CN115024871A

CN115024871A - Intervene conveying and recovery unit and interim support system of interveneing of support

Info

Publication number: CN115024871A
Application number: CN202210422656.7A
Authority: CN
Inventors: 刘西伟; 狄伟伟; 杨映红; 张静; 豆笑笑
Original assignee: Beijing Purun Medical Devices Co ltd
Current assignee: Beijing Purun Medical Devices Co ltd
Priority date: 2022-04-21
Filing date: 2022-04-21
Publication date: 2022-09-09

Abstract

The invention provides a conveying and recovering device of an interventional stent and a temporary interventional stent system, which comprises a conveying sheath tube and a guide rod, wherein the conveying sheath tube is provided with a guide hole which is axially communicated, the guide rod can be inserted into the guide hole in a mode of axially moving relative to the conveying sheath tube, and the axial length of the guide rod is greater than that of the conveying sheath tube; the trailing end of the guide rod has a bore for facilitating tying of a wire, and the leading end of the guide rod has a radially or circumferentially outwardly projecting grip. The invention can realize the delivery release and the recovery of the stent device by the matching use of the delivery sheath tube and the guide rod, the whole system has simple structure, easy operation and short learning curve, the stent device is assembled into the delivery system from the clinical site before an operation, namely, the ducted mesh stent is compressed to the tail part of the sheath tube, and then the guide mechanism is tensioned and locked, and the stent device does not need to be compressed by the tube wall of the delivery system for a long time, thereby ensuring better mechanical support effect.

Description

Intervene conveying and recovery unit and interim support system of interveneing of support

Technical Field

The invention relates to the technical field of medical instruments, in particular to a conveying and recovering device of an interventional stent and a temporary interventional stent system.

Background

The treatment of Benign Prostatic Hyperplasia (BPH) mainly includes watchful waiting, medication and surgical treatment. Drugs for treatment of BPH counteract the dynamic component of urinary outflow obstruction by relaxing smooth muscles in the bladder neck, prostate capsule and prostatic urethra. Current clinical drug therapies exhibit irreversible side effects such as headache, dizziness, nausea, erectile dysfunction, ejaculatory dysfunction, decreased libido, heart failure, and the like. Poor medication compliance also results from the presence of its side effects, resulting in a medication failure rate of up to 30% over two years. However, the operation is invasive, such as the electroexcision or enucleation commonly selected clinically, which requires hospitalization and long-term urinary catheter insertion, and causes postoperative infection, decreased libido and loss of reproductive function of the patient.

Prostatic Urethra Lift (PUL) is a non-surgical treatment to alleviate the symptoms of prostatic hyperplasia, and has been proposed by AUA group level C to improve the urinary flow pathway by implanting permanent implants without affecting the ejaculation and erection functions of the patient. The permanent implant can be covered by the urinary duct epithelium after being implanted into the urinary duct, can be completely epithelialized within 3-6 months, and can keep the integrity of the urethra. In the treatment in the mode, the implant continuously exists as a foreign body, the release of metal ions of the stent can have irritation inflammatory response to tissues, granulation tissues and epithelial hyperplasia of different degrees can be generated in the lumen of the stent after operation, the urethral orifice is blocked, lower urinary tract symptoms occur again, at the moment, the stent needs to be taken out through operation, and the pain of secondary operation is brought to a patient. It has been reported that this approach faces a very high risk of secondary surgical removal of the permanent implant, with a 5 year re-removal rate of 10%. It is a solution to develop a degradable stent as a temporary stent by using degradable implants, for example, patent CN 102551932A discloses a urethral stent which mainly comprises macromolecules such as PGA or PLA, etc., and has the characteristics of better biocompatibility, smaller verification response, no need of taking out or replacing, etc., thereby greatly reducing the pain of patients, for example, patent CN 103170007 a discloses a degradable porous urethral repair stent made of PCL or PLA-CL, etc. But the degradable macromolecules become brittle at the later stage of degradation, form larger fragments, easily and mechanically block the urethra, and cause great risk of urinary retention.

Disclosure of Invention

In view of the above problems, the present invention is directed to provide a device for delivering and retrieving an interventional stent and a system for a temporary interventional stent, so that a tube-mesh stent for temporary interventional treatment of a human body can be non-invasively inserted into a prostate part, and expanded and retained in a urethra of the prostate part for a certain period of time after being released, and the stent device generates a longitudinal supporting force in surrounding tissues of an inner wall of the urethra to relieve urethral contraction, and then after a certain period of time, the device is removed from the urethra to treat BPH-related symptoms, reduce pain of a patient, and cause no sequelae, particularly damage related to reproductive and sexual functions. The purpose of the invention is realized by the following technical scheme:

the invention firstly provides a conveying and recovering device of an interventional stent, which comprises a conveying sheath tube and a guide rod, wherein the conveying sheath tube is provided with a guide hole which is axially communicated, the guide rod can be inserted into the guide hole in a mode of axially moving relative to the conveying sheath tube, and the axial length of the guide rod is greater than that of the conveying sheath tube; the trailing end of the guide rod has a bore for facilitating tying of a wire, and the leading end of the guide rod has a radially or circumferentially outwardly projecting grip. The guide rod is defined herein as a shaft having a cylindrical shape, which may be a solid rod, a hollow rod, or a tubular structure.

