Tissue shaping device, system, and implantation and retrieval methods

Abstract

The present application provides a kind of tissue shaping device, system and its implantation and recovery method, the tissue shaping device includes proximal anchoring structure, proximal connecting rod connected with proximal anchoring structure, distal anchoring structure, distal connecting rod connected with distal anchoring structure, elastic connecting structure connecting proximal connecting rod and distal connecting rod, the distal anchoring structure is made of super-elastic material, it can be switched between gathering or opening state, and with the proximal anchoring structure connected wire.The present application also includes the tissue shaping system of the tissue shaping device and implantation device.And the implantation and recovery method of the tissue shaping device of the present application.The present application can realize the continuous adjustment function of tissue, shaping process is mild, long-term effect is good;And design can overcome doctor misoperation, improve the success rate of operation;Also convenient to pull a period of time, such as anchor failure removal, re-implantation.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a tissue shaping device, system, and method for implantation and retrieval thereof. Background Technology

[0002] In clinical medicine, tissue shaping and tissue lifting are two important biomechanical intervention techniques used to address various tissue abnormalities or functional reconstruction problems, such as benign prostatic hyperplasia (BPH), which is prevalent in middle-aged and elderly men. Prostate lifting surgery is one approach to BPH treatment. Existing lifting designs involve pulling the tissue with sutures, which are essentially rigid, providing immediate results. However, the long-term lifting effect may be limited as the tissue is shaped under stress. Furthermore, in prostate stent expansion, while the stent and tissue achieve a certain stress / strain balance in the short term, the long-term support effect is often insufficient. Summary of the Invention

[0003] The purpose of this invention is to provide a tissue shaping device and system that enables continuous tissue adjustment, provides a gentle shaping process, and achieves good long-term results. The design can also overcome doctor's errors and improve the success rate of surgery. It is also convenient to remove and re-implant the tissue if the anchor fails after a period of lifting. With the help of a surface coating, it reduces the chemical and mechanical stimulation to the tissue in the early stage of implantation and reduces patient discomfort.

[0004] To address the aforementioned technical problems, this invention provides a tissue shaping device, comprising a proximal anchoring structure, a proximal connecting rod connected to the proximal anchoring structure, a distal anchoring structure, a distal connecting rod connected to the distal anchoring structure, an elastic connecting structure connecting the proximal connecting rod and the distal connecting rod, wherein the distal anchoring structure is made of a hyperelastic material and can switch between a converged or open state; and a filament connected to the proximal anchoring structure.

[0005] Optionally, the proximal anchoring structure and the distal anchoring structure are "multi-petal" shaped, with each anchoring structure having at least two petals for anchoring tissue.

[0006] Optionally, the surface of the petal in contact with the tissue is a rounded arc with a radius ranging from 0.05mm to 5mm; the angle of the outermost apex of the petal ranges from 10° to 150°.

[0007] Optionally, the elastic connection structure can be a stretchable wire, spring, or mesh structure.

[0008] Optionally, the proximal anchoring structure, distal anchoring structure, proximal connecting rod, distal connecting rod, and elastic connecting structure, once implanted as a whole, can be spatially linear, curved, or surface-curved.

[0009] Optionally, one or more surfaces of the proximal anchoring structure, the distal anchoring structure, the proximal connecting rod, the distal connecting rod, and the elastic connecting structure may be coated.

[0010] The present invention also provides a tissue shaping system, including the aforementioned tissue shaping device and an implantation device for implanting the shaping device into tissue. The implantation device includes a sheath, a head device disposed within the sheath and movable relative to it, a puncture needle with an inner lumen disposed within the head device, and a control handle for controlling the implantation device. The tissue shaping device is held in the inner lumen of the puncture needle. The head device is provided with a cutting area, and one end of the filament is connected to the proximal anchoring structure, and the other end passes through the cutting area and is connected to the control handle.

[0011] This invention also provides a method for implanting a tissue shaping device. Using the tissue shaping system, the tissue shaping device is loaded into the puncture needle of the implantation device via a pressure grip. The distal end of the sheath of the implantation device is implanted into the tissue to be shaped. The sheath is then withdrawn to expose the head device. The control handle is braked to control the head device to release the puncture needle. The puncture needle, carrying the tissue shaping device, enters the tissue to be shaped. The distal end of the puncture needle penetrates the tissue to be shaped. The puncture needle is then withdrawn, and the distal anchoring structure is anchored distally to the tissue to be shaped. The puncture needle is further withdrawn, and the proximal anchoring structure is anchored proximally to the tissue to be shaped. The suture is cut using the blade of the cutting area, and the implantation device is withdrawn.

[0012] The present invention also provides a method for retrieving a tissue shaping device, wherein an external force is applied axially to the proximal anchoring structure of the tissue shaping device as described in any one of claims 1-7, and under the action of the external force, the petals of the distal anchoring structure gradually converge from opening, enter the shaping tissue from the distal side of the shaping tissue and withdraw from the shaping tissue, thereby removing the tissue shaping device from the body.

