CN112754727A

CN112754727A - Urethra implant and urethra implant assembly

Info

Publication number: CN112754727A
Application number: CN202110371826.9A
Authority: CN
Inventors: 孙颖浩
Original assignee: Debao Hengsheng Technology Service Co ltd
Current assignee: Debao Hengsheng Technology Service Co ltd
Priority date: 2021-04-07
Filing date: 2021-04-07
Publication date: 2021-05-07

Abstract

The embodiment of the application provides a urethra implant and a urethra implantation assembly, the urethra implant mainly comprises a supporting pipe and anchoring structures arranged at two opposite ends of the supporting pipe, wherein the anchoring structures are used for anchoring at two opposite ends of the supporting pipe respectively at a bladder neck opening anastomosis section and a urethra broken end anastomosis section so as to provide bridging between the bladder neck opening anastomosis section and the urethra broken end anastomosis section, and therefore supporting and shaping are provided for the bladder neck opening anastomosis section and the urethra broken end anastomosis section.

Description

Urethra implant and urethra implant assembly

Technical Field

The application relates to the technical field of medical equipment, in particular to a urethral implant and a urethral implant assembly.

Background

The male urethra starts from the inner urethra orifice of the neck of the bladder and ends at the outer urethra orifice, has the functions of male urination and semen excretion, is about 16 to 22cm long, has an average pipe diameter of 5 to 7mm, and can be divided into a urethra cavernous body part, a urethra ball part, a urethra membrane part and a prostate part. The external meatus of the urethra, the portion from the corpus cavernosum of the urethra to the bulbar urethra is clinically called the anterior urethra. The portion of the urethral membrane, the prostatic urethra, to the neck of the bladder is called the posterior urethra. Wherein, the urethral membrane part is about 1cm long, is surrounded by the striated sphincter of urethra (namely external sphincter of urethra) innervated by the body, and can realize the urine control through the control of the autonomic consciousness. The urethra prostate part is the part of the urethra that passes through the prostate, and is about 2.5cm long. The lower urinary tract of a male consists of the bladder and the urethra, the radical surgical excision of malignant prostate tumors needs to complete the excision of the prostate and the seminal vesicle and then to re-inosculate the neck of the bladder and the urethra, while the radical surgical excision of malignant muscle-invasive bladder tumors needs to excise the bladder, the prostate and the seminal vesicle together. For the above two groups of patients who have undergone posterior urethrotomy reconstruction, a common postoperative complication is a transient or permanent loss of urinary control and sexual function.

In summary, the main problems of the prior art include: the incidence rate of urinary incontinence after radical prostatectomy is high, and the difficulty in performing the operation of matching the urethra with the bladder is high after the prostate gland is removed.

Disclosure of Invention

In view of the above, the present application provides an artificial urethra and an artificial urethra implantation kit, so as to solve the problems in the prior art, and facilitate the recovery of urine control function after male posterior urethrotomy reconstruction surgery.

The present application provides a urethral implant, comprising:

supporting a tube; and

anchoring structures provided at opposite ends of the support tube;

the anchoring structures are used for respectively anchoring the two opposite ends of the supporting tube to the bladder neck anastomosis section and the urethra broken end anastomosis section so as to provide bridging between the bladder neck anastomosis section and the urethra broken end anastomosis section, and therefore support and shape are provided for the bladder neck anastomosis section and the urethra broken end anastomosis section.

Optionally, the support tube is made of a ductile material.

Optionally, the inner tubular wall of the support tube comprises a urethral mucosa layer.

Optionally, the urethral mucosa layer comprises a bioabsorbable material comprising porcine bladder extracellular matrix.

Optionally, the support tube is of a straight tube type or a trumpet type.

Optionally, the anchoring structure comprises at least one of barbs, cilia.

Optionally, each of the barbs or cilia in the anchoring structure is in one of a spiral distribution, a uniform distribution, and a random distribution.

Optionally, the inclination direction of each of the barbs or cilia in the anchoring structure is the same or different.

Optionally, the inclination angle of each barb or cilia in the anchoring structure is greater than 0 ° and equal to or less than 90 °.

Optionally, the inclination angle of each of the barbs or cilia is greater than or equal to 30 ° and less than or equal to 45 °.

