Disclosure of Invention
It is an object of the present invention to provide a prostate intra-luminal thermal therapy catheter that enables adaptive sizing of the heating balloon according to the inner diameter of the patient's urethra.
A prostate intra-luminal thermal treatment catheter for achieving the foregoing object, comprising:
the catheter body is internally provided with a plurality of inner cavity channels, wherein the inner cavity channels comprise a first balloon cavity channel, a reflux cavity channel and a wiring cavity channel;
A positioning balloon arranged outside the tube body and communicated with the first balloon cavity, wherein gas or liquid can be filled into the positioning balloon from the first balloon cavity so as to enable the positioning balloon to be inflated and positioned at the bladder port, and
The thermal therapy saccule is arranged at the outer side of the tube body and communicated with the wiring cavity, a thermal therapy assembly is arranged in the thermal therapy saccule, and wiring connected with the thermal therapy assembly is arranged in the wiring cavity;
The back flow cavity is communicated with the positioning balloon and the thermal therapy balloon, and the filled gas or liquid flows between the positioning balloon and the thermal therapy balloon through the back flow cavity so as to keep the pressure balance between the positioning balloon and the thermal therapy balloon, so that the thermal therapy balloon is inflated to a size suitable for being attached to the inner wall of the urethra.
In one or more embodiments, the two ends of the tube body are respectively provided with a guide head and a rear end component, the guide head is used for guiding the catheter to be inserted into the urethra, the rear end component provides a plurality of interfaces, and the interfaces comprise a first balloon cavity interface and a connecting plug;
the first balloon cavity channel interface is communicated with the positioning balloon through the first balloon cavity channel so as to inject gas or liquid into the positioning balloon through the first balloon cavity channel interface, and a one-way valve is arranged at the first balloon cavity channel interface;
the connecting plug is connected with the wiring in the wiring cavity, and the backflow cavity and the rear end assembly are blocked.
In one or more embodiments, the inner lumen channel further comprises a urinary lumen, the catheter head has a urinary port, the port in the rear end assembly comprises a urinary lumen port, and the urinary port is communicated with the urinary lumen port through the urinary lumen.
In one or more embodiments, the thermal therapy catheter further comprises a closed balloon, the positioning balloon, the thermal therapy balloon, and the closed balloon being disposed in sequence from the guide head toward the back end assembly;
The inner cavity channel further comprises a second balloon cavity channel, the interface in the rear end assembly comprises a second balloon cavity channel interface, the second balloon cavity channel interface is communicated with the closed balloon through the second balloon cavity channel, a one-way valve is arranged at the second balloon cavity channel interface, and gas or liquid is injected into the closed balloon through the second balloon cavity channel interface so as to enable the closed balloon to be inflated;
The positioning balloon and the sealing balloon after the inflation respectively seal the urethra to form a sealing cavity at the affected part of the urethra, and the thermal therapy balloon carries out thermal therapy on the affected part at the sealing cavity.
In one or more embodiments, a liquid medicine outlet is formed in the tube body wall of at least one side of the thermal therapy balloon, the inner cavity channel further comprises a liquid medicine inner cavity, the interface in the rear end assembly further comprises a liquid medicine inner cavity interface, and a one-way valve is arranged at the liquid medicine inner cavity interface;
Wherein the liquid medicine inner cavity is communicated with the liquid medicine outlet and the liquid medicine inner cavity interface so as to allow the liquid medicine to be conveyed into the closed cavity through the liquid medicine inner cavity interface.
In one or more embodiments, the liquid medicine outlets are respectively arranged on the tube body walls at two sides of the thermal therapy balloon.
In one or more embodiments, the thermal therapy assembly includes a plurality of heating units and at least one temperature measuring unit;
Each heating unit comprises a radio frequency electrode ring and a radio frequency wire which are sleeved on the outer side of the pipe body, and the radio frequency wire is connected with the plug and the radio frequency electrode ring;
The temperature measuring unit comprises a temperature measuring electrode ring and a temperature measuring wire, wherein the temperature measuring electrode ring and the temperature measuring wire are sleeved on the outer side of the pipe body, and the temperature measuring wire is connected with the plug and the temperature measuring electrode ring.