[0013] In summary, the tissue shaping device, system, and implantation and retrieval method provided by this invention not only have a gentle shaping process and can achieve continuous tissue adjustment, resulting in good long-term effects, but also allow for retraction or recovery, compensating for surgical errors. Furthermore, surface coating treatment can reduce patient discomfort. Attached Figure Description

[0014] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention.

[0015] Figure 1a This is an overall schematic diagram of the tissue shaping device according to an embodiment of the present invention.

[0016] Figure 1bThis is a schematic diagram of another variation of the elastic connection structure according to an embodiment of the present invention.

[0017] Figure 2a This is a schematic diagram of the minimum apex angle of the petals in an embodiment of the present invention.

[0018] Figure 2b This is a schematic diagram of the maximum apex angle of the petals in an embodiment of the present invention.

[0019] Figure 3 This is a schematic diagram of the tissue shaping system in an embodiment of the present invention.

[0020] Figure 4 This is a schematic diagram of the cutting of the filaments during the implantation process in an embodiment of the present invention. Detailed Implementation

[0021] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0022] As used in this invention, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, “proximal” and “distal” generally refer to two corresponding parts, including not only endpoints. The term “proximal” refers to a closer relative position, while the term “distal” refers to a more distant relative position. Additionally, as used in this invention, “connected,” “linked,” and “one element disposed on another” should be interpreted broadly, generally indicating only a contact, connection, coupling, mating, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element. It should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of the other element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0023] This invention provides a tissue shaping device; please refer to [the relevant documentation]. Figure 1a , 1bAs shown, it includes: a distal anchoring structure 10, a distal connecting rod 20 connected to the distal anchoring structure 10, a proximal anchoring structure 50, a proximal connecting rod 40 connected to the proximal anchoring structure 50, an elastic connecting structure 30 connecting the distal connecting rod 10 and the proximal connecting rod 50, wherein the distal anchoring structure 10 is made of a hyperelastic material and can switch between a converged or open state; and a thread 60 connected to the proximal anchoring structure 50.

[0024] This invention can be used for tissue lifting in various clinical scenarios, including urinary tissue, digestive tissue, cardiovascular tissue, and bone. One embodiment of this invention addresses benign prostatic hyperplasia (BPH) in patients. To effectively and sustainably lift prostatic hyperplasia tissue, this embodiment designs a distal anchoring structure 10 and a proximal anchoring structure 50, both designed as a "multi-petal" structure. The petals of the distal anchoring structure are made of a hyperelastic material (such as nickel-titanium alloy). Through the nonlinear elastic deformation capability of materials like nickel-titanium alloy, adaptive mechanical support and long-term morphological stability of the tissue are achieved. Furthermore, nickel-titanium alloy, due to its excellent biocompatibility, mechanical properties, and corrosion resistance, meets the requirements of medical applications. Each anchoring structure has at least two petals for anchoring the tissue; for more uniform tissue anchoring, 3-5 petals are optimal. Figure 1a , 1b In this structure, there are four petals. The petals of the proximal anchoring structure can also be made of the aforementioned hyperelastic material.

[0025] To further enhance the elastic lifting and support force, the elastic connection structure 30 is a stretchable wire, spring, or mesh structure. Figure 1a The middle part is an S-shaped spring, and the schematic diagram of the mesh structure is as follows: Figure 1b As shown, it can be formed by weaving or laser cutting.

[0026] The proximal anchoring structure 50, proximal connecting rod 40, elastic connecting structure 30, distal connecting rod 20, and distal anchoring structure 10 are connected sequentially and are spatially linear after implantation. Figure 3 As shown; it can also be curved or curved (not shown) to stretch and constrain tissue size, to gradually and continuously shape tissue, and can be used not only for prostate tissue, but also for shaping in digestive and skeletal fields.

[0027] To reduce mechanical and chemical irritation to prostate tissue, one or more surfaces of the proximal anchoring structure 50, proximal connecting rod 40, elastic connecting structure 30, distal connecting rod 20, and distal anchoring structure 10 are coated, or targeted drug release is achieved near the tissue to minimize its impact. The coating or drug design must simultaneously meet requirements for biocompatibility, mechanical buffering, and chemical stability.

[0028] Figure 2a and 2b The surface of the petal in contact with the tissue is a rounded arc with a radius ranging from 0.05 mm to 5 mm; the angle of the outermost apex of the petal ranges from 10° to 150°.

[0029] Another embodiment of the present invention also provides a tissue shaping system, such as Figure 3 As shown, the device includes the aforementioned tissue shaping apparatus and an implantation device for implanting the shaping apparatus into the tissue. The implantation device includes a sheath (not shown), a head device 100 disposed within the sheath and movable relative to it, a puncture needle 80 with an inner lumen disposed within the head device 100, the tissue shaping apparatus being held within the inner lumen of the puncture needle 80; and a control handle (not shown) for controlling the implantation device; to facilitate cutting the suture 60 at the end of implantation, as... Figure 4 As shown, the head device 100 is provided with a cutting area 90. The thread 60 is a polyester thread, one end of which is connected to the proximal anchoring structure 50, and the other end passes through the cutting area 90 and is connected to the control handle.

