CN118121817A - Balloon assembly for administration to the prostate - Google Patents
Balloon assembly for administration to the prostate Download PDFInfo
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- CN118121817A CN118121817A CN202311264186.7A CN202311264186A CN118121817A CN 118121817 A CN118121817 A CN 118121817A CN 202311264186 A CN202311264186 A CN 202311264186A CN 118121817 A CN118121817 A CN 118121817A
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- shaped
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Classifications
-
- 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
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- 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
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- 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
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1078—Urinary tract
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/16—Male reproductive, genital organs
- A61M2210/166—Prostate
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The present application provides a balloon assembly for administration to the prostate, the balloon assembly comprising: the medical balloon comprises a balloon catheter, a positioning balloon, an olive-shaped balloon, a pressurized liquid channel, a guide wire channel and the like, wherein the positioning balloon plays a role in positioning, so that the stability of operation is improved, and the outer surface of the olive-shaped balloon is provided with a medicinal composition which is contacted with an area to be treated during operation. The balloon component disclosed by the application is combined with the existing instrument to treat the prostate diseases, so that the expansion of the benign hyperplasia section narrow urethra of the prostate can be safely realized, the restenosis of the urinary tract is reduced, and the aim of enabling a patient to urinate normally is fulfilled.
Description
Technical Field
The present invention relates to the field of medical technology, and more particularly to a balloon assembly for administration to the prostate, also known as a prostate drug coating dilation catheter set.
Background
Prostatic hyperplasia is one of common diseases of middle-aged and elderly men at present, and the incidence of the prostatic hyperplasia is gradually increased along with the aging of the global population. The symptoms include frequent urination, urgent urination, waiting for urination, difficult urination, prolonged urination time, etc. The current common surgical modes are: transurethral prostatectomy (TURP), transurethral prostata urethral suspension (Urolift), transurethral thermal ablation, and the like. However, there are a number of problems in the current surgical methods, such as: long operation time, long hospitalization time after operation, massive hemorrhage during operation, a series of complications during operation and the like, and patients often need multiple operations to ensure normal urination.
Disclosure of Invention
The prostate medicine balloon component is a new technology, the technology is characterized in that paclitaxel or other medicines are smeared on the surface of a special balloon, the balloon is placed into the bladder and the prostate of a patient through the urethra, after the balloon is fully expanded, the urethral stricture of the hyperplasia part of the prostate is eliminated, the hyperplasia inhibition effect of the paclitaxel can be realized, the re-hyperplasia of the prostate is avoided, the urethral restenosis is caused, and the patient can urinate normally. The prostate balloon assembly is used as an instrument to solve the problem of prostate stenosis, and is a novel and safe treatment method.
The application discloses an administration balloon component, which is characterized in that medicines are smeared on the surface of a balloon, and the balloon is placed in a prostate and a bladder through a urethra, so that the prostatic hyperplasia can be treated, and the problem of difficult urination is solved.
The technical scheme disclosed by the application comprises the following embodiments:
embodiment 1, a prostate administration balloon assembly comprising an olive shaped balloon, also referred to as a balloon assembly for administration to the prostate, comprising:
the balloon catheter, a positioning balloon fixedly arranged at the far end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter,
The balloon catheter has a guidewire channel and a pressurized fluid channel, wherein the pressurized fluid channel is in communication with the positioning balloon and the olive-shaped balloon, the guidewire channel is not in communication with the pressurized fluid channel,
The drug delivery balloon assembly further comprises a sheath for accommodating the positioning balloon, the olive balloon and the corresponding balloon catheter such that the positioning balloon and the olive balloon can reciprocate in the sheath, the sheath having an outer diameter of 2mm to 10mm, preferably 4mm to 8mm, or 5mm to 7mm,
The outer surface of the olive-shaped balloon is provided with a drug composition layer,
Wherein the positioning balloon is for placement in a bladder of a patient for positioning a balloon catheter, the olive balloon is for placement in a prostate of the patient for dilating and administering the prostate by contacting an inner wall of the prostate, the sheath has a length that is greater than a length of the balloon catheter in the patient when in use and less than a length of the balloon catheter, and such that at least the positioning balloon and the olive balloon are exposed when the sheath is retracted proximally relative to the balloon catheter. In the present application, the term "olive-shaped balloon" means an "administration balloon" for being received in the prostatic urethra to be administered in contact with the prostate, and thus, the term "olive-shaped balloon" in the present application has the same meaning as the term "administration balloon" and means a balloon adjacent to the positioning balloon, which has a olive shape with a pharmaceutical composition provided on the outer surface for administering in contact with the prostate by being received in the prostatic urethra.
Embodiment 2, the balloon assembly of embodiment 1, further comprising a balloon connection disposed between the positioning balloon and the olive balloon, the balloon connection having an outer diameter smaller than the outer diameters of the positioning balloon and the olive balloon.
