CN212491101U - Drug-coated balloon catheter - Google Patents

Abstract

The utility model provides a drug coating balloon catheter, which comprises a pushing catheter, a drug coating balloon fixed at the far end of the pushing catheter, a sheath movably sleeved outside the pushing catheter, and a contraction mechanism connected with the sheath; the sheath is provided with at least one adjusting seam from the far end to the near end, the contraction mechanism comprises at least one adjusting line, the adjusting line movably penetrates through the part of the sheath positioned at two sides of the adjusting seam, and each adjusting line comprises a movable nesting structure; the movable nesting structure is tightened, and the parts of the adjusting wire pulling sheath positioned at the two sides of the adjusting seam are mutually closed or mutually overlapped so as to reduce the radial size of the sheath after accommodating the drug coating balloon; and releasing the movable nested structure, and releasing the constraint of the adjusting line on the adjusting seam. The drug coating balloon catheter can reduce the outer diameter of the far end of the sheath after accommodating the drug coating balloon, and is easy to pass and convey at the narrow part of the blood vessel.

Description

Drug-coated balloon catheter

Technical Field

The utility model belongs to the technical field of medical instrument, especially, relate to a medicine coating sacculus pipe.

Background

Arterial stenosis has been a disease troubling human beings, and in order to cure the disease, the human beings go through treatment stages of a naked balloon, a naked stent, a drug eluting stent and the like, however, the treatment schemes have different defects. The drug-coated balloon catheter is produced by transportation, a channel is established for blood circulation through balloon expansion, and drugs carried on the balloon can effectively inhibit proliferation of smooth muscle cells and prevent vascular restenosis.

The existing drug coating balloon catheter usually applies a drug coating on the outer surface of a balloon, and then expands the drug coating balloon after being conveyed to a diseased part according to the characteristics of the diseased part. However, in the conveying process of the drug-coated balloon catheter, the drug loss rate is up to more than 50 percent due to the flushing of high-speed flowing blood, so that the drug amount released by the drug-coated balloon at a diseased part is reduced, and the treatment effect is influenced; meanwhile, after the drugs flushed by blood fall off, blood vessels may be blocked, and the metabolic burden of the body may be increased.

In order to solve the problem of drug loss in the conveying process, the drug coating balloon catheter with the protective sleeve is provided, namely, the protective sleeve is sleeved outside the drug-loaded balloon, the protective sleeve and the balloon are pushed to a target position through a human blood vessel together, then the protective sleeve is withdrawn, the drug-loaded balloon is exposed, and then the balloon is expanded. Although the drug coating balloon catheter with the protective sleeve avoids the loss of drugs in the conveying process, in order to enable the protective sleeve to be smoothly withdrawn, the inner diameter of the protective sleeve is larger than the diameter of the wound balloon flap, and the protective sleeve has a certain thickness, so that the overall outer diameter of the drug coating balloon catheter is increased, and the passing and conveying of the far end of the drug coating balloon catheter at the vascular stenosis part are not facilitated.

SUMMERY OF THE UTILITY MODEL

In order to solve the technical problem, the utility model provides a drug-coated balloon catheter, which comprises a pushing catheter, a drug-coated balloon fixed at the far end of the pushing catheter, a sheath movably sleeved outside the pushing catheter, and a contraction mechanism connected with the sheath; the sheath is provided with at least one adjusting seam from the far end to the near end, the contraction mechanism comprises at least one adjusting line, the adjusting line movably penetrates through the part of the sheath, which is positioned at two sides of the adjusting seam, and each adjusting line comprises a movable nesting structure; tightening the movable nesting structure, and drawing the parts of the sheath positioned at the two sides of the adjusting seam by the adjusting wire to mutually close or mutually stack so as to reduce the radial size of the sheath after accommodating the drug-coated balloon; and releasing the movable nested structure, and releasing the constraint of the adjusting line on the adjusting seam.

The utility model provides a medicine coating sacculus pipe not only sets up the sheath and reduces the medicine loss rate of medicine coating sacculus in transportation process, still sets up the shrink mechanism who is connected with the sheath, and the sheath is seted up at least one from the distal end towards its near-end and is adjusted the seam, and shrink mechanism includes at least one regulation line that has movable nested structure, one it is located one to adjust the line activity ground and pass the sheath adjust the part of seam both sides, through tightening up activity nested structure can make the sheath be located adjust the part of seam both sides and draw close each other or range upon each other, and the radial dimension behind the medicine coating sacculus is acceptd to the sheath can reduce, and the whole external diameter of medicine coating sacculus pipe distal end reduces thereupon to medicine coating sacculus pipe distal end easily passes through the narrow position of blood vessel and easily carries at the narrow position of blood.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic structural view of a drug-coated balloon catheter according to an embodiment of the present invention.

Fig. 2 is a schematic partial cross-sectional structural view of the drug-coated balloon catheter of fig. 1.

Fig. 3 is a sectional view taken along line III-III in fig. 1.

