CN113730768A - Dilatation balloon and balloon dilatation catheter - Google Patents
Dilatation balloon and balloon dilatation catheter Download PDFInfo
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- CN113730768A CN113730768A CN202010408663.2A CN202010408663A CN113730768A CN 113730768 A CN113730768 A CN 113730768A CN 202010408663 A CN202010408663 A CN 202010408663A CN 113730768 A CN113730768 A CN 113730768A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1034—Joining of shaft and balloon
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Abstract
The invention provides an expansion balloon and a balloon expansion catheter, wherein the expansion balloon comprises a balloon body and a limiting part, and the balloon body can stretch between a contraction state and an unfolding state and between the unfolding state and an expansion state; the balloon body comprises a first section, a second section and a third section which are sequentially connected along the axial direction; the limiting portion is configured to limit a radial dimension of the second segment to be less than a radial dimension of the first segment or the third segment at least during expansion of the balloon body from the unfolded state to the expanded state. So the configuration, the sacculus body is by the flexible in-process of fold condition to the expansion state of solution, and the radial dimension that is located the first section and the third section at both ends is great, and the radial dimension that is located the second section in the middle of is less, ensures that the location of expansion sacculus can not take place to slide, and high efficiency high quality ground expands pathological change leaflet, avoids forming complications such as perivalvular leakage.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an expansion balloon and a balloon expansion catheter.
Background
Aortic Stenosis (AS) is one of the most common valvular heart diseases among heart valvular diseases, and seriously harms human health. For patients with severe aortic stenosis, surgical aortic valve replacement has been the only treatment to prolong their lives, but older patients often have contraindications for surgery due to advanced age, poor health, severe disease, or other complications. An increasing number of clinical results demonstrate that interventional therapy is an effective treatment for patients at these high risks or who are at too great a risk for traditional open chest surgery. Existing interventional procedures include aortic valvuloballoon angioplasty (BAV) and transcatheter aortic valve placement (TAVI). Balloon dilatation catheters are required in both aortic valvuloballoon angioplasty (BAV) and transcatheter aortic valve placement (TAVI). In aortic valvuloballoon angioplasty (BAV), a diseased native aortic valve is directly dilated with a balloon. In transcatheter aortic valve placement (TAVI), on one hand, a balloon is used for pre-dilation to expand calcified valve annulus, creating a good access condition for artificial valve implantation; on the other hand, after the aortic valve is implanted, the valve balloon catheter is expanded to ensure that the artificial valve is well unfolded and the adherence is improved, so that the treatment effect is improved.
The aortic valve sacculus expansion catheter consists of an expandable valve sacculus, a double-cavity tube body and two connecting pieces, wherein the valve sacculus is required to have the performances of low compliance, size stability, quick expansion and recovery, puncture resistance, high explosion resistance, no movement, synchronous expansion and the like; the size of the inner cavity of the double-cavity tube body is compatible with the guide wire with the corresponding specification, and the outer cavity needs to be unobstructed to ensure that the filling and pumping-back time is as short as possible.
At present, the valve balloon structure mostly adopts a straight cylinder type design or an 8-shaped design, and an inner tube is usually a circular hollow tube. The straight-tube structure is beneficial to the even expansion of the saccule at the lesion part, and the excessive expansion and tearing of valve leaflets are avoided. However, when the cylindrical balloon is expanded, the balloon is easily moved when being squeezed by the heavily calcified valve leaflets, so that the balloon deviates from the lesion position, and the effect of expanding the lesion valve leaflets cannot be achieved. The 8-shaped balloon structure can lock the lesion position through the middle waist (waist), the occurrence probability of the movement is reduced to a certain extent, but the waist section of the 8-shaped balloon structure is short in size, expansion of the balloon is limited aiming at serious calcified lesions, and after the balloon is completely expanded, the middle waist and two ends have obvious diameter difference, so that the artificial biological valve is not fully expanded, complications such as perivalvular leakage and the like are easily formed, and the balloon is not suitable for TAVI operation.
Disclosure of Invention
The invention aims to provide an expansion balloon and a balloon expansion catheter, which aim to solve the problems that the balloon is easy to move or form paravalvular leakage and the like in the conventional balloon expansion catheter.
In order to solve the above technical problem, the present invention provides an expansion balloon, including: a balloon body and a limiting part;
the balloon body can be stretched and contracted between a contraction state and an unfolding state and between the unfolding state and an expansion state; the balloon body comprises a first section, a second section and a third section which are sequentially connected along the axial direction;
the limiting portion is configured to limit a radial dimension of the second segment to be smaller than a radial dimension of the first segment or the third segment at least during expansion and contraction of the balloon body from the unfolded state to the expanded state.
Optionally, the limiting part includes: the flexible sleeve or the braided wire is sleeved outside the balloon body.
Optionally, the flexible sleeve is configured such that, when the balloon body is in the expanded state, a sum of a radial dimension of the second section and a wall thickness of the flexible sleeve is adapted to a radial dimension of the first or third section.
Optionally, when the balloon body is in the expanded state, the axial length of the second section is between 10% and 40% of the sum of the axial lengths of the first section, the second section and the third section.
Optionally, the inner side wall of the flexible sleeve is provided with a protruding structure, and the protruding structure is configured to protrude outward from the outer wall of the flexible sleeve under the action of the balloon body in the process that the balloon body stretches from the unfolded state to the expanded state.
Optionally, the initial inner diameter of the flexible sleeve when the flexible sleeve is not sleeved on the balloon body is not greater than the maximum radial dimension of the balloon body when the balloon body is in the contracted state; the flexible sleeve is also configured to be sleeved outside the balloon body and then stretch along with the stretching of the balloon body.
Optionally, the flexible sleeve limits the radial dimension of the second section to be smaller than the radial dimension of the first section or the third section in the process of telescoping the balloon body from the contracted state to the expanded state.
Optionally, the initial inner diameter of the flexible sleeve when the flexible sleeve is not sleeved on the balloon body is larger than the maximum radial size of the balloon body when the balloon body is in the contracted state; the flexible sleeve is configured to fit the second section in a co-folded manner when sleeved outside the balloon body.
Optionally, an initial inner diameter of the flexible sleeve when the flexible sleeve is not sleeved on the balloon body is smaller than a radial size of the second section when the balloon body is in the expanded state, and the flexible sleeve is further configured to be sleeved outside the balloon body and then extend and retract along with extension and retraction of the balloon body.
Optionally, the length of the flexible sleeve ranges from 90% to 130% of the axial length of the balloon body, the flexible sleeve includes a fourth section, a fifth section and a sixth section which are connected in sequence, the fourth section, the fifth section and the sixth section respectively correspond to the first section, the second section and the third section, and a radial binding force of the fifth section to the balloon body is greater than a radial binding force of the fourth section and the sixth section to the balloon body.
Optionally, the flexible sleeve is configured to select: the fourth section and the sixth section are at least one of a hollow section, the wall thickness of the fourth section and the sixth section is smaller than that of the fifth section, and the elastic modulus of the material of the fourth section and the sixth section is smaller than that of the material of the fifth section.
