Medicated depth delivery device

Abstract

The present disclosure relates to a medicine depth delivery device, which comprises a delivery part with a containing structure for containing a medicine, a needle connected with the containing structure, and a positioning part sleeved on the needle, the positioning part having a positioning structure and a scale arranged at the bottom end thereof, the positioning structure comprising a first positioning structure and a second positioning structure, the first positioning structure and the second positioning structure being flipped towards the radial outside of the body relative to the body, the first positioning structure having a first opening with the body, the second positioning structure having a second opening with the body, and the opening directions of the first opening and the second opening being opposite to each other. By being provided with the positioning structure and the positioning part with the scale, the positioning part can be fixed to the desired position in the case of delivering the medicine to the choroid and scleral space, and the effect of high-precision depth delivery is achieved in combination with the previously measured scleral thickness.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and in particular to a drug delivery device for a fixed depth. Background Technology

[0002] The eyeball is an extremely intricate organ in the human body, approximately 22-24 mm in diameter. The outer layer of the eyeball is the eyeball wall tissue, while the inner layer is filled with water-like aqueous humor and vitreous humor. Simply put, it's like a water-filled balloon or a camera. To maintain the transparent optical system, the inside of the eyeball lacks blood vessels; therefore, the tissues within the eyeball are supplied with nutrients through the eyeball wall tissue. Consequently, when treating eye diseases, medication can be administered via injection into the eyeball through the eyeball wall tissue.

[0003] The eyeball wall is composed of three layers: the outermost sclera (tough in texture), the middle choroid (rich in blood vessels), and the innermost retina (for imaging and visual signal transmission). The sclera acts as a protective barrier for the eyeball, while the choroid transports nutrients and removes waste; both serve the retina. Therefore, retinal diseases or scientific research can be conducted by injecting medication into the eye through the sclera.

[0004] Currently, there are two methods for intraocular drug injection. One method involves directly penetrating all three layers of tissue to reach the inside of the eyeball. This method results in the drug being metabolized quickly, leading to a short duration of effect. The other method involves the needle tip reaching the subchoroidal region, similar to subcutaneous injection of sustained-release medication, which can provide a longer-lasting effect. However, the choroidal tissue is richly vascularized; if the needle tip ruptures a blood vessel during injection, it can cause severe bleeding, harming the patient and affecting the drug delivery. Summary of the Invention

[0005] To overcome the problems existing in related technologies, this disclosure provides a drug delivery device with a fixed depth.

[0006] According to an embodiment of this disclosure, a drug depth-controlled delivery device is provided, the drug depth-controlled delivery device comprising:

[0007] The conveying unit includes a receiving structure for receiving a pharmaceutical agent;

[0008] A needle, which is connected to the accommodating structure;

[0009] A positioning part is fitted onto the needle tip. The positioning part includes a body on which a scale is provided.

[0010] The positioning part further includes a positioning structure, which includes a first positioning structure and a second positioning structure. The first positioning structure and the second positioning structure are flipped relative to the body toward the radially outward side of the body. The first positioning structure has a first opening between itself and the body, and the second positioning structure has a second opening between itself and the body. The openings of the first opening and the second opening are opposite to each other.

[0011] Optionally, the first opening faces the needle, and the second opening faces the delivery section.

[0012] Optionally, the positioning structure includes at least two first positioning structures, which are evenly distributed along the circumferential direction of the body.

[0013] The positioning structure includes at least two second positioning structures, which are evenly distributed along the circumferential direction of the body.

[0014] Optionally, the first positioning structure and the second positioning structure are disposed on one side near the bottom end of the body.

[0015] Optionally, the positioning part further includes a plurality of through holes, which penetrate the sidewall of the body;

[0016] The positioning part further includes a one-way valve, and the through hole is disposed between the one-way valve and the positioning structure;

[0017] The one-way valve is open in the opposite direction to the injection direction of the drug.

[0018] Optionally, the plurality of through holes are evenly distributed along the circumferential direction of the body.

[0019] Optionally, a pressure sensing unit is provided on the needle tip.

