Disclosure of Invention
The invention provides a drug stent delivery device, which aims to solve the technical problems that the existing self-expanding drug stent has long pushing distance in a catheter, is easy to cause abrasion of a drug coating, fall off of particles of the drug coating and even has the risk of thrombus and embolism.
The invention discloses a drug stent conveying device, which comprises a sheath tube, a pushing guide wire and a protective umbrella, wherein the sheath tube comprises a handle and a tube body connected with one end of the handle, and an operation cavity of the handle is communicated with a tube cavity of the tube body; one end of the pushing guide wire is arranged in the lumen and is positioned at one end of the tube body close to the distal end; the other end of the pushing guide wire penetrates through the lumen and the operation cavity to the outside; the protective umbrella comprises two protective umbrella sheets which are oppositely arranged, one ends of the two protective umbrella sheets are respectively arranged at one end of the pushing guide wire close to the far end, and a first interlayer for accommodating a medicine bracket is formed between the two protective umbrella sheets; wherein, the protection umbrella can move along with the pushing guide wire.
Further, the protection umbrella further comprises two protection sub-umbrella sheets which are oppositely arranged, one ends of the two protection sub-umbrella sheets are respectively arranged at one end of the pushing guide wire, which is far away from the far end, the other ends of the two protection sub-umbrella sheets face the far end, and a second interlayer for accommodating the drug bracket is formed between the two protection sub-umbrella sheets.
Further, the protective umbrella sheet and/or the protective sub umbrella sheet are/is made of polymer film materials.
Further, the polymer film material comprises one or more of PTFE, PE, PI, PP, nylon and Pebax.
Further, the tube body is gradually softened from the proximal end toward the distal end.
Further, at least one braiding layer formed by metal materials or high polymer materials is arranged in the tube body.
Further, the metal material comprises stainless steel or nickel-titanium alloy, or the polymer material comprises any one or more of nylon, polyimide and PTFE.
Further, the braid includes a compliant segment proximate the distal end, the compliant segment being of a spiral braid construction.
Further, the sheath tube further comprises a regulating wire, and the regulating wire is arranged in the tube body; one end of the regulating wire is connected with the compliant section, and the other end of the regulating wire is arranged on the handle; the material of the regulating and controlling yarn is the same as that of the braiding layer; wherein the control wire is operated to move and bend the compliant segment.
Further, the handle comprises a liquid injection port and a sliding button, and the liquid injection port is communicated with the operation cavity; the sliding button is connected to the handle in a sliding manner and is connected with the other end of the regulating wire.
Further, the pipe body further comprises an inner layer located in the woven layer, and the inner layer is made of PTEE material.
Further, a transition section is arranged at the part of the push guide wire close to the distal end, and the wire diameter of the transition section is gradually reduced from the proximal end to the distal end.
Further, the drug stent delivery device further comprises a reinforcing spring, wherein the reinforcing spring is sleeved on the transition section.
Further, the drug stent delivery device further comprises a support block, wherein the support block is arranged on the pushing guide wire and is positioned in the first interlayer.
Further, the drug stent delivery device further comprises a pushing block, wherein the pushing block is arranged at one end of the transition section with a small wire diameter and is positioned at one end of the reinforcing spring close to the distal end.
Further, the drug stent delivery device further comprises a developing member, wherein the developing member is arranged on the pushing guide wire; the developing member is located between the supporting block and the pushing block.
Further, the drug stent delivery device further comprises a flexible member disposed at an end of the push guidewire proximal to the distal end; the flexible piece is of a spring structure.
The drug stent delivery device provided by the invention can realize the following technical effects:
1. the invention improves the structure of the drug stent conveying device, so that the mode of conveying the drug stent by the drug stent conveying device is different from the existing conveying mode, the existing conveying mode needs to establish a passage, and the conveying mode of the drug stent conveying device does not need to be established.
The conveying process of the existing drug stent is specifically as follows:
1.1 Firstly, enabling one end of the micro-guide wire to enter a blood vessel and reach a focus;
1.2 Sleeving the middle guide wire on the micro guide wire and reaching the focus, wherein the micro guide wire plays a role in guiding;
1.3 Sleeving the microcatheter on the microcatheter so that the microcatheter is positioned in the middle catheter and one end of the microcatheter reaches the focus;
1.4 Extracting the micro-guide wire;
1.5 One end of the micro-catheter positioned outside is in butt joint with the guide sheath;
1.6 The drug support is arranged in the introducing sheath, sequentially passes through the introducing sheath and the microcatheter and finally reaches the focus. The existing drug stent has complicated conveying flow, long pushing distance in the catheter, easy abrasion of the drug coating, falling off of particles of the drug coating, and even the risk of thrombus and embolism.