Optionally, the flexible sleeve and the balloon body are connected by at least one of sewing, knitting, welding and bonding.
Optionally, the flexible sleeve is connected with the balloon body in a sewing and weaving manner, the sewing and weaving manner includes not less than one sewing group, each sewing group includes not less than two sewing units, and the sewing units are arranged at intervals along the axial direction of the balloon body.
Optionally, the length of the flexible sleeve is adapted to the length of the second section.
Optionally, the expansion balloon further comprises a fixing member, the fixing member is disposed inside the first section and/or the third section, and has no axial degree of freedom with respect to the balloon body, the fixing member is flared toward the second section, and the fixing member is configured to expand a radial dimension of a connection between the first section and/or the third section and the second section when the balloon body is in the contracted state, so that the radial dimension of the connection between the first section and/or the third section and the second section is not less than a sum of the radial dimension of the second section and a wall thickness of the flexible sleeve.
Optionally, the dilatation balloon further comprises an inner tube, and the inner tube is fixedly arranged inside the balloon body along the axial direction of the balloon body; the fixing part comprises a connecting section and a flaring section, the connecting section is sleeved on the inner tube and fixedly connected with the inner tube, one end of the flaring section is connected with the connecting section, the other end of the flaring section is a free end and is in a flaring shape, and the outer diameter of the connecting section is not larger than the minimum inner size of the balloon body in the contraction state.
Optionally, the flared section has at least one split groove arranged in the axial direction of the fixing member.
In order to solve the above technical problem, the present invention also provides an expansion balloon, including: a balloon body;
the balloon body can be stretched and contracted between a contraction state and an unfolding state and between the unfolding state and an expansion state; the balloon body comprises a first section, a second section and a third section which are sequentially connected along the axial direction;
the second segment has a lower expansion than either the first segment or the third segment, and the second segment is configured to have a radial dimension that is less than a radial dimension of either the first segment or the third segment at least during expansion and contraction of the balloon body from the unfolded state to the expanded state.
In order to solve the above technical problems, the present invention also provides a balloon dilatation catheter comprising: the dilatation balloon and the catheter are as above, the far end of the balloon body is closed, the near end of the balloon body is connected with the catheter, and the catheter is used for transmitting filling fluid to drive the balloon body to stretch and contract.
In summary, in the dilatation balloon and the balloon dilatation catheter provided by the invention, the dilatation balloon comprises the balloon body and the limiting part, and the balloon body can be stretched and contracted between a contraction state and an unfolded state and between the unfolded state and an expansion state; the balloon body comprises a first section, a second section and a third section which are sequentially connected along the axial direction; the stop portion is configured to limit a radial dimension of the second segment to be less than a radial dimension of the first segment or the third segment at least during expansion of the balloon body from the unfolded state to the expanded state. So the configuration, the flexible in-process of sacculus body by unfolding the state to the expansion state, the radial dimension that is located the first section and the third section at both ends is great, and the radial dimension that is located the second section in the middle of is less, forms the structure of similar dog bone shape, ensures that the location of expansion sacculus can not take place to slide. Furthermore, the limiting part only limits the radial size of the second section of the balloon body in the expansion process, but not limits the radial size of the balloon body in the expansion state, when the balloon body is in the expansion state, the size of the second section of the balloon body can be close to or equal to the size of the first section and the third section, and a waist section with a 8-shaped structure cannot be formed, so that on one hand, an operator can select the specification of the balloon which is most suitable for treatment easily, and the diseased valve leaflets can be expanded efficiently and high-quality; on the other hand, the artificial biological valve can be fully expanded to avoid complications such as paravalvular leakage and the like, and the TAVI operation quality is improved.
Drawings
It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:
FIG. 1 is a schematic view of a balloon dilation catheter provided in accordance with a preferred embodiment of the present invention;
FIG. 2 is a schematic view of a dilation balloon provided in accordance with a preferred embodiment of the present invention in an expanded state;
FIG. 3 is a schematic view of a preferred embodiment of the present invention providing a dilation balloon in a deflated state;
FIG. 4 is a schematic illustration of a dilation balloon provided in accordance with a preferred embodiment of the present invention during dilation;
FIG. 5 is a schematic view of a flexible sleeve provided in accordance with a preferred embodiment of the present invention;
fig. 6(a) is a schematic cross-sectional view of a flexible sleeve and a balloon body according to a preferred embodiment of the present invention, wherein the flexible sleeve is disposed in an attached manner;
FIG. 6(B) is a schematic cross-sectional view of a flexible sleeve and balloon body according to a preferred embodiment of the invention, wherein the flexible sleeve is arranged in a co-foldable manner;
FIG. 7(A) is a schematic view of a suture weave of a flexible sleeve and a balloon body, including a schematic view of a suture unit, according to a preferred embodiment of the present invention;
FIG. 7(B) is a schematic representation of a suture weave of a flexible sleeve with a balloon body, including a representation of one suture set, according to a preferred embodiment of the present invention;
FIG. 8 is a schematic view of a dilation balloon provided in accordance with another preferred embodiment of the present invention in an expanded state;
FIG. 9 is a schematic view of an inflation balloon provided in accordance with another preferred embodiment of the present invention in a deflated state;
FIG. 10 is a schematic view of a flexible sleeve provided in accordance with another preferred embodiment of the present invention;
fig. 11 is a development view of a fourth segment of a flexible sleeve provided in accordance with another preferred embodiment of the present invention.
In the drawings:
1-expanding the balloon; 6-a developing ring; 7-a catheter; 71-an inner tube; 8-a sheath; 9-liquid through cavity; 10-a guidewire lumen; 11-a connector;
10-a balloon body; 11-first stage; 12-a second segment; 13-third stage; 14-a taper section;
20-a flexible sleeve; 21-fourth stage; 22-fifth section; 23-sixth section; 24-seventh paragraph; 25-raised structures;
30-a suture group; 31-a stitching unit; 40-a fixing piece; 41-connecting section; 42-flared section.
Detailed Description
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.
As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the term "or" is generally used in its sense including "and/or", the term "proximal" generally being the end near the operator, the term "distal" generally being the end near the lesion in the patient, and "one end" and "the other end" and "proximal" and "distal" generally referring to the corresponding two parts, including not only the end points, unless the content clearly dictates otherwise.
The invention provides an expansion balloon and a balloon expansion catheter, and aims to solve the problems that the balloon is easy to move or form paravalvular leakage and the like in the conventional balloon expansion catheter.
The following description refers to the accompanying drawings.