Embodiment 3, the balloon assembly of embodiment 1, wherein the positioning balloon and the olive balloon are in direct communication, without a balloon connection therebetween. In the present application, the term "balloon connection", also called "balloon neck", is used interchangeably and refers to a connection that may exist between two balloons, which connection is neither in shape to a positioning balloon nor to an olive balloon.
Embodiment 4, the balloon assembly of embodiment 1, wherein the pressurized fluid channel comprises a positioning balloon pressurized fluid channel and an olive-shaped balloon pressurized fluid channel, the positioning balloon pressurized fluid channel and the olive-shaped balloon pressurized fluid channel not communicating with each other, the positioning balloon pressurized fluid channel having a positioning balloon pressurized fluid channel through-hole in communication with the positioning balloon, the olive-shaped balloon pressurized fluid channel having an olive-shaped balloon pressurized fluid channel through-hole in communication with the olive-shaped balloon.
Embodiment 5, the balloon assembly of embodiment 1, wherein the sheath has a sheath front made of a low strength material and a sheath rear made of a high strength material, the sheath front being longer than 2mm and shorter than the distance between the two balloons, such that the balloon cannot be expanded by pressurization when the positioning balloon and the olive balloon are in the sheath rear.
Embodiment 6, the balloon assembly of embodiment 1 or 5, wherein the inner diameter of the sheath is such that the positioning balloon and the olive balloon can be received again in the sheath when the positioning balloon and the olive balloon are contracted after being expanded under the pressure of the pressurized liquid.
Embodiment 7, the balloon assembly of embodiment 1, wherein longitudinal cuts of the outer surfaces of the positioning balloon and the olive balloon each independently have a convex arc-like profile at the ends.
Embodiment 8, the balloon assembly of embodiment 1, wherein longitudinal cuts of the outer surfaces of the positioning balloon and the olive balloon are each independently angled at 30 to 50 degrees from the balloon catheter at the ends.
Embodiment 9, the balloon assembly of embodiment 1, wherein the pharmaceutical composition layer comprises at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.
Embodiment 10, the balloon assembly of any of embodiments 1-7, wherein the radial dimensions of the positioning balloon and the olive balloon when inflated are each independently 6-40mm, such as 10 to 35mm, such as 12 to 30mm, such as 15 to 25mm, such as 16 to 23mm.
Embodiment 11, the balloon assembly of any of embodiments 1-10, wherein the positioning balloon and the olive balloon are both non-compliant or low-compliant balloons.
When the prostate administration balloon assembly containing the olive-shaped balloon in the embodiment is used for treating the prostatic hyperplasia, the operation can be completed by only enabling the olive-shaped balloon in the balloon assembly to be in contact with the urethra part wrapped by the prostate (also called as prostatic urethra) and expanding, and the treatment flow is simple and safe. The administration saccule is arranged in an olive shape, and the shape is matched with the shape of the prostatic urethra in a healthy state, so that the prostatic urethra can be properly expanded, and the prostatic hyperplasia can be inhibited by contact administration; the olive shaped balloon tip design can also prevent external urethral sphincter injury. Some embodiments are that the positioning balloon and the olive-shaped balloon are respectively and independently provided with a pressurizing liquid channel, and the pressurizing of the two balloons is completely and independently carried out, so that the controllability is strong, the positioning is convenient, and the operation time is greatly shortened. In some embodiments, the two balloon ends are arranged at an included angle with the balloon catheter, the balloon catheter is made of a non-compliant material, and the balloon is convenient to be stored in the balloon sheath after the drug administration is finished, so that the safety of an operation can be further improved, and meanwhile, the excellent operation effect is ensured.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following brief description of the drawings of the embodiments will make it apparent that the drawings in the following description relate only to some embodiments of the present disclosure, not to limit the present disclosure.
FIG. 1 shows a schematic view of the positioning balloon and the olive balloon of example 1, both unexpanded;
FIG. 2 shows a schematic view of the positioning balloon of example 1 after inflation;
FIG. 3 shows a schematic view of the positioning balloon and the olive balloon of example 1 after expansion;
FIG. 4 shows a schematic representation of the independent pressurization of the positioning balloon and the olive balloon described in example 2;
FIG. 5 shows a schematic diagram of a cross section of the balloon catheter described in example 2;
Reference numerals: 1-balloon catheter, 2-positioning balloon, 3-olive balloon, 4-sheath, 5-pressurizing liquid channel, 6-guide wire channel, 7-balloon catheter front, 8-balloon catheter rear, 9-positioning balloon pressurizing liquid channel, 10-olive balloon pressurizing liquid channel, 11-positioning balloon pressurizing liquid channel through hole, 12-olive balloon pressurizing liquid channel through hole, 13-balloon catheter grille.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present disclosure more apparent, the technical solutions of the embodiments of the present disclosure will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present disclosure. It will be apparent that the described embodiments are some, but not all, of the embodiments of the present disclosure. All other embodiments, which can be made by one of ordinary skill in the art without the need for inventive faculty, are within the scope of the present disclosure, based on the described embodiments of the present disclosure.