The conveying process of the drug stent conveying device of the invention is specifically as follows:
2.1 Firstly, enabling one end of the micro-guide wire to enter a blood vessel and reach a focus;
2.2 Sleeving the middle guide tube on the micro guide wire and reaching the focus;
2.3 Extracting the micro-guide wire;
2.4 The end, close to the far end, of the tube body of the sheath tube of the drug stent delivery device is directly inserted into the middle catheter, when the drug stent delivery device reaches a focus, the push guide wire is directly pushed to the far end, the protective umbrella and the drug stent move together with the push guide wire to reach the focus, and the drug stent self-expands and completes the transition from a compressed state to an expanded state. The pushing guide wire is pushed far away (a certain distance is defined by the operator according to the experience of the operator, the distance is automatically determined during operation), then the pushing guide wire is pulled out, the other end of the protective umbrella is changed from the proximal end to the distal end, and the protective umbrella has enough flexibility due to the material property of the protective umbrella, the inner wall of a blood vessel is not damaged when the protective umbrella is overturned, and finally the pushing guide wire is pulled out, so that the protective umbrella is recovered together with the pushing guide wire.
The drug stent delivery device adopts the sheath tube to replace the leading-in sheath and the micro-catheter, changes the existing delivery mode, reduces the use of auxiliary instruments, saves the cost, reduces the pushing distance of the drug stent in the catheter, and reduces the risks of abrasion of the drug coating and falling of particles of the drug coating.
2. In the conveying process of the drug stent, the pulling length of the regulating wire is controlled, so that the bending angle of one end of the tube body away from the handle can be changed more flexibly, the tube body can quickly pass through tortuous and bifurcated blood vessels during operation, the tube body can reach a lesion part more quickly, the operation time is saved, the X-ray radiation is reduced, and the pain of a patient is reduced.
3. The guide sheath is not needed, and the operation flow of the operation is simplified.
The foregoing general description and the following description are exemplary and explanatory only and are not restrictive of the invention.
Detailed Description
For a more complete understanding of the nature and the technical content of the embodiments of the present invention, reference should be made to the following detailed description of embodiments of the invention, taken in conjunction with the accompanying drawings, which are meant to be illustrative only and not limiting of the embodiments of the invention. In the following description of the technology, for purposes of explanation, numerous details are set forth in order to provide a thorough understanding of the disclosed embodiments. However, one or more embodiments may still be practiced without these details. In other instances, well-known structures and devices may be shown simplified in order to simplify the drawing.
The terms first, second and the like in the description and in the claims of embodiments of the invention and in the above-described figures are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate in order to describe embodiments of the invention herein. Furthermore, the terms "comprise" and "have," as well as any variations thereof, are intended to cover a non-exclusive inclusion.
In the embodiments of the present invention, the terms "upper", "lower", "inner", "middle", "outer", "front", "rear", and the like indicate the azimuth or the positional relationship based on the azimuth or the positional relationship shown in the drawings. These terms are only used to facilitate a better description of embodiments of the invention and their examples and are not intended to limit the scope of the indicated devices, elements or components to the particular orientation or to be constructed and operated in a particular orientation. Also, some of the terms described above may be used to indicate other meanings in addition to orientation or positional relationships, for example, the term "upper" may also be used to indicate some sort of attachment or connection in some cases. The specific meaning of these terms in embodiments of the present invention will be understood by those of ordinary skill in the art in view of the specific circumstances.
In addition, the terms "disposed," "connected," "secured" and "affixed" are to be construed broadly. For example, "connected" may be in a fixed connection, a removable connection, or a unitary construction; may be a mechanical connection, or an electrical connection; may be directly connected, or indirectly connected through intervening media, or may be in internal communication between two devices, elements, or components. The specific meaning of the above terms in the embodiments of the present invention will be understood by those of ordinary skill in the art according to the specific circumstances.
The term "plurality" means two or more, and "plurality" means two or more.
It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other.
In the present invention, the distal end means an end far from the operator at the time of surgery, and the proximal end means an end near the operator at the time of surgery.
