SUMMERY OF THE UTILITY MODEL
In order to solve the technical problem, an object of the utility model is to provide a sacculus pipe can ensure that the sacculus can fully expand at sufficient in-process, reduces the loss of medicine, improves the transfer rate of medicine, can not form the air cock in human body moreover, improves the security.
In order to achieve the above object, the present invention provides a balloon catheter, comprising a catheter main body and a balloon disposed at a distal end of the catheter main body; wherein the surface of the balloon is provided with an administration hole;
the balloon catheter has a first state and a second state; when the balloon catheter is in the first state, the administration hole does not penetrate through the balloon wall; when the balloon catheter is in the second state, the administration hole penetrates through the balloon wall and is used for releasing the liquid medicine.
Optionally, the drug delivery hole is disposed on an outer surface of the balloon and does not penetrate through an inner surface of the balloon when the balloon catheter is in the first state, or the drug delivery hole is disposed on an inner surface of the balloon and does not penetrate through an outer surface of the balloon.
Optionally, when the balloon catheter is in the first state, the depth of the administration hole is 1% to 99% of the wall thickness of the balloon.
Optionally, the depth of the administration hole is 80% of the wall thickness of the balloon when the balloon catheter is in the first state.
Optionally, the number of the drug delivery holes is multiple, and when the balloon catheter is in the first state, the depths of the drug delivery holes are the same or different.
Optionally, the shape of the administration hole is a regular shape or an irregular shape.
Optionally, the number of the administration holes is multiple, and the shapes of the administration holes are the same or different.
Optionally, the number of the administration holes is multiple, and the multiple administration holes are regularly or irregularly distributed on the balloon.
Optionally, the balloon is shaped as a straight or dumbbell after expansion.
Optionally, the balloon is made of a visualization material.
Optionally, the balloon comprises a first balloon and a second balloon nested within the first balloon;
the drug delivery holes comprise a first drug delivery hole and a second drug delivery hole, the first drug delivery hole is formed in the surface of the first balloon, and the second drug delivery hole is formed in the surface of the second balloon;
when the balloon catheter is in the first state, the first administration hole does not penetrate through the balloon wall of the first balloon; when the balloon catheter is in the second state, the first administration hole penetrates through the balloon wall of the first balloon and is used for releasing the liquid medicine; the second administration hole always penetrates through the balloon wall of the second balloon.
Optionally, the balloon comprises a first balloon and a second balloon nested within the first balloon;
the drug delivery holes comprise a first drug delivery hole and a second drug delivery hole, the first drug delivery hole is formed in the surface of the first balloon, and the second drug delivery hole is formed in the surface of the second balloon;
when the balloon catheter is in the first state, the second administration hole does not penetrate through the balloon wall of the second balloon; when the balloon catheter is in the second state, the second administration hole penetrates through the balloon wall of the second balloon and is used for releasing the liquid medicine; the first drug delivery hole penetrates through the balloon wall of the first balloon all the time.
Optionally, the first dosing hole and the second dosing hole are arranged in a staggered manner.
Optionally, the drug delivery hole is used for penetrating through the balloon wall under the pressure of the drug solution when the drug solution fills the balloon.
The utility model discloses a sacculus pipe is provided with the administration hole on the sacculus surface, and the administration hole does not link up with the sacculus before releasing the liquid medicine, so that the sacculus can fully expand at sufficient in-process, thereby fully laminate with the vascular wall, and then after the inside pressure of sacculus reaches a definite value, because the structure of administration hole department is weaker, make the administration hole break and leak under the pressure effect of liquid medicine, thereby release the liquid medicine, make the liquid medicine that fills can continuously shift to pathological change position, reach the purpose of targeted therapy. The structure of the medicine feeding hole ensures the effect of expanding blood vessels by the balloon, so that the medicine liquid can be transferred to the pathological change part in time, the loss of the medicine liquid is reduced, the excessive medicine is prevented from entering the human body circulation, and the side effect of the medicine on the human body is reduced. Moreover, before the drug delivery hole is broken and leaked, air in the balloon can be completely emptied conveniently in the folding process, so that air cannot be left in the balloon, the passing outer diameter of the balloon is reduced, and the capacity of the balloon passing through a lesion part is improved. And the saccule is emptied before entering the body, no air exists in the saccule, the probability of forming air embolism in the blood vessel is reduced, the safety of the operation is improved, and the operation risk is reduced.