Referring to fig. 1 to 10, fig. 1 is a schematic diagram of a balloon dilatation catheter according to a preferred embodiment of the present invention, fig. 2 is a schematic diagram of an dilatation balloon according to a preferred embodiment of the present invention in an expanded state, fig. 3 is a schematic diagram of an dilatation balloon according to a preferred embodiment of the present invention in a contracted state, fig. 4 is a schematic diagram of an dilatation balloon according to a preferred embodiment of the present invention in an expanding process, fig. 5 is a schematic diagram of a flexible sleeve according to a preferred embodiment of the present invention, fig. 6(a) is a schematic diagram of a cross section of a flexible sleeve and a balloon body according to a preferred embodiment of the present invention, wherein the flexible sleeve is disposed in an attached manner, fig. 6(B) is a schematic diagram of a cross section of a flexible sleeve and a balloon body according to a preferred embodiment of the present invention, wherein the flexible sleeve is disposed in a co-folded manner, fig. 7(a) is a schematic view of suture braiding of a flexible sleeve and a balloon body according to a preferred embodiment of the present invention, which includes a schematic view of a suture unit, fig. 7(B) is a schematic view of suture braiding of a flexible sleeve and a balloon body according to a preferred embodiment of the present invention, which includes a schematic view of a suture group, fig. 8 is a schematic view of an expanded balloon according to another preferred embodiment of the present invention in an expanded state, fig. 9 is a schematic view of an expanded balloon according to another preferred embodiment of the present invention in a contracted state, fig. 10 is a schematic view of a flexible sleeve according to another preferred embodiment of the present invention, and fig. 11 is an expanded view of a fourth segment of a flexible sleeve according to another preferred embodiment of the present invention.
As shown in fig. 1, a balloon dilation catheter according to one embodiment of the present invention includes: the balloon 1 and the catheter 7 are expanded. Preferably, the catheter 7 is a double-layer structure and comprises an outer tube and an inner tube 71, the dilatation balloon 1 comprises a balloon body 10, the distal end of the balloon body 10 is closed, and the proximal end of the balloon body 10 is connected with the distal end of the outer tube of the catheter 7. The inner tube 71 of the catheter 7 penetrates out of the far end of the outer tube and extends into the balloon body 10, the inner tube 71 is fixedly arranged inside the balloon body 10 in a penetrating mode along the axial direction of the balloon body 10, a guide wire mainly penetrates through the inner tube 71, and a developing ring 6 is further arranged on the inner tube 71. A gap is formed between the outer tube and the inner tube 71, and the gap is used for transmitting the filling fluid, when the filling fluid is transmitted to the balloon body 10 through the catheter 7, the balloon body 10 is expanded, and when the filling fluid is extracted from the balloon body 10 through the catheter 7, the balloon body 10 is contracted. Further, the balloon dilatation catheter further comprises accessories such as a sheath 8, a liquid through cavity 9, a guide wire cavity 10 and a connecting piece 11, the sheath 8 comprises a three-way component inside, and the liquid through cavity 9, the guide wire cavity 10 and the catheter 7 are connected to the three-way component respectively. Optionally, the guide wire cavity 10 and the inner tube 71 of the catheter 7 are positioned on the trunk branch of the three-way component and are communicated with each other, and the three-way component is in a straight-through configuration; the liquid through cavity 9 is positioned on the side branch of the three-way component, and the liquid through cavity 9 is communicated with the outer pipe of the catheter 7. The proximal ends of the liquid passage lumen 9 and the guidewire lumen 10 are respectively connected with a connector 11 for connecting with an externally adapted component, and the components of the balloon dilatation catheter can be selected and configured by those skilled in the art according to the prior art.
Referring to fig. 2 to 10, the inflatable balloon 1 includes a balloon body 10 and a limiting portion, wherein the balloon body 10 is capable of being stretched between a contracted state and an unfolded state, and between the unfolded state and an expanded state; the balloon body 10 comprises a first section 11, a second section 12 and a third section 13 which are sequentially connected along the axial direction, and the limiting part is configured to limit the radial dimension of the second section 12 to be smaller than the radial dimension of the first section 11 or the third section 13 at least in the process that the balloon body 10 stretches from the unfolded state to the expanded state (including the process that the balloon body 10 is in the unfolded state and in the expanded state). Generally, the balloon body 10 is in a collapsed configuration when in a deflated state. When the inflation fluid is delivered to the balloon body 10 through the inflation fluid conduit 7, the balloon body 10 is first deployed from the deflated state until the unfolded state is reached. When the balloon body 10 is in the unfolded state, the folded state of the balloon body 10 is basically unfolded and is approximately circular in the radial direction, and then when the balloon body 10 is continuously conveyed with filling fluid, the balloon body 10 is elastically deformed by itself and is continuously expanded from the unfolded state until reaching the expanded state. In general, the expanded state of the balloon body 10 refers to a state of the balloon when the internal pressure of the balloon reaches a nominal (rated) pressure of the balloon or more, that is, a state when the balloon is used (when the balloon is fully expanded). Conversely, withdrawal of inflation fluid from the balloon body 10 may cause the balloon body 10 to deflate. The radial dimension herein refers to the distance from the outer sidewall of the balloon body 10 to the axis of the balloon body 10. In particular, since the outer contour shape of the balloon body 10 in the contracted state is not necessarily a complete circle (e.g., a folded and contracted outer circumference), the radial dimension herein refers to the maximum distance from the outer sidewall of the balloon body 10 to the axis of the balloon body 10. Referring to fig. 2 to 4, based on the above configuration, in the process of extending and contracting the balloon body 10 from the unfolded state to the expanded state, the radial dimensions of the first section 11 and the third section 13 at the two ends are larger, and the radial dimension of the second section 12 in the middle is smaller, so as to form a dog-bone-like structure (as shown in fig. 4), thereby ensuring that the positioning of the expanded balloon 1 does not slip. Furthermore, the limiting part only limits the radial dimension of the second section 12 of the balloon body 10 in the expansion process, but does not limit the radial dimension of the balloon body 10 in the expansion state, when the balloon body 10 is in the expansion state, the dimension of the second section 12 of the balloon body can be close to or equal to the dimension of the first section 11 and the third section 13, a waist section with a structure like a 8 shape cannot be formed, the balloon in the expansion state is similar to a straight-tube balloon, and in the pre-expansion of BAV operation or TAVI operation, an operator can select the balloon specification which is most suitable for treatment according to the size of the native valve leaflet and/or valve ring of the pathological change, so that the pathological change part can be expanded more quickly and uniformly; after the aortic valve in the TAVI operation is implanted, the artificial biological valve can be fully expanded, and the complications such as paravalvular leakage and the like are avoided, so that the TAVI operation quality is improved.
In an exemplary embodiment, the material of the balloon body 10 is selected from one or more combinations of polyester, polyamide, polyvinyl chloride, nylon elastomer and polyurethane elastomer, the balloon body 10 preferably further includes two tapered sections 14, the two tapered sections 14 are respectively connected to the distal end of the first section 11 and the proximal end of the third section 13, an included angle a of the tapered sections 14 ranges from 20 ° to 70 °, preferably from 30 ° to 50 °, further, the distal end of the tapered section 14 located at the distal end of the first section 11 has a closed head, the proximal end of the tapered section 14 located at the proximal end of the third section 13 has a connector, the connector is used for connecting with the outer tube of the catheter 7, and the connector is further used for the inner tube 71 of the catheter 7 to pass through.
