Patent Application
20210386419
This application claims the benefit of Taiwan Patent Application No. 109119984, filed on Jun. 14, 2020. The entirety of the Application is incorporated herein by reference.
The present invention relates to a positioning device, particularly a positioning device for positioning abnormal tissues.
Positioning is a common procedure required in medical practices. For example, in a tumor excision surgery, a positioning procedure is usually required to target the lesion using computerized tomographic guidance with localization techniques before an excision procedure. However, the dye used for the positioning procedure, although intuitive, is time-sensitive so that the excision procedure must be performed as soon as possible after the positioning procedure, otherwise, the dye may diffuse and mislead the evaluation because of the difficulty in controlling the staining area. Also, the other drawback of the dye is that it may trigger allergic reactions in some patients. In addition to said dye-based positioning, another approach commonly used is “metal implantation”, in which a spring ring or a small needle (hookwire) is implanted around the lesion for positioning, but this method also has the risk of implant displacement and bleeding.
Accordingly, researchers in the field are now developing new methods for positioning to reduce the risk and improve the accuracy of the learned positioning procedure.
A positioning device for medical procedures is disclosed to improve the drawbacks of known positioning procedures. The positioning device not only provides good fixation and ensures precise positioning, but also reduces invasive injuries during the positioning procedure and prolongs the operable time between the positioning procedure and excision procedure.
The positioning device for abnormal tissues of the present invention comprises a positioning tube, a guiding needle, and a positioning suture. The positioning tube is provided with a receiving space and has an outer diameter. The guiding needle has an inner diameter that is greater than the outer diameter of the positioning tube so that the guiding needle is able to be disposed on an outer side of the positioning tube. The positioning suture has a body portion and a head portion connected to the body portion, in which the widest part of the head portion corresponds to the inner diameter of the guiding needle to allow the positioning suture to be accommodated in the receiving space. Therefore, when the guiding needle is inserted into the abnormal tissue, the positioning tube is inserted into the abnormal tissue along with the inner diameter of the guiding needle; and when the positioning suture is injected into the abnormal tissue, the head portion and a portion of the body portion are retained inside the abnormal tissue while the rest of the body portion being exposed outside the abnormal tissue.
According to an embodiment, the positioning tube has an opening, whereby the head portion of the positioning suture is at least partially exposed at the opening while the positioning suture is accommodated in the receiving space.
According to an embodiment, the head portion is provided with a top end and a tail end correspondingly, and the top end is a closed end.
According to an embodiment, the widest part of the head portion is located at the opening with the top end of the head portion being exposed outside the opening when the positioning suture is accommodated in the receiving space.
According to an embodiment, the positioning device further comprises a syringe. The syringe is sleeved on the positioning tube via an end opposite to the opening to provide a pushing force. Through the pushing force, the positioning suture accommodated in the receiving space can be pushed out to complete the positioning.
According to an embodiment, the opening is beveled, and the body portion and the head portion are integrally formed. However, in other embodiments, the material used to form the body portion and the head portion may not be the same, or the body portion and the head portion may be individually manufactured and then assembled. The present invention is not limited thereto.
According to an embodiment, the receiving space is further filled with a biologically acceptable substance. The biologically acceptable substance may be selected as required without any limitation. For example, the biologically acceptable substance may be a bio-gel to aid in wound healing, a drug to inhibit the growth of the lesion, or a saline solution to avoid introducing air into the body and has a lubricating effect to assist movements of the positioning suture during the procedure. According to an embodiment, a surface of the positioning suture is coated with a developer. For example, developers such as Indocyanine Green (ICG), iodine oil, methylene blue, and the like, can be used.
According to an embodiment, the head portion is sleeved on the body portion, and the positioning suture further comprises a plurality of first fixing portions which are fixed to the head portion on the body portion.
According to an embodiment, the body portion further comprises a plurality of second fixing portions that are distributed thereon in a range of 15 cm from the head portion.
According to an embodiment, the second fixing portion is formed in a configuration of barb-shaped, fish bone-shaped, hollow cone-shaped, knot-shaped, or comb-shaped.
According to an embodiment, the head portion has elasticity. For example, the head portion may be made of a material having elasticity, whereby the head portion is suitably flexible to allow it to be accommodated in the guiding needle.
According to an embodiment, the head portion is in the form of cone-shaped or bullet-shaped.
According to an embodiment, the head portion is in the form of umbrella-shaped, knot-shaped, hollow cone-shaped, or comb-shaped.
The above and other features and advantages of the present invention will be clearly understood by the following description of the embodiments.