Detailed Description
The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the invention in a schematic manner, and only the components related to the invention are shown in the drawings rather than being drawn according to the number, shape and size of the components in actual implementation, and the form, quantity and proportion of the components in actual implementation may be changed at will, and the layout of the components may be more complicated.
Furthermore, each embodiment described below has one or more technical features, which does not mean that all technical features of any embodiment need to be implemented simultaneously by a person using the present invention, or that all technical features of different embodiments can be implemented separately. In other words, in the implementation of the present invention, based on the disclosure of the present invention, and depending on design specifications or implementation requirements, a person skilled in the art can selectively implement some or all of the technical features of any embodiment, or selectively implement a combination of some or all of the technical features of a plurality of embodiments, thereby increasing the flexibility in implementing the present invention.
To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention. As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the meaning of "a plurality" generally includes at least two unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. It should also be understood that the present invention repeats reference numerals and/or letters in the various embodiments. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed. It will also be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or one or more intervening elements may be present. Herein, the proximal end is the end near the operator, and the distal end is the end that enters the body first.
The utility model discloses a core thought is to provide a sacculus pipe, be provided with the administration hole on the sacculus surface, be used for releasing the liquid medicine, nevertheless before releasing the liquid medicine, the administration hole does not run through the sacculus wall, there is not the problem that the liquid medicine leaks from the sacculus, do so, the integrality of sacculus has been guaranteed, make the sacculus can keep at the pressure of full in-process, thereby can fully expand and fully laminate with the vascular wall, reduce the loss of liquid medicine, improve the transfer rate of medicine, prevent that excessive medicine from getting into the human circulation, reduce the side effect of medicine to the human body. When the pressure in the balloon reaches a certain value, the structure at the administration hole is weak (namely, the wall of the balloon at the administration hole is thin, the pressure limit strength is low, and the balloon is easy to break), so that the balloon is easy to break under the pressure action of the liquid medicine at the administration hole, and after the balloon is broken, the liquid medicine in the balloon can be released, and the liquid medicine is transferred to a lesion part, thereby achieving the purpose of targeted therapy. In particular, since the administration hole does not initially penetrate the balloon, it is easy to completely evacuate air inside the balloon during folding so that no air remains inside the balloon, thereby reducing the passing outer diameter of the balloon so that the passing outer diameter of the balloon can be easily designed to a theoretical minimum value. It will be appreciated that the smaller the outer diameter of the balloon, the easier it is to pass through the lesion and the greater its ability to pass through the lesion. It will be understood that the through outer diameter is the smallest outer diameter of the balloon catheter through the lesion. In addition, because the saccule is emptied before entering the body, the inside of the saccule does not have air, thereby reducing the probability of forming air embolism in the blood vessel, improving the safety of the operation and reducing the operation risk.
The balloon catheter provided by the invention is further described with reference to the accompanying drawings and preferred embodiments.
Fig. 1 is a schematic structural view of a balloon catheter according to a preferred embodiment of the present invention. As shown in fig. 1, The embodiment of The present invention provides aballoon catheter 100, and Theballoon catheter 100 may be of a coaxial whole Exchange type (OTW) or a Rapid Exchange type (Rapid Exchange System), and The specific Exchange form is not limited.
Theballoon catheter 100 of the present embodiment is a drug-infused balloon to provide drugs to the lesion site through the holes on the surface of the balloon. Specifically, theballoon catheter 100 includes aballoon 11 and a cathetermain body 12, and theballoon 11 is disposed at a distal end of the cathetermain body 12. Theballoon 11 may be a single layer balloon or a multi-layer balloon, without limitation. By single layer balloon is meant that the number ofballoons 11 is one, but that theballoons 11 have only one wall made of the same material. By a multilayer balloon is meant that the number ofballoons 11 is one, but that theballoon 11 consists of a multilayer wall made of different materials, for example of two layers of walls of different materials.
