion of the annular groove is connected to the linear groove.

[0038] According to the above (6), when the needle hub is engaged with the cannula hub, the needle hub can rotate relative to the cannula hub and can prevent the needle from being loosened or slipping out of the cannula during operation. Moreover, the orientation of the needle hub and the needle connected to the needle hub can be confirmed under the guidance of the positioning groove.

[0039] (7) The decompression device implantation kit according to (5) above is characterized in that:

[0040] Anti-slip grooves are provided on the outer peripheral surface of the sleeve seat of the sleeve, and / or

[0041] Anti-slip grooves are provided on the outer peripheral surface of the first section side.

[0042] According to the above (7), since the anti-slip grooves are provided, it is easier for the operator to hold the device during use, thereby increasing stability during operation.

[0043] (8) The decompression device implantation kit according to (1) above is characterized in that:

[0044] The decompression member is composed of a decompression pad and / or a decompression gel.

[0045] The pressure relief pad is formed of Teflon filaments, polyester fibers or nylon fibers;

[0046] The pressure-reducing gel is formed of polylactic acid, cellulose, hyaluronic acid or gelatin.

[0047] According to (8) above, the pressure relief member is composed of a pressure relief pad and / or a pressure relief gel. Unlike the pressure relief balloons used in the prior art, the pressure relief member of the present application does not primarily utilize self-elastic expansion. Therefore, it does not cause damage to surrounding tissues during expansion, nor does it require a large amount of manpower and material resources to precisely control the expansion force. In addition, the material of the pressure relief member can be a bioinert material to maintain long-term effect, or a biocompatible and degradable material that can automatically degrade and be absorbed by the human body after a period of time.

[0048] (9) The decompression device implantation kit according to (8) above is characterized in that:

[0049] The decompression pad or the decompression gel is mixed with a developing material, and the developing material is iopamidol or other developing materials containing iodine and gadolinium.

[0050] According to the above (9), mixing the developing material into the decompression member facilitates development under CT or MRI.

[0051] (10) A method for implanting a pressure reducing device, using the pressure reducing device implantation kit according to any one of (1) to (9) above, characterized in that the method comprises the following steps:

[0052] Inserting the puncture needle into the cannula, and rotating the puncture needle seat relative to the cannula seat while the needle seat of the puncture needle abuts against the cannula seat;

[0053] piercing the epidermis using the cannula into which the puncture needle is inserted;

[0054] After removing the puncture needle from the cannula, inserting the solid needle into the cannula, and rotating the solid needle seat relative to the cannula seat while the needle seat of the solid needle abuts against the cannula seat;

[0055] causing the distal end of the cannula into which the solid needle is inserted to reach a target site;

[0056] After removing the solid needle from the cannula, inserting the pressure reducing member into the cannula;

[0057] Inserting the delivery needle into the cannula, at this time, the decompression member is sandwiched between the second arc-shaped thin piece of the delivery needle and the first arc-shaped thin piece of the cannula;

[0058] In a state where the needle seat of the delivery needle abuts against the cannula seat, the needle seat of the delivery needle and the cannula seat are rotated relative to each other until the positioning pin abuts against the needle seat of the delivery needle along the rotation direction, at which time, the second arc-shaped sheet overlaps with the first arc-shaped sheet to expose the decompression member;

[0059] The delivery needle and the cannula are removed together to complete the implantation of the pressure reducing member.

[0060] Effects of the Invention

[0061] According to the present invention, when implanting the decompression device, there is no need to open a large area of ​​the target site (for example, performing a craniotomy on the patient), which reduces the difficulty of implanting the decompression device, reduces the labor intensity of the operator, shortens the time required for the implantation operation, and creates a small wound, reducing the burden and pain of the patient, and can accurately deliver the decompression device to the target site. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1 1 is a schematic exploded perspective view showing a decompression member implantation kit according to the present invention.

[0063] Figure 2 It is a schematic three-dimensional diagram of the sleeve seat of the pressure reducing device implantation kit of the present invention.

[0064] Figure 3 It is a schematic three-dimensional diagram of the cannula seat and the needle seat of the decompression component implant kit of the present invention in a state where they have not yet been matched.

[0065] Figure 4 It is a schematic cross-sectional view of the cannula seat and the needle seat of the decompression component implant kit of the present invention in the matched state.

[0066] Figure 5 This is a schematic perspective view showing a state in which the delivery needle of the decompression device implantation kit of the present invention has been inserted into the cannula but has not yet been rotated.