Hereinafter, an example is provided to illustrate the embodiment of the present invention. The advantages and efficacy of the invention will become more apparent by the disclosure of the invention. The accompanying drawings are simplified and used for illustrative purposes. The number, shape, and size of the components shown in the drawings may be modified to suit the actual situation, and the configuration of the components may be more complex as well. Other aspects of the invention may also be practiced or applied, and variations and adjustments may be made without departing from the spirit and scope of the invention as defined herein.
The positioning tube 10 is a metallic hollow tube provided with a receiving space 11. The positioning tube 10 has two opposite ends, one of which is an opening 12, which is beveled; the other end of which is a connecting part 13 corresponding to the opening 12. In another embodiment, the opening 12 may also be realized as a blunt end. Besides, as shown in
The positioning suture 20 comprises a body portion 21 and a head portion 22 connected to the body portion 21. The body portion 21 and the head portion 22 are integrally formed. The material to be used is not particularly limited, but preferably a material that gives the positioning suture 20 flexibility, such as nylon, degradable or non-degradable polymers, and the like.
In a preferred embodiment, regarding
During implementation, first, inserting the guiding needle 50 into the target abnormal tissue T, and allowing the positioning tube 10 to inserted into the abnormal tissue T along with the inner diameter of the guiding needle 50. Then, injecting the positioning suture 20 into the abnormal tissue, allowing the head portion 22 and a portion of the body portion 21 to be retained inside the abnormal tissue T while the rest of the body portion 21 to be exposed outside the abnormal tissue T.
In the case of excising a lung cancer nodule, first, inserting the guiding needle 50 into the abnormal tissue T at the targeted position for initial positioning. Then, filling the positioning tube 10 with the positioning suture 20, allowing the positioning tube 10 to insert the target position along with the inner diameter of the guiding needle 50. In other embodiments, the guiding needle 50 can be omitted and the positioning tube 10 can be inserted directly into the abnormal tissue T at the target position for initial positioning. Alternatively, it is possible to omit the positioning tube 10 while inserting the guiding needle 50 into the abnormal tissue T at the target position and feeding the positioning suture 20 into the tube of the guiding needle 50 to complete the positioning procedure. Moreover, the positioning can be completed by each of these embodiments simply by the positioning suture 20 without using a syringe 40.
As shown in the embodiments and the drawings above, the head portion 22 is preferably configured with a narrow top end 221 and a wide tail end 222 as a cone-shaped or a bullet-shaped configuration. The head portion 22 may also be configured as an umbrella-shaped structure as shown in
In other embodiments, the head portion 22 may also be constructed in a configuration ofknot-shaped (
For the positioning suture 20, it is preferred that the leading section of the body portion 21, as illustrated in
Following the above, as illustrated in
In other embodiments, each second fixing portion 211 can also be realized as a hollow cone-shaped (
Except for the positioning suture 20, the receiving space 11 of the positioning tube 10 can also be filled with a biologically acceptable substance that can be injected continuously during the positioning process. The substance not only helps to propel the positioning suture 20 but also prevents air from being injected into the body, causing adverse effects such as blood clots. The “biologically acceptable substance” can be selected as needed, for example, a bio-gel that helps the wound to heal, a drug that inhibits the growth of the lesion, or simply a saline solution as a mediator to propel the positioning suture 20.
In the embodiment, the positioning suture 20 may be suitably processed to allow the developer to be attached thereon. There is no limitation on the type of developer. Indocyanine Green (ICG), iodine oil, methylene blue, and other dyes can be used to enhance the positioning effect of the positioning suture 20 of the present invention.
For example, when removing a nodule of lung cancer, the positioning suture 20 and the saline solution can be filled into the positioning tube 10. Then, inserting the positioning tube 10 into the target position and applying an external force to push the syringe 40 to generate a pushing force in the positioning tube 10 for pushing the positioning suture 20 and the saline solution out of the receiving space 11. Then, the positioning suture 20 reached the target position has the head portion 22 and part of the body portion 21 with the second fixing portion 211 retained inside the tissue, while part of the body portion 21 exposed outside the tissue for positioning, thereby marking the area to be removed for subsequent surgical excision.
The positioning suture 20 of the present invention not only provides good fixation and ensures precise positioning, but also includes barbs to reduce the risk of displacement of the positioning suture due to movement of the body or organ before an operation, extending the operable time between the positioning procedure and excision procedure. However, these are just a few examples of applications. The positioning device 1 of the present invention is not limited to be used in a tumor excision surgery but also applicable to various organs and tissues for injection and positioning surgery.
| Number | Date | Country | Kind |
|---|---|---|---|
| 109119984 | Jun 2020 | TW | national |