Next, as shown in fig. 2 and 3, a plurality of administration holes 111 are opened on the surface of theballoon 11, the number of administration holes 111 is not required, and the shape of the administration holes 111 is not limited, and may be a regular shape as shown in fig. 2 to 4, or an irregular shape as shown in fig. 5. The regular-shapedadministration hole 111 may be circular, rectangular, triangular, quadrangular, polygonal, elliptical, or the like. Further, the shape of the administration holes 111 on theballoon 11 may be the same or different. Further, theballoon 11 may be provided with the regular-shaped administration holes 111, the irregular-shaped administration holes 111 may be provided at the same time, or the regular-shaped administration holes 111 or the irregular-shaped administration holes 111 may be provided in theballoon 11 in a uniform manner. For example, as shown in fig. 2 and 4, acircular administration hole 111 is uniformly provided in theballoon 11; alternatively, as shown in fig. 3, arectangular administration hole 111 is provided in theballoon 11; alternatively, as shown in fig. 5, theballoon 11 may be provided with both anoval administration hole 111 and an irregularly shapedadministration hole 111. Therefore, theadministration hole 111 may be provided in various ways, and the present invention is not limited thereto.
It will be appreciated that, regardless of the drug delivery holes 111, when theballoon catheter 100 is in the first state (i.e., the initial state), the drug delivery holes 111 do not extend through the balloon wall, i.e., only extend through the outer surface of the balloon or only extend through the inner surface of the balloon, but do not extend through both the inner and outer surfaces of theballoon 11. However, when theballoon catheter 100 is in the second state (i.e. after thedrug delivery hole 111 is ruptured and leaked, which is the use state), thedrug delivery hole 111 penetrates the balloon wall, that is, penetrates the outer surface and the inner surface of the balloon, to release the drug solution. In some embodiments, as shown in fig. 6, theinner surface 112 of the balloon is perforated to form the drug delivery holes 111, and the depths of the drug delivery holes 111 may be the same or different, for example, the depths of the drug delivery holes 111 may be different to accommodate a balloon with a non-uniform wall thickness, and none of the drug delivery holes 111 penetrates through theouter surface 113 of the balloon. In other embodiments, as shown in fig. 7, theouter surface 113 of the balloon is perforated to form the drug delivery holes 111, and the depths of the drug delivery holes 111 may be the same or different, for example, the depths of the drug delivery holes 111 may be different to accommodate balloons with non-uniform wall thickness, and none of the drug delivery holes 111 penetrate theinner surface 112 of the balloon. The utility model discloses do not add the restriction to the formation mode ofdosing hole 111, can punch on the surface ofsacculus 11 through the syringe and form circularshape dosing hole 111 for example, or use laser etching process to punch on the surface ofsacculus 11 and form regular or irregularly shapeddosing hole 111. It should be understood that the wall thickness of the balloon is usually very small, for example, only 0.03mm to 0.04mm, and the drug delivery hole that does not penetrate through the balloon is processed on the balloon wall that is so thin, and there is a certain difficulty in the process, in order to overcome this difficulty, it is preferable to form thedrug delivery hole 111 that does not penetrate through the balloon wall on the surface of theballoon 11 by using a laser etching process, and in order to ensure the drilling precision, optimization is made on laser control parameters, preferably, the focal point of the laser is at a predetermined depth in the thickness direction of the balloon, and the focal point of the laser is much smaller than the wall thickness of the balloon, and further, the laser light source is preferably a carbon dioxide, ultraviolet or blue light source, the energy of the laser is 0.001MW to 1000MW, and the laser wavelength is preferably 1nm to 2000nm, so as to facilitate the precise processing of thedrug delivery hole 111 that does not penetrate through.
Further, the drug delivery holes 111 may be regularly or irregularly distributed on theballoon 11, for example, as shown in fig. 2 to 4, the drug delivery holes 111 may be regularly distributed on theballoon 11, and for example, as shown in fig. 5, the drug delivery holes 111 may be irregularly distributed on theballoon 11. Preferably, the administration holes 111 are irregularly distributed on theballoon 11, which is not only beneficial to reducing the aperture of the administration holes 111, but also convenient to adapt to irregular lesion positions, and realizes targeted administration of the irregular lesion positions. In addition, in the first state, the depth of theadministration hole 111 is preferably 1% to 99% of the balloon wall thickness, and more preferably 80% of the balloon wall thickness, so that theadministration hole 111 can be ruptured and leaked under the action of low medical liquid pressure. In addition, the administration holes 111 are preferably distributed along the entire circumference of theballoon 11 to achieve 360 ° administration.