Fig. 4 is a cross-sectional view of the sheath of fig. 3 in its natural state.

Fig. 5 is a schematic view of the connection of the portions of the sheath on either side of the adjustment slit in fig. 1 to the retraction mechanism.

Fig. 6 is a perspective view of the sheath of fig. 5 corresponding to the adjustment seam.

FIG. 7 is a schematic view of the adjustment line of FIG. 5 when the plurality of folded sections are not nested.

FIG. 8 is a perspective view of one embodiment of the sheath when the portion of the sheath corresponding to the adjustment slit is constrained by the adjustment line.

Fig. 9 is a perspective view of another embodiment of the sheath when the portion corresponding to the adjustment slit is restrained by the adjustment line.

Fig. 10 to 12 are schematic views of the use of the drug-coated balloon catheter of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 1 to 5, a drug-coated balloon catheter 100 according to an embodiment of the present invention includes a catheter holder 10, a pushing catheter 20 fixedly connected to a distal end of the catheter holder 10, a drug-coated balloon 30 fixedly connected to a distal end of the pushing catheter 20, a sheath 40 movably sleeved outside the pushing catheter 20, and a contraction mechanism 50 connected to the sheath 40. The sheath 40 moves axially relative to the pusher catheter 20 to receive or expose the drug-coated balloon 30 at the distal end of the pusher catheter 20, i.e., axial movement of the sheath 40 can cause the drug-coated balloon 30 to extend from the distal end of the sheath 40 and be exposed to the lesion of the stenosis in the vessel. It can be understood that the drug-coated balloon 30 is accommodated in the sheath 40, and when the drug-coated balloon is conveyed in a human blood vessel, the sheath 40 can reduce the drug loss of the drug coating on the surface of the drug-coated balloon 30 caused by blood flow scouring, which is beneficial to reducing the drug loss rate of the drug-coated balloon 30 and improving the drug utilization rate.

It is important to note that sheath 40 defines at least one adjustment slit 41 from its distal end toward its proximal end, retraction mechanism 50 includes at least one adjustment wire 51, an adjustment wire 51 movably passes through portions 43 of sheath 40 on either side of an adjustment slit 41, and each adjustment wire 51 includes a movable nesting feature. The movable nested structure is tightened, the adjusting wire 51 pulls the parts 43 of the sheath 40 positioned at the two sides of the adjusting slit 41 to mutually close or mutually stack, so that the radial size of the sheath 40 after accommodating the drug-coated balloon 30 is reduced, the overall outer diameter of the distal end of the drug-coated balloon catheter 100 is reduced, and the distal end of the drug-coated balloon catheter 100 is easy to pass through and be conveyed at the stenotic part of the blood vessel; in addition, tightening the movable nesting structure to reduce the radial dimension of the sheath 40 after receiving the drug-coated balloon 30 also enables the sheath 40 to tightly wrap around the drug-coated balloon 30, further reducing the drug loss rate of the drug-coated balloon 30 during delivery. Releasing the movable nested structure, releasing the restriction of the adjusting line 51 to the adjusting seam 41, and restoring the portions 43 of the sheath 40 at the two sides of the adjusting seam 41 to the natural state, that is, the initial state of the sheath 40 when the adjusting line 51 is not tightened, the sheath 40 no longer tightly surrounds the drug-coated balloon 30, and moving the sheath 40 axially towards the proximal end, the drug-coated balloon 30 can easily extend out from the distal end of the sheath 40.

The sheath 40 is preferably made of a biocompatible material, including but not limited to e-PTFE, FEP, PET, or other materials with a low coefficient of friction, or silicone, polyurethane, polyether amide, or other highly elastic materials. In this embodiment, the sheath 40 is made of a material having a low coefficient of friction to facilitate axial movement of the sheath 40 along the pusher catheter 20.

The adjusting wire 51 may be a single-strand wire or a multi-strand wire made of a biocompatible polymer material, and is preferably made of a polymer material such as PTFE, dacron, or the like. In this embodiment, the adjustment wire 51 is a medical suture.

Adjustment slits 41 may be formed by cutting the entire sheath 40 from its distal end toward its proximal end, or may be integrally formed during manufacture of sheath 40. The axial length of the adjusting slit 41 is greater than or equal to the axial length of the drug-coated balloon 30, that is, the adjusting slit 41 is opened at least at the position of the distal end of the sheath 40 corresponding to the drug-coated balloon 30.

Specifically, as shown in fig. 1 to 3, in this embodiment, the sheath 40 is provided with an adjustment slit 41 from the distal end to the proximal end thereof, the circumferential width of the adjustment slit 41 is small, an adjustment wire 51 movably passes through the portions 43 of the sheath 40 on both sides of the adjustment slit 41, when the movable nesting structure of the adjustment wire 51 is tightened, and the portions 43 of the sheath 40 on both sides of the adjustment slit 41 are stacked, so that the radial dimension of the sheath 40 corresponding to the portion of the adjustment slit 41 (i.e., the portion of the sheath 40 corresponding to the portion of the drug-coated balloon 30) is reduced after the drug-coated balloon 30 is accommodated. Preferably, the axial length of the adjustment slit 41 is about 10mm greater than the axial length of the drug-coated balloon 30, so as to ensure that the drug-coated balloon 30 can be tightly wrapped by the sheath 40 at all positions along the axial direction when the movable nesting structure of the adjustment wire 51 is tightened.

