Deformable implantable infusion port

Abstract

The deformable implantable infusion port comprises a port body, the port body comprises a rigid head part, a rigid tail part and an elastic middle part connecting the rigid head part and the rigid tail part, an inclined silica gel diaphragm is arranged at the upper part of the elastic middle part, and a plurality of rigid sheets which are partially stacked in sequence are arranged on the inner surface of the bottom of the elastic middle part and are used for preventing an injection needle from penetrating and buffering impact; the rigid sheet structure allows the elastic middle part to maintain deformability after implantation to adapt to a subcutaneous curved surface. The device is light and thin in structure, high in puncture safety, convenient for postoperative positioning, and especially suitable for long-term implantation in superficial layer parts such as hand backs and foot backs.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to a deformable implantable infusion port. Background Art

[0002] An implantable infusion port is a medical device widely used for patients who require long-term intravenous infusion. It usually includes a port body implanted subcutaneously and a flexible catheter inserted into a blood vessel. By being set subcutaneously, this type of device enables patients to avoid repeated punctures of peripheral veins during multiple infusions, improving the convenience and comfort of treatment. Currently, most of the infusion ports commonly used clinically are composed of a hard material for the port body housing, with a silicone diaphragm provided at the top for repeated punctures, and a metal or high-hardness plastic structure at the bottom to withstand the pressure of the needle.

[0003] However, the existing infusion ports still have the following several key technical problems:

[0004] First of all, during the puncture process, after the needle penetrates through the silicone diaphragm, if not properly controlled, it is very easy to touch or impact the rigid structure at the bottom of the port body. Especially in the case of common angular errors, excessive puncture depth, or patient body position changes clinically, the tip of the needle often directly contacts the metal bottom plate or the hard plastic base, resulting in dulling, bending of the needle tip, and even generation of metal microchips. At the same time, such impacts may also cause adverse consequences such as diaphragm tearing, loss of seal, and contamination of the inner cavity of the port body, seriously affecting the service life of the port body and the infusion safety of patients.

[0005] Secondly, in order to provide sufficient bottom protection, in the prior art, a large-area metal plate is often used to cover the bottom of the port body. Although this structure has the ability to prevent penetration, it will significantly increase the overall rigidity of the port body, weaken its deformation ability under the skin, and is not conducive to fitting and adapting to the body movement after implantation. Especially in shallow areas such as the back of the hand and the instep, where the tissue thickness is limited, the large-area rigid bottom plate often causes problems such as local tenderness, uneven tissue tension, and difficulty in suturing, reducing the wearing comfort of patients and their postoperative compliance. Summary of the Invention

[0006] The purpose of the present invention is to provide a deformable implantable infusion port, which has a flexible structure for fitting, safe puncture, and prevention of displacement, has a bottom anti-penetration and buffering function and the advantage of postoperative palpation and positioning, and is suitable for long-term implantation and use in shallow areas.

[0007] The technical solution adopted by the present invention is as follows:

[0008] A deformable implantable infusion port, comprising:

[0009] A port body; one end of the port body is provided with a rigid head, and the other end is provided with a rigid tail; the rigid head and the rigid tail are connected by an elastic middle part;

[0010] The rigid tail is provided with a liquid outlet joint;

[0011] On one side of the upper part of the elastic middle part close to the rigid head, there is a silica gel diaphragm for puncture, and the silica gel diaphragm is inclined towards the direction of the liquid outlet joint;

[0012] On the inner surface of the bottom of the elastic middle part, there are multiple rigid sheets stacked partially in sequence to block the penetration of the injection needle, covering the inner surface of the bottom of the elastic middle part, and the unstacked parts of the rigid sheets are respectively adhered to the inner surface of the elastic middle part;

[0013] When the rigid sheets are stacked, they are inclined at a certain angle, and the inclination direction is the same as that of the silica gel diaphragm;

[0014] During use, the elastic middle part can be bent and deformed adaptively along the stacking direction.

[0015] Among them, the rigid head has a dome-shaped outer shape, which is used to reduce the implantation trauma and improve the palpation recognition degree.

[0016] Among them, an annular positioning flange is arranged on the outer surface of the rigid tail, which is used to provide stable support during subcutaneous implantation and prevent the port body from shifting.