[0067] Figure 6 1 is a schematic perspective view showing a state in which the delivery needle of the decompression device implantation kit of the present invention has been inserted into the cannula and rotated.

[0068] Description of Reference Numerals

[0069] 1- casing; 11- window; 12- first curved sheet;

[0070] 2-puncture needle; 3-solid needle; 4-delivery needle; 41-second curved sheet;

[0071] 5-pressure relief member; 5a-pressure relief pad; 5b-pressure relief gel; 6-cannula seat; 61-positioning sheath;

[0072] 7-needle seat; 7a-first section; 7b-second section; 71-positioning groove; 71a-linear groove; 71b-annular groove; 8-syringe;

[0073] 100-Pressure Relief Piece Implant Kit. DETAILED DESCRIPTION

[0074] The following is a detailed description of the specific embodiments of the present invention in conjunction with the accompanying drawings. In the accompanying drawings, the same reference numerals represent the same elements, and those skilled in the art should be aware that the specific structures, dimensions, and proportions shown in the accompanying drawings are intended to illustrate the present invention and are not intended to limit the present invention.

[0075] In this specification, unless otherwise expressly stated, the terms "first" and "second" are used merely to distinguish between components and should not be construed as indicating an order. Unless otherwise expressly stated, the terms "connected" and "fixed" should be understood in a broad sense, including but not limited to direct, indirect, and detachable connection and fixation.

[0076] In the specification, for the sake of convenience, the terms "distal end" and "proximal end" are relative to the operator operating the device. The "distal end" refers to the end away from the operator when the operator operates it, and the "proximal end" refers to the end close to the operator when the operator operates it.

[0077] In addition, in this embodiment, the implantation of a pressure relief pad or pressure relief gel into the McElroy capsule is used as an example for description. However, those skilled in the art should know that the present invention is also applicable to the implantation of a long strip or gel-like material into any other target area.

[0078] like Figure 1 As shown, the decompression component implantation kit of the present invention includes: a cannula 1, a puncture needle 2, a solid needle 3, a delivery needle 4 and a decompression component 5 (which can be a decompression pad 5a and / or a decompression gel 5b, which will be described in detail later).

[0079] The interior of the cannula 1 is a hollow structure with a channel inside, in order to facilitate the insertion of the puncture needle 2, the solid needle 3 and the delivery needle 4 and to facilitate the placement of the pressure relief member 5 inside. Figure 2 As shown, the proximal end of the cannula 1 has a cannula seat 6, the inner wall of which is provided with a positioning sheath 61, and the distal end of the cannula 1 is open. The positioning sheath 61 is generally a rectangular protrusion, but can also be a protrusion of any other shape, such as a square, wedge, or column.

[0080] The tube wall of the sleeve 1 has a window 11 for inserting the decompression member 5. The window 11 is positioned, for example, near the sleeve seat 6 and has a long strip opening. The opening length of the window 11 can be different specifications such as 1 cm, 1.5 cm, 2 cm, etc. The operator needs to choose the sleeve 1 with which specification of window 11 to use according to the length of the decompression member 5 to be implanted. Those skilled in the art should know that the position of the window 11 is not fixed, and the specific position of the window can be determined according to the length of the sleeve and the actual usage. The distal end of the sleeve 1 has a first arc-shaped thin sheet 12, and the opening direction of the first arc-shaped thin sheet 12 is the same as that of the window 11. The first arc-shaped thin sheet 12 is composed of a part of the side surface of the cylinder, preferably in a semicircular shape.

[0081] The sleeve seat 6 of the sleeve 1 is cylindrical. Specifically, it can be formed with a diameter that gradually decreases from the ends of the cylinder toward the center. Of course, the outer wall of the sleeve seat 6 can be any suitable shape as long as it is suitable for the operator to grip. In addition, the sleeve seat 6 can also be provided with anti-slip grooves on the outer circumference to further facilitate the operator's grip and increase stability during operation. The specific form of the anti-slip grooves is not limited and can be annular concave and convex patterns or other forms of anti-slip grooves.