[0020] Optionally, the needle tip is provided with an illumination unit.

[0021] Optionally, the conveying unit further includes a driving structure connected to the accommodating structure.

[0022] Optionally, the front end of the needle has a bevel that is inclined at a preset angle relative to the axis of the body, the preset angle being 45°±5°.

[0023] The technical solutions provided by the embodiments of this disclosure may include the following beneficial effects: By setting a detachable positioning part with a positioning structure and scale, when delivering the agent to the cavity space between the choroid and sclera, combined with the pre-measured scleral thickness, the positioning part can be fixed to the desired position, achieving the effect of high-precision fixed-depth delivery.

[0024] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this disclosure. Attached Figure Description

[0025] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0026] Figure 1 This is a schematic diagram of a drug delivery device at a fixed depth, according to an exemplary embodiment.

[0027] Figure 2 This is a partial schematic diagram of a drug delivery device at a fixed depth, according to an exemplary embodiment.

[0028] Figure 3 This is a partial schematic diagram of a drug delivery device at a fixed depth, according to an exemplary embodiment.

[0029] Figure 4 This is a partial schematic diagram of a drug delivery device at a fixed depth, according to an exemplary embodiment. Detailed Implementation

[0030] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of apparatuses and methods consistent with some aspects of the invention as detailed in the appended claims.

[0031] Currently, there are two methods for delivering medication into the eyeball.

[0032] The first method involves the needle penetrating all three layers of tissue to reach the inside of the eyeball and injecting the medication. However, the medication is metabolized quickly and has a short duration of effect.

[0033] The second method involves inserting the needle tip under the choroid, similar to a subcutaneous injection of a sustained-release drug, which can maintain its effect for a long time. However, the choroid is a richly vascularized tissue, and rupturing any blood vessels can cause massive bleeding. There is a potential cavity between the choroid and sclera, much like clothing and lining, which are normally together but can be easily separated. Therefore, many studies aim to inject drugs into this cavity. This injection method avoids bleeding, provides a longer duration of action, and does not damage other tissues. The sclera is only a few millimeters thick, and ensuring precise penetration of the sclera without damaging the choroid presents a significant technical challenge.

[0034] To address the aforementioned problems, this disclosure proposes a drug delivery device with a fixed depth, comprising a delivery section having a receiving structure and a needle connected to the receiving structure, as well as a positioning section fitted onto the needle, wherein the receiving structure is used to receive the drug. The positioning part includes a graduated body and positioning structures. The positioning structures include a first positioning structure and a second positioning structure. The first and second positioning structures are rotated radially outward relative to the body, meaning the positioning structure protrudes from the outer wall of the body. When the needle is inserted into the eyeball, the positioning structure protruding from the outer wall of the body can be fixed to the tough sclera. The first positioning structure has a first opening between itself and the body, and the second positioning structure has a second opening between itself and the body. The openings of the first and second openings face each other. The first and second positioning structures, with their openings facing each other, can be fixed to the outer and inner walls of the sclera, respectively. The first positioning structure can limit the positioning part from further penetration to avoid damaging the choroid. Combined with the scleral thickness measured by ultrasound or other methods, the positioning part penetrates the eyeball along with the needle as the delivery part pushes the needle in. The depth of penetration can be roughly judged by the graduations on the positioning part. When the desired position is reached, the first positioning structure, protruding from the outer wall of the body, cannot penetrate further, thus limiting the penetration of the positioning part and achieving the effect of fixed-depth injection.

[0035] According to an exemplary embodiment, this embodiment provides a drug depth-controlled delivery device, such as... Figure 1 As shown, the drug delivery device in this embodiment includes a delivery unit 1, a needle 2, and a positioning unit 3. The delivery unit 1 includes a receiving structure 11 for containing the drug. The receiving structure 11 is connected to the needle 2. The connection method can be a fixed connection or installation together through a connecting structure.