Further, the head end of the conveying sheath pipe is provided with a wire fixing piece, the wire fixing piece can be a fixing hole for tying a wire, or a boss, a convex edge, a groove and other structures for winding the wire, and can also be a clamp and the like, as long as the free end of the wire can be fixed.

Further, the delivery sheath is formed at a tip end thereof with an expanding portion gradually increasing in radial dimension, and the guide hole has an input hole section increasing in radial dimension at the expanding portion.

Furthermore, a funnel-shaped or half-cut funnel-shaped open component is connected to the expansion part of the head end of the conveying sheath tube.

Further, the outer diameter of the conveying sheath pipe is 2-8 mm, and the inner diameter of the conveying sheath pipe is 1.8-7 mm; the outer diameter of the guide rod is 1.5-4 mm.

The invention further provides a temporary interventional stent system which comprises a stent device and the conveying and recovering device, wherein the stent device comprises a pipe mesh stent which can be pressed and expanded, a fixed end and a recovering lead, the head end of the pipe mesh stent is gathered and contracted in the fixed end, the lead is connected to the fixed end, the length of the lead is greater than that of a conveying sheath tube, and the free end of the lead can be tied on a perforation of a guide rod.

Furthermore, the fixed end head adopts a bundle tube type structure.

Furthermore, the lead is made of PET, nylon, polyethylene or medical surgical suture and the like.

Furthermore, the tube-mesh stent is prepared from medical shape memory alloy, and the surface of the tube-mesh stent can be coated with related slow-release drugs so as to avoid inflammatory reaction during interventional therapy.

The invention has the beneficial effects that:

(1) the stent device is placed into a human body through a minimally invasive surgery by virtue of the conveying and recovering device, the tubular mesh stent can generate longitudinal supporting force in the tissue of the inner wall of the urethra, and expand the prostate part of the urethra to relieve urethral contraction, so that the urethral shaping effect of the prostate part is achieved, the stent device can be taken out after symptoms are relieved after a period of time, and can be used for treating BPH (BPH) related symptoms in daily surgery or outpatient service, improving the life quality and reducing the pain of a patient, avoiding sequelae such as sexual function and reproductive function damage, striving for time for the patient with the requirement on the sexual function and the reproductive function, avoiding implant retention and avoiding secondary intervention in the progressive stage of diseases;

(2) the conveying and recovering device can realize the conveying release and recovery of the stent device by matching the conveying sheath tube and the guide rod, the whole system has simple structure, easy operation and short learning curve, the stent device is assembled into the conveying system from the clinical site before operation, namely, the tubular mesh stent is compressed to the tail part of the sheath tube, and then the guide mechanism is tensioned and locked, and the stent device does not need to be compressed by the tube wall of the conveying system for a long time, thereby ensuring better mechanical support effect;

(5) the tube mesh stent is connected with the guide wire through the fixed end, when the tube mesh stent is implanted into a urethra prostate part, the guide wire extends along the urethra and extends out of the genitals, after the tube mesh stent is implanted, after a period of time when symptoms are relieved, the conveying sheath tube is inserted into the urethra prostate part along the guide wire, the mesh stent is pulled by the guide wire, the tail end of the mesh stent gradually enters the conveying sheath tube and is gradually compressed to the tail end of the sheath tube, and the sheath tube is withdrawn to complete recovery.

Drawings

FIG. 1 is a schematic view of a preferred embodiment of the guide rod of the present invention;

FIG. 2 is a schematic view of a delivery sheath according to a preferred embodiment of the present invention;

FIG. 3 is a schematic view of the bracket assembly of the present invention;

FIG. 4 is a schematic view of a guidewire loading delivery and retrieval device for a stent device employing the temporary interventional stent system of the present invention;

FIG. 5 is a schematic view showing the assembly or retrieval of the stent device through the delivery sheath;

FIG. 6 is a schematic view of the stent device assembled or retrieved into a delivery sheath;

FIG. 7 is a schematic view of another preferred embodiment of the loading of a tube mesh stent into a delivery and retrieval device;

in the figure:

100-conveying and recovery means; 120-a delivery sheath; 200-a rack device;

110-a guide bar; 120 a-sheath basis; 201 (201') -a tubular mesh stent;

110 a-head end of guide rod; 120 b-an expansion portion; 202-a conductive line;

110 b-the tail end of the guide bar; 121-a wire fixation; 203-fixing the tip.