In one or more embodiments, the thermal therapy assembly further comprises a heat transfer electrode ring sleeved outside the tube body, and the heat transfer electrode ring and the radio frequency electrode ring are uniformly distributed outside the tube body in the thermal therapy balloon.
In one or more embodiments, the thermal therapy balloon has a wall thickness that is no greater than the positioning balloon.
In one or more embodiments, the wiring cavity is plugged by a silicone after the wiring is routed within the wiring cavity.
The invention has the advantages that one or the combination of the following steps:
1) By arranging the reflux cavity channel which is communicated with the thermal therapy balloon and the positioning balloon in the catheter, the internal pressure of the thermal therapy balloon and the internal pressure of the positioning balloon are balanced, so that when the catheter is inserted into the urethra with different inner diameters, the pressure of the inner wall of the urethra on the thermal therapy balloon is utilized, the size of the thermal therapy balloon can be adjusted according to the different inner cavity diameters of the urethra, and the self-adaptive size adjustment of the thermal therapy balloon in the urethra of a patient is realized.
2) By arranging the heat transfer electrode ring in the thermal therapy balloon, the fluid in the thermal therapy balloon can be heated more uniformly.
Detailed Description
The following discloses a number of different embodiments or examples of implementing the subject technology. Specific examples of components and arrangements are described below for purposes of simplifying the disclosure, and of course, these are merely examples and are not intended to limit the scope of the application. For example, a first feature described later in this specification may be formed above or on a second feature, and may include embodiments in which the first and second features are formed in direct contact, as well as embodiments in which additional features may be formed between the first and second features, such that no direct contact may be made between the first and second features. In addition, the disclosure may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed. Further, where a first element is described as being coupled or combined with a second element, the description includes embodiments in which the first and second elements are directly coupled or combined with each other, and also includes embodiments in which one or more other intervening elements are added to indirectly couple or combine the first and second elements with each other.
It should be noted that where used, the description of upper, lower, left, right, front, rear, top, bottom, forward, reverse, clockwise and counterclockwise are used for convenience only and do not imply any particular orientation of securement. In fact, they are used to reflect the relative position and/or orientation between the various parts of the object.
It is noted that these and other figures are merely examples, which are not drawn to scale and should not be construed as limiting the scope of the invention as it is actually claimed. In addition, the conversion modes in the different embodiments may be appropriately combined.
Without addressing one or more of the problems of the prior art, the present invention provides a prostate intra-cavity thermal treatment catheter, as shown in fig. 1, which is a schematic view of an embodiment of the prostate intra-cavity thermal treatment catheter, and in fig. 2, which is a schematic cross-sectional view taken along the A-A direction in fig. 1.
Referring to fig. 1 and 2 in combination, the prostate intra-cavity thermo-therapeutic catheter includes a tube body 1, a positioning balloon 2, and a thermo-therapeutic balloon 3.
The tube body 1 is provided with a plurality of inner cavities, as shown in fig. 2, wherein the inner cavities comprise a first balloon cavity 11, a reflux cavity 12 and a wiring cavity 13. The inner passages may be separated by a plurality of inner walls 100 disposed and extending inside the tube 1, as shown in fig. 2. A plurality of inner channels are defined between the plurality of inner walls 100.
The positioning balloon 2 is arranged on the outer peripheral side of the tube body 1 and is communicated with the first balloon cavity 11. Specifically, as shown in fig. 1, a positioning balloon opening 20 is formed on the outer wall of the tube body 1, so that the interior of the positioning balloon 2 passing through the positioning balloon opening 20 is communicated with one end of the first balloon cavity 11, when gas or liquid is introduced into the other end of the first balloon cavity 11, the gas or liquid can be introduced into the positioning balloon 2 from the first balloon cavity 11, and the interior of the positioning balloon 2 is filled with fluid and inflated, so that the tube body 1 is positioned at the bladder orifice by the positioning balloon 2 in the inflated state.