As shown in fig. 1 and 2, the invention discloses a drug stent delivery device, which comprises a sheath tube 1, a pushing guide wire 2 and a protective umbrella 3. The sheath 1 includes a handle 11 and a tube 12, an operation chamber 111 is formed in the handle 11, and a tube chamber 121 is formed in the tube 12. One end of the handle 11 is fixedly connected with one end of the tube body 12, and the operation cavity 111 is communicated with the tube cavity 121. One end of the push wire 2 is disposed in the lumen 121 and at the distal end of the tube 12, and the end of the push wire 2 in the lumen 121 is the distal end. The other end of the pushing wire 2 penetrates through the lumen 121 and the operation cavity 111 to the outside, and one end of the pushing wire 2 located outside is the end close to the proximal end. The protective umbrella 3 is arranged at one end of the pushing guide wire 2 close to the distal end, and when the pushing guide wire 2 is positioned in the pipe cavity 121, the protective umbrella 3 is also positioned in the pipe cavity 121.
As shown in fig. 1 and 3, the protective umbrella 3 includes two protective umbrella pieces 31, and the two protective umbrella pieces 31 are disposed opposite to each other. The protective umbrella sheet 31 is a strip-shaped arc sheet, and the section of the protective umbrella sheet 31 is semicircular. When two protection umbrella pieces 31 set up relatively, the one end of two protection umbrella pieces 31 all sets up in the one end that push seal wire 2 is close to the distal end, and the other end of two protection umbrellas 3 sets up towards the proximal end, and the space between two protection umbrella pieces 31 can be regarded as first intermediate layer 32, and first intermediate layer 32 is used for holding a part or whole of medicine support, and the protection umbrella can prevent that the medicine coating of medicine support from receiving wearing and tearing in the transportation process. Wherein, when the pushing guide wire 2 moves from the proximal end to the distal end, the protective umbrella 3 can move along with the pushing guide wire 2, and the protective umbrella 3 can enter the blood vessel from the inside of the lumen 121.
Optionally, the length of the protective umbrella 31 is in the range of 5mm to 60mm.
Optionally, the protective umbrella sheet 31 is made of a polymer film material. This allows the protective umbrella 31 to be flexible enough to avoid scratching the inner wall of the blood vessel and reduce the risk of intravascular hemorrhage. Meanwhile, after the drug stent is expanded, when the drug stent is taken out, the other end of the protective umbrella sheet 31 is changed from the proximal end to the distal end, so that the protective umbrella sheet 31 and the push guide wire 2 can be conveniently taken out.
Optionally, as shown in fig. 4, the protection umbrella 3 further includes two protection sub-umbrella sheets 33, and the two protection sub-umbrella sheets 33 are disposed opposite to each other. The protective sub-umbrella sheet 33 is a long arc-shaped sheet, and the section of the protective sub-umbrella sheet 33 is semicircular. When the two protection sub-umbrella sheets 33 are oppositely arranged, one ends of the two protection sub-umbrella sheets 33 are arranged at one ends of the pushing guide wire 2 far away from the far end, and the other ends of the two protection sub-umbrella sheets 33 are arranged towards the far end. The space between the two protective sub-sheets 33 can be regarded as a second sandwich 34, the second sandwich 34 being intended to accommodate part of the medicament holder.
Optionally, the protective sub-umbrella sheet 33 is made of a polymer film material. This allows the protective umbrella 31 to be flexible enough to avoid scratching the inner wall of the blood vessel and reduce the risk of intravascular hemorrhage.
Preferably, the polymer film material comprises one or more of PTFE, PE, PI, PP, nylon and Pebax.
Alternatively, as shown in FIG. 5, the tube 12 may be tapered from the proximal end to the distal end. The pipe body 12 comprises at least one woven layer 14, at least one inner layer 13 and at least one outer layer 15, wherein the woven layer 14 is positioned between the inner layer 13 and the outer layer 15, and the inner layer 13 is matched with the outer layer 15 and coats the woven layer 14. The plurality of braiding wires are crossly braided to form the tubular braiding layer 14, the braiding density of the braiding layer 14 is gradually reduced from the proximal end to the distal end, the braiding structure of one end of the braiding layer 14 close to the distal end is a spiral braiding structure, the spiral braiding structure is a compliant section 141 of the braiding layer 14, and the compliant section 141 in the spiral braiding structure can further improve the bending compliance of the tube body. The braided wire is made of a metal material or a polymer material. Preferably, the metallic material comprises stainless steel or nickel titanium alloy. Preferably, the polymer material comprises one or more of nylon, polyimide and PTFE. The inner layer 13 is positioned in the braiding layer 14, and the inner layer 13 is made of PTEE material for reducing friction between the drug stent and the inner layer in the conveying process. The outer layer 15 is located outside the braid 14, however, the outer layer 15 may also be made of PTEE material to reduce friction between the tube and the inner wall of the vessel.