[0036] In this embodiment, as Figure 1 As shown, the delivery unit 1 is a syringe, including a receiving structure 11 and a driving structure 12 slidably connected to the receiving structure 11. The driving structure 12 cooperates with the receiving structure 11 to form a receiving space 13, which has an opening for the needle 2 connected to the receiving structure 11. The receiving structure 11 also includes a push plate 111, allowing the driving structure 12 to slide within the receiving structure 11 under external force. Figure 1 Taking the indicated orientation as an example, when the containing structure 11 is empty, inserting the needle 2 into the medicine bottle causes the structure 12 to move upward under external force. This reduces the pressure within the containing space 13, making the pressure inside the medicine bottle greater than the pressure inside the containing space 13, thus allowing the medicine to enter the containing space 13. Figure 1Taking the indicated orientation as an example, during injection, the clamping and accommodating structure 11 inserts the needle 2 and the positioning part 3 into the predetermined position. External force acts on the push plate 111 and the driving structure 12 on the accommodating structure 11, slowly pushing the driving structure 12 downward to deliver the medicine in the accommodating space 13 to the desired position in the eyeball.

[0037] In some possible embodiments, the accommodating structure 11 can be an infusion bottle. In this case, the driving structure 12 is used to conduct and balance the pressure inside the accommodating structure 11 with the external atmospheric pressure. The pressure at the needle 2 is greater than the pressure inside the eyeball, and the drug is affected by gravity, so that the drug can be delivered into the eyeball through the needle 2.

[0038] like Figure 2 and Figure 3 As shown, the positioning part 3 includes a body 31 with a scale 35 and a positioning structure 32 disposed on the body 31. The zero mark of the scale 35 is located at the bottom of the positioning part 3, and the scale 35 is configured to display the depth of the positioning part 3 entering the sclera. The scale 35 is disposed on the outer surface of the positioning part 3. If it were disposed inside the positioning part 3, different reading angles might cause errors, leading to incorrect insertion depth and even threatening patient safety. The positioning structure 32 is used to limit and fix the positioning part 3 when it reaches the predetermined position, protecting the choroid from puncture and damage by the positioning part 3 and the needle 2. The positioning part 3 can be made of silicone or metal.

[0039] like Figure 3As shown, the positioning structure 32 includes a first positioning structure 321 and a second positioning structure 322. The first positioning structure 321 and the second positioning structure 322 are flipped relative to the body 31 and radially outward from the body 31, that is, the positioning structure 32 protrudes from the outer wall of the body 31. When the needle 2 is inserted into the eyeball, the opening of the first positioning structure 321 faces downward and protrudes from the body 31. When the first positioning structure 321 contacts the outer wall of the sclera, the protruding first positioning structure 321 can be fixed on the tough sclera, restricting the insertion of the positioning part 3 and having a limiting function. The first positioning structure 321 has a first opening 3211 between itself and the body 31, and the second positioning structure 322 has a second opening 3221 between itself and the body 31. The openings of the first opening 3211 and the second opening 3221 face each other. The first positioning structure 321 and the second positioning structure 322, with their openings facing each other, can be fixed to the outer and inner walls of the sclera, respectively. The first positioning structure 321 can limit the positioning part 3 from further penetrating and thus preventing damage to the choroid. The second positioning structure 322, fixed to the inner wall of the sclera, can prevent the positioning part 3 from detaching from the sclera. By combining the patient's scleral thickness measured by ultrasound and other methods, as the delivery unit 1 pushes the needle deeper into the eyeball, the positioning unit 3 also penetrates the eyeball. The depth of the positioning unit 3 can be roughly judged by the scale 35 on the positioning unit 3. When the desired position is reached, the first positioning structure 321 protrudes from the outer wall of the body 31, so that the first positioning structure 321 is fixed to the outer wall of the sclera, thereby limiting the penetration of the positioning unit 3. At the same time, the second positioning structure 322, which is fixed to the inner wall of the sclera, can prevent the positioning unit 3 from falling off the eyeball, thereby achieving the effect of fixed-depth injection.

[0040] by Figure 2 Taking the orientation shown as an example, the first positioning structure 321 faces downwards, the second positioning structure 322 faces upwards, the second positioning structure 322 is located below the first positioning structure 321, and both the first positioning structure 321 and the second positioning structure 322 are located at a position far away from the top of the positioning part 3.