In an exemplary embodiment, the first, second and third segments 11, 12, 13 of the balloon body 10 are all straight segments, the sum of the axial lengths of the first, second and third segments 11, 12, 13 ranges between 15mm and 45mm, and the nominal diameters of the first, second and third segments 11, 12, 13 range between 6mm and 30 mm. It is to be understood that the nominal diameter, herein, represents the outer diameter of each section of the balloon body 10 after full deployment at the nominal (nominal) pressure. Preferably, the length of the second section 12 is between 10% and 40%, preferably 25%, of the sum of the axial lengths of the first section 11, the second section 12 and the third section 13 of the balloon body 10; correspondingly, the sum of the axial lengths of the first section 11 and the third section 13 is between 60% and 90%, preferably 75%, of the sum of the axial lengths of the first section 11, the second section 12 and the third section 13 of the balloon body 10. When a balloon body 10 in a contracted state is inflated, the first section 11 and the third section 13 at the two ends of the balloon body 10 are expanded first due to the limitation of the limiting part, and the second section 12 is restrained by the flexible sleeve 20 during expansion, and is not expanded or slightly expanded, so that a dog-bone-like structure is formed (as shown in fig. 4). When the balloon body 10 is inflated to a first predetermined pressure (the first predetermined pressure being in the range of 0.1atm to 0.9atm, preferably 0.5atm), the difference between the radial dimensions of the first and third sections 11, 13 and the second section 12 is between 1mm and 8mm, preferably 4 mm. With the continuous filling of the balloon body 10, the limiting portion is expanded by the outer wall of the balloon body 10, and when the balloon body is filled to a second preset pressure (which may be 2.5atm to 16atm, depending on the specification of the balloon and the specific use requirement, the second preset pressure is the nominal (rated) pressure of the balloon in general), the outer diameters of the regions of the expansion balloon 1 are all equal or close, that is, the outer diameter of the first section 11, the sum of the outer diameter of the second section 12 and the thickness of the limiting portion, and the outer diameter of the third section 13 are substantially equal or close. It will be appreciated that one skilled in the art may select the appropriate inflation pressure value or size for the balloon body 10 depending on the actual specifications of the balloon body 10 and the stop.
Optionally, the limiting portion includes a flexible sleeve 20 or a braided wire sleeved outside the balloon body 10. In the following description, it is exemplified that the limiting portion includes a flexible sleeve 20, and the flexible sleeve 20 is configured such that, when the balloon body 10 is in the expanded state, the sum of the radial dimension of the second section 12 and the wall thickness of the flexible sleeve 20 is adapted to the radial dimension of the first section 11 or the third section 13. It will be appreciated that if the flexible sleeve 20 extends more than half a circumference in the circumferential direction of the balloon body 10, the sum of the radial dimension of the second section 12 and the wall thickness of the flexible sleeve 20 should comprise the total thickness of the two radially outer walls of the flexible sleeve 20. As shown in fig. 2, the flexible sleeve 20 may be a single-layer or multi-layer hollow tubular member, and the material of the flexible sleeve 20 is mainly selected from a polymer material with elasticity, such as one or more of Polyethylene (PE), rubber, polyurethane (TPU), and silicone. The flexible sleeve 20 has a certain wall thickness, and for reasons of manufacturing process, when the flexible sleeve 20 is made of a single-layer tube, the wall thickness range of the single-layer tube is preferably between 0.3mm and 1.0mm, and the nominal diameter of the second section 12 of the balloon body 10 can be slightly smaller than that of the first section 11 and the third section 13 of the balloon body 10, so as to ensure that the overall nominal diameter of the expansion balloon 1 is kept the same after the balloon body 10 is completely expanded, the outer contour is approximately in a straight-tube shape, and the expansion form of the expansion balloon 1 is optimized, on the one hand, an operator can select the balloon specification most suitable for treatment more easily, and the diseased valve leaflets are expanded with high efficiency and high quality; on the other hand, the artificial biological valve can be fully expanded to avoid complications such as paravalvular leakage and the like, and the TAVI operation quality is improved. It should be understood that the sum of the radial dimension of the second section 12 and the wall thickness of the flexible sleeve 20 is adapted to the radial dimension of the first section 11 or the third section 13, which may mean that the sum of the radial dimension of the second section 12 and the wall thickness of the flexible sleeve 20 is equal to the radial dimension of the first section 11 or the third section 13, or that the sum of the radial dimension of the second section 12 and the wall thickness of the flexible sleeve 20 is slightly larger or smaller than the radial dimension of the first section 11 or the third section 13, which is similar to the radial dimension of the first section 11 or the third section 13. In some embodiments, the radial dimension of the first segment 11 is equal to the radial dimension of the third segment 13, while in other embodiments, the radial dimension of the first segment 11 may be different from the radial dimension of the third segment 13, which is not limited by the present invention. The nominal diameter of the second section 12 is smaller than the nominal diameters of the first section 11 and the third section 13, so that the expansion balloon can keep a straight shape after being completely expanded, and in addition, the flexible sleeve 20 with a certain thickness can be matched, so that a larger change space is provided for the thickness of the flexible sleeve 20, and more functions can be realized.
Preferably, referring to fig. 5, the inner side wall of the flexible sleeve 20 is provided with a protruding structure 25, and the protruding structure 25 is configured to protrude outward of the outer wall of the flexible sleeve 20 under the action of the balloon body 10 in the process that the balloon body 10 is stretched from the unfolded state to the expanded state (including when the balloon body 10 is in the unfolded state and in the expanded state). The projection structure 25 may include a circumferentially continuous or discontinuous annular body, and further, the projection structure 25 includes a plurality of annular bodies, and the plurality of annular bodies are arranged at intervals along the axial direction. Of course, the protrusion structures 25 may also include scattered protrusions which may be irregularly distributed, or the protrusion structures 25 may include abrasive particles, etc., and the shape and arrangement of the protrusion structures 25 are not limited in the present invention. It can be understood that, according to the different sizes, different hardnesses, and the like of the protruding structures 25, the protruding structures 25 may protrude outward of the outer wall of the flexible sleeve 20 at any time when the balloon body 10 is expanded from the unfolded state to the expanded state, but not limit the entire process of the balloon body 10 expanding from the unfolded state to the expanded state, and the protruding structures 25 all protrude outward of the outer wall of the flexible sleeve 20. The arrangement of the protruding structure 25 not only increases the friction force between the flexible sleeve 20 and the outer wall of the balloon body 10, which is beneficial to fixing the flexible sleeve 20, but also realizes that when the flexible sleeve 20 is inflated in the balloon body 10, the protruding structure 25 will be exposed outside the outer wall of the flexible sleeve 20 due to the thinning of the wall thickness of the flexible sleeve 20, so as to increase the friction force between the flexible sleeve 20 and the focus, and further prevent the movement. More preferably, the outer wall surface of the flexible sleeve 20 and/or the balloon body 10 is coated with medical lubricant (e.g., fluorosilicone oil) or a hydrophilic coating having a lubricating effect, and the hydrophilic coating is usually a lubricating coating made of a polyvinylpyrrolidone (PVP) polymer material or the like, so as to increase the lubricating property, reduce the damage to the vascular tissue when the dilatation balloon is inserted, and improve the passability of the dilatation balloon near the lesion area.