As shown in fig. 4, in a natural state, that is, when the adjustment wire 51 is not tightened and the adjustment slit 41 is not restricted, the inner diameter of the sheath 40 is larger than the outer diameter of the drug-coated balloon 30 wound by the flap, and a radial gap is formed between the drug-coated balloon 30 accommodated in the sheath 40 and the sheath 40, which facilitates the sheath 40 to move in the axial direction so that the drug-coated balloon 30 smoothly extends from the distal end of the sheath 40; as shown in fig. 3, in a state that the adjusting wire 51 and the movable nesting structure thereof are tightened, the inner diameter of the sheath 40 corresponding to the position of the adjusting slit 41 is equal to the outer diameter of the drug-coated balloon 30 accommodated in the sheath 40, and the inner wall of the sheath 40 corresponding to the position of the adjusting slit 41 tightly wraps the surface of the drug-coated balloon 30.

It is understood that in other embodiments, when the circumferential width of the adjustment slit 41 is larger, the adjustment wire 51 is tightened, so that the portions 43 of the sheath 40 on both sides of the adjustment slit 41 are close to each other but not stacked on each other, the circumferential width of the adjustment slit 41 is also reduced, and the radial dimension of the sheath 40 after receiving the drug-coated balloon 30 can also be reduced.

Of course, in order to avoid the drug coating on the surface of the drug-coated balloon 30 from being exposed at the adjustment slits 41 and causing drug loss due to blood flow scouring, the circumferential width of the adjustment slits 41 should be minimized so that the portions 43 of the sheath 40 on both sides of the adjustment slits 41 can be stacked after the adjustment wires 51 are tightened, and the drug-coated balloon 30 will not be exposed at the adjustment slits 41.

In other embodiments, the sheath 40 may also be provided with a plurality of adjustment slits 41, the portions 43 of the sheath 40 on both sides of each adjustment slit 41 are movably provided with an adjustment thread 51, and the radial dimension of the sheath 40 after accommodating the drug-coated balloon 30 is reduced by tightening the movable nesting structure of each adjustment thread 51 to make the portions 43 of the sheath 40 on both sides of each adjustment slit 41 close to or overlap each other. Preferably, when the sheath 40 is provided with the plurality of adjusting seams 41, the plurality of adjusting seams 41 are symmetrically distributed about the axial line of the sheath 40, so that after the plurality of adjusting wires 51 are tightened, the restraining force of the plurality of adjusting wires 51 on the sheath 40 is relatively uniform, and the part of the sheath 40 corresponding to the adjusting seams 41 is not easily bent due to uneven stress.

More specifically, referring to fig. 5 to 8, in the present embodiment, a row of first stitching holes 411 and a row of second stitching holes 412 are respectively formed on two sides of the adjusting slit 41 of the sheath 40, and when the portions 43 of the sheath 40 located on two sides of the adjusting slit 41 are stacked, the first stitching holes 411 and the second stitching holes 412 are correspondingly communicated one by one; the adjusting line 51 is folded in half in advance for multiple times, and comprises a first end 511, a second end 512 opposite to the first end 511, and multiple folded sections 513 which are located between the first end 511 and the second end 512 and are connected with each other in sequence; each of the two folded sections 513 passes through a corresponding and communicated first suture hole 411 and second suture hole 412, the two folded sections 513 sequentially pass through the corresponding and communicated first suture hole 411 and second suture hole 412 from the distal end to the proximal end of the sheath 40, and in each two adjacent folded sections 513, the folded section 513 located on the proximal side is nested and passes through the folded section 513 located on the distal side, and the two folded sections 513 nested in sequence form a movable nesting structure of the adjustment line 51, that is, the movable nesting structure of the adjustment line 51 sequentially passes through the corresponding and communicated first suture hole 411 and second suture hole 412 from the distal end to the proximal end of the sheath 40.