In some other embodiments, which are different from those illustrated, the communication mentioned in one or more embodiments of the present invention may have many suitable variations or modifications, but is not limited thereto, as in the manner in which the first balloon channel 11 communicates with the positioning balloon 2, the first balloon channel 11 may have a length of tubule extending out of the outer side wall of the tube through which the positioning balloon 2 communicates with the first balloon channel 11. The communication modes mentioned in one or more embodiments described below may also be the same or equivalent, and thus will not be described in detail.
With continued reference to the drawings, the thermal therapy balloon 3 is disposed at the outer peripheral side of the tube body 1 and is communicated with the wiring cavity 13, and a thermal therapy assembly is disposed in the thermal therapy balloon 3, and is used for heating the thermal therapy balloon 3 to heat the focus of the patient. Wherein, wiring for connecting the thermal therapy components is arranged in the wiring cavity 13. Specifically, as shown in fig. 1, a wiring opening 30 may be provided in the outer wall of the pipe body 1, and wiring may be routed through the wiring opening into the wiring channel 13 and extend along the wiring channel 13.
Wherein, the reflux cavity 12 is communicated between the positioning balloon 2 and the thermal therapy balloon 3, and the gas or liquid filled into the positioning balloon 2 flows between the positioning balloon 2 and the thermal therapy balloon 3 through the reflux cavity 12, thereby keeping the pressure balance of the positioning balloon 2 and the thermal therapy balloon 3, so that the thermal therapy balloon 3 is filled to a size suitable for being attached to the inner wall of the urethra. Specifically, as shown in fig. 1, a reflux cavity outlet 121 and a reflux cavity inlet 122 are respectively formed on the outer wall of the tube body 1, the reflux cavity inlet 122 is communicated with the inner cavity of the thermal therapy balloon 3, and the reflux cavity outlet 121 is communicated with the inner cavity of the positioning balloon.
Specifically, when the internal pressure of the balloon increases after the positioning balloon 2 is inflated, the positioning balloon 2 is communicated with the thermal therapy balloon 3 through the reflux cavity channel 12, so that the fluid in the positioning balloon 2 can release the internal pressure of the thermal therapy balloon 3 from the reflux cavity outlet 121 to enable the fluid to flow into the thermal therapy balloon 3 from the reflux cavity inlet 122, and when the internal of the thermal therapy balloon 3 is inflated with the fluid, the surface of the balloon slowly expands and can be clung to the mucosa of the affected part of the prostate. When the surface of the balloon is tightly attached to the mucosa of the affected part, the internal pressure of the thermal therapy balloon 3 can be generated due to the compression action of the mucosa on the outer wall of the thermal therapy balloon 3, so that the internal pressure of the positioning balloon 2 and the internal pressure of the thermal therapy balloon 3 are balanced gradually, and the aim that the thermal therapy balloon 3 can be tightly attached to the inner wall of the affected part of the urethra is achieved. At the same time the positioning balloon 2 is also capable of inflation and closing the urethral inlet.
In the existing heat treatment catheter, the outer diameter of a heating balloon on the heat treatment catheter inserted into the urethra of a patient is not adjustable, namely, the expansion force of the heating balloon inserted into the catheter of the urethra of the patient is the same for the heating balloons with different inner cavity diameters of the urethra, and the inner diameter pressure of the urethra cavity of the patient is the same. By arranging the reflux cavity 12 which is communicated with the thermal therapy balloon 3 and the positioning balloon 2 in the catheter, the internal pressure of the thermal therapy balloon 3 and the internal pressure of the positioning balloon 2 are balanced, so that the pressure of the inner wall of the urethra to the thermal therapy balloon 3 when the catheter is inserted into the urethra with different inner diameters is ensured, the size of the thermal therapy balloon 3 can be adjusted according to the different inner diameters of the urethra, and the self-adaptive size adjustment of the thermal therapy balloon 3 in the urethra of a patient is realized.