The following terms in the present application have the specific meanings:
The direction along the catheter is defined herein as "longitudinal", the direction perpendicular to the catheter is defined as "radial", and the balloon is primarily expanded in the radial direction.
The part that reaches the region to be treated first in use is defined as "front", and the direction opposite to "front" is defined as "rear" in the present application.
In the present application, each term has its ordinary meaning as understood in the art, unless specifically indicated otherwise or as understood by the context.
The application discloses a prostate administration balloon assembly containing an olive-shaped balloon, which comprises: a balloon catheter, a positioning balloon fixedly arranged at the distal end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter, wherein the balloon catheter is provided with a guide wire channel and a pressurized liquid channel, the pressurized liquid channel is communicated with the positioning balloon and the olive-shaped balloon, the guide wire channel is not communicated with the pressurized liquid channel, the administration balloon assembly further comprises a sheath tube for accommodating the positioning balloon, the olive-shaped balloon and the corresponding balloon catheter, so that the positioning balloon and the olive-shaped balloon can reciprocate in the sheath tube, the sheath has an outer diameter of 2mm to 10mm, preferably 4mm to 8mm, or 5mm to 7mm, and the outer surface of the olive balloon is provided with a layer of pharmaceutical composition, wherein the positioning balloon is for placement in the bladder of a patient for positioning a balloon catheter for placement in the prostate of a patient for dilating and administering the prostate by contacting the inner wall of the prostate, the sheath has a length that is greater than the length of the balloon catheter in use in the patient and less than the length of the balloon catheter, and such that at least the positioning balloon and the olive balloon are exposed when the sheath is retracted proximally relative to the balloon catheter. The guide wire channel can enable the balloon catheter to reach a selected area to be treated along the guide wire under the guidance of the guide wire. During treatment, a guide wire is firstly arranged, then a sheath tube is arranged with the help of a sheath core, then the sheath core is withdrawn, and then a balloon catheter is arranged through the sheath tube, namely, the balloon is pushed to a required position. It should be noted that the sheath core used in the placement of the sheath has a meaning generally understood by those skilled in the art, and is used to nest within the sheath to assist in the safe entry of the sheath into the body. When the balloon catheter enters the region to be treated along the urethra, the sheath tube is pulled to the rear part of the balloon catheter to expose the positioning balloon, then the pressurizing liquid is injected into the positioning balloon through the pressurizing liquid channel, and after the positioning balloon is completely expanded, the positioning balloon is positioned in the bladder of the patient. And then continuing to pull the sheath tube towards the rear of the balloon catheter until the olive-shaped balloon is exposed, and continuing to inject pressurized liquid into the pressurized liquid channel until the olive-shaped balloon is fully expanded. After the drug on the surface of the olive-shaped balloon is administered to the surface of the prostate, pumping out pressurized liquid through the pressurized liquid channel, generating negative pressure in the positioning balloon and the olive-shaped balloon, completing the contraction and folding of the positioning balloon and the olive-shaped balloon under the action of the negative pressure, moving the sheath tube, and completely accommodating the balloon in the sheath tube so as to prevent the puncture and damage to the human body when the balloon catheter is pulled backwards, and finally enabling the sheath tube and the balloon catheter to be withdrawn from the human body at the same time, thereby completing the treatment. The sheath of the present application has an outer diameter in the range of 2mm to 10mm, preferably 4mm to 8mm, or 5mm to 7mm, and an inner diameter substantially close to the outer diameter, typically 0.3 to 0.6mm smaller than the outer diameter, so that the balloon catheter with the balloon can be moved within the sheath. The balloon catheter can enter a human body through the sheath tube during treatment, and the balloon is retracted into the sheath tube after the treatment is completed, so that the balloon catheter is smoothly withdrawn.
In some embodiments, further comprising a balloon neck disposed between the positioning balloon and the olive balloon, the balloon neck having an outer diameter that is less than the outer diameters of the positioning balloon and the olive balloon. Having a smaller diameter neck portion allows the olive balloon and the positioning balloon to be anchored more firmly in the body cavity, thereby preventing the balloon from sliding randomly in the body cavity. If the olive shaped balloon slides or leaves the lesion, it may cause injury to the healthy lumen.
In some embodiments, the positioning balloon and the olive balloon are in direct communication, with no neck between the two balloons. There is no neck between the positioning balloon and the olive balloon. The application discloses a balloon inflation device, which is characterized in that a positioning balloon is directly connected with an olive-shaped balloon, and the positioning balloon is provided with a neck connecting surface.