Wherein the first end 511 of the adjustment wire 51 is fixed relative to the proximal end of the sheath 40, the second end 512 of the adjustment wire 51 is a free end relative to the proximal end of the sheath 40, and the doubled-over section 513 of the adjustment wire 51 corresponding to the proximal end of the adjustment slit 41 is detachably connected relative to the proximal end of the sheath 40. Specifically, as shown in fig. 5, in the present embodiment, the retracting mechanism 50 further includes a main body 53 provided with a cylinder 531, and a retrieving member 55 provided on the main body 53, the main body 53 is fixedly sleeved on the proximal end of the sheath 40, the retrieving member 55 is rotatably connected to the main body 53, in the present embodiment, the retrieving member 55 is a wire spool rotatably connected to the main body 53; the first end 511 of the adjustment wire 51 is fixedly connected to the body member 53 and fixed relative to the proximal end of the sheath 40; the second end 512 of the adjustment wire 51 is connected to the retraction member 55, and the retraction member 55 is rotatable relative to the body member 53, whereby the second end 512 of the adjustment wire 51 is free relative to the body member 53, i.e. relative to the proximal end of the sheath 40; the folded section 513 of the adjustment wire 51 corresponding to the proximal end of the adjustment slit 41 is movably sleeved onto the column 531, so that the folded section 513 corresponding to the proximal end of the adjustment slit 41 is detachably connected with respect to the proximal end of the sheath 40. With the half sections 513 corresponding to the proximal ends of the adjustment slits 41 fitted over the cylindrical body 531, by rotating the retrievers 55, the second ends 512 of the adjustment wires 51 can be tightened or loosened, so that the lengths of the adjustment wires 51 are correspondingly changed, thereby adjusting the nesting tightness between the movable nesting structures (i.e., the plurality of half sections 513) of the adjustment wires 51. When the movable nested structure of the adjusting line 51 needs to be released, the folded sections 513 of the adjusting line 51 corresponding to the proximal ends of the adjusting slits 41 are separated from the cylinder 531, then the retrieving part 55 is rotated to wind the second end 512 of the adjusting line 51 to drive the folded sections 513 to sequentially slide out and release from the corresponding adjacent far-side folded sections 513 from the proximal end of the sheath 40 towards the distal end until the adjusting line 51 is completely wound onto the retrieving part 55 except the first end 511, and the movable nested structure of the adjusting line 51 is released.

It should be noted that, when the folded sections 513 are sequentially moved from the distal end to the proximal end of the sheath 40 to pass through the corresponding and connected first suture hole 411 and second suture hole 412 and are nested with each other, two different embodiments are possible. Specifically, referring to fig. 8, in one embodiment, a plurality of folded sections 513 pass through the first suture hole 411 and the second suture hole 412 which are correspondingly communicated, and penetrate out of the inner side of the sheath 40 to the outer side, and then are sequentially nested; referring to fig. 9, in another embodiment, a plurality of folded sections 513 are inserted from the outside to the inside of the sheath 40 through a first suture hole 411 and a second suture hole 412 which are correspondingly connected, and then are sequentially nested. It can be understood that, for convenience, the two folded sections 513 corresponding to the proximal ends of the adjustment slits 41 are sleeved on the cylinder 531 or detached from the cylinder 531, and the two ends (i.e., the first end 511 and the second end 512) of the adjustment wire 51 are connected to the main body 53 and the recovery part 55, respectively, the two ends of the adjustment wire 51 and the two folded sections 513 corresponding to the proximal ends of the adjustment slits 41 are located outside the sheath 40, so that, when the plurality of the two folded sections 513 are sequentially nested outside the sheath 40, the two folded sections 513 corresponding to the proximal ends of the adjustment slits 41 are located outside and directly sleeved on the cylinder 531, and the two ends of the adjustment wire 51 are led out to the outside of the sheath 40 through between the portions of the sheath 40 located at the two sides of the adjustment slits 41, as shown in fig. 8; when the plurality of half-folded sections 513 are sequentially nested inside the sheath 40, both ends of the adjustment wire 51 are positioned outside and directly connect the main body piece 53 and the recovering piece 55, respectively, and the half-folded section 513 corresponding to the proximal end of the adjustment slit 41 is drawn outside the sheath 40 through between portions of the sheath 40 positioned on both sides of the adjustment slit 41, as shown in fig. 9. The two ends of the adjusting line 51 and the folded section 513 corresponding to the proximal end of the adjusting slit 41 are located outside the sheath 40, which is convenient for operation and simple in structure.

Referring to fig. 2-4, in the present embodiment, the catheter hub 10 includes a guidewire tube and an inflation tube disposed at a distal end of the guidewire tube, and an axis of the guidewire tube and an axis of the inflation tube are at an angle. The proximal end of the guide wire barrel is provided with a guide wire port 11, and the proximal end of the filling barrel is provided with a filling port 12. The distal end of the push catheter 20 axially penetrates through both ends of the drug-coated balloon 30 and is hermetically connected with the drug-coated balloon 30 by welding, bonding or fixing by a fixing member. The pusher catheter 20 includes a first portion 21 housed within the drug-coated balloon 30 and a second portion 22 exposed outside of the drug-coated balloon 30. The inside of propelling movement pipe 20 is provided with a wire chamber 201 and a sufficient chamber 202 along the axial, and wire chamber 201 axial runs through the both ends of propelling movement pipe 20, and wire chamber 201 and sufficient chamber 202 keep apart each other and set up side by side, and the first portion 21 of propelling movement pipe 20 has still been seted up the inside sacculus of the sufficient chamber 202 of intercommunication and medicine coating sacculus 30 and has been filled mouthful 203.