Although one embodiment of the prostate intra-cavity thermal treatment catheter is described above, in other embodiments of the prostate intra-cavity thermal treatment catheter, the prostate intra-cavity thermal treatment catheter may have more details in many respects relative to the above-described embodiments, and at least some of these details may have various variations. At least some of this detail and some variations are described below in some examples.
Fig. 3 is a schematic cross-sectional view of fig. 2 along the direction B-B, referring to fig. 1 to 3, in one embodiment of the prostate intra-luminal thermal treatment catheter, the two ends of the tube 1 are respectively provided with a guide head 4 and a rear end assembly 5, the guide head 4 is used for guiding the catheter to be inserted into the urethra of the patient, and the rear end assembly 5 is provided with a plurality of interfaces including a first balloon lumen interface 51 and a connection plug 52. The first balloon lumen interface 51 communicates with the positioning balloon 2 through the first balloon lumen 11 such that gas or liquid can be injected into the positioning balloon 2 through the first balloon lumen interface 51, wherein a one-way valve is provided at the first balloon lumen interface 51 to prevent backflow of fluid. The connection plug 52 is connected to the wiring in the wiring channel 13 so that the heating of the thermal treatment assembly is started by inserting the connection plug 52 e.g. onto a radio frequency thermal treatment instrument.
Wherein, the back flow cavity 12 and the back end component 5 are blocked, so that a self-balancing cavity is formed among the thermal therapy balloon 3, the positioning balloon 2 and the back flow cavity 12.
In other embodiments, not limited to the embodiments shown, there are many suitable modifications or variations of the structural form of the intraluminal prostate thermal treatment catheter. As in one embodiment, the intra-prostate thermal catheter may be provided with other forms of guide members that guide into the patient's urethra than the form of guide head 4 in the figures. As another embodiment, the rear end assembly 5 may be formed by separate post-manufacturing connection, instead of being integrally formed at the end of the pipe body 1. As in yet another embodiment, the first balloon lumen interface 51 may be provided without a one-way valve and the degree of inflation of the balloon interior may be manually manipulated. As in the further embodiment, the return channel 12 is provided only between the thermo-therapeutic balloon 3 and the positioning balloon 2 and does not extend towards the back end assembly 5.
With continued reference to fig. 1-3, in one embodiment of the prostate intra-luminal thermal therapy catheter, the lumen tract further comprises a urinary catheterization lumen 14 with a catheterization port 40 at the lead 4, and the interface in the back end assembly 5 comprises a catheterization lumen interface 53, the catheterization port 40 being in communication with the catheterization lumen interface 53 through the catheterization lumen 14 to effect urination within the patient's urethra. In one embodiment, the catheterization lumen interface 53 may be connected to medical devices such as external catheterization bags or dropsy bags to enable catheterization of a patient during treatment.
In one embodiment of the prostate intra-cavity thermal treatment catheter, the thermal treatment catheter further comprises a sealing balloon 6, wherein the positioning balloon 2, the thermal treatment balloon 3 and the sealing balloon 6 are arranged in sequence from the guide head 4 towards the rear end assembly 5 as shown in the figure, and the positioning balloon 2 is adjacent to the end of the guide head 4. The sealing balloon 6 is closer to the end of the rear end assembly 5, and the thermal therapy balloon 3 is arranged between the positioning balloon 2 and the sealing balloon 6.
The inner lumen also includes a second balloon lumen 15, the interface in the back end assembly 5 includes a second balloon lumen interface 54, the second balloon lumen interface 54 communicates with the closed balloon 6 through the second balloon lumen 15, and a one-way valve is also provided at the second balloon lumen interface 54 to prevent backflow of fluid. A gas or liquid is injected into the closed balloon 6 through the second balloon lumen interface 54 so that the closed balloon 6 is inflated and expanded by the fluid.
The positioning balloon 2 and the sealing balloon 6 in the filled state are respectively inflated to seal the urethra, so that a sealed cavity is formed at the affected part of the urethra, and the heat treatment balloon 3 carries out heat treatment on the affected part at the sealed cavity.