In some embodiments, the pressurized fluid channel comprises a positioning balloon pressurized fluid channel and an olive-shaped balloon pressurized fluid channel, the positioning balloon pressurized fluid channel and the olive-shaped balloon pressurized fluid channel not in communication with each other, the positioning balloon pressurized fluid channel having a positioning balloon pressurized fluid channel through-hole in communication with the positioning balloon, the olive-shaped balloon pressurized fluid channel having an olive-shaped balloon pressurized fluid channel through-hole in communication with the olive-shaped balloon. The single pressurization control of the positioning balloon and the olive-shaped balloon is realized through the connection mode of the positioning balloon and the positioning balloon pressurization liquid channel and the connection mode of the olive-shaped balloon and the olive-shaped balloon pressurization liquid channel. By means of independent control, the expansion of the two balloons does not affect each other, and human injury caused by excessive expansion of one balloon is avoided. After the treatment is finished, the pressurizing liquid can be extracted from the two saccules respectively, so that orderly contraction and folding are realized, and the injury to the human body is prevented.
In some embodiments, the sheath has a sheath front made of a low strength material and a sheath rear made of a high strength material, the sheath front having a length greater than 2mm and shorter than the distance between the two balloons, such that the balloons cannot be inflated by pressurization when the positioning balloon and the olive balloon are in the sheath rear. The distance between the two balloons is the minimum distance between the parts with the radial dimension larger than 12mm after the two balloons are expanded, and the purpose of the arrangement is to arrange the front part of the sheath tube made of low-strength materials with a certain length so as to ensure that the sheath tube does not damage a human body. The sheath tube is made of low-strength materials, such as silica gel, so that when the sheath tube is inserted into the urethra, the prostate and the bladder, the human organ tissues are not easily damaged, and after the medicine application is finished, the balloon is easily contained in the front part of the sheath tube made of the low-strength materials, so that the two balloons can be smoothly and sequentially contained in the sheath tube. The rear part of the sheath tube is made of high-strength materials, such as PVC materials, so that the olive-shaped saccule is not expanded when the pressure is applied for the first time, and the urethra, the prostate and the bladder are prevented from being damaged. It should be noted that, the high-strength material and the low-strength material according to the present application are both relative to the environment in which the human body is used, when the material is made into the device according to the present application, the material having higher strength and being able to withstand the pressure of the pressurized fluid is referred to as a high-strength material, whereas when the material is made into the device according to the present application, the material having lower strength and being less likely to cause damage to the human body is referred to as a low-strength material.
In some embodiments, the inner diameter of the sheath is such that the positioning balloon and the olive balloon can be re-received in the sheath when the positioning balloon and the olive balloon are re-contracted after being expanded under the pressure of the pressurized fluid. If the positioning balloon and the olive-shaped balloon are not retracted into the sheath tube to be directly pulled out of the body after contraction, not only the damage to the human body can be caused by the pulling, but also the residual medicine can be smeared on the passing area of the balloon, so that other tissues are damaged. It is necessary to set the diameter of the sheath within a reasonable range so that the balloon is easily incorporated into the sheath.
In some embodiments, the longitudinal sections of the outer surfaces of the positioning balloon and the olive balloon each independently have a convex arc-like profile at the ends. The structure that the end is equipped with protruding arciform profile suits with human structure, avoids damaging bladder or prostate when pressure boost liquid passageway pressurizes. When pressurized, the balloon can slide slightly, so that the damage to the external urethral sphincter caused by the balloon when the balloon is expanded is effectively avoided.
In some embodiments, the longitudinal sections of the outer surfaces of the positioning balloon and the olive balloon are each independently angled from 30 to 50 degrees from the balloon catheter at the ends. The feature that the balloon end forms an included angle of 30 to 50 degrees with the balloon catheter is suitable for the structure of a human body. This range of 30 to 50 degrees is the most suitable range, and if the angle is too large, the balloon shape does not match the prostatic urethra shape, affecting the drug delivery effect; when the angle is too small, the balloon is difficult to expand after pressurization to prop the prostate of a patient so as to obtain enough space, the operation effect is affected, the slight sliding self-adaptive effect is difficult to exist, and the external urethral sphincter is easy to damage. The included angle refers to the included angle between the surface of the balloon, which is positioned at the position with the radial dimension of 12mm, and the balloon catheter when the balloon is expanded.
In some embodiments, the pharmaceutical composition layer contains at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier. The drug carrier preferably comprises a hydrophilic drug carrier and/or a hydrophobic drug carrier. In some embodiments, the pharmaceutical carrier is at least one selected from iopamidol, iopromide, PEG, PVP. The existing drug coating balloon interventional therapy technology attaches the drug for inhibiting cell proliferation to the surface of the balloon, and the drug surface is attached to the diseased part through the expansion of the balloon, so that the effect of directly administering the drug to the diseased part for inhibiting proliferation is achieved. Both paclitaxel and rapamycin have the effect of inhibiting cell proliferation, and are widely applied to the treatment fields of anticancer and the like in clinic. Both drugs are lipophilic drugs, the lipophilic drugs paclitaxel and/or rapamycin being combined with the hydrophilic drug carrier arbitrarily to form the pharmaceutical composition, the hydrophilic drug carrier can form a coating with a high contact surface between the lipophilic drug molecules and the prostate, enhance dissolution and release of the lipophilic drug molecules, and possibly alter drug delivery and its interaction with tissues. The pharmaceutical composition is loaded on the surface of the olive-shaped balloon as a balloon coating, and after the olive-shaped balloon is expanded, the pharmaceutical composition is loaded and fully contacted with a region to be treated, the target pharmaceutical dose is uniformly and rapidly released, and clinical experience shows that the contact is only needed for a short time of 10 minutes, so that the pharmaceutical composition is sufficient for full administration, the cell proliferation is inhibited, and the prostatic cell proliferation is prevented.