[0017] Among them, the elastic middle part is made of thermoplastic elastomer, medical silica gel or polyurethane material, and has good flexibility and biocompatibility.

[0018] Among them, the rigid sheet is made of a polymer composite material or a bio-inert metal material, with a thickness of 0.2 mm to 0.6 mm, and the edges are rounded to avoid cutting the middle structure.

[0019] Among them, the number of the rigid sheets is 3 to 6, and each sheet is stacked at an angle of 10° to 20° relative to the previous sheet to form a controllable guiding bending structure.

[0020] Among them, the thickness of the silica gel diaphragm is 0.5 mm to 1.0 mm, and a directional micro-convex point marking structure is arranged on the surface for guiding the puncture direction; the overall structural height of the port body does not exceed 8 mm, and the length is 20 mm to 40 mm, which is suitable for implantation in the superficial anatomical areas of the back of the hand or the instep.

[0021] Among them, the liquid outlet joint is provided with an internal thread structure or a clamping groove structure for connecting a flexible catheter and providing a liquid-tight seal after the connection is completed.

[0022] The using method of the deformable implantable infusion port includes the following steps:

[0023] ① Preoperative preparation: Evaluate the patient's condition, select a suitable implantation site, and perform local anesthesia and aseptic disinfection of the operative area;

[0024] ② Catheter pre - placement: Insert the catheter into the target blood vessel through venous puncture and confirm that the distal position is correct.

[0025] ③ Subcutaneous pocket creation: Incise the skin at the selected site, separate the subcutaneous tissue to form a subcutaneous cavity that matches the shape of the port body.

[0026] ④ Infusion port implantation and connection: Implant the infusion port into the pocket, connect the liquid outlet joint of the port body to the catheter and fix the connection.

[0027] ⑤ Incision closure: After adjusting the positioning of the infusion port, suture the skin incision and perform aseptic dressing to keep the infusion port stably placed under the skin.

[0028] ⑥ Positioning and use: During clinical infusion, the doctor identifies the position of the silicone diaphragm by palpation.

[0029] ⑦ Puncture and injection: The injection needle is inserted along the inclined direction of the silicone diaphragm. The partially overlapping rigid sheets form a lever - type stop structure, which can absorb the impact force while blocking the needle from further penetration, reducing the damage to the needle tip.

[0030] ⑧ Completion of infusion: Connect the external infusion system to inject the medicine, verify that the liquid path is unobstructed and there is no leakage, and then pull out the needle after the infusion is completed.

[0031] In summary, due to the adoption of the above - mentioned technical solution, the beneficial effects of the present invention are as follows:

[0032] In the present invention, multiple rigid sheets are sequentially and partially overlapped at the bottom of the elastic middle part of the port body. Each rigid sheet only partially covers the bottom area, and a multi - layer protection structure is formed through the angular difference between the sheets. This design can effectively prevent the injection needle from penetrating the bottom of the port body. Even if the puncture angle deviates or the depth has an error, it can still be blocked by the rigid sheet structure, significantly improving the anti - damage ability of the port body during multiple punctures and extending its service life.

[0033] The partially overlapping structure also constitutes a micro - scale lever system: each rigid sheet is adhered on one side and freely extends at the other end. When the needle impacts the rigid sheet, the rigid sheet can undergo a small - amplitude elastic rotation or movement, thereby playing a role in buffering and energy absorption. And the silicone diaphragm is inclined, and the partially overlapping rigid sheets also form an inclined structure. This mechanism effectively reduces the risk of needle blunting, deformation or breakage, ensuring the safety of clinical puncture.

[0034] The partially overlapping structure of the rigid sheets does not inhibit the overall deformation ability of the elastic middle part, so that after the port body is implanted under the skin, it can still undergo controllable bending deformation with the movement of the human body or tissue extrusion, improving the fitting property and wearing comfort, and is especially suitable for superficial tissue areas such as the back of the hand and the instep of the foot. Description of the Drawings

[0035] Figure 1 Structural schematic diagram of the infusion port of the present invention;

[0036] Figure 2 Schematic diagram of the concave arc surface during injection of the infusion port of the present invention;

[0037] Figure 3 Flow schematic diagram of the usage method of the infusion port of the present invention.