With continued reference to fig. 1-3, in one embodiment of the prostate intra-luminal thermal therapy catheter, a medical fluid outlet 160 is provided in the wall of at least one side of the thermal therapy balloon 3, the lumen channel further includes a medical fluid lumen 16, the interface in the back end assembly 5 further includes a medical fluid lumen interface 55, and a one-way valve is provided at the medical fluid lumen interface 55 to prevent backflow of fluid. Wherein, the liquid medicine inner cavity 16 is communicated with the liquid medicine outlet 160 and the liquid medicine inner cavity interface 55 to allow the liquid medicine to be conveyed into the closed cavity between the positioning balloon 2 and the closed balloon 6 through the liquid medicine inner cavity interface 55, thereby realizing the function of conveying the liquid medicine to the heat treatment part.
In one embodiment of the intra-luminal prostate thermal treatment catheter, the liquid medicine outlets 160 are disposed on the wall of the tube on both sides of the thermal treatment balloon 3 as shown in the drawing, and in other embodiments different from the drawing, the number and disposition of the liquid medicine outlets 160 may be changed or modified, but not limited thereto, as in one embodiment, the liquid medicine outlets 160 may be disposed on only one side of the wall of the tube of the thermal treatment balloon 3. As in another embodiment, the liquid medicine outlet 160 may be a plurality of disposed at both sides of the thermo-therapeutic balloon 3, respectively.
As fig. 4 shows a partially enlarged schematic view of the portion E of fig. 3, the thermal treatment assembly of the thermal treatment balloon 3 comprises a plurality of heating units and at least one thermometry unit. The heating unit comprises a radio frequency electrode ring 31 and a radio frequency lead 32 sleeved on the outer side of the pipe body 1, and the temperature measuring unit comprises a temperature measuring electrode ring 33 and a temperature measuring lead 34 sleeved on the outer side of the pipe body 1. Wherein the rf lead 32 connects the rf electrode ring 31 with the connection plug 52 to energize the rf electrode ring 31 by an external device. The thermometric lead 34 connects the thermometric electrode ring 33 with the connection plug 52 to enable the thermometric electrode ring 33 to monitor the temperature in the thermal therapy balloon 3 by the external device.
With continued reference to fig. 4, in one embodiment of the thermal treatment catheter in the prostate cavity, the thermal treatment assembly further includes a heat transfer electrode ring 35 sleeved on the outer side of the tube body 1, the heat transfer electrode ring 35 is used for uniformly transferring heat to the interior of the thermal treatment balloon 3, wherein the heat transfer electrode ring 35 and the radio frequency electrode ring 31 are uniformly distributed in the thermal treatment balloon 3 along the extending direction of the tube body 1, so as to realize uniform heat conduction to the fluid in the thermal treatment balloon 3.
In one embodiment of the intra-luminal thermal treatment catheter for the prostate, the thermo-therapeutic balloon 3 has a wall thickness not larger than that of the positioning balloon 2, so that when the positioning balloon 2 and the thermo-therapeutic balloon 3 are inflated together and then are abutted against the inner wall of the urethra, the fluid in the thermo-therapeutic balloon 3 presses the inner wall of the urethra to be smaller than the positioning balloon 2 and heat is more easily transferred to the affected part of the urethra because the thermo-therapeutic balloon 3 has a thinner inner wall.
In one embodiment of the prostate intra-luminal thermal therapy catheter, after the wiring is routed within the wiring channel 13, the wiring channel 13 is plugged with silicone to achieve insulation.
In one embodiment of the prostate intra-luminal thermal therapy catheter, the gas or liquid infused in one or more embodiments as previously described is physiological saline.
Fig. 5 shows a schematic cross-sectional view along the direction D-D in fig. 2, and fig. 6 shows a schematic cross-sectional view along the direction C-C in fig. 2, please refer to fig. 1 to 6 in combination.