Wherein, the guide wire port 11 is communicated with the guide wire cavity 201 to accommodate and pass through the guide wire; the filling cavity 202 is communicated with the filling port 12 and the balloon filling opening 203, and the filling port 12, the filling cavity 202 and the balloon filling opening 203 form a channel for filling or pressure relief of the drug coating balloon 30, so that the drug coating balloon 30 is filled or pressure relief by pumping liquid into or out of the drug coating balloon 30. Specifically, the inflation port 12 may be connected to an external pressure pump, and the inflation fluid enters or exits the interior of the drug-coated balloon 30 via the inflation port 12, the inflation lumen 202, and the balloon inflation port 203 to achieve inflation or deflation of the drug-coated balloon 30.

In other embodiments, the user may provide multiple filling ports 12 on the catheter hub 10 depending on the actual state of the diseased tissue and the time required for filling, and accordingly, multiple filling lumens 202 may be provided inside the pusher catheter 20.

Further, as shown in fig. 2, the distal end of the pushing catheter 20 is further provided with at least one visualization locating mark 23, preferably, the visualization locating mark 23 is provided at the proximal end and/or the distal end of the first portion 21 of the pushing catheter 20 corresponding to the drug-coated balloon 30, and the visualization locating mark 23 is made of a radiopaque material for locating the drug-coated balloon 30 during the operation. The development positioning mark 23 may take various forms such as a ring, a thread, a strip, or a dot, and is fixed on the pushing catheter 20 by a common technique such as crimping, heat fusing, bonding, welding, or riveting. In this embodiment, two developing positioning marks 23 are disposed at positions of the first portion 21 of the push catheter 20 corresponding to two ends of the drug-coated balloon 30, so as to accurately position the drug-coated balloon 30.

Referring to fig. 2 to 4 again, as mentioned above, in the present embodiment, a drug-coated balloon 30 is fixedly disposed at the distal end of the pushing catheter 20, and the drug-coated balloon 30 includes a balloon body 31 and a drug coating 32 covering the outer surface of the balloon body 31. The balloon body 31 is an expandable balloon, and the balloon body 31 can be selectively filled with liquid or drained of liquid, so that the adherence of the drug-coated balloon 30 can be improved; the drug coating 32 covers at least a portion of the outer surface of the balloon body 31. The drug coating layer 32 is formed on the balloon body 31 mainly by coating.

Wherein, the drug coating 32 contains active drugs for inhibiting smooth muscle cell proliferation, such as paclitaxel, rapamycin, etc.; optionally, the drug coating 32 may further comprise a carrier for promoting rapid release of the active drug from the outer surface of the balloon body 31 or promoting absorption of the diseased tissue, including but not limited to organic acid salts or polyols. In this example, paclitaxel was used as the active drug and mannitol was used as the carrier.

As shown in fig. 2, the balloon body 31 of the drug-coated balloon 30 includes a working section 311 and two connecting sections 312. The working section 311 of the drug-coated balloon 30 is disposed in the middle of the drug-coated balloon 30, and the two connecting sections 312 are disposed at two opposite ends of the working section 311. The working section 311 of the drug-coated balloon 30 is substantially cylindrical, so that after the drug-coated balloon 30 is expanded, the working section 311 can be attached to the blood vessel of the lesion site, and the active drug can be effectively transferred to the inner wall of the blood vessel of the lesion site. The two connecting sections 312 of the drug-coated balloon 30 are generally tapered. The two connecting segments 312 of the drug-coated balloon 30 are fixedly attached to opposite sides of the first portion 21 of the pusher catheter 20. Considering that the contact part of the drug-coated balloon 30 with the blood vessel is mainly the working section 311, in this embodiment, the drug coating 32 may be disposed on the outer surface of the balloon body 31 corresponding to the working section 311.

It should be noted that the length of the drug-coated balloon 30 is generally in the range of 30-320mm, the length of the working section 311 (i.e., the effective length of the drug-coated balloon 30) is in the range of 20-300mm, and the diameter of the working section 311 is in the range of 2-15 mm. Wherein, the effective length refers to the length which can be attached to the inner wall of the blood vessel after the saccule is expanded. The size specifications of the drug-coated balloon 30, such as diameter, effective length, etc., can be selected according to the diameter of the blood vessel of the lesion part to be dilated.

It is understood that in other embodiments, the number of drug-coated balloons 30 fixedly disposed at the distal end of the pusher catheter 20 may be multiple so as to simultaneously dilate multiple lesions. For example, the plurality of drug-coated balloons 30 are fixedly disposed at the distal end of the same push catheter 20, and the axial distance between two adjacent drug-coated balloons 30 may be zero or may be spaced at a certain distance according to the lesion site. The plurality of drug-coated balloons 30 may be identical or different in shape and diameter. The arrangement of the multiple drug coating balloons 30 can not only treat different focuses simultaneously, but also block blood flow after one of the drug coating balloons 30 is inflated, so that the drug coating 32 on the surface of the other drug coating balloon 30 is prevented from being washed away by blood flow. In this case, the drug coating 32 may not be provided on the balloon body 31 that is inflated first, to reduce the cost of the device.