[0030] Another embodiment of the present invention provides a method for implanting a tissue shaping device, such as... Figure 3 As shown, using the tissue shaping system, the tissue shaping device is loaded into the implantation device via a pressure grip. The suture 60 passes through the inner lumen of the puncture needle 80, and the implantation device is implanted near the prostate tissue 70 to be shaped. The puncture needle 80 is released via a control handle, puncturing the capsule of the prostate tissue and entering the distal side 71 of the prostate tissue 70 with the distal anchoring structure 10. The distal end of the puncture needle 80 penetrates the capsule of the prostate tissue 70 and anchors the distal anchoring structure 10 on the outer side 71 of the prostate tissue. The puncture needle 80 is withdrawn, and the petals of the proximal anchoring structure 50 are anchored into the proximal side 72 of the prostate tissue 70. After anchoring is completed, as... Figure 4 As shown, by operating the control handle, the suture 60 is cut using the blade of the cutting area 90, and the implantation device is withdrawn. After implantation, the distal anchoring structure 10 remains outside the capsule of the prostate tissue 70, the proximal connecting rod 40, the elastic connecting structure 30, and the distal connecting rod 20 remain at the hyperplastic site of the prostate tissue 70, and the proximal anchoring structure 50 remains on the urethral side.

[0031] This invention also provides a method for retrieving a tissue shaping device. An external force is applied axially to the proximal anchoring structure of the tissue shaping device. Under this force, the petals of the distal anchoring structure gradually close and detach from the shaped tissue. If necessary, ice water is used to further close the petals, reducing their volume and constraint on the tissue, facilitating easy removal. Finally, the tissue shaping device is withdrawn from the body.

[0032] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A tissue shaping device, characterized in that, include: The near-end anchoring structure, the near-end connecting rod connected to the near-end anchoring structure, the far-end anchoring structure, the far-end connecting rod connected to the far-end anchoring structure, the elastic connecting structure connecting the near-end connecting rod and the far-end connecting rod, the far-end anchoring structure being made of a hyperelastic material and capable of switching between a converged or open state; and the thread connected to the near-end anchoring structure.

2. The tissue shaping device according to claim 1, characterized in that, The proximal and distal anchoring structures are "multi-petal" shaped, with each anchoring structure having at least two petals for anchoring tissue.

3. The tissue shaping device according to claim 2, characterized in that, The surface of the petal in contact with the tissue is a rounded arc with a radius ranging from 0.05mm to 5mm; the angle of the outermost apex of the petal ranges from 10° to 150°.

4. The tissue shaping device according to claim 1, characterized in that, The elastic connection structure is a stretchable wire, spring, or mesh structure.

5. The tissue shaping device according to any one of claims 1-4, characterized in that, The proximal anchoring structure, proximal connecting rod, elastic connecting structure, distal connecting rod, and distal anchoring structure, once implanted as a whole, can be spatially linear, curved, or surface-curved.

6. The tissue shaping device according to claim 5, characterized in that, One or more surfaces of the near-end anchoring structure, the far-end anchoring structure, the near-end connecting rod, the far-end connecting rod, and the elastic connection structure are coated.

7. A tissue shaping system, characterized in that, The invention includes a tissue shaping device as described in any one of claims 1-6, and an implantation device for implanting the shaping device into tissue. The implantation device includes a sheath, a head device disposed within the sheath and movable relative to it, a puncture needle with an inner lumen disposed in the head device, and a control handle for controlling the implantation device. The tissue shaping device is held in the inner lumen of the puncture needle. The head device is provided with a cutting area, and one end of the filament is connected to the proximal anchoring structure, and the other end passes through the cutting area and is connected to the control handle.

8. A method for implanting a tissue shaping device, characterized in that, Using the tissue shaping system as described in claim 7, the tissue shaping device is loaded into the puncture needle of the implantation device via a pressure grip. The distal end of the sheath of the implantation device is implanted into the tissue to be shaped. The sheath is then withdrawn to expose the head device. The control handle is braked to control the head device to release the puncture needle. The puncture needle, carrying the tissue shaping device, enters the tissue to be shaped. The distal end of the puncture needle penetrates the tissue to be shaped. The puncture needle is then withdrawn, and the distal anchoring structure is anchored distal to the tissue to be shaped. The puncture needle is further withdrawn, and the proximal anchoring structure is anchored proximal to the tissue to be shaped. The suture is cut using the blade of the cutting area, and the implantation device is withdrawn.

9. A method for recycling a tissue shaping device, characterized in that: When an external force is applied axially to the proximal anchoring structure of the tissue shaping device as described in any one of claims 1-7, the petals of the distal anchoring structure gradually converge under the action of the external force, enter the shaping tissue from the distal side of the shaping tissue and withdraw from the shaping tissue, thereby removing the tissue shaping device from the body.

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