In the present application, the coating position of the pharmaceutical composition is not particularly limited. It will be appreciated by those skilled in the art that the pharmaceutical composition is primarily coated on the olive shaped balloon. In some embodiments, the pharmaceutical composition is also coated on the positioning balloon, for example on the side of the positioning balloon facing the olive balloon. In some embodiments, the pharmaceutical composition may also be applied to the junction of the positioning balloon and the olive balloon, where the coating is primarily used to treat the internal urethral sphincter.
In some embodiments, the radial dimensions of the positioning balloon and the olive balloon when inflated are each independently 6-40mm, such as 10 to 35mm, such as 12 to 30mm, such as 15 to 25mm, such as 16 to 23mm. The radial dimension of the balloon has a direct relationship with the positioning effect of the positioning balloon, whether it will cause prostate or bladder injury. When the radial size of the positioning balloon and the olive-shaped balloon is too large during expansion, the balloon is expanded due to injection of pressurized liquid, and the bladder and the prostate are excessively expanded from the inside due to the too large radial size of the balloon, so that complications such as urethral hemorrhage and the like are easily caused. When the radial dimension of the balloon is smaller, the positioning balloon cannot be positioned accurately, so that the olive-shaped balloon can reciprocate after being expanded, can not be accurately administered to an affected part, and can not be fully expanded to cause the prostatic part with the urethral stricture. The selection of a balloon of appropriate radial dimensions, subject to different individual differences, depends on prior medical observations and diagnostics. In addition, the longitudinal dimensions of the positioning balloon and the olive balloon are each independently 20-60mm, such as 30 to 50mm, such as 20 to 30mm,30 to 40mm. Likewise, the selection of a balloon of appropriate longitudinal dimension is dependent on prior medical observations and diagnostics, subject to different individual differences.
In some embodiments, the positioning balloon and the olive balloon are both non-compliant or low-compliant balloons. The compliance of the balloon is mainly manifested in the ability of the balloon diameter to vary with pressure. The compliance of the balloon is closely related to materials, and common materials comprise nylon and special polyethylene, so that the balloon has good physical properties such as ultra-thin thickness, low compliance, high pressure resistance and the like, and the non-compliance and low compliance balloon ensures the safety of a patient and prevents the excessive expansion of the balloon, so that the prostate or the bladder of the patient is accidentally injured.
The balloon may be manufactured by blow molding or other molding process and may include materials that do not interact with the drug coating or materials such as: nylon, polyether block amide (PEBA), polyvinyl chloride (PVC), polyester, polyurethane, derivatives thereof, or combinations thereof. The balloon and the catheter can be bonded together by a hot melting method, and can also be bonded by adopting a proper adhesive. The materials and methods of making the balloon assembly are not particularly limited and may be selected by those skilled in the art according to actual needs.
The above-described ranges may be used alone or in combination. The application will be more readily understood by the following examples.
Examples
Example 1
As shown in fig. 1-3, a prostate administration balloon assembly including an olive-shaped balloon in this embodiment includes: the balloon catheter 1, the positioning balloon 2 fixedly arranged at the far end of the balloon catheter 1, and the olive-shaped balloon 3 adjacent to the positioning balloon 2 and fixedly arranged on the balloon catheter 1 are directly connected without a neck connecting surface.
The balloon catheter 1 has a guide wire channel 6 and a pressurized fluid channel 5, wherein the pressurized fluid channel 5 is in communication with the positioning balloon 2 and the olive-shaped balloon 3, the guide wire channel 6 is not in communication with the pressurized fluid channel 5,
The drug delivery balloon assembly further comprises a sheath 4 for accommodating the positioning balloon 2, the olive balloon 3 and the corresponding balloon catheter 1, such that the positioning balloon 2 and the olive balloon 3 are capable of reciprocating in the sheath 4, a layer of pharmaceutical composition is provided on the outer surface of the olive balloon 3,
Wherein the positioning balloon 2 is for placement in a bladder of a patient for positioning the balloon catheter 1, the olive-shaped balloon 3 is for placement in a prostate of the patient for dilating and administering the prostate by contacting an inner wall of the prostate, the sheath 4 has a length that is greater than a length of the balloon catheter 1 in a patient's body when in use and less than a length of the balloon catheter 1, and such that at least the positioning balloon 2 and the olive-shaped balloon 3 are exposed when the sheath 4 is retracted proximally relative to the balloon catheter 1.