Further, thecatheter body 12 includes anouter tube 121 and aninner tube 122, theinner tube 122 is inserted into theouter tube 121, and a distal end of theinner tube 122 extends out of a distal end of theouter tube 121. The proximal end of theballoon 11 is connected to anouter tube 121 and the distal end of theballoon 11 is connected to aninner tube 122. Wherein, theinner tube 122 is used for guiding a wire, a perfusion channel is formed between theouter tube 121 and theinner tube 122, a distal end of the perfusion channel is communicated with the inner cavity of theballoon 11 to deliver a liquid medicine to the inside of theballoon 11 through the perfusion channel, during the process of delivering the liquid medicine, firstly when theadministration hole 111 is not opened, theballoon 11 can be filled with the liquid medicine, and after theadministration hole 111 is opened, the liquid medicine is released through theadministration hole 111.
Further, a visualization structure made of a visualization material is provided on the section of theinner tube 122 inside theballoon 11 for positioning theballoon 11 during the procedure. The visualization structures may includeproximal visualization structure 123 anddistal visualization structure 124, which may be visualization points, visualization rings, or visualization segments. For example, the image-developing structure may be embedded in theinner tube 122 or may be integrally formed with theinner tube 122. For example, during manufacture, some of the length of theinner tube 122 inside theballoon 11 is designed to be visualized, such that the visualization structure is integrally formed with theinner tube 122. The near-end developing structure 123 is arranged corresponding to the near end of theballoon 11, so that the position of the near end of the balloon can be conveniently developed and positioned under X-rays, and the far-end developing structure 124 is arranged corresponding to the far end of theballoon 11, so that the position of the far end of the balloon can be conveniently developed and positioned under X-rays.
Preferably, theballoon 11 is made of a developing material, so that theballoon 11 itself can be developed, and the expanded state of theballoon 11 can be observed conveniently during the operation, so that the doctor can perform the operation more accurately. The imaging material from which theballoon 11 is made is not limited, and includes, but is not limited to, barium sulfate. The shape of theballoon 11 may be straight, that is, theballoon 11 after being expanded is a cylinder with a uniform diameter, so as to be convenient for matching with a blood vessel with a uniform diameter. In other embodiments, theballoon 11 may be dumbbell-shaped, i.e., large at both ends and small in the middle. Considering that the blood vessel has a certain taper for long lesions, the shape of theballoon 11 is preferably dumbbell-shaped in order to make the drug contact with the blood vessel wall sufficiently and to prevent the balloon at the distal end from damaging the normal blood vessel. The dumbbell-shapedballoon 11 also has the advantages that the balloon can be plugged at two ends, so that the liquid medicine is prevented from running off to the far end, and the transfer rate of the liquid medicine is ensured. Wherein, when theballoon 11 is dumbbell-shaped, theadministration hole 111 is mainly provided on the middle flat section.
Further, the balloon catheter further includes ahandle 13, and thehandle 13 may be "Y" shaped, disposed at the proximal end of thecatheter body 12, and may be connected to the proximal ends of theinner tube 122 and theouter tube 121. Further, a plurality of luer fittings, such as two luer fittings, may be provided on thehandle 13, through which a guide wire may be threaded into the catheter, and an external liquid supply device may be connected to the luer fittings to deliver a liquid medicine into the catheter. Further, the balloon catheter further comprises astress diffusion tube 14, and theouter tube 121 is connected with thehandle 13 through thestress diffusion tube 14. The effect of thestress diffusion tube 14 is to reduce the loss of push force during catheter advancement. Further, thestress diffusion tube 14 is connected to thehandle 13 by means of physical bonding, for example, the inner diameter of thehandle 13 is larger than the outer diameter of thestress diffusion tube 14, so that thestress diffusion tube 14 can be inserted into thehandle 13 and bonded together by means of elastic deformation.
Next, the operation of the balloon catheter of the present embodiment will be described further.