As shown in fig. 6(a), in an exemplary embodiment, the flexible sleeve 20 may be disposed in an attached manner, an initial inner diameter of the flexible sleeve 20 when the flexible sleeve 20 is not sleeved on the balloon body 10 is not greater than a maximum radial dimension (i.e., a profile value) of the balloon body 10 when the balloon body 10 is in the contracted state, and the flexible sleeve 20 is configured to be sleeved on an outer portion of the balloon body 10 and then extend and contract along with the expansion and contraction of the balloon body 10. It should be understood that the telescoping of the flexible sleeve 20 herein refers primarily to telescoping in the radial direction, and is not limited to changes in axial length. Specifically, the balloon body 10 expands radially after filling and contracts radially after being collapsed by the balloon body 10. In practice, the flexible sleeve 20 and the balloon body 10 have a small change in axial length, and thus the influence on the inflatable balloon of the present embodiment is small. Further, the balloon body 10 is generally in a contracted state when being pre-shaped, which is mainly a folded state, and the outer surface of the balloon body 10 generally presents an accordion shape. When the balloon body 10 is in the contracted state by freely extending and contracting, the maximum radial dimension of the folded balloon body 10 is referred to as a profile value (profile value) of the balloon body 10. Optionally, when the flexible sleeve 20 is in a free state, the inner diameter of the flexible sleeve 20 is not greater than the profile value of the balloon body 10, and preferably, when the flexible sleeve 20 is in the free state, the inner diameter of the flexible sleeve 20 is 70% to 100% of the profile value of the balloon body 10, so that when the flexible sleeve 20 is sleeved outside the balloon body 10, the radial dimension of the balloon body 10 is further limited, thereby being more beneficial to fixing the flexible sleeve 20. Typically, such flexible sleeves 20 have an elongation > 600% to achieve a good telescoping following the telescoping of the balloon body 10. It should be understood that the shape of the outer surface of the balloon body 10 in the contracted state is not particularly limited in this embodiment, and the above corrugated balloon body 10 is merely an example and is not limited. Preferably, when the flexible sleeve 20 is disposed in an attached manner, the flexible sleeve 20 limits the radial dimension of the second section 12 to be smaller than the radial dimension of the first section 11 or the third section 13 in the whole expansion and contraction process of the balloon body 10 from the contracted state to the expanded state. The flexible sleeve 20 keeps the inner diameter smaller than the outer diameter (including the accordion shape) of the second segment 12 at any time during the whole expansion and contraction process of the balloon body 10, which is beneficial to reduce the maximum radial dimension (profile value) of the whole expansion balloon 1 and is also beneficial to fix the position of the attached flexible sleeve 20.
Further, the flexible sleeve 20 is connected to the balloon body 10 by at least one of sewing, weaving, welding and bonding. In an exemplary embodiment, the flexible sleeve 20 is connected with the balloon body 10 by means of a stitch knitting manner, the stitch knitting manner includes no less than one stitch group 30, each stitch group 30 includes no less than two stitch units 31, and the stitch units 31 are arranged at intervals along the axial direction of the balloon body 10. Fig. 7(a) shows a molding step of one suture unit 31, in which a suture step of one suture unit 31 is illustrated from step S1 to step S5, and fig. 7(B) shows an illustration of one suture group 30, the suture group 30 including 5 suture units 31, the number of suture units 31 being variable according to the length of the flexible sleeve 20, and the interval between every two suture units 31 being preferably between 1mm and 4 mm. Alternatively, the material of the suture line may be high-strength polymer fiber, each suture unit 31 may be formed by sewing a single suture line, and then the integral fixed connection is formed by the form of suture line bonding, or several or all suture units 31 may be integrally sewed, so as to prevent the flexible sleeve 20 from moving in the axial direction of the balloon body 10. The beginning or terminating ends of the suture may be secured to the proximal or distal end of the balloon body 10 by gluing, fusion welding, or the like. The flexible sleeve 20 is connected with the balloon body 10 in a sewing and weaving mode, so that on one hand, the flexible sleeve 20 can be prevented from displacing and sliding; on the other hand, the tensile strength of the flexible sleeve 20 in the axial direction can be increased, and the possibility of breakage of the flexible sleeve 20 is reduced. In yet another aspect, when the flexible sleeve 20 is broken by accident (e.g., sharp calcified lesion puncture), the broken portions can be connected by suture to prevent it from being trapped in the body. Preferably, the sewing weaving manner includes a plurality of sewing groups 30, and the plurality of sewing groups 30 are uniformly distributed along the circumferential direction of the balloon body 10.
As shown in fig. 6(B), in another example, the flexible sleeve 20 may be arranged in a concertina type manner. The initial inner diameter of the flexible sleeve 20 when the flexible sleeve is not sleeved on the balloon body 10 is larger than the maximum radial dimension of the balloon body 10 when the balloon body 10 is in a contracted state; the flexible sleeve 20 is configured to fit the second section 12 in a co-folded manner when sleeved on the exterior of the balloon body 10. Specifically, when the balloon body 10 is in the contracted state, the folded state is formed, the initial inner diameter of the flexible sleeve 20 is larger than the profile value of the balloon body 10, the flexible sleeve 20 is also sleeved outside the balloon body 10 in the folded state, and the flexible sleeve and the balloon body are in the co-folded state. It is to be understood that the flexible sleeve 20 is not limited to conforming to the folded configuration of the balloon body 10 as in fig. 6(B), but may have a void between the folded configuration of the balloon body 10. Preferably, the initial inner diameter of the flexible sleeve 20 is much greater than the profile value of the balloon body 10, i.e. there is a large gap between the flexible sleeve 20 and the folded configuration of the balloon body 10, but the initial inner diameter of the flexible sleeve 20 is smaller than the radial dimension of the balloon body 10 in the expanded state. Preferably, when the flexible sleeve 20 is disposed in a co-folding manner, the flexible sleeve 20 does not limit the radial dimension of the second section 12 to be smaller than the radial dimension of the first section 11 or the third section 13 when the balloon body 10 is expanded from the collapsed state to the unfolded state, and only limits the radial dimension of the second section 12 to be smaller than the radial dimension of the first section 11 or the third section 13 when the balloon body 10 is expanded from the unfolded state to the expanded state.