The length of the balloon catheter 1 is 500mm, the length of the balloon catheter 1 in a patient during treatment is 250mm, and the length of the balloon catheter 1 is larger than the length of the balloon catheter in the patient, so that the external operation space is ensured. The outer diameter of the sheath tube 4 is 4mm, the length of the sheath tube is 300mm, the 3mm of the front part of the sheath tube is made of silica gel, and the outer diameter of the sheath tube 4 is set to be 4mm enough to accommodate the positioning balloon 2, the olive-shaped balloon 3 and the balloon catheter 1, so that the positioning balloon can be accommodated after the drug administration is finished. The front part of the sheath tube is 3mm and is made of silica gel, so that the human organ tissues are not easy to scratch, and meanwhile, the storage after the drug administration is finished is facilitated. The positioning balloon 2 is made of nylon 66, has non-compliance, has a radial dimension of 30mm when expanded, forms an included angle of 40 degrees with the balloon catheter 1 at the end, and the olive-shaped balloon 3 is made of nylon 66, also has non-compliance, has a radial dimension of 30mm when expanded, and forms an included angle of 30 degrees with the balloon catheter 1 at the end. The non-compliant material is selected, the neck part is not arranged between the two saccule, and the non-compliant material is directly manufactured by integral blow molding, so that the saccule can not be continuously expanded after pressurization, and the safety of the operation is greatly improved. The positioning balloon 2 and the olive-shaped balloon 3 form an included angle of 40 degrees with the balloon catheter 1 at the end part, so that the positioning balloon is easy to slide, and the internal urethral sphincter and the external urethral sphincter are prevented from being damaged.
The method of use of this embodiment is as follows;
the guide wire is first set, then the sheath is introduced, the anterior segment of the guide wire is positioned in the bladder under the condition of ultrasonic B, and then the prostate administration balloon assembly with the olive-shaped balloon is penetrated from the tail of the guide wire until penetrating into the anterior segment of the guide wire. Positioning the prostate administration balloon assembly containing the olive shaped balloon.
As shown in fig. 1-2, the sheath 4 is moved toward the balloon catheter rear portion 8 until the positioning balloon 2 is completely exposed, at which time the movement of the sheath 4 is stopped and the positioning balloon 2 is pressurized through the pressurizing liquid passage 5. The pressurization is stopped until the positioning balloon 2 is completely expanded. The balloon catheter 1 is gently pulled, and when slight resistance is felt, the positioning balloon 2 is positioned near the bladder orifice of the prostate, and positioning is completed.
As shown in fig. 3, the sheath 4 continues to move along the balloon catheter 1 toward the rear portion 8 of the balloon catheter until the olive-shaped balloon 3 is completely exposed, and the outer edge of the olive-shaped balloon 3 is uniformly provided with a layer of a pharmaceutical composition comprising paclitaxel and iopromide having a thickness of about 50 micrometers. The pressurizing fluid passage 5 pressurizes the olive-shaped balloon 3 until the olive-shaped balloon 3 is fully expanded. The layer of the pharmaceutical composition on the surface of the olive-shaped balloon 3 is contacted with the diseased region of the prostate, expands the narrow region of the urethra and rapidly releases the drug to the contacted region, and after a preset expansion time is reached, the pressurizing liquid is pumped out through the pressurizing liquid channel 5, and the sheath tube 4 is moved to the front part 7 of the balloon catheter, so that the pressureless positioning balloon 2 and the olive-shaped balloon 3 are accommodated in the sheath tube 4. And finally, completely withdrawing the prostate administration balloon assembly containing the olive-shaped balloon, and ending the treatment.
By adopting the prostate administration balloon therapy containing the olive-shaped balloon in the embodiment, the operation time can be greatly shortened, the operation can be completed only by contacting the balloon with the prostate, and the therapy flow is simple. And, two sacculus tip sets up with sacculus pipe 1 is 40 degrees contained angles, adopts non-compliance material to make, and the sacculus accomodates the setting of going into the sacculus sheath pipe after the dosing can improve the security of operation, guarantees splendid operation effect simultaneously.
Example 2
As shown in fig. 4 to 5, the connection relationship between the components in this embodiment is substantially identical to that in embodiment 1, except that the pressurizing liquid channel 5 in embodiment 1 is divided into a positioning balloon pressurizing liquid channel 9, an olive-shaped balloon pressurizing liquid channel 10 by a balloon catheter grating 13, and positioning balloon pressurizing liquid channel through holes 11 and olive-shaped balloon pressurizing liquid channel through holes 12 are respectively added on the surface of the balloon catheter 1.