[0038] Markings in the figure: 1, port body; 11, rigid head; 12, rigid tail; 13, elastic middle part, 131, concave arc surface; 14, liquid outlet joint; 2, silicone diaphragm; 3, rigid sheet. Detailed implementation manners

[0039] In order to make the purpose, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0040] See Figure 1 and 3 , the present invention relates to a deformable implantable infusion port, which is suitable for shallow subcutaneous implantation and long-term indwelling use, and is especially suitable for anatomical superficial parts such as the back of the hand and the back of the foot. The infusion port includes the following components and structural configurations:

[0041] Port body 1: The whole is in a long strip shape, with the long axis arranged towards the implantation direction, and the outer shape is a low-profile ellipsoid or a slender rounded rectangle. The total length is 20 mm to 40 mm, the maximum height does not exceed 8 mm, and the width is 8 mm to 15 mm. The specific dimensions depend on the implantation site. The port body includes a rigid head 11 at one end and a rigid tail 12 at the other end, and the two are connected into one body through an elastic middle part 13. The overall outer shell of the port body can be made of materials such as polyetheretherketone (PEEK) and medical polyurethane to meet the requirements of biocompatibility, structural strength and MRI compatibility.

[0042] Rigid head 11: The outer shape is a dome shape, and the top is slightly arched, which is used to provide a palpation recognition feeling and guide the distribution of skin tension. During implantation, it guides the port body to slide into the subcutaneous pocket and forms a front-end positioning stop point to prevent forward movement. The length is about 5 mm to 8 mm, and it is integrally formed with the elastic middle part by heat melting or interference fit.

[0043] Rigid tail 12 and liquid outlet joint 14: The tail structure is thickened, and an external annular positioning flange is provided to form a stable support area under the skin. The liquid outlet joint 14 is arranged at the end of the rigid tail, and the structural form is cylindrical or frustum-shaped; an internal thread or an annular groove is provided at the end for connecting with a catheter, and the sealing performance is good; the outer diameter is 3 to 6 mm, which is adapted to a 5Fr to 8Fr flexible catheter. PEEK or titanium alloy can be selected, and the rest of the parts are made of high-strength medical polymers.

[0044] The elastic middle part 13 is located in the middle section of the port body and is made of flexible material, which allows controlled bending deformation in the vertical direction; its upper part is a concave arc surface 131, and the lower part is provided with a rigid sheet 3 structure support. Specifically,

[0045] The inner concave arc surface 131 is statically shallowly disc-shaped, with a depth of about 0.5 to 1.5 mm; it is used to adapt to the embedding of subcutaneous tissue so that the port body does not shake during puncture. The material is thermoplastic elastomer TPE, medical silicone or polyurethane, etc., which must have softness, biocompatibility and high resilience. The length is about 50% to 60% of the total length of the port body, and the thickness is controlled within the range of 2 to 4 mm.

[0046] The silicone diaphragm 2 is located on the upper surface of the side of the elastic middle part close to the rigid head, and is inclined at an angle of 15° to 25° toward the liquid outlet joint; the inclined setting facilitates the needle to enter in a fixed direction to avoid piercing the bottom. The thickness is 0.5mm to 1.0mm, and the diameter is 5mm to 8mm; the surface can be provided with micro-convex points or notches for postoperative palpation positioning. The material is high-strength silicone rubber, which can be punctured multiple times and has automatic closure.

[0047] The rigid sheet 3 is composed of 3 to 6 pieces arranged on the inner bottom surface of the elastic middle part, and partially stacked in sequence at an inclined angle; each piece is a flat thin sheet, and a single end is adhered to the inner surface to form a cantilever structure with a free end that can be slightly lifted, forming a micro lever system as a whole. Each piece is deflected 10° to 20° relative to the previous piece, and the overall tilt direction is consistent with the silicone diaphragm. The length of a single piece is 5mm to 10mm, the width is about 5mm, and the thickness is 0.2mm to 0.6mm; the material can be PEEK sheet, carbon fiber reinforced composite material or medical stainless steel, and the edges are rounded and chamfered to prevent cutting or tearing the elastic middle part. A stop is provided during the needle puncture process to prevent the needle from piercing the bottom of the port body; the multi-layer structure forms a flexible lever buffer system when subjected to force, disperses the impact force, and prevents the needle tip from becoming blunt or bending; it works in conjunction with the elastic middle part to enable the port body to have the ability to bend in a specific direction and enhance adaptability.