Optionally, as shown in fig. 5 and 6, the sheath 1 further includes a regulating wire 4, where the regulating wire 4 is disposed in the tube 12, and the regulating wire 4 is located between the outer layers 15 of the braid 14, one end of the regulating wire 4 is connected with one end of the compliant section 141 near the distal end, and the other end of the regulating wire 4 penetrates the handle 11 to the outside. Wherein, through carrying out the pull to the one end that regulating and controlling silk 4 is located the external world for the one end that regulating and controlling silk 4 is located the body 12 drives gentle and agreeable section 141 and bends, and the one end that body 12 kept away from handle 11 promptly bends. Through the control to the pull length of regulating and controlling silk 4, the body 12 of being convenient for can change bending angle more nimble from the one end of handle 11, and quick through tortuous, bifurcated blood vessel in the art of being convenient for can let the body reach pathological change position more quick.
Alternatively, the material of the regulating wire 4 is the same as the material of the braiding wires configured as the braiding layer 14.
Alternatively, as shown in fig. 1 and 6, the handle 11 includes a slide button 16. The outer surface of the handle 11 is constructed with an opening 17, the opening 17 enabling the braid 14 to be exposed to the outside, or the operation chamber 111 communicates with the outside through the opening 17. The slide button 16 is disposed in the opening 17, and the slide button 16 is movable in the opening 17 along the longitudinal direction of the handle 11. The end of the control wire 4 away from the compliant segment 141 enters the opening 17 and is fixedly connected with the end of the slide button 16 located in the opening 17, at this time, the slide button 16 is located at the end of the handle 11 away from the proximal end, and the compliant segment 141 is in a non-bending state. The regulating wire 4 is pulled through the sliding button 16, so that the bending angle of the end of the tube body 12 away from the handle 11 can be flexibly adjusted by an operator.
Alternatively, as shown in fig. 1 and 2, the handle 11 includes a pouring spout 18. The liquid filling port 18 is located at one side of the handle 11 in the longitudinal direction thereof, and the liquid filling port 18 communicates with the operation chamber 111. The fill port 18 can facilitate registration of a syringe with a liquid, such as injection of a contrast medium.
Alternatively, as shown in fig. 3, the pushing wire 2 is configured with a transition section 21 and a flexible section 27, the flexible section 2 is located at a portion of the pushing wire 2 near the distal end, and the transition section 21 is disposed between the flexible section 27 and the pushing wire 2. The wire diameter of the flexible section 27 is smaller than that of the pushing guide wire 2, the wire diameter of one end of the transition section 21 close to the pushing guide wire 2 is larger than that of one end of the transition section 21 close to the flexible section 27, one end of the transition section 21 with a large wire diameter is connected with one end of the pushing guide wire 2 close to the distal end, one end of the transition section 21 with a small wire diameter is connected with one end of the flexible section 27, namely, the wire diameter of the transition section 21 is gradually reduced from the proximal end to the distal end. This can increase the flexibility of the pushwire 2, facilitating its flexible passage through tortuous and bifurcated vessels.
In the present invention, both the transition section 21 and the flexible section 27 can be considered as part of the push wire 2.
Alternatively, as shown in fig. 3, one end of both protective umbrella blades 31 are provided on the flexible section 27.
Alternatively, as shown in fig. 3, one end of both protective sub-sheets 33 are provided on the flexible section 27.
Optionally, as shown in fig. 3, the drug-stent delivery device further comprises a stiffening spring 22, the stiffening spring 22 being sleeved on the transition section 21. The transition section 21 is provided with the reinforcing spring 22, so that the flexibility of the pushing guide wire 2 can be improved, and meanwhile, the structural strength of the pushing guide wire can be guaranteed.