The method of use of this embodiment is as follows;
The guide wire is firstly arranged, then the sheath tube is introduced, the front section of the guide wire is positioned in the bladder under the condition of ultrasonic B, and then the prostate administration balloon component containing the olive-shaped balloon penetrates from the tail of the guide wire until penetrating into the front section of the guide wire.
The positioning balloon 2 and the olive-shaped balloon 3 are respectively sleeved and fixed on the balloon catheter 1, and the two balloons are not communicated with each other. The positioning balloon 2 is pressurized through the positioning balloon pressurizing liquid channel 9, the olive-shaped balloon 3 is pressurized through the olive-shaped balloon pressurizing liquid channel 10, the positioning balloon pressurizing liquid channel 9 and the olive-shaped balloon pressurizing liquid channel 10 are provided with the balloon in front of the catheter grid 13, and the two pressurizing channels are not communicated with each other.
As shown in fig. 4, the sheath 4 is moved toward the rear portion 8 of the balloon catheter until the positioning balloon 2 is completely exposed, at which time the movement of the sheath 4 is stopped, and the positioning balloon 2 is pressurized through the positioning balloon pressurizing liquid passage 9, at which time the inside of the olive-shaped balloon 3 is completely pressureless. The pressurization is stopped until the positioning balloon 2 is completely expanded. The balloon catheter 1 is gently pulled, and when slight resistance is felt, the positioning balloon is positioned near the bladder orifice of the prostate, so that positioning is completed. The sheath 4 is moved towards the balloon catheter rear portion 8 until the olive-shaped balloon 3 is completely exposed, pressurizing the olive-shaped balloon 3 through the olive-shaped balloon pressurizing liquid channel 10, and independent pressure control of the positioning balloon 2, the olive-shaped balloon 3 can be achieved due to the presence of the balloon grid 13. The pressurization is stopped until the positioning balloon 2 and the olive-shaped balloon 3 are completely expanded. At this time, neither the positioning balloon 2 nor the olive balloon 3 can move.
The outer edge of the olive-shaped saccule 3 is uniformly provided with a medicinal composition layer consisting of paclitaxel, iopromide, PEG or PVP with the thickness of about 50 micrometers. The layer of the pharmaceutical composition on the surface of the olive-shaped balloon 3 is contacted with the diseased region of the prostate, expands the narrow region of the urethra and releases the drug to the contacted region rapidly, and after a preset expansion time is reached, the pressurizing liquid is pumped out through the positioning balloon pressurizing liquid channel 9 and the olive-shaped balloon pressurizing liquid channel 10, and the sheath tube 4 is moved towards the front part 7 of the balloon catheter, so that the positioning balloon 2 and the olive-shaped balloon 3 without pressure are accommodated in the sheath tube 4. And finally, completely withdrawing the prostate administration balloon assembly containing the olive-shaped balloon, and ending the treatment.
The length of the balloon catheter 1 is 500mm, the length of the balloon catheter 1 in a patient during treatment is 300mm, and the length of the balloon catheter 1 is larger than the length of the balloon catheter in the patient, so that the external operation space is ensured. The outer diameter of the sheath tube 4 is 12mm, the length is 350mm, the front part 2mm of the sheath tube is made of silica gel, and the outer diameter of the sheath tube 4 is set to be 5mm enough to accommodate the positioning balloon 2, the olive-shaped balloon 3 and the balloon catheter 1, so that the positioning balloon can be accommodated after the drug administration is finished. The front part of the sheath tube is 2mm and is made of silica gel, so that the human organ tissues are not easy to scratch, and meanwhile, the storage after the drug administration is finished is facilitated. The positioning balloon 2 is made of nylon 66, has non-compliance, has a radial dimension of 30mm when expanded, forms an included angle of 45 degrees with the balloon catheter 1 at the end, and the olive-shaped balloon 3 is made of nylon 66, also has non-compliance, has a radial dimension of 30mm when expanded, and forms an included angle of 45 degrees with the balloon catheter 1 at the end. The non-compliant material is selected, no neck is arranged between the two balloons, the two balloons are respectively manufactured by blow molding, and the two balloons are sequentially and tightly sleeved on the balloon catheter 1. The positioning balloon 2 and the olive-shaped balloon 3 form an included angle of 45 degrees with the balloon catheter 1 at the end part, so that the positioning balloon is easy to slide, and the internal urethral sphincter and the external urethral sphincter are prevented from being damaged.
By adopting the prostate administration balloon therapy containing the olive-shaped balloon in the embodiment, the operation can be completed only by contacting the balloon with the prostate, and the therapy flow is simple. Meanwhile, the pressurizing liquid channels are respectively and independently arranged for the positioning balloon and the olive-shaped balloon, so that safety and controllability are ensured. The two balloon ends are arranged at an included angle of 45 degrees with the balloon catheter 1, are made of non-compliant materials, and are accommodated into the balloon sheath after the drug administration is finished, so that the safety of the operation can be further improved, and meanwhile, the excellent operation effect is ensured.