It should be noted that, when the plurality of drug-coated balloons 30 are fixedly disposed at the distal end of the push catheter 20, the axial length of the adjustment slit 41 formed in the sheath 40 should be greater than or equal to the overall axial length of the plurality of drug-coated balloons 30, that is, the adjustment slit 41 is formed at least at the position corresponding to the plurality of drug-coated balloons 30 at the distal end of the sheath 40, and by tightening the adjustment wire 51 and the movable nesting mechanism thereof, the radial dimension of the distal end of the sheath 40 after accommodating the plurality of drug-coated balloons 30 is reduced, so that the overall outer diameter of the distal end of the drug-coated balloon catheter 100 is reduced therewith, and the distal end of the drug-coated balloon catheter 100 is easily conveyed through a stenotic site and at the stenotic site.

Referring again to fig. 1 and 2, in order to facilitate manipulation of the sheath 40 to move axially relative to the push catheter 20, the drug-coated balloon catheter 100 further includes a sliding mechanism 60 connected to the proximal end of the sheath 40, and the sliding mechanism 60 includes a supporting member 61 sleeved outside the push catheter 20 and a sliding member 62 connected between the sheath 40 and the supporting member 61. In this embodiment, the pushing catheter 20, the sheath 40, the supporting member 61 and the sliding member 62 are coaxially disposed. The sliding member 62 slides along the axial direction of the pushing catheter 20 through the supporting member 61, so as to drive the sheath 40 to move axially relative to the pushing catheter 20, thereby accommodating the drug-coated balloon 30 in the sheath 40 or exposing the drug-coated balloon 30 out of the sheath 40.

As shown in fig. 1 and 2, the main body 53 of the retracting mechanism 50 is fixedly connected to the distal end of the sliding member 62, and when the sliding member 62 drives the sheath 40 to move, the main body 53 moves along with the sliding member 62 and is fixed relative to the sheath 40. The proximal end of sheath 40 can be fixedly connected to the distal end of slider 62 through body member 53, body member 53 being fixedly secured over the proximal end of sheath 40; the proximal end of the sheath 40 may also be fixedly connected directly to the body member 53 and the body member 53 fixedly connected to the distal end of the slide 62, i.e. the body member 53 is connected between the proximal end of the sheath 40 and the distal end of the slide 62.

In this embodiment, the supporting member 61 is a telescopic structure, and has an extended state in an initial state and a compressed state when an axial force is applied, and when the supporting member 61 is in the extended state, the drug-coated balloon 30 is accommodated in the sheath 40; when struts 61 are in a compressed state, drug-coated balloon 30 is exposed outside sheath 40. Specifically, as shown in fig. 1 and 2, the support 61 is a plurality of sleeves that are nested together when the slide 62 slides proximally relative to the pusher catheter 20, and the sheath 40 moves axially relative to the pusher catheter 20 toward the proximal end of the pusher catheter 20 to expose the drug-coated balloon 30 to the environment of the blood vessel. In this manner, the operator can drive axial relative movement between the sheath 40 and the pusher catheter 20 by controlling the axial sliding of the slide 62.

The supporting member 61 is a telescopic structure formed by at least two sleeves, when the supporting member 61 is in an extended state, the diameters of the plurality of sleeves can be gradually increased or decreased from the proximal end of the supporting member 61 to the distal end of the supporting member 61, the diameters between any two adjacent sleeves have a difference, and the value range of the diameter difference is 0.4mm to 1.2 mm. In this embodiment, the supporting member 61 includes a first sleeve 611 at the distal end, a second sleeve 612 at the proximal end, and a third sleeve 613 sleeved between the first sleeve 611 and the second sleeve 612, wherein the diameters of the first sleeve 611, the second sleeve 612, and the third sleeve 613 are gradually decreased, the distal end of the first sleeve 611 is fixedly connected to the proximal end of the sliding member 62, the proximal end of the second sleeve 612 is fixedly connected to the catheter hub 10, and the push catheter 20 sequentially passes through the opposite ends of each sleeve. It is understood that in other embodiments, the diameters of the first sleeve 611, the second sleeve 612 and the third sleeve 613 may be gradually increased, the distal end of the first sleeve 611 is fixedly connected to the proximal end of the sliding member 62, and the proximal end of the second sleeve 612 is fixedly connected to the proximal end of the push catheter 20 and/or the distal end of the catheter hub 10.

In other embodiments, the support 61 may be provided without the third sleeve 613, or with more third sleeves 613, and the number of third sleeves 613 may be specifically designed according to the actual sliding distance of the sliding member 62.