[0048] The rigid head 11 and the elastic middle part 13 are connected by polymer hot melting or integral injection molding to ensure sealing and rigid-flexible transition; the rigid tail 12 and the liquid outlet connector 14 are integrally formed, or connected to the catheter by threaded screw connection / snap-on connection; the rigid sheets 3 are respectively adhered to the inner wall at the bottom of the elastic middle part 13, and the bonding area is about 1 / 3 of the sheet length, and the rest is in a freely stacked state; the silicone diaphragm 2 is embedded in the opening above the elastic middle part and fixed by an embedded pressing or annular clamping method.

[0049] For further information, see Figure 2, the upper part of the elastic middle part 13 is a concave arc surface 131 in the static state. After implantation, the subcutaneous tissue sinks into and adheres to the concave arc surface 131. When the injection needle penetrates from the silicone diaphragm 2, it sinks into the subcutaneous tissue that adheres to the concave arc surface 131 to resist the deformation of the elastic middle part 13. The structure of the concave arc surface 131 is a shallow dish-shaped depression in the static state, with a depth of about 0.5 - 1.5 mm; it is used to adapt to the embedding of subcutaneous tissue so that the port body does not shake during puncture. The material is thermoplastic elastomer TPE, medical silicone, polyurethane, etc., and it needs to have softness, biocompatibility and high resilience. The length is about 50% - 60% of the total length of the port body, and the thickness is controlled within the range of 2 - 4 mm.

[0050] Compared with the conventional planar structure, the concave arc surface enables the subcutaneous tissue to naturally sink into this concave area after implantation, thus stabilizing the position of the port body; in addition, during the puncture process, the tissue that sinks into the concave arc surface will "wrap" the upper part of the port body in the reverse direction, forming a tissue-port body-skin triangular support system, effectively preventing the port body from deforming or shifting under the puncture pressure; simply put, using the tissue to lock the structure itself is a self-stabilizing design without additional auxiliary tools. Since the subcutaneous tissue enters the concave area, under the action of the puncture pressure, the elastic middle part of the port body will not sink as a whole, but press tightly against the tissue arc surface to form a reaction force; it is equivalent to an "upward supporting force" automatically appearing in the system to balance the downward force of the puncture needle, ensuring the stability of the puncture point.

[0051] And because the concave area forms a depression perception area under the skin, the doctor can perceive the shape of the port body by touching, so as to quickly complete the puncture positioning; this shape forms a micro-concave touch on the skin surface, improving the operation efficiency and accuracy.

[0052] The usage method of the deformable implantable infusion port provided by the present invention includes the following steps:

[0053] The first step: preoperative preparation

[0054] Before the operation, the doctor evaluates the position suitable for implanting the infusion port according to the patient's treatment plan and vascular conditions, and preferably selects the areas of the dorsal hand, dorsal foot or superficial tissue of the forearm. The evaluation content includes local skin tension, venous direction, subcutaneous fat thickness and patient cooperation. After confirming no skin infection, tissue induration or excessive relaxation, the selected area is fully disinfected and a local anesthetic (such as 1% lidocaine) is injected to provide a painless basis and tissue relaxation state for subsequent operations.

[0055] The second step: catheter pre-arrangement

[0056] The doctor uses the conventional Seldinger technique to insert a guide wire into the target vein through a puncture cannula, such as the basilic vein on the back of the hand, the median cubital vein in the elbow, or the dorsal vein of the foot. The catheter is inserted along the guide wire into the venous passage, ensuring that its distal end is positioned in the central unobstructed area of the blood vessel, and the patency of the catheter passage is verified by aspirating with normal saline. An appropriate length of the outer end of the catheter is reserved to facilitate connection to the outflow adapter of the infusion port.