The foregoing is merely exemplary embodiments of the present disclosure and is not intended to limit the scope of the disclosure, which is defined by the appended claims.
Claims (11)
1. A balloon assembly for administration to a prostate, comprising:
the balloon catheter, a positioning balloon fixedly arranged at the far end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter,
The balloon catheter has a guidewire channel and a pressurized fluid channel, wherein the pressurized fluid channel is in communication with the positioning balloon and the olive-shaped balloon, the guidewire channel is not in communication with the pressurized fluid channel,
The drug delivery balloon assembly further comprises a sheath for accommodating the positioning balloon, the olive balloon and the corresponding balloon catheter such that the positioning balloon and the olive balloon can reciprocate in the sheath, the sheath having an outer diameter of 2mm to 10mm, preferably 4mm to 8mm, or 5mm to 7mm,
The outer surface of the olive-shaped balloon is provided with a drug composition layer,
Wherein the positioning balloon is for placement in a bladder of a patient for positioning a balloon catheter, the olive balloon is for placement in a prostate of the patient for dilating and administering the prostate by contacting an inner wall of the prostate, the sheath has a length that is greater than a length of the balloon catheter in the patient when in use and less than a length of the balloon catheter, and such that at least the positioning balloon and the olive balloon are exposed when the sheath is retracted proximally relative to the balloon catheter.
2. The balloon assembly according to claim 1, further comprising a balloon connection disposed between the positioning balloon and the olive balloon, the balloon connection having an outer diameter that is smaller than the outer diameters of the positioning balloon and the olive balloon.
3. The balloon assembly according to claim 1, wherein the positioning balloon and the olive balloon are in direct communication, with no balloon connection therebetween.
4. The balloon assembly according to claim 1, wherein the pressurized fluid passage comprises a positioning balloon pressurized fluid passage and an olive-shaped balloon pressurized fluid passage, the positioning balloon pressurized fluid passage and the olive-shaped balloon pressurized fluid passage not communicating with each other, the positioning balloon pressurized fluid passage having a positioning balloon pressurized fluid passage through hole in communication with the positioning balloon, the olive-shaped balloon pressurized fluid passage having an olive-shaped balloon pressurized fluid passage through hole in communication with the olive-shaped balloon.
5. The balloon assembly of claim 1, wherein the sheath has a sheath front and a sheath rear, the sheath front being made of a low strength material, the sheath front being longer than 2mm and shorter than the distance between two balloons, the sheath rear being made of a high strength material such that the balloon cannot be inflated by pressurization when the positioning balloon and the olive balloon are in the sheath rear.
6. The balloon assembly according to claim 1 or 5, wherein the inner diameter of the sheath is such that the positioning balloon and the olive balloon can be re-received in the sheath in case the positioning balloon and the olive balloon are re-contracted after being expanded under the pressure of a pressurized liquid.
7. The balloon assembly according to claim 1, wherein longitudinal sections of the outer surfaces of the positioning balloon and the olive balloon each independently have a convex arc-like profile at the ends.
8. The balloon assembly of claim 1, wherein longitudinal sections of the outer surfaces of the positioning balloon and the olive balloon are each independently angled at 30 to 50 degrees from the balloon catheter at the ends.
9. The balloon assembly of claim 1, wherein the pharmaceutical composition layer comprises at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.
10. The balloon assembly according to any of claims 1-7, wherein the radial dimensions of the positioning balloon and the olive balloon upon inflation are each independently 6-40mm, such as 10 to 35mm, such as 12 to 30mm, such as 15 to 25mm, such as 16 to 23mm.
11. The balloon assembly of any of claims 1-10, wherein the positioning balloon and the olive balloon are both non-compliant or low-compliant balloons.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2023112615701 | 2023-09-27 | ||
| CN202311261570 | 2023-09-27 |
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| Publication Number | Publication Date |
|---|---|
| CN118121817A true CN118121817A (en) | 2024-06-04 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311264186.7A Pending CN118121817A (en) | 2023-09-27 | 2023-09-28 | Balloon assembly for administration to the prostate |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN119034087A (en) * | 2024-10-30 | 2024-11-29 | 上海玮沐医疗科技有限公司 | Drug balloon delivery catheter |
| CN119607975A (en) * | 2024-12-18 | 2025-03-14 | 中国人民解放军总医院第四医学中心 | A portable bone adhesive vacuum mixing device for intraoperative use |
-
2023
- 2023-09-28 CN CN202311264186.7A patent/CN118121817A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN119034087A (en) * | 2024-10-30 | 2024-11-29 | 上海玮沐医疗科技有限公司 | Drug balloon delivery catheter |
| CN119607975A (en) * | 2024-12-18 | 2025-03-14 | 中国人民解放军总医院第四医学中心 | A portable bone adhesive vacuum mixing device for intraoperative use |
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