Optionally, as shown in fig. 3, the drug-stent delivery device further comprises a support block 23, the support block 23 being arranged on the flexible section 27, the support block 23 being located in a middle position of the flexible section 27. The placement of the support blocks 23 on the flexible segment 27 may also be considered as the placement of the support blocks 23 on the push wire 2. Support blocks 23 are positioned within first interlayer 32. The medicine support is clamped through the cooperation of the supporting block 23 and the protective umbrella 3, so that the medicine support can be more stably fixed on the pushing guide wire.
Optionally, as shown in fig. 3, the drug-stent delivery device further includes a pushing block 24, where the pushing block 24 is disposed at the junction of the transition section 21 and the flexible section 27, that is, the pushing block 24 is disposed at the end of the transition section 21 with a smaller wire diameter. The pushing block 24 is located at the end of the reinforcing spring 22 near the distal end, and one side surface of the pushing block 24 abuts against the end of the reinforcing spring 22 near the distal end, so that the pushing block 24 plays a limiting role on the reinforcing spring 22. The pushing block 24 is arranged at the joint of the transition section 21 and the flexible section 27, so that the pushing guide wire 2 has enough flexibility and enough pushing force, and the pushing block 24 can push the drug stent to play a role in pushing when the drug stent is conveyed by the drug stent conveying device. Preferably, one end of the two protective umbrella pieces 33 is disposed on one side of the pushing block 24 near the distal end.
Optionally, as shown in fig. 3, the drug-stent delivery device further comprises a developing member 25, the developing member 25 being a developing spring or developing block. When the developing member 25 is a developing spring, the developing spring is sleeved on the flexible section 27 and is located between the supporting block 23 and the pushing block 24. When the developing member 25 is a developing block, the developing block having a cylindrical shape is disposed on the flexible section 27 and is located between the supporting block 23 and the pushing block 24. The developing member 25 is made of any one or more of platinum tungsten alloy, platinum iridium alloy, gold and tantalum. A developing member 25 is provided on the push wire 2 to facilitate the operator's observation of the position of the drug stent.
Alternatively, as shown in fig. 1, when two protective umbrella sheets 31 are present in the protective umbrella 3, the developing member may be located in the first interlayer 32.
Alternatively, as shown in fig. 4, when the protective umbrella 3 further has two protective sub-umbrella sheets 33, the developing member 25 is located in the second interlayer 34.
Optionally, as shown in fig. 3, the drug-stent delivery device further comprises a flexible member 26, the flexible member 26 being of the same material as the developing member 25. The flexible member 26 is wound in a spring structure by the developing wire, and the flexible member 26 is disposed at an end portion of the flexible section 27 near the distal end. Thus, the end, close to the distal end, of the pushing guide wire 2 has enough flexibility, so that the damage to the inner wall of a blood vessel is avoided, and the risk of bleeding is reduced.
The assembly process of an exemplary embodiment:
as shown in fig. 1 to 3 and 7, the other ends of the two protection umbrella sheets 31 are made to face distally, the drug stent in the expanded state is sleeved on the supporting block 23, then the two protection umbrella sheets 31 are turned over, the other ends of the two protection umbrella sheets 31 are made to face proximally, at this time, a first interlayer 32 is formed between the two protection umbrella sheets 31, and the drug stent is located in the first interlayer 32. The space of the first interlayer 32 becomes smaller as the drug stent transitions from the expanded state to the compressed state, and the coating abrasion and drug coating particle shedding of the drug stent during delivery can be prevented as the wrapping of the drug stent in the compressed state is completed. Then, the end of the pushing wire 2 near the proximal end is sequentially inserted through the lumen 121 of the tube body 12 and the operation lumen 111 of the handle 11, and is exposed to the outside. Finally, the end of the pushing guide wire 2 exposed to the outside is pulled, so that the two protective umbrella sheets 31 and the drug stent in the first interlayer 32 enter the lumen 121 and are positioned at the end of the tube body 12 close to the distal end.
The above description and the drawings illustrate embodiments of the invention sufficiently to enable those skilled in the art to practice them. Other embodiments may include structural and other modifications. The embodiments represent only possible variations. Individual components and functions are optional unless explicitly required, and the sequence of operations may vary. Portions and features of some embodiments may be included in, or substituted for, those of others. The embodiment of the present invention is not limited to the structure that has been described above and shown in the drawings, and various modifications and changes may be made without departing from the scope thereof. The scope of the invention is limited only by the appended claims.