[0082] In addition, in this embodiment, a triangular mark is provided on the outer surface of the cannula seat 6 (e.g., the outer surface at the proximal end). This triangular mark aligns with a positioning pin 61 within the cannula seat 6. Therefore, when the operator operates the cannula seat 6, the position of the positioning pin 61 can be determined by the position of the triangular mark on the outer surface of the cannula seat 6. The mark indicating the position of the positioning sheath does not necessarily need to be triangular; it can also be any other shape. Furthermore, the opening direction of the first arcuate sheet 12 (the direction of the arc recess) and the opening direction of the window 11 can also be aligned with this mark. Thus, by confirming the position of this mark, the orientation of the cannula 1 can be determined, thereby improving operational convenience.

[0083] like Figure 1 As shown, the puncture needle 2, the solid needle 3 and the delivery needle 4 are all slender in shape with a diameter that matches the inner diameter of the cannula. The puncture needle 2, the solid needle 3 and the delivery needle 4 can slide along the inner wall of the cannula in the cannula 1. The distal end of the puncture needle 2 is sharp (for example, in the shape of a needle tip) and can extend further to the distal side from the distal end of the cannula 1. In other words, when the puncture needle 2 is inserted into the cannula 1, the sharp distal end of the puncture needle 2 is exposed at the distal end of the cannula 1, so that the operator can perform the puncture operation. The distal end of the solid needle 3 is smooth and blunt. For example, it can be designed to be flat-headed, hemispherical, etc., thereby avoiding damage to surrounding tissues when inserted into the target site (such as the McMaster capsule) during operation.

[0084] Solid needle 3 is configured such that, when inserted into cannula 1, the distal end of solid needle 3 is located at the same position as the distal end of cannula 1, or slightly more distally than the distal end of cannula 1. In other words, at the distal end, the end of solid needle 3 is substantially flush with or slightly protrudes from the end of cannula 1. Thus, the coordination of solid needle 3 and cannula 1 enables cannula 1 to smoothly reach the target site without causing damage to surrounding tissue. Furthermore, once the distal end of the solid needle reaches the target site, the distal end of the cannula is substantially located at the same target site. This ensures that the pressure relief device is accurately delivered to the target site when the solid needle is removed and the pressure relief device is inserted.

[0085] The delivery needle 4 is constructed such that, when inserted into the cannula 1, the distal end of the delivery needle 4 is located at the same position as the distal end of the cannula 1. Thus, when the distal end of the cannula 1 is already located at the target site, when the delivery needle 4 is used to push the pressure relief member 5 inside the cannula to the farthest end, the pressure relief member 5 can be exactly located at the target site for implantation. The delivery needle 4 is generally elongated in shape, and has a second curved thin sheet 41 integrally formed at the distal end. The length of the second curved thin sheet 41 is greater than or equal to the length of the window 11 of the cannula 1 (the length referred to here refers to the length along the needle axis). Thus, during the insertion of the delivery needle 4 into the cannula 1, the window 11 of the cannula 1 can be pre-sealed to prevent the pressure relief member 5 in the cannula 1 from being squeezed out of the window 11 during the pushing process.

[0086] The second curved sheet 41 can be equal to or longer than the first curved sheet 12, as long as the distal end of the delivery needle 4 and the distal end of the cannula 1 are located at the same position when the delivery needle 4 is inserted into the cannula 1. The second curved sheet 41 is also composed of a portion of the cylindrical side surface as the first curved sheet 12. In other words, the second curved sheet 41 can be regarded as a portion formed by cutting away a portion of the circumferential wall of the slender needle tube, preferably in the shape of a semicircular arc surface. Those skilled in the art should know that the curvature radius of the first curved sheet 12 and the second curved sheet 41 are not necessarily the same, but preferably, the two curved sheets have the same curvature radius. More preferably, the two curved sheets have the same arc shape and can be combined to form an elongated circle or a perfect circle. The specially shaped cannula 1 and distal end of the delivery needle 4 ensure that the pressure relief member 5 remains within the roughly cylindrical space enclosed by the two curved thin sheets when pushed to the target location, and prevents the pressure relief member 5 from tilting during the pushing process and being misplaced. The edges of the first curved thin sheet 12 and the second curved thin sheet 41 are rounded to prevent damage to nerves and blood vessels during operation.

[0087] When the delivery needle is inserted into the cannula, the delivery needle is configured to rotate relative to the cannula, shifting the second curved sheet between a position aligned with the first curved sheet and a position overlapping the first curved sheet. This allows the delivery needle to be rotated to expose the pressure relief member located between the first and second curved sheets, allowing the pressure relief member to adhere to the target site. In other words, the coordination of the first and second curved sheets ensures reliable retention during delivery and allows for release of the pressure relief member after delivery to the target site. Unlike previous methods, such as those employing a pressure relief balloon, this eliminates the need for further pushing the balloon out of the cannula, allowing precise control of the release position of the pressure relief member.