Preferably, the initial inner diameter of the flexible sleeve 20 is in the range of 40% to 80% of the outer diameter of the balloon body 10 in the expanded state. One skilled in the art can set the initial inner diameter of the flexible sleeve 20 based on the material properties of the flexible sleeve 20 and the desired size of the diametrical drop of the balloon body 10. Optionally, the flexible sleeve 20 is a single-layer tube structure, and the wall thickness of the single-layer tube structure ranges from 0.005mm to 0.3 mm. Because the wall thickness of the flexible sleeve 20 is smaller, and the initial inner diameter is closer to the diameter of the balloon body 10 after filling, the flexible sleeve 20 can be folded together with the balloon body 10 in the processing process, so that the whole expansion balloon 1 can be compressed and enter the sheath tube more easily after being folded.
When the co-folding method is adopted, the flexible sleeve 20 and the balloon body 10 are connected in a partial connection manner, preferably in a welding manner, an adhesion manner, or the like. The welding can adopt hot air, laser, ultrasonic wave or microwave and other modes; because the temperature can influence the performance of the balloon body 10, when the melting point of the flexible sleeve 20 is far lower than that of the balloon body 10, the flexible sleeve is bonded by using an adhesive method preferentially. Alternatively, the welding points or bonding points may be formed in a dot shape or a linear shape; preferably, the welding points or the bonding points are uniformly distributed around the axis of the balloon body 10, so that the balloon body 10 is prevented from being stressed unevenly in all directions to interfere with the unfolding of the balloon body 10, and the balloon body 10 is prevented from being bent in the unfolding process; excessive welding or bonding affects the elongation of the flexible sleeve 20 because the welds or bonds do not extend freely, preferably the area of the welds or bonds is less than 40% of the total area of the flexible sleeve 20. Of course, in other embodiments, when the flexible sleeve 20 and the balloon body 10 are folded together, the flexible sleeve 20 and the balloon body 10 may be connected by sewing and weaving as described above, and since the sewing units 31 in one sewing group 30 are all arranged along the axial direction of the balloon body 10, when the area of the sewing unit 31 is small, the extensibility of the flexible sleeve 20 in the radial direction is not affected. Preferably, the plurality of suture groups 30 are uniformly distributed along the circumferential direction of the balloon body 10 and are disconnected from each other, that is, different suture groups 30 are sewn with different sutures, so as to avoid the sutures from affecting the ductility of the flexible sleeve 20.
As shown in fig. 2 to 4, in a preferred embodiment, the length of the flexible sleeve 20 is adapted to the length of the second section 12. It is to be understood that adapted here means that the length of the flexible sleeve 20 is equal or similar to the length of said second section 12. The flexible sleeve 20 partially covers the balloon body 10, and preferably, the flexible sleeve 20 is a hollow tubular member with a uniform inner diameter, and the flexible sleeve 20 is axially homogeneous. The balloon body 10 is partially covered by the flexible sleeve 20, so that the balloon expansion capacity through the focus is better; and the manufacturing process is simple and convenient because the flexible sleeve 20 is homogeneous along the axial direction. When the flexible sleeve 20 partially covers the balloon body 10, the flexible sleeve 20 may be preferably sleeved on the balloon body 10 in a co-folding manner, and the flexible sleeve 20 may be partially connected with the balloon body 10, or may be connected only by friction force, preferably by welding or bonding. When the flexible sleeve 20 partially covers the balloon body 10, the flexible sleeve can also be sleeved on the balloon body 10 in an attaching manner.
Preferably, referring to fig. 2 and 3, the dilatation balloon further comprises a fixing member 40, the fixing member 40 is disposed inside the first section 11 and/or the third section 13, and has no axial freedom with respect to the balloon body 10, the fixing member 40 is flared toward the second section 12, and the fixing member 40 is configured to expand the radial dimension of the junction of the first section 11 and/or the third section 13 and the second section 12 when the balloon body 10 is in the contracted state, so that the radial dimension of the junction of the first section 11 and/or the third section 13 and the second section 12 is not less than the sum of the radial dimension of the second section 12 and the wall thickness of the flexible sleeve 20. The retaining member 40 is configured to retain the flexible sleeve 20 in an axial position, to prevent dislodging of the flexible sleeve 20, and to better retain it in a desired position, such as the second section 12 of the balloon body 10. On the other hand, the flexible sleeve 20 may have a certain binding effect on the balloon body 10 in the folded state, which may cause the outer surface of the whole inflatable balloon to be uneven, thereby affecting the pushing performance, and the fixing member 40 may be manufactured with a "step" not smaller than the outer diameter of the flexible sleeve 20, so as to prevent the edge of the flexible sleeve 20 from being pushed up when human tissue contacts the edge of the flexible sleeve 20.
Preferably, the fixing member 40 includes a connecting section 41 and a flaring section 42, the connecting section 41 is sleeved on the inner tube 71 of the catheter 7 and is fixedly connected with the inner tube 71, one end of the flaring section 42 is connected with the connecting section 41, the other end of the flaring section 42 is a free end and is in a flaring shape, and the outer diameter of the connecting section 41 is not greater than the minimum inner size of the balloon body 10 in the contraction state, so that the fixing member 40 can be smoothly installed. Alternatively, the axial position of the anchor 40 is determined by the length of the flexible sleeve 20 and the second section 12. Preferably, the fixing piece 40 is fixed at a position 0-2 mm away from the edge of the flexible sleeve; the fixing member 40 may be made of one or more materials selected from teflon, polyolefin, polyester, polyamide, polyvinyl chloride, nylon elastomer, and polyurethane elastomer, for example. Preferably, the flared section 42 is tapered, and the maximum diameter of the flared end of the flared section 42 ranges from 105% to 200%, more preferably from 170% to 200%, of the profile value of the balloon body 10. Preferably, the flared section 42 has at least one split groove disposed along the axial direction of the fixing member 40, so that the fixing member 40 can be folded to be squeezed to a smaller diameter, thereby facilitating loading. It is to be understood that the shape of the fixing member 40 is not limited to the above-described tapered shape, but may be other shapes such as a cylindrical shape and the like.