[0057] Step 3: Create a subcutaneous pocket

[0058] Make a skin incision about 20 - 30 mm long at the planned implantation site. After incising the dermis, use a blunt scissors to separate along the subcutaneous tissue to create a shallow pocket that matches the shape of the infusion port. The length of the pocket is slightly longer than the length of the port body, and the depth is controlled between 6 - 8 mm, so that the port body can be embedded without excessive compression. The direction of the pocket needs to be consistent with the orientation of the silicone diaphragm to facilitate puncture positioning.

[0059] Step 4: Implantation and connection of the infusion port

[0060] The doctor holds the infusion port in the right hand and slowly advances the port body into the pocket through one end of the head. During the advancement process, the elastic structure in the middle of the port body will automatically conform to the curvature of the pocket and deform slightly to achieve natural fitting. Insert the pre - placed catheter into the outflow adapter at the tail of the port body and tighten or snap - fit it to form a sealed and non - detachable connection. At this time, adjust the position of the port body so that the silicone diaphragm is directly above the subcutaneous tissue and is tilted towards the direction of the catheter.

[0061] Step 5: Close the incision

[0062] After the connection is completed, the doctor checks whether the position of the port body is stable and whether the catheter has no excessive tension or torsion. After confirmation, suture the incision layer by layer. First, suture the subcutaneous tissue with absorbable sutures, and then suture the epidermis with 4 - 0 or 5 - 0 sutures, or use skin glue for closure. Cover the surgical area with a sterile dressing and apply mild pressure bandaging to promote the port body to fit the tissue and reduce postoperative floating.

[0063] Step 6: Post - operative positioning and palpation identification

[0064] After the operation, the doctor or nurse locates the infusion port before clinical use. Since the upper surface of the elastic middle part of the port body is provided with a concave arc - shaped structure, the subcutaneous tissue will naturally sink into this arc - shaped area, forming a slight depression on the surface, making the silicone diaphragm easy to identify by palpation. This structure not only provides a stable puncture platform but also avoids the problem of displacement of the traditional port body due to skin tension.

[0065] Step 7: Puncture and injection

[0066] During the infusion operation, the doctor or nurse locates the silicone diaphragm with the pulp of the finger, passes through the center of the concave structure, and inserts the Huber needle (non-cutting needle) into the diaphragm at an angle of 15° to 25°. After the needle enters the port body and is pressed down to the bottom, it will touch the built-in multiple rigid sheets that are partially stacked. This structure forms a local lever action and elastic deformation under the impact of the needle, performing dual functions of stopping and buffering, preventing the needle from penetrating the bottom or being damaged, and enhancing the service life of the port body and the puncture safety.

[0067] Step 8: Complete the infusion

[0068] After the needle is inserted, connect the infusion pipeline to conduct liquid infusion. Confirm that the backflow is smooth, the liquid flows smoothly, and there is no leakage or blockage. After the infusion is completed, pull out the puncture needle, and the silicone diaphragm automatically seals the puncture opening by relying on the material's resilience. Subsequently, disinfect the puncture site and cover it with a dressing, and the entire usage process ends.

[0069] Through the above operation method, the infusion port of the present invention can form a highly conforming and clearly positioned structure under the skin, and through the unique "elastic middle part + concave positioning area + rigid sheet protection structure" cooperation mechanism, it has significant advantages in improving the use safety, puncture stability, and patient comfort.

[0070] The deformable implantable infusion port of the present invention is particularly suitable for special patient groups with weak superficial subcutaneous tissues, limited mobility, or the need for infusion with body position changes, such as elderly and emaciated patients, long-term bedridden patients, or infant leukemia patients. Traditional chest infusion ports are prone to discomfort or difficult puncture during lateral lying, prone lying, or limb movement due to their fixed position and high rigidity. However, the elastic middle part structure adopted by the present invention can naturally conform to the subcutaneous morphology, combined with multiple anti-puncture buffer sheets at the bottom and the concave positioning area, and can achieve safe and stable puncture operations in areas such as the dorsal foot, dorsal hand, and distal forearm, significantly improving the use comfort and clinical adaptability, and meeting the medical needs of implanting in atypical parts.