[0088] The puncture needle 2, the solid needle 3 and the delivery needle 4 all have a needle seat 7 at their proximal ends. Figure 3 and Figure 4 As shown, the needle hub 7 comprises a first section 7a and a second section 7b. The first section 7a and second section 7b are integrally formed, with the diameter of the first section 7a being larger than the diameter of the second section 7b. When the needle hub 7 is mated with the cannula hub 6, the first section 7a of the needle hub 7 is exposed outside the cannula 1 (i.e., the diameter of the distal end surface of the first section 7a is greater than or equal to the diameter of the proximal end surface of the cannula hub 6). The outer circumference of the first section 7a may be provided with anti-slip grooves to facilitate gripping by the operator during manipulations such as pushing. However, these anti-slip grooves or other anti-slip measures may be omitted, or other anti-slip measures may be employed. The second section 7b of the needle hub 7 is adapted to mate with the inner diameter of the cannula hub 6 and can be inserted into the cannula hub 6, allowing the second section 7b to slide within the cannula hub 6. When the second section 7b is fully inserted into the cannula hub 6, the first section 7a abuts the proximal end surface of the cannula hub 6. Since the first section 7a abuts against the cannula seat 6 when inserted to a predetermined position, the matching state between the needle seat 7 and the cannula 1 can be easily grasped without visual confirmation, and the problem of over-insertion will not occur.

[0089] A positioning groove 71 is provided on the outer wall of the second section 7b of the needle seat 7. The positioning groove 71 can cooperate with the positioning pin 61 inside the sleeve seat 6 so that the positioning pin 61 can slide along the positioning groove 71. Figure 3 and Figure 4As shown, the positioning groove 71 is divided into two parts. The first part is a linear groove 71a, which extends from the distal end of the second section 7b of the needle hub 7 (the beginning of the first part) to the proximal end (the tail end of the first part) along a direction parallel to the axis of the needle hub 7. In other words, it is formed along the entire length of the outer wall of the second section. The second part is an annular groove 71b, which extends half a circle clockwise or counterclockwise around the proximal end of the second section 7b of the needle hub 7, starting from the end connected to the linear groove 71a. In other words, the linear groove 71a is vertical, while the annular groove 71b is semicircular. The beginning of the annular groove 71b is connected to the tail end of the linear groove 71a, that is, the positioning groove is generally L-shaped. Thus, when the positioning sheath 61 slides along the head end of the linear groove 71a to the tail end and enters the annular groove 71b, the puncture needle 2, solid needle 3 and delivery needle 4 with the needle seat 7 can rotate relative to the sleeve 1 and be fixed in the axial direction to prevent the puncture needle 2, solid needle 3 and delivery needle 4 from loosening and slipping out during the process of puncturing, pushing or delivering the decompression pad or decompression gel.

[0090] In addition, in this embodiment, the outer surface of the first section 7a of the needle hub 7 has a hollow circle mark and a concentric circle mark. The hollow circle mark and the concentric circle mark are arranged opposite each other, that is, the hollow circle mark is aligned with the linear groove 71a of the positioning groove 71 (also aligned with the leading end of the annular groove 71b), and the concentric circle mark is aligned with the trailing end of the annular groove 71b of the positioning groove 72. Therefore, when the triangular mark on the outer surface of the cannula hub 6 is aligned with the hollow circle mark, it indicates that the positioning sheath 61 in the cannula hub 6 is aligned with the linear groove 71a of the positioning groove 71. When the triangular mark on the outer surface of the cannula hub 6 is aligned with the concentric circle mark, it indicates that the needle hub and the cannula hub are axially locked and fixed. In addition, the opening direction of the second arc-shaped thin sheet 41 of the transport needle 4 (the direction of the arc recess) can also be aligned with the concentric circle mark of the transport needle needle seat (that is, away from the hollow circle mark). Since the opening direction of the first arc-shaped thin sheet 12 of the sleeve 1 is aligned with the triangular mark of the sleeve seat 6, when the triangular mark of the sleeve seat 6 is aligned with the hollow circle mark of the transport needle needle seat, it means that the second arc-shaped thin sheet 41 is opposite to the first arc-shaped thin sheet 12, and when the triangular mark of the sleeve seat 6 is aligned with the concentric circle mark of the transport needle needle seat, it means that the second arc-shaped thin sheet 41 coincides with the first arc-shaped thin sheet 12.