[0041] The positioning of the first positioning structure 321 and the second positioning structure 322 must be supported by data, and their positioning is related to the scleral thickness of the patient's eye measured by instruments such as B-ultrasound.

[0042] like Figure 3 As shown, the distance between the first positioning structure 321 and the second positioning structure 322 is slightly greater than the thickness of the sclera. When the first positioning structure 321 contacts the outer wall of the sclera, the tip of the opening of the second positioning structure 322 has already exceeded the inner wall of the sclera. At this time, the bottom end of the positioning part 3 has already caused deformation of the choroid within a safe range. At this time, the first positioning structure 321 and the second positioning structure 322, which have opposite opening directions, fix the positioning part by clamping the scleral wall.

[0043] like Figure 3 As shown, the distance between the second positioning structure 322 and the bottom end of the positioning part 3 is such that the length of the positioning part 3 protruding from the inner wall of the sclera will not compress or damage the patient's choroid.

[0044] In this embodiment, there is no limitation on the shape of the positioning structure 32. For example, it can be a spike-shaped structure, a square structure, or an irregular shape, as long as it can fix and limit the positioning part 3.

[0045] like Figure 3 and Figure 4 As shown, the positioning part 3 is also provided with a plurality of through holes 34. The plurality of through holes 34 penetrate the side wall of the body 31 and are evenly distributed along the circumferential direction of the body 31. In the vertical direction, the plurality of through holes 34 are located between the bottom end of the body 31 and the second positioning structure 322.

[0046] like Figure 3 and Figure 4 As shown, the positioning part 3 is also provided with a one-way valve 33, and the one-way valve 33 is located at the bottom end of the positioning part 3. Multiple through holes 34 are provided between the one-way valve 33 and the positioning structure 32. The one-way valve 33 is composed of multiple petal pieces. In the unloaded state, the multiple petal pieces can be tightly closed. When the needle 2 passes through the positioning part 3, the petal pieces are opened, and at this time, it has the function of clamping connection between the needle 2 and the positioning part 3.

[0047] Among them, with Figure 2 Taking the orientation shown as an example, the one-way valve 33 of the positioning part 3 is oriented vertically upwards, while the delivery direction of the needle 2 is vertically downwards. That is, the oriented direction of the one-way valve 33 is opposite to the delivery direction of the needle 2. Figure 4 The body 31 of the positioning part 3 is a bidirectional tubular structure. When the driving delivery part 1 delivers the medication, the medication in the needle 2 flows vertically downward from above along the inner wall of the body 31 of the positioning part 3. The bottom end of the positioning part 3 is in close contact with the choroid plexus. If a one-way valve 33 is not provided, a large amount of medication will have a great impact on the choroid plexus, causing damage to the choroid plexus. By providing a one-way valve 33 that is opposite to the delivery direction, the medication can be prevented from moving in a straight line along the inner wall of the body 31 of the positioning part 3, thus avoiding direct impact of the medication on the choroid plexus and protecting the choroid plexus.

[0048] like Figure 4 As shown, during drug delivery, because the conduction direction of the one-way valve 33 is opposite to the delivery direction, when an external force is applied to the drug in the accommodating structure 11, the drug will enter the cavity between the sclera and the choroid through multiple through holes 34. The multiple through holes in different directions allow the drug to be distributed to more locations. In the delivery direction, the one-way valve 33 has a blocking effect on the drug, so that the drug will not directly impact the choroid and plays a role in protecting the choroid.

[0049] like Figure 2 As shown, the needle 2 and the positioning part 3 are detachably installed. The inner wall of the body 31 of the positioning part 3 fits against the diameter of the needle 2. The detachable installation method can be friction contact or snap-fit, as long as it allows the needle 2 and the positioning part 3 to be connected and separated. When the needle 2 and the positioning part 3 are in the assembled state, the needle 2 can drive the positioning part 3 into the sclera. When the needle 2 penetrates the sclera, it drives the positioning part 3 to move together. To ensure that the positioning part 3 can be firmly fixed on the sclera, the positioning structure 32 of the positioning part 3 can be inserted. At this time, the external force controls the position of the positioning part 3 to remain unchanged, and pulls the receiving structure 11 to move the needle 2 outward. Then the needle 2 and the positioning part 3 are installed together and continue to be pushed into the eyeball. This can avoid the needle 2 contacting the choroid and causing bleeding, and can also fix the positioning part 3 more firmly on the sclera.