[0071] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A deformable implantable infusion port, characterized in that, Comprising: A port body (1); one end of the port body (1) is provided with a rigid head (11), and the other end is provided with a rigid tail (12); the rigid head (11) and the rigid tail (12) are connected by an elastic middle part (13); The rigid tail (12) is provided with a liquid outlet joint (14); On one side of the upper part of the elastic middle part (13) close to the rigid head (11), there is a silica gel diaphragm (2) for puncture, and the silica gel diaphragm (2) is inclined towards the direction of the liquid outlet joint (14); On the inner surface of the bottom of the elastic middle part (13), there are multiple rigid sheets (3) stacked in sequence and partially overlapping to block the penetration of the injection needle, covering the inner surface of the bottom of the elastic middle part (13), and the non-overlapping parts of the rigid sheets (3) are respectively adhered to the inner surface of the elastic middle part (13); When the rigid sheets (3) are stacked, they are inclined at a certain angle, and the inclination direction is the same as that of the silica gel diaphragm (2); After implantation, the elastic middle part (13) can be adaptively bent and deformed along the stacking direction.

2. The deformable implantable infusion port according to claim 1, wherein: The rigid head (11) has a dome-shaped outer shape, which is used to reduce the implantation trauma and improve the palpation recognition degree.

3. The deformable implantable infusion port according to claim 1, wherein: On the outer surface of the rigid tail (12), there is an annular positioning flange, which is used to provide stable support during subcutaneous implantation to prevent the port body from shifting.

4. The deformable implantable infusion port according to claim 1, wherein: The elastic middle part (13) is made of thermoplastic elastomer, medical silica gel or polyurethane material, and has good flexibility and biocompatibility.

5. The deformable implantable infusion port according to claim 1, wherein: The rigid sheet (3) is made of a high molecular composite material or a bio-inert metal material, with a thickness of 0.2 mm to 0.6 mm, and the edges are rounded to avoid cutting the middle structure.

6. The deformable implantable infusion port according to claim 1, wherein: The number of the rigid sheets (3) is 3 to 6, and each sheet is stacked at an angle of 10° to 20° relative to the previous sheet to form a controllable guiding bending structure.

7. The deformable implantable infusion port according to claim 1, wherein: The thickness of the silica gel diaphragm (2) is 0.5 mm to 1.0 mm, and the surface is provided with a directional micro-convex point marking structure for guiding the puncture direction; the overall structure height of the port body (1) does not exceed 8 mm, and the length is 20 mm to 40 mm, which is suitable for implantation in the superficial anatomical areas of the back of the hand or the instep.

8. The deformable implantable infusion port according to claim 1, characterized in that: The liquid outlet joint (14) is provided with an internal thread structure or a clamping groove structure for connecting a flexible catheter and providing a liquid-tight seal after the connection is completed.

9. The method for using a deformable implantable infusion port according to any one of claims 1 to 8, characterized in that, Including the following steps: ① Preoperative preparation: Evaluate the patient's condition, select a suitable implantation site, and perform local anesthesia and aseptic disinfection of the operative area; ② Catheter pre-placement: Insert the catheter into the target blood vessel through venous puncture and confirm that the distal position is correct; ③ Establish a subcutaneous pocket: Incise the skin at the selected site, separate the subcutaneous tissue, and form a subcutaneous cavity matching the outer shape of the port body; ④ Implantation and connection of the infusion port: Implant the infusion port into the pocket, connect the liquid outlet joint of the port body with the catheter and fix the connection; ⑤ Close the incision: After adjusting the positioning of the infusion port, suture the skin incision and perform aseptic dressing to keep the infusion port stable in the subcutaneous tissue; ⑥ Positioning and use: During clinical infusion, the doctor identifies the position of the silica gel diaphragm by palpation; ⑦Puncture and injection: The injection needle is inserted along the inclined direction of the silicone diaphragm. The partially stacked rigid sheets form a lever-type stop structure, which can absorb the impact force while preventing the needle from further penetrating, reducing the damage to the needle tip; ⑧Complete the infusion: Connect an external infusion system to inject the liquid medicine, verify that the liquid path is unobstructed and there is no leakage, and then pull out the needle after the infusion is completed.

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