The prostate intra-luminal thermal therapy catheter in one or more embodiments as described above may be used in a thermal therapy apparatus by inserting the proximal guide 4 of the catheter from the patient's urethra during therapy until the positioning balloon 2 reaches the bladder completely, and then injecting saline through the one-way valve of the first balloon lumen interface 51 to fill the positioning balloon 2 and then pulling the catheter outward until the positioning balloon 2 is positioned at the bladder port. At this time, the thermal therapy balloon 3 is placed on the affected part of the prostatic urethra of the patient, the internal pressure of the balloon is increased after the positioning balloon 2 is filled, and as the positioning balloon 2 is communicated with the thermal therapy balloon 3 through the reflux cavity 12, the physiological saline in the positioning balloon 2 can automatically release the internal pressure of the positioning balloon 2 from the reflux cavity outlet 121 to enable the physiological saline to flow into the thermal therapy balloon 3 from the reflux cavity inlet 122, when the physiological saline is filled in the thermal therapy balloon 3, the surface of the balloon slowly expands and can be clung to the mucosa of the affected part of the prostatic urethra, and as long as the surface of the balloon clung to the mucosa of the affected part to enable the internal pressure of the thermal therapy balloon 3 to be generated, the internal pressure of the positioning balloon 2 and the internal pressure of the thermal therapy balloon 3 are balanced gradually, so that the internal pressure of the thermal therapy balloon 3 can be clung to the inner wall of the affected part of the urethra of the urethral urethra can be achieved. And meanwhile, physiological saline is injected through the second saccule cavity interface 54 one-way valve to enable the sealing saccule 6 to be filled and then seal the urethra of the patient, so that the affected part of the urethra basically forms a sealing cavity.
At this time, the connecting plug 52 is connected with the radio frequency thermal therapeutic instrument, the heating unit in the thermal therapeutic assembly of the thermal therapeutic balloon 3 transmits the controllable radio frequency power output by the radio frequency thermal therapeutic instrument to the radio frequency electrode ring 31 through the connecting plug 52 and the radio frequency lead 32, the physiological saline in the thermal therapeutic balloon 3 is heated to perform electric-thermal conversion as a medium, and the temperature measuring unit in the thermal therapeutic assembly transmits the measured instant temperature to the radio frequency thermal therapeutic instrument through the temperature measuring lead 34, the temperature measuring electrode ring 33 and the connecting plug 52 to achieve instant time control temperature, so that the thermal therapeutic balloon 3 is kept at constant temperature, and thermal therapy is performed on the focus part of a patient.
Meanwhile, the liquid medicine can be injected from the injector interface of the liquid medicine cavity interface 55, the liquid medicine flows out from the liquid medicine outlet 160 through the liquid medicine cavity 16, the liquid medicine is reserved in the sealing area between the positioning balloon 2 and the sealing balloon 6 at the periphery of the thermal therapy balloon 3, and the liquid medicine in the sealing area is warmed through the heated thermal therapy balloon 3 to achieve the purpose of targeted thermal therapy of the liquid medicine.
The invention has the advantages that one or the combination of the following steps:
1) By arranging the reflux cavity channel which is communicated with the thermal therapy balloon and the positioning balloon in the catheter, the internal pressure of the thermal therapy balloon and the internal pressure of the positioning balloon are balanced, so that when the catheter is inserted into the urethra with different inner diameters, the pressure of the inner wall of the urethra on the thermal therapy balloon is utilized, the size of the thermal therapy balloon can be adjusted according to the different inner cavity diameters of the urethra, and the self-adaptive size adjustment of the thermal therapy balloon in the urethra of a patient is realized.
2) By arranging the heat transfer electrode ring in the thermal therapy balloon, the fluid in the thermal therapy balloon can be heated more uniformly.
While the invention has been described in terms of preferred embodiments, it is not intended to be limiting, but rather to the invention, as will occur to those skilled in the art, without departing from the spirit and scope of the invention. Therefore, any modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention fall within the protection scope defined by the claims of the present invention.