[0050] In some possible embodiments, after the positioning part 3 is fixed, the needle 2 can be removed to determine the position for bidirectional treatment. In cases of choroidal hemorrhage or other exudates, the needle 2 can be pulled out, and the positioning part 3, being a conductive structure, can release excess substances from the tissue. Alternatively, after the needle 2 is pulled out, other treatment instruments or auxiliary treatment instruments can be inserted into the tissue through the positioning part 3 to assist in treatment.

[0051] like Figure 2 As shown, the front end of the needle 2 has a bevel at a preset angle relative to the axis of the needle body, which is 45°±5°. On the one hand, an excessively large angle will reduce the sharpness of the needle tip of the needle 2, and may excessively compress the sclera when passing through the tough sclera, making it impossible to penetrate the sclera. On the other hand, an excessively small angle will increase the longitudinal length of the needle tip of the needle 2, allowing the tip to penetrate the sclera, but without creating a large enough through hole in the sclera so that the positioning part 3 can enter.

[0052] like Figure 2 As shown, the needle 2 includes a needle body 21 and a pressure sensing unit 22 disposed near the needle tip. When the needle 2 penetrates the sclera, the pressure sensing unit 22 does not sense any pressure and stops penetrating further, thereby protecting the tissue from damage. The pressure inside the tissue is also closely related to the lesion. The data from the pressure sensing unit 22 can be used to understand whether a lesion has occurred and the extent of the lesion.

[0053] like Figure 2As shown, an illumination unit 23 is provided at one end of the needle body 2 near the needle tip. In this embodiment, the illumination unit 23 can be fiber optic illumination. Since the sclera, choroid, and retina have a certain degree of light transmittance, the delivery position can be located by the flashing red light on the outer surface of the sclera or by the red light transmitted through the retina as seen by a microscope during surgery.

[0054] The specific implementation method of this embodiment is as follows: When using the drug delivery device at a fixed depth, the patient's scleral thickness is first measured by instruments such as B-ultrasound, and the positioning part 3 is processed according to the measured value.

[0055] Processing: At this time, the positioning part 3 has a one-way valve 33, a through hole 34 and a scale 35, but does not have a positioning structure 32. The distance between the second positioning structure 322 and the bottom end of the positioning part 3 does not need to be determined based on the previously measured value. It is sufficient to ensure that the through hole 34 is not damaged. The distance between the first positioning structure 321 and the second positioning structure 322 should be slightly larger than the previously measured value to ensure that the first positioning structure 321 and the second positioning structure 322 can be fixed on the outer wall and inner wall of the sclera, respectively.

[0056] After the positioning part 3 is processed, a rod-shaped object that fits against the inner wall of the body 31 of the positioning part 3 is inserted along the conduction direction of the one-way valve 33. Part of the rod-shaped object is inside the positioning part 3 and part of it is outside the positioning part 3. The needle 2 is inserted in the opposite direction to the conduction direction of the one-way valve 33. The rod-shaped object is aligned with the needle 2. The positioning part 3 is moved along the conduction direction of the one-way valve 33 and the positioning part 3 is fitted onto the needle 2.

[0057] The rod-shaped object serves to open the one-way valve 33 and connect with the needle 2, allowing the positioning part 3 to be transferred onto the needle 2.

[0058] After installation, the device is inserted into the patient's eye tissue. During the insertion process, when the pressure sensing unit 22 is observed to disappear (the pressure is perceived to disappear at the moment of penetration), the positioning part 3 is fixed, the receiving structure 11 is pulled back to drive the needle 2 and the positioning part 3 to generate relative displacement, the positioning part 3 is unfixed, and the receiving structure 11 is pushed to drive the needle 2 and the positioning part 3 to continue insertion.