In this embodiment, when the drug-coated balloon catheter 100 is in the initial state, the sheath 40 is sleeved outside the drug-coated balloon 30, the first sleeve 611, the third sleeve 613 and the second sleeve 612 are sequentially connected in a sleeved manner, at this time, the adjusting wire 51 and the movable nesting structure thereof penetrating through the sheath 40 are in a tightened state, and the portions 43 of the sheath 40 at the two sides of the adjusting slit 41 are mutually stacked, so that the radial dimension of the sheath 40 after accommodating the drug-coated balloon 30 is reduced, and the overall outer diameter of the distal end of the drug-coated balloon catheter 100 is reduced accordingly, so that the distal end of the drug-coated balloon catheter 100 is easily conveyed through and at a stenosed part of a blood vessel; when the drug-coated balloon 30 reaches the lesion site, the operator releases the movable nesting structure to release the restriction of the adjustment line 51 to the adjustment slit 41 of the distal portion of the sheath 40, the portions 43 of the sheath 40 at both sides of the adjustment slit 41 return to the natural state, so that the drug-coated balloon 30 easily extends from the distal end of the sheath 40, and then the sliding member 62 is operated to withdraw the proximal end of the push catheter 20, the sliding member 62 drives the sheath 40 to move proximally, and under the pushing action of the sliding member 62, the first sleeve 611 and the third sleeve 613 sequentially slide proximally, so that the sleeves are sequentially stacked together, and at this time, the drug-coated balloon 30 is exposed out of the sheath 40 and exposed in blood. It can be understood that the sleeves sleeved outside the push catheter 20 can prevent the push catheter 20 from bending, so as to ensure the smoothness of the withdrawal of the sheath 40.

In other embodiments, the support 61 may be a bellows with a telescopic structure, and when the sliding member 62 is withdrawn towards the proximal end of the pushing catheter 20, the bellows is compressed and deformed, so that the axial length of the support 61 is reduced to expose the drug-coated balloon 30 out of the sheath 40.

In other embodiments, the supporting element 61 may also be a hollow sleeve with a rigid structure, the outer diameter of the supporting element 61 is smaller than the inner diameter of the sheath 40, the distal end of the sliding element 62 is fixedly connected to the proximal end of the sheath 40, the sliding element 62 is slidably connected to the supporting element 61, and when the sliding element 62 drives the sheath 40 to withdraw towards the proximal end of the push catheter 20, the sliding element 62 and the sheath 40 slide on the supporting element 61, which can also realize that the drug-coated balloon 30 is exposed out of the sheath 40.

Referring to fig. 10-12, a procedure for treating a stenotic lesion 71 of a blood vessel 70 using a drug-coated balloon catheter 100 of the present invention is shown.

Firstly, the drug-coated balloon 30 is accommodated in the distal end of the sheath 40, the adjusting wire 51 and the movable nesting structure thereof are tightened, and the parts 43 of the sheath 40 positioned at the two sides of the adjusting seam 41 are mutually overlapped, so that the radial dimension of the sheath 40 accommodating the drug-coated balloon 30 is reduced, and the overall outer diameter of the distal end of the drug-coated balloon catheter 100 is reduced; the distal portion of the drug-coated balloon catheter 100 is then delivered to the stenotic lesion 71 of the blood vessel 70 through the delivery sheath and guidewire, as shown in fig. 10.

Then, the folded section 513 of the adjusting wire 51 corresponding to the proximal end of the sheath 40 is released, the retracting member 55 is rotated to retract the adjusting wire 51, and the restriction of the adjusting wire 51 to the sheath 40 is released, so that the distal end of the sheath 40 corresponding to the drug-coated balloon 30 is restored to the original state; the control slide 62 causes the sheath 40 to retract toward the proximal end of the push catheter 20, i.e., the sheath 40 slides toward the proximal end of the push catheter 20 until the drug-coated balloon 30 is exposed outside the sheath 40, at which time the drug-coated balloon 30 is exposed in the blood vessel 70 and aligned with the stenotic lesion 71, as shown in fig. 11.

Finally, the drug-coated balloon 30 is inflated, after the drug-coated balloon 30 is inflated, the blood vessel 70 of the stenotic lesion 71 is fully expanded, and the drug coating 32 is released from the surface of the drug-coated balloon 30 and transferred to the blood vessel wall to exert the drug effect, as shown in fig. 12. Then, the drug-coated balloon 30 can be decompressed, and the patient is removed from the body, thereby completing the operation.