[0091] The pressure relief member 5 can be a pressure relief pad 5a or a pressure relief gel 5b, or a combination of both. The pressure relief member 5 can be made of a bioinert and biocompatible material, such as Teflon filaments, polyester fibers, nylon yarns, and the like. Due to their bioinertness, these materials can provide long-term effectiveness, thereby preventing neuralgia caused by nerve compression by blood vessels. If the practitioner believes that after a period of separation between the nerve and the blood vessels, the position of the blood vessels will stabilize and prevent recurrence of pain by contact with the nerves, the pressure relief member 5 can be made of a biocompatible, degradable material, such as polylactic acid, cellulose, hyaluronic acid, or gelatin. Unlike pressure relief balloons used in the prior art, the pressure relief member of this application does not primarily utilize its own elastic expansion mechanism. Therefore, the expansion process does not damage surrounding tissues, and precise control of the expansion force does not require extensive manpower and material resources. Since the average person's McMaster bursa is approximately 2 cm in size, the pressure relief member 5 can be 1 to 2 cm long, and its diameter can be varied, as long as it ensures smooth insertion within the cannula 1 and meets clinical needs.

[0092] A developing material may be mixed into the decomposable or non-degradable decompression member 5 to facilitate imaging under CT or MRI. The developing material must be metabolizable, such as iopamidol or other developing materials containing iodine or gadolinium.

[0093] When using the decompression component implantation kit of the present invention, craniotomy is not required. The decompression component only needs to be implanted through percutaneous puncture, which reduces the risk of craniotomy and the burden and pain of the patient. The wound recovers quickly and no irreversible damage is caused to the nerves.

[0094] The following describes in detail the method for using the pressure reducing device implant kit of the present invention through specific embodiments.

[0095] In clinical practice, the operator will first give the patient general anesthesia and place the patient's head under the C-arms image-assisted surgical guidance system. The screen of the auxiliary system will be continuously monitored during the operation.

[0096] First, the operator aligns the hollow circle mark of the needle seat of the puncture needle with the triangular mark of the cannula seat, and inserts the puncture needle into the cannula. When the needle seat of the puncture needle abuts against the cannula seat, the needle seat of the puncture needle and the cannula seat are rotated relative to each other. At this time, the positioning sheath of the cannula seat has been stuck in the annular groove of the needle seat of the puncture needle.

[0097] After thoroughly disinfecting the patient's face, insert the cannula with the attached needle into the cheek approximately 3 cm from the corner of the patient's mouth, taking care to prevent the sharp distal end of the needle from protruding from the mouth. The cannula with the attached needle is advanced through the cheek until it reaches the foramen ovale and, with slight force, penetrates the foramen ovale. Inside the foramen ovale is Meckel's capsule, where the root of the trigeminal nerve is located.

[0098] Next, keep the cannula stationary and remove the puncture needle from the cannula. Align the hollow circle mark on the solid needle hub with the triangle mark on the cannula hub, and insert the solid needle into the cannula. While the solid needle hub abuts against the cannula hub, rotate the solid needle hub and the cannula hub relative to each other. At this point, the positioning sheath of the cannula hub has been inserted into the annular groove of the solid needle hub.

[0099] The cannula equipped with a solid needle is carefully and slowly pushed into the Meckel's capsule and inserted into the location where the blood vessels and trigeminal nerve meet to separate the blood vessels from the trigeminal nerve. The smooth, blunt distal end of the solid needle can avoid damaging the tissue within the Meckel's capsule.

[0100] Then, keep the cannula stationary and remove the solid needle in the cannula. Place the decompression pad into the hollow interior of the cannula through the window of the cannula or use a syringe to squeeze the decompression gel into the hollow interior of the cannula through the window. After the decompression pad or decompression gel is placed in the cannula, align the hollow circle mark of the needle seat of the delivery needle with the triangle mark of the cannula seat, and insert the delivery needle into the cannula. When the needle seat of the delivery needle abuts against the cannula seat, the second arc-shaped sheet at the distal end of the delivery needle and the first arc-shaped sheet at the distal end of the cannula are relative and combined to form a perfect circle. At this time, the decompression member is sandwiched between the perfect circle formed by the second arc-shaped sheet and the first arc-shaped sheet, as shown in FIG. Figure 5 shown.