Firstly, after theballoon 11 enters the body, after theballoon 11 is positioned by the developing structure on theinner tube 122, the liquid medicine is sent into theballoon 11 through the perfusion channel, so that theballoon 11 is inflated, and after theballoon 11 reaches the nominal diameter, the pressure is kept unchanged, so that theballoon 11 is kept in a fully expanded state and fully contacts with the blood vessel wall, and then the pressurization or the pressure maintenance can be continued until theadministration hole 11 is broken and leaked, the liquid medicine is released, and the liquid medicine is released through theadministration hole 111 and absorbed by the lesion part, so that the corresponding treatment effect is achieved. By the arrangement, when the targeted drug delivery is realized, excessive drugs can be prevented from entering human body circulation, and the side effect of the drugs on the human body is reduced. Moreover, the administration holes 111 on the surface of theballoon 11 can be distributed in 360 degrees in the circumferential direction, 360-degree all-directional administration is realized, and the administration efficiency is high.
Furthermore, the utility model is not limited to the type of the drug to be administered, such as anti-tumor drug, antibiotic, thrombolytic drug, antithrombotic drug, vasodilator developer, etc. In addition, the surface of theballoon 11 can be provided with a hydrophilic coating to improve the lubricity of the surface of the balloon.
Further, theballoon catheter 100 of the present embodiment may include a single balloon, or two nested balloons. As shown in fig. 8, when theballoon catheter 100 includes two nested balloons, afirst balloon 11a (outer balloon) and a second balloon 11b (inner balloon) may be included, the second balloon 11b being nested within thefirst balloon 11 a; wherein, a first administration hole (not shown) is provided on the surface of thefirst balloon 11 a; when theballoon catheter 100 is in the first state, the first administration hole does not penetrate through the balloon wall of thefirst balloon 11 a; when theballoon catheter 100 is in the second state, the first administration hole penetrates through the balloon wall of thefirst balloon 11 a; a second administration hole (not shown) is provided in the surface of the second balloon 11b, and the second administration hole is always inserted through the balloon wall of the second balloon 11b in the first state and the second state. In a similar way, in the filling process, the double balloons can be fully expanded and fully contacted with the vascular wall, the air inside the double balloons can be emptied in the folding process, the air embolism formed in the body can be avoided, and the double balloons are small in outer diameter and strong in ability of passing through the pathological change part. More specifically, after the medical fluid enters the second balloon 11b through the perfusion channel in theconduction body 12, the second balloon 11b and thefirst balloon 11a are fully expanded, after the second balloon 11b and the first balloon are fully expanded, the medical fluid is continuously perfused into the second balloon 11b, and under the pressure of the medical fluid, the medical fluid flows into thefirst balloon 11a through the second administration hole in the second balloon 11b, and after the first administration hole in thefirst balloon 11a is broken, the medical fluid overflows into the blood vessel from the first administration hole in thefirst balloon 11 a. The design of the double saccules is beneficial to preventing the liquid medicine from being directly sprayed into the blood vessel at a higher speed through the buffer action of the outer saccule, reducing the stimulation effect on the blood vessel and reducing the occurrence of vasospasm. Alternatively, the second administration hole of the second balloon 11b may not penetrate through the balloon wall in the initial state and be ruptured after subsequent pressurization, and the first administration hole of thefirst balloon 11a may always penetrate through the balloon wall of thefirst balloon 11a, more specifically, when theballoon catheter 100 is in the first state; when theballoon catheter 100 is in the second state, the second administration hole penetrates through the balloon wall and is used for releasing the liquid medicine. Furthermore, it will be appreciated that the first drug delivery aperture in the first balloon and the second drug delivery aperture in the second balloon are offset.
Finally, it should be understood that theballoon catheter 100 of the present embodiment may be applicable to an unbranched blood vessel or a branched blood vessel, and may be used for treatment of a blood vessel or cancer, and not only may be more accurately administered, but also the administration safety is higher, and at the same time, the transfer rate of the drug is also high, and the ability of passing through a diseased region is stronger, and the passability is better, and in addition, the side effect of the drug on the human body is reduced, and on the other hand, slow release and long-term treatment of the drug may also be achieved, and the action period of the drug is increased, and the treatment effect is improved.
The above description is only for the preferred embodiment of the present invention, and not for any limitation of the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure all belong to the protection scope of the present invention.