The utility model discloses another embodiment provides a drug coating sacculus pipe is similar basically with the structure of the drug coating sacculus pipe 100 of first embodiment, and the difference lies in: in the second embodiment, the sheath 40 is provided with at least one adjusting slit 41 extending from the distal end to the proximal end, compared with the first embodiment, the axial length of the adjusting slit 41 is equal to the axial length of the sheath 40, and the whole sheath 40 is constrained by the adjusting wire 51, so that the whole external diameter of the part of the sheath 40 of the drug-coated balloon catheter inserted into the human body is reduced, and the sheath can be applied to a delivery sheath with a smaller internal diameter. Further, after the sheath 40 is released from the constraint of the adjustment wire 51, the friction between the sheath 40 and the push catheter 20 is reduced, which facilitates the withdrawal of the sheath 40 to expose the drug-coated balloon 30.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims (14)

1. A drug coating sacculus catheter comprises a pushing catheter, a drug coating sacculus fixed at the far end of the pushing catheter, and a sheath movably sleeved outside the pushing catheter, and is characterized by further comprising a contraction mechanism connected with the sheath; the sheath is provided with at least one adjusting seam from the far end to the near end; the contraction mechanism comprises at least one adjusting line, the adjusting line movably penetrates through the part of the sheath, which is positioned on two sides of the adjusting seam, and each adjusting line comprises a movable nesting structure; and tightening the movable nesting structure, and drawing the parts of the sheath positioned at the two sides of the adjusting seam by the adjusting wire to mutually draw together or mutually stack.

2. The drug-coated balloon catheter of claim 1, wherein the adjustment slit has an axial length greater than or equal to an axial length of the drug-coated balloon.

3. The drug-coated balloon catheter of claim 1, wherein the sheath has an inner diameter that is larger than an outer diameter of the drug-coated balloon housed within the sheath in a natural state; under the state of tightening the movable nesting structure, the inner diameter of the part of the sheath corresponding to the adjusting seam is equal to the outer diameter of the drug-coated balloon accommodated in the part of the sheath.

4. The drug-coated balloon catheter as claimed in claim 1, wherein the sheath is provided with a row of first suture holes and a row of second suture holes on both sides of the adjustment slit, respectively, and when the portions of the sheath on both sides of the adjustment slit are stacked on each other, the first suture holes and the second suture holes are in one-to-one correspondence communication, and the movable nesting structure of the adjustment thread sequentially moves through the first suture holes and the second suture holes in correspondence communication from the distal end toward the proximal end of the sheath.

5. The drug-coated balloon catheter of claim 4, wherein one end of the adjustment wire is fixed relative to the proximal end of the sheath, the other end of the adjustment wire is a free end relative to the proximal end of the sheath, the portion between the two ends of the adjustment wire comprises a plurality of folded sections sequentially connected with each other, and one of the folded sections movably passes through a corresponding communicated first suture hole and second suture hole; for each adjacent two of the pairs of segments, the proximally located pair of segments nests through the distally located pair of segments; the fold back section corresponding to the proximal end of the adjusting seam is detachably connected relative to the proximal end of the sheath; the plurality of folded sections which are nested in sequence form the movable nesting structure.

6. The drug-coated balloon catheter of claim 5, wherein the retraction mechanism further comprises a main body member and a retriever disposed on the main body member, the main body member being fixedly secured to the proximal end of the sheath, one end of the adjustment wire being fixedly attached to the main body member, the other end of the adjustment wire being attached to the retriever, the retriever being rotatably attached to the main body member.

7. The drug-coated balloon catheter of claim 6, wherein a post is disposed on the main body member, and the pair of segments corresponding to the proximal ends of the adjustment slits are movably sleeved on the post.

8. The drug-coated balloon catheter of claim 7, wherein both ends of the adjustment wire and the pair of segments corresponding to the proximal ends of the adjustment slits are located outside the sheath.

9. The drug-coated balloon catheter of claim 6, further comprising a sliding mechanism coupled to the proximal end of the sheath, the sliding mechanism including a support member sleeved outside the push catheter and a sliding member coupled between the sheath and the support member; the sliding piece slides along the axial direction of the pushing catheter through the support piece, so that the drug coating balloon is contained in the sheath or exposed outside the sheath; the main body piece is fixedly connected with the far end of the sliding piece.

10. The drug-coated balloon catheter of claim 9, wherein the support member is a telescoping structure having an elongated state in an initial state and a compressed state under axial force, the drug-coated balloon being contained within the sheath when the support member is in the elongated state; the drug-coated balloon is exposed outside the sheath when the support is in a compressed state.

11. The drug-coated balloon catheter of claim 10, wherein the support member is a plurality of sleeves nested within one another, the plurality of sleeves being stacked together when the drug-coated balloon is exposed outside the sheath.

12. The drug-coated balloon catheter of claim 9, further comprising a catheter hub, wherein the proximal ends of the support member and the push catheter are fixedly attached to a distal end of the catheter hub.

13. The drug-coated balloon catheter of claim 1, wherein the distal end of the push catheter is provided with at least one visualization locator mark.

14. The drug-coated balloon catheter of claim 8, wherein when the plurality of folded sections are sequentially nested outside the sheath, both ends of the adjustment wire are led out to the outside of the sheath through between portions of the sheath located on both sides of the adjustment slit; or when the plurality of folded sections are nested on the inner side of the sheath in sequence, the folded sections corresponding to the near end of the adjusting seam are led out to the outer side of the sheath through the space between the parts of the sheath positioned on the two sides of the adjusting seam.

Images