111-a grip; 122-a gripping member;

112-perforation; 123-a guide hole;

Detailed Description

The technical solutions of the preferred embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. It is to be understood that the described embodiments are merely a few embodiments of the invention, and not all embodiments.

The present embodiment provides a temporary interventional stent system, which includes a delivery and retrieval device 100 and a stent device 200. The stent device 200 comprises a tube mesh stent 201(201 ') which can be pressed and expanded, a fixed end 203 and a guide wire 202, the conveying and recovering device 100 comprises a conveying sheath tube 120 and a guide rod 110, the head end of the tube mesh stent 201 (201') is gathered and contracted in the fixed end 203, and the guide wire 202 is connected to the fixed end 203.

In a preferred embodiment, the fixing end 203 is of a bundle tube structure, and the tail end of the lead 202 and the head end of the tube mesh support 201 (201') are integrally connected in the bundle tube and fixed in the bundle tube.

In a preferred embodiment, the wire 202 may be made of PET, nylon, polyethylene, or surgical suture.

In a preferred embodiment, the tubular mesh stent 201(201 ') is made of a medical shape memory alloy, preferably a medical NiTi alloy, exhibiting superior superelasticity, and in the illustrated embodiment, the tubular mesh stent 201 is formed by laser engraving a thin metal-walled tube, and in other embodiments, the tubular mesh stent 201' shown in fig. 7 may be a stent woven by using wires, and may be woven by using metal wires having a diameter of 0.3mm to 1.5 mm.

In the illustrated embodiment, the delivery sheath 120 has a guide hole 123 extending axially therethrough, the guide rod 110 is axially movably inserted into the guide hole 123 relative to the delivery sheath, and the axial length of the guide rod 110 is greater than the axial length of the delivery sheath 120; the trailing end 110b of the guide rod has a through-hole 112 for facilitating tying of a wire, the length of the wire 202 is longer than that of the delivery sheath 120, the free end of the wire 202 can be tied by the through-hole 112, and the leading end 110a of the guide rod has a grip 111 that is radially or circumferentially outwardly convex.

It should be noted that, in the present embodiment, the guiding rod 110 is defined as a shaft-shaped object with a cylindrical shape, which may be a solid rod, a hollow rod or a tubular structure, preferably the tubular structure shown in fig. 1, the through hole 112 may be a through hole penetrating through the wall thickness of one side, and a structure facilitating the tying of the wires is formed by the end of the tubular structure, or a through hole structure with two open ends is formed on the tube wall, and the free end of the wire sequentially passes through the two open ends of the through hole to complete the tying; when the guiding rod 110 is designed by a solid rod or other similar structures, a ring-shaped groove or other structures may be etched on the outer wall of the tail end 110b of the guiding rod, so that the wire 202 can be clamped in the groove structure to complete tying and fixing.

In a preferred embodiment, the head end of the conveying sheath 120 should be provided with a wire fixing member 121, and the wire fixing member 121 may be a fixing hole for tying the wire, or a boss, a ridge, a ring groove, or the like for winding the wire, or a clamp, or the like, as long as the fixing of the free end of the wire can be achieved.

In the illustrated embodiment, the guide rod 110 is inserted into the delivery sheath 120 from the guide hole section by forming the expanded portion 120b having a gradually increasing radial dimension at the tip end of the delivery sheath 120, and the guide hole 123 has an input hole section having a radially increasing radial dimension at the expanded portion, that is, the diameter of the input hole section is larger than the diameter of the guide hole 123 in the sheath body portion 120a of the delivery sheath 120.

In order to facilitate the holding of the delivery tilted tube 120, a holding member 122 having a funnel-shaped or half-cut funnel-shaped opening structure is further connected to the expanding portion 120b at the head end of the delivery sheath 120, as shown in fig. 2.

In a preferred embodiment, the outer diameter of the conveying sheath pipe is 2-8 mm, and the inner diameter of the conveying sheath pipe is 1.8-7 mm; the outer diameter of the guide rod is 1.5-4 mm.

The working principle of the temporary interventional stent system of the embodiment is as follows:

when the stent device 200 is assembled to the delivery sheath 120, the guide rod 110 is inserted into the delivery sheath 120 from the head end (the expanded portion 120b shown in the figure) of the delivery sheath 120, so that the through hole 112 passes out from the tail end of the delivery sheath 120, as shown in fig. 4, the guide wire 202 of the stent device is tied by passing through the through hole 121 of the guide rod, the guide rod 110 is then pulled out of the delivery sheath 120 from the head end of the delivery sheath 120, the guide wire 202 is then extended out to the head end of the sheath, the guide wire 202 is tensioned, the fixing tip 203 connected to the guide wire 202 is pulled to enter the guide hole 123 of the delivery sheath 120, and then compressed by the pressure of the sheath wall with the mesh stent 201 (201'), as shown in fig. 6, and finally enters the tail portion of the delivery sheath 120 as a whole, and then the guide wire is fixed at the head end of the delivery sheath, thus completing the assembly of the stent device 200 and the delivery sheath 120.