In another preferred embodiment, as shown in fig. 8 and 9, the length of the flexible sleeve 20 ranges between 90% and 130% of the axial length of the balloon body 10, optionally the length of the flexible sleeve 20 ranges between 8mm and 80mm, the nominal diameter of the flexible sleeve 20 (the outer diameter of the flexible sleeve 20 after full deployment at nominal pressure) ranges between 5mm and 23mm, and the wall thickness of the flexible sleeve 20 ranges between 0.005mm and 2.0 mm. The flexible sleeve 20 comprises a fourth section 21, a fifth section 22 and a sixth section 23 which are sequentially connected, wherein the fourth section 21, the fifth section 22 and the sixth section 23 respectively correspond to the first section 11, the second section 12 and the third section 13, namely the fourth section 21 mainly covers the first section 11, the fifth section 22 mainly covers the second section 12 and the sixth section 23 mainly covers the third section 13. Wherein the radial restraining force of the fifth segment 22 against the balloon body 10 is greater than the radial restraining force of the fourth segment 21 and the sixth segment 23 against the balloon body 10. When the length of the flexible sleeve 20 ranges between 90% and 130% of the axial length of the balloon body 10, the flexible sleeve 20 may be considered to cover substantially the entire balloon body 10. The flexible sleeve 20 is non-homogeneous along the axial direction of the balloon body 10 to change the local mechanical property of the fifth section 22, so that when the balloon body 10 is expanded, the fifth section 22 is slowly expanded, and the balloon body 10 forms a dog-bone-shaped structure at the initial stage of expansion. Preferably, the flexible sleeve 20 further includes two seventh segments 24, the two seventh segments 24 are respectively located at the distal end of the fourth end 21 and the proximal end of the sixth segment 23, the axial length of the seventh segment 24 is adapted to the axial length of the tapered segment 14, and the seventh segment 24 mainly covers the tapered segment 14, and may also cover a partial closing head and a partial connecting head. The provision of the seventh section 24 may enhance the overall securement of the flexible sleeve 20. The seventh section 24 is not limited in arrangement, and may be of a uniform diameter, or may be of a tapered diameter to better match the transition connection between the tapered section 14 and the conduit 7. The flexible sleeve 20 covers the whole balloon body 10 basically in the axial direction, and the flexible sleeve 20 can wrap all suture line areas to avoid the braided wires hooking the native tissues in the operation process; the resilience of the flexible sleeve 20 can also help the balloon body 10 to contract rapidly after being deflated, thereby improving the retractability.
In order to change local mechanical properties, the flexible sleeve 20 is non-homogeneous along the axial direction of the balloon body 10, and three preferable solutions are provided below, and one of them can be selected by those skilled in the art, or several of them can be selected for combined use. Of course, other schemes can be selected by those skilled in the art, and the invention is not limited thereto.
Scheme 1: the fourth section 21 and the sixth section 23 are hollow sections. As shown in fig. 10, for example, the fourth and sixth segments 21 and 23 are configured as hollow-out segments, which can make the radial binding force of the fourth and sixth segments 21 and 23 smaller than that of the fifth segment 22; preferably, the hollow section includes a plurality of hollows arranged along the circumferential direction of the flexible sleeve 20, as shown in fig. 11, 3 hollows (the hollows are elliptical portions in fig. 11), and the flexible sleeve 20 and the balloon body 10 form a connection between two circumferentially adjacent hollows, for example, a suture group 30 is provided as described above. The shape of the hollow can be circular, oval, polygonal (square or trapezoid), it should be understood that the number of the hollow along the circumference of the flexible sleeve 20 is not limited to 3, and those skilled in the art can adjust the shape according to the actual situation.
Scheme 2: the wall thickness of the fourth section 21 and the sixth section 23 is smaller than the wall thickness of the fifth section 22. It is apparent that the radial restraining force of the fourth and sixth segments 21, 23 is now less than the radial restraining force of the fifth segment 22.
Scheme 3: the modulus of elasticity of the material of the fourth section 21 and the sixth section 23 is smaller than the modulus of elasticity of the material of the fifth section 22. The material of the fourth and sixth sections 21, 23 is different from the material of the fifth section 22, and the material of the fourth and sixth sections 21, 23 has a smaller elastic modulus and a smaller radial restraining force than the material of the fifth section 22.
In other embodiments, the limiting portion includes a braided wire, and the braided wire is braided on at least the outer surface of the second segment 12 to form a constraining force on at least the second segment 12, so that the radial dimension of the second segment 12 is smaller than the radial dimension of the first segment 11 or the third segment 13 during the expansion and contraction of the balloon body 10 from the unfolded state to the expanded state. The second section of the balloon body may be similar or equal in size to the first and third sections when the balloon body is in the expanded state.
In other embodiments, the balloon may include only the balloon body 10, and not the attached stopper, wherein the second section 12 has an expansion performance lower than that of the first section 11 or the third section 13, and the second section 12 is configured to have a radial dimension smaller than that of the first section 11 or the third section 13 at least during the expansion and contraction of the balloon body 10 from the unfolded state to the expanded state. Optionally, the expansion properties include material properties such as elasticity and/or elongation. Preferably, the first section 11, the second section 12 and the third section 13 are integrally formed. In practice, the material of the second section 12 may be configured differently from the first section 11 and the third section 13, so that the second section 12 has a lower self-expanding capacity, and so configured, when the balloon body 10 is expanded, the expansion of the first section 11 or the third section 13 can be achieved faster than the expansion of the second section 12, so that the radial dimension of the second section 12 is smaller than the radial dimension of the first section 11 or the third section 13. The second section of the balloon body may be similar or equal in size to the first and third sections when the balloon body is in the expanded state.
In summary, in the dilatation balloon and the balloon dilatation catheter provided by the invention, the dilatation balloon comprises the balloon body and the limiting part, and the balloon body can be stretched between a contraction state and an unfolded state and between the unfolded state and an expansion state; the balloon body comprises a first section, a second section and a third section which are sequentially connected along the axial direction; the stop portion is configured to limit a radial dimension of the second segment to be less than a radial dimension of the first segment or the third segment at least during expansion of the balloon body from the unfolded state to the expanded state. So the configuration, the flexible in-process of sacculus body by unfolding the state to the expansion state, the radial dimension that is located the first section and the third section at both ends is great, and the radial dimension that is located the second section in the middle of is less, forms the structure of similar dog bone shape, ensures that the location of expansion sacculus can not take place to slide. Furthermore, the limiting part only limits the radial size of the second section of the balloon body in the expansion process, but not limits the radial size of the balloon body in the expansion state, when the balloon body is in the expansion state, the size of the second section of the balloon body can be close to or equal to the size of the first section and the third section, and a waist section with a 8-shaped structure cannot be formed, so that on one hand, an operator can select the specification of the balloon which is most suitable for treatment easily, and the diseased valve leaflets can be expanded with high efficiency and high quality; on the other hand, the artificial biological valve can be fully expanded to avoid complications such as paravalvular leakage and the like, and the TAVI operation quality is improved.
It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, similar parts between the embodiments may be referred to each other, and different parts between the embodiments may also be used in combination with each other, which is not limited by the present invention. The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.
Claims (19)
1. An dilatation balloon, comprising: a balloon body and a limiting part;
the balloon body can be stretched and contracted between a contraction state and an unfolding state and between the unfolding state and an expansion state; the balloon body comprises a first section, a second section and a third section which are sequentially connected along the axial direction;
the limiting portion is configured to limit a radial dimension of the second segment to be smaller than a radial dimension of the first segment or the third segment at least during expansion and contraction of the balloon body from the unfolded state to the expanded state.
2. The dilation balloon of claim 1, wherein the stop comprises: the flexible sleeve or the braided wire is sleeved outside the balloon body.
3. The dilation balloon of claim 2, wherein the flexible sleeve is configured such that, when the balloon body is in the expanded state, a sum of a radial dimension of the second section and a wall thickness of the flexible sleeve matches a radial dimension of the first or third section.
4. The dilation balloon of claim 2, wherein the axial length of the second segment is between 10% and 40% of the sum of the axial lengths of the first, second, and third segments when the balloon body is in the expanded state.