[0101] The needle seat of the delivery needle and the sleeve seat are rotated relative to each other until the positioning pin abuts against the needle seat of the delivery needle in the rotation direction. At this time, the triangular mark of the sleeve seat is aligned with the concentric circle mark of the needle seat of the delivery needle, and the second arc-shaped thin piece at the distal end of the delivery needle coincides with the first arc-shaped thin piece at the distal end of the sleeve, exposing the decompression piece between the second arc-shaped thin piece and the first arc-shaped thin piece, such as Figure 6 shown.

[0102] At this point, the pressure relief device makes contact with the tissue between the blood vessels and the trigeminal nerve, adhering to the tissue surface through a small amount of tissue fluid. Finally, the delivery needle and cannula are removed together, revealing that the pressure relief device has adhered to and blocked the blood vessels and trigeminal nerve, completing its implantation.

[0103] If the operator believes that multiple pressure relief devices need to be placed, after placing the first pressure relief device, the delivery needle is removed and the cannula is slightly withdrawn to a position that does not exceed the foramen ovale. Then, the above steps are repeated starting from the step of inserting the solid needle to place multiple pressure relief devices.

[0104] Those skilled in the art should be aware that various changes can be made to the present invention without departing from the spirit of the present invention, and these changes should be understood to be included in the scope of the claims of the present invention.

Claims

1. A pressure relief device implant kit, characterized in that: include: A cannula having a hollow interior and a cannula seat at the proximal end thereof, a positioning sheath being provided on the inner wall of the cannula seat, an open distal end thereof, a window for inserting the pressure reducing member into the cannula wall, and a first arcuate sheet at the distal end thereof, the window and the first arcuate sheet opening in the same direction; a puncture needle having a sharp distal end and capable of extending further distally from the distal end of the cannula; A solid needle, wherein the distal end of the solid needle is smooth and blunt; A delivery needle; the delivery needle has a second arc-shaped thin sheet at the distal end, the length of the second arc-shaped thin sheet is greater than or equal to the length of the window of the cannula, and the length of the second arc-shaped thin sheet is greater than or equal to the length of the first arc-shaped thin sheet, When the delivery needle is inserted into the cannula, the delivery needle is configured to be rotatable relative to the cannula so that the second arc-shaped sheet switches between a position corresponding to the first arc-shaped sheet and a position overlapping the first arc-shaped sheet; Pressure relief components made of biocompatible materials; The proximal ends of the puncture needle, the solid needle and the delivery needle are each provided with a needle seat, and each needle seat is provided with a positioning groove that cooperates with the positioning sheath; The puncture needle, the solid needle and the delivery needle are all configured to be able to be inserted into the cannula; The needle seats of the puncture needle, the solid needle and the delivery needle all have an integrally formed first section and a second section, the diameter of the first section is larger than the diameter of the second section, the second section is configured to be inserted into the cannula seat, and when the second section is inserted into the cannula seat, the first section abuts against the end surface of the proximal side of the cannula seat.

2. The decompression member implantation kit according to claim 1, characterized in that: The solid needle is configured such that, when inserted into the cannula, the distal end of the solid needle is located at the same position as the distal end of the cannula, or the distal end of the solid needle is located slightly more distally than the distal end of the cannula.

3. The decompression member implantation kit according to claim 1, wherein: The transport needle is configured such that, when inserted into the cannula, a distal end portion of the transport needle and a distal end portion of the cannula are located at the same position.

4. The decompression member implantation kit according to claim 1, characterized in that: The positioning groove includes a straight groove and an annular groove. The linear groove is formed along the entire length of the outer wall of the second section. The annular groove is formed at one end side of the linear groove located on the first segment side, and is formed within a half circumference along the circumference of the second segment in a manner that one end portion of the annular groove is connected to the linear groove.

5. The decompression member implantation kit according to claim 1, characterized in that: Anti-slip grooves are provided on the outer peripheral surface of the sleeve seat of the sleeve, and / or Anti-slip grooves are provided on the outer peripheral surface of the first section side.

6. The pressure reducing device implantation kit according to claim 1, characterized in that: The decompression member is composed of a decompression pad and / or a decompression gel. The pressure relief pad is formed of Teflon filaments, polyester fibers or nylon fibers; The pressure-reducing gel is formed of polylactic acid, cellulose, hyaluronic acid or gelatin.

7. The pressure reducing member implantation kit according to claim 6, characterized in that: The decompression pad or the decompression gel is mixed with a developing material, and the developing material is iopamidol.

Images