When the lesion is implanted and released, the delivery sheath 120 is inserted into the prostate part of the urethra, the guide rod 110 is inserted into the delivery sheath to contact the fixed end 203 of the stent device, then the guide wire 202 tied at the end of the delivery sheath 120 is unfastened, the guide rod 110 is inserted into the guide hole 123 of the delivery sheath 120 to push the fixed end 203 and the mesh stent 201 ((201')) out of the sheath and release the mesh into the bladder, the delivery sheath is withdrawn, after the orientation of the interventional device is adjusted (can be adjusted by the guide rod), the guide wire is tensioned to pull the interventional device back to the prostate part of the urethra, so that the auxiliary stent part is abutted against the depression before the middle part of the prostate urethra is connected with the bladder neck, the interventional device is fixed, the release is completed, the delivery sheath 120 and the guide rod 110 are withdrawn, and the free end of the guide wire 202 is ensured to be exposed outside the genitals to facilitate the later-stage stent device recovery.

When the stent device is recovered, the guide rod 110 is firstly inserted into the conveying sheath 120, then the free end of the lead 202 exposed outside the genitals penetrates into the perforation 112 of the guide rod to be tied, the guide rod 110 is lifted out of the conveying sheath 120 from the head end of the conveying sheath, the lead 202 can be stretched out to the head end of the sheath, the lead 202 is tensioned, the conveying sheath is inserted into the prostatic urethra part along the lead and is close to the fixed end of the stent device, the fixed end is firstly inserted into the conveying sheath 120, the ductular meshwork stent 201 is subjected to the tension effect to ensure that the head end of the ductular meshwork stent enters the conveying sheath 120 along the guide hole 123 and is compressed by the pressure of the wall of the sheath, finally, the whole ductular meshwork stent enters the tail part of the sheath, and then the conveying sheath is taken out, thus completing the recovery of the stent device.

Finally, it is noted that the above-mentioned preferred embodiments illustrate rather than limit the invention, and that, while the invention has been described in detail with reference to the foregoing preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the scope of the invention as defined by the appended claims; the sizes in the drawings and the embodiments are not related to specific objects, and are not used for limiting the protection scope of the invention, and the sizes of the objects can be selected and changed according to actual needs.

Claims

1. The conveying and recovering device for the interventional stent is characterized by comprising a conveying sheath and a guide rod, wherein the conveying sheath is provided with a guide hole which is axially communicated, the guide rod can be inserted into the guide hole in a mode of being axially movable relative to the conveying sheath, and the axial length of the guide rod is greater than that of the conveying sheath; the trailing end of the guide rod has a bore for facilitating tying of a wire, and the leading end of the guide rod has a radially or circumferentially outwardly projecting grip.

2. The device for delivering and retrieving an interventional stent of claim 1, wherein the head end of the delivery sheath is provided with a wire fixing member.

3. The device for delivering and retrieving an interventional stent according to claim 1 or 2, wherein the delivery sheath is formed at a tip end thereof with an expansion portion having a gradually increasing radial dimension, and the pilot hole has an input hole section having an increasing radial dimension at the expansion portion.

4. The device for delivering and retrieving an interventional stent of claim 3, wherein a funnel-shaped or half-cut funnel-shaped open member is connected to the expanded portion of the head end of the delivery sheath.

5. The device for conveying and recovering the interventional stent as defined in any one of claims 1 to 4, wherein the conveying sheath has an outer diameter of 2 to 8mm and an inner diameter of 1.8 to 7 mm; the outer diameter of the guide rod is 1.5-4 mm.

6. A temporary interventional stent system comprising a stent device and the delivery and retrieval device of any one of claims 1 to 5, the stent device comprising a tube mesh stent which can be crimped and expanded, a fixed tip and a wire, wherein the head end of the tube mesh stent is gathered and contracted in the fixed tip, the wire is connected to the fixed tip, the length of the wire is greater than that of a delivery sheath, and the free end of the wire can be tied to a perforation of a guide rod.

7. A temporary interventional stent system according to claim 6, wherein the fixed tip is of a bundle tube type structure.

8. A temporary interventional stent system of claim 6, wherein the guidewire is fabricated from PET, nylon, polyethylene or surgical sutures, etc.

9. A temporary interventional stent system according to any one of claims 5 to 8, wherein the tubular mesh stent is fabricated from a medical shape memory alloy.