5. The dilation balloon of claim 2, wherein the inner side wall of the flexible sleeve is provided with a raised structure configured to project outwardly of the outer wall of the flexible sleeve under the influence of the balloon body during expansion and contraction of the balloon body from the unfolded state to the expanded state.
6. The dilation balloon of claim 2, wherein an initial inner diameter of the flexible sleeve when not sleeved over the balloon body is no greater than a maximum radial dimension of the balloon body when the balloon body is in the deflated state; the flexible sleeve is also configured to be sleeved outside the balloon body and then stretch along with the stretching of the balloon body.
7. The dilation balloon of claim 6, wherein the flexible sleeve limits a radial dimension of the second segment to less than a radial dimension of the first segment or the third segment during telescoping of the balloon body from the collapsed state to the expanded state.
8. The dilation balloon of claim 2, wherein the initial inner diameter of the flexible sleeve when not sleeved over the balloon body is greater than a maximum radial dimension of the balloon body when the balloon body is in the deflated state; the flexible sleeve is configured to fit the second section in a co-folded manner when sleeved outside the balloon body.
9. The dilation balloon of claim 8, wherein an initial inner diameter of the flexible sleeve when not sleeved over the balloon body is smaller than a radial dimension of the second section when the balloon body is in the expanded state, the flexible sleeve further configured to be sleeved over an exterior of the balloon body and then expand and contract with expansion and contraction of the balloon body.
10. The dilation balloon of claim 2, wherein the flexible sleeve has a length in a range of between 90% and 130% of an axial length of the balloon body, the flexible sleeve comprising sequentially connected fourth, fifth and sixth segments corresponding to the first, second and third segments, respectively, wherein a radial constraining force of the fifth segment to the balloon body is greater than a radial constraining force of the fourth and sixth segments to the balloon body.
11. The dilation balloon of claim 10, wherein the flexible sleeve is configured to select: the fourth section and the sixth section are at least one of a hollow section, the wall thickness of the fourth section and the sixth section is smaller than that of the fifth section, and the elastic modulus of the material of the fourth section and the sixth section is smaller than that of the material of the fifth section.
12. The dilation balloon of any one of claims 6, 8, 10, wherein the flexible sleeve is connected to the balloon body by at least one of stitch knitting, welding and bonding.
13. The dilatation balloon of claim 12 wherein the flexible sleeve is coupled to the balloon body by a stitch weave comprising no less than one stitch group, each stitch group comprising no less than two stitch units spaced apart along an axial direction of the balloon body.
14. The dilation balloon of claim 2, wherein the length of the flexible sleeve is adapted to the length of the second section.
15. The dilation balloon of claim 14, further comprising a fixation member disposed inside the first section and/or the third section and having no axial freedom with respect to the balloon body, the fixation member flaring in a direction of the second section, the fixation member being configured to expand a radial dimension of a junction of the first section and/or the third section with the second section when the balloon body is in the deflated state such that the radial dimension of the junction of the first section and/or the third section with the second section is no less than a sum of the radial dimension of the second section and a wall thickness of the flexible sleeve.
16. The dilation balloon of claim 15, further comprising an inner tube fixedly disposed through an interior of the balloon body in an axial direction of the balloon body; the fixing part comprises a connecting section and a flaring section, the connecting section is sleeved on the inner tube and fixedly connected with the inner tube, one end of the flaring section is connected with the connecting section, the other end of the flaring section is a free end and is in a flaring shape, and the outer diameter of the connecting section is not larger than the minimum inner size of the balloon body in the contraction state.
17. The dilation balloon of claim 16, wherein the flared section has at least one split groove disposed axially of the fixation member.
18. An dilatation balloon, comprising: a balloon body;
the balloon body can be stretched and contracted between a contraction state and an unfolding state and between the unfolding state and an expansion state; the balloon body comprises a first section, a second section and a third section which are sequentially connected along the axial direction;
the second segment has a lower expansion than either the first segment or the third segment, and the second segment is configured to have a radial dimension that is less than a radial dimension of either the first segment or the third segment at least during expansion and contraction of the balloon body from the unfolded state to the expanded state.
19. A balloon dilation catheter comprising a dilation balloon according to any one of claims 1 to 18 and a catheter, the distal end of the balloon body being closed and the proximal end of the balloon body being connected to the catheter, the catheter being adapted to deliver an inflation fluid to drive the expansion and contraction of the balloon body.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010408663.2A CN113730768A (en) | 2020-05-14 | 2020-05-14 | Dilatation balloon and balloon dilatation catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010408663.2A CN113730768A (en) | 2020-05-14 | 2020-05-14 | Dilatation balloon and balloon dilatation catheter |
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| Publication Number | Publication Date |
|---|---|
| CN113730768A true CN113730768A (en) | 2021-12-03 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010408663.2A Withdrawn CN113730768A (en) | 2020-05-14 | 2020-05-14 | Dilatation balloon and balloon dilatation catheter |
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| Country | Link |
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| CN (1) | CN113730768A (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5147302A (en) * | 1989-04-21 | 1992-09-15 | Scimed Life Systems, Inc. | Method of shaping a balloon of a balloon catheter |
| US20150297872A1 (en) * | 2012-10-28 | 2015-10-22 | Edge Medical, Llc | Apparatus and method for aiding organ treatment |
| US20150306359A1 (en) * | 2014-04-23 | 2015-10-29 | Intervalve, Inc. | Post Dilation Balloon With Marker Bands For Use With Stented Valves |
| US20160082230A1 (en) * | 2014-09-22 | 2016-03-24 | Cook Medical Technologies Llc | Compliant sleeve for vascular balloon |
| CN207928567U (en) * | 2017-06-01 | 2018-10-02 | 刘逸 | A kind of orientation extruding sacculus dilating catheter |
| CN212416629U (en) * | 2020-05-14 | 2021-01-29 | 上海微创心通医疗科技有限公司 | Dilatation balloon and balloon dilatation catheter |
-
2020
- 2020-05-14 CN CN202010408663.2A patent/CN113730768A/en not_active Withdrawn
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5147302A (en) * | 1989-04-21 | 1992-09-15 | Scimed Life Systems, Inc. | Method of shaping a balloon of a balloon catheter |
| US20150297872A1 (en) * | 2012-10-28 | 2015-10-22 | Edge Medical, Llc | Apparatus and method for aiding organ treatment |
| US20150306359A1 (en) * | 2014-04-23 | 2015-10-29 | Intervalve, Inc. | Post Dilation Balloon With Marker Bands For Use With Stented Valves |
| US20160082230A1 (en) * | 2014-09-22 | 2016-03-24 | Cook Medical Technologies Llc | Compliant sleeve for vascular balloon |
| CN207928567U (en) * | 2017-06-01 | 2018-10-02 | 刘逸 | A kind of orientation extruding sacculus dilating catheter |
| CN212416629U (en) * | 2020-05-14 | 2021-01-29 | 上海微创心通医疗科技有限公司 | Dilatation balloon and balloon dilatation catheter |
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