[0059] After the positioning unit 3 reaches the predetermined position, subsequent treatment is carried out according to the treatment plan, which may include delivering drugs into the eye or draining the accumulated tissue fluid in the eye.

[0060] Other embodiments of the invention will readily occur to those skilled in the art upon consideration of the specification and practice of the embodiments disclosed herein. This application is intended to cover any variations, uses, or adaptations of this disclosure that follow the general principles of this disclosure and include common knowledge or customary techniques in the art not disclosed herein. The specification and examples are to be considered exemplary only, and the true scope and spirit of the invention are indicated by the following claims.

[0061] It should be understood that the present invention is not limited to the precise structure described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of the invention is limited only by the appended claims.

Claims

1. A medicament depth-controlled delivery device, characterized in that The utility model relates to a kind of injection needle and its positioning structure, including: Delivery part, the delivery part includes accommodation structure, the accommodation structure is used to accommodate medicament; Needle, the needle is connected with the accommodation structure; Positioning part, the positioning part is sleeved on the needle, and the positioning part includes body, and scale is arranged on the body; The positioning part further includes positioning structure, the positioning structure includes first positioning structure and second positioning structure, the first positioning structure and the second positioning structure are opposite the body and are turned to the radial outside of the body, the first positioning structure has first opening with the body, the second positioning structure has second opening with the body, the opening direction of the first opening and the second opening is opposite; The first opening is towards the needle, and the second opening is towards the delivery part;The first positioning structure and the second positioning structure are fixed on the outer wall and the inner wall of the sclera respectively; The positioning part further includes a plurality of through holes, and the through holes penetrate the side wall of the body;The positioning part further includes a one-way valve, and the through holes are arranged between the one-way valve and the positioning structure;The conduction direction of the one-way valve is opposite to the injection direction of the medicament; The one-way valve includes petal piece;When the needle passes through the positioning part, the petal piece is opened, and the needle and the positioning part have clamping connection function; When the needle and the positioning part are in assembled state, the needle drives the positioning part to enter the sclera, and when the needle penetrates the sclera, the position of the positioning part is controlled unchanged, the needle is pulled outwards by the accommodation structure, and then the needle and the positioning part are installed together, and continue to advance to the inside of eyeball, so as to avoid the needle from contacting choroid and causing bleeding phenomenon, and the positioning part can be fixed on the sclera; When the delivery part is driven to deliver, the medicament in the needle flows downward along the inner wall of the body of the positioning part, the bottom end of the positioning part is in close contact with the choroid, and the one-way valve prevents the medicament from moving linearly along the inner wall of the body of the positioning part all the time, so as to avoid the medicament from directly impacting the choroid; The medicament enters the interstice between the sclera and the choroid through a plurality of through holes.

2. The pharmaceutical depth-controlled delivery device of claim 1, wherein, The positioning structure includes at least two first positioning structures, and the at least two first positioning structures are uniformly arranged along the circumferential direction of the body; The positioning structure includes at least two second positioning structures, and the at least two second positioning structures are uniformly arranged along the circumferential direction of the body.

3. The drug depth-controlled delivery device according to any of claims 1-2, characterized in that, The first positioning structure and the second positioning structure are arranged on one side close to the bottom end of the body.

4. The pharmaceutical depth-controlled delivery device of claim 1, wherein, A plurality of through holes are uniformly arranged along the circumferential direction of the body.

5. The pharmaceutical depth-controlled delivery device of claim 1, wherein, A pressure sensing unit is arranged on the needle.

6. The pharmaceutical depth-controlled delivery device of claim 1, wherein, An illumination unit is arranged on the needle.

7. The pharmaceutical depth-controlled delivery device of claim 1, wherein, The delivery part further includes a driving structure connected with the accommodation structure.

8. The pharmaceutical depth-controlled delivery device of claim 1, wherein, The front end of the needle has an inclined surface inclined at a preset angle relative to the axis of the body, and the preset angle is 45°±5°.

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