Optionally, each of the barbs in the anchoring structure may not penetrate the bladder neck anastomosis segment/the urethral severed end anastomosis segment, partially penetrate the bladder neck anastomosis segment/the urethral severed end anastomosis segment, or completely penetrate the bladder neck anastomosis segment/the urethral severed end anastomosis segment;

and wherein the length of each barb in the anchoring structure is between 0.1mm and 2 mm.

Optionally, the barbs also extend over the outer tube wall of the support tube.

Optionally, the urethral implant further comprises a sheath, wherein the anchoring structure portion of the support tube or the support tube as a whole may be sleeved in the sheath to facilitate delivery of the support tube between the bladder neck anastomosis section and the urethra broken end anastomosis section.

The present application further provides a urethral implant assembly for use in the resected reconstruction of a male posterior urethra, wherein the urethral implant assembly comprises:

the urethral implant of any of the above; and

a prostate implant having a receiving structure;

the urethra implant can be contained in the containing structure, so that the prostate implant wrapped on the outer side of the urethra implant provides support for a cavity formed in a pelvic cavity after a prostate gland is removed.

Optionally, the urethral implant assembly further comprises an alignment structure provided to the receiving structure and/or the support tube for providing positional alignment between the prostate implant and the urethral implant.

Optionally, the alignment structure includes a protruding portion disposed on the accommodating structure; or

The alignment structure comprises a concave part arranged on the containing structure and a convex part arranged on the supporting tube.

According to the technical scheme, the urethra implant is used for replacing the urethra with the resected prostate part, the urethra function can be better guaranteed, the postoperative function recovery is improved, and the damage caused by excessive traction of human tissues due to direct suturing of the bladder and the urethra can be avoided.

Moreover, this application utilizes the design of anchoring structure, can supply the relative both ends of stay tube anchor the anastomotic section of the neck of the mouth of the neck fast and the anastomotic section of the broken end of urethra, not only can reduce the degree of difficulty of inosculating to can shorten the operation time by a wide margin.

In addition, the urethral mucosa surface layer is arranged on the inner tube wall of the supporting tube, so that the functions of resisting calculus, resisting bacteria and reducing rejection can be provided.

In addition, the urethral implant of the present application can be further used in conjunction with a prostate implant to provide support for the cavity formed after the removal of the prostate within the pelvic cavity to enhance the recovery of the urodynamic function.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Drawings

In order to more clearly illustrate the detailed description of the present application or the technical solutions in the prior art, the drawings needed to be used in the detailed description of the present application or the prior art description will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural view of one embodiment of a urethral implant provided in accordance with an embodiment of the present application;

FIG. 2 is a schematic structural view of another embodiment of a urethral implant provided in accordance with an embodiment of the present application;

FIG. 3 is a schematic structural view of yet another embodiment of a urethral implant provided in accordance with an embodiment of the present application;

FIG. 4 is a schematic view of a urethra implant according to an embodiment of the present application in use;

FIG. 5 is an enlarged view taken at A in FIG. 4;

FIG. 6 is a schematic view of another urethral implant according to an embodiment of the present application in use;

FIG. 7 is an enlarged view of FIG. 6 at B;

figures 8-13 are schematic views of different embodiments of anchoring structures of a urethral implant provided by embodiments of the present application;

figure 14 is a schematic structural view of one embodiment of a urethral implant assembly provided in accordance with embodiments of the present application;

figure 15 is a schematic structural view of another embodiment of a urethral implant assembly provided in accordance with embodiments of the present application;

FIG. 16 is an enlarged view at G of FIG. 15;

figure 17 is a schematic structural view of yet another embodiment of a urethral implant assembly provided in accordance with embodiments of the present application;

fig. 18 is an enlarged view of fig. 17 at F.

Reference numerals:

1: a urethral implant;

12: supporting a tube;

122: a urethral mucosa layer;

14: an anchoring structure;

142: a barb;

16: a sheath;

21: a bladder neck-mouth anastomosis section;

22: a urethra broken end anastomosis section;

3: a urethral implant assembly;

32: aligning structure;

321: a first protruding portion;

322: a recessed portion;

323: a second protruding part;

4: a prostate implant;

42: an accommodating structure.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and together with the description, serve to explain the principles of the application.

Detailed Description

The technical solutions of the present application will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

The terminology used in the embodiments of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in the examples of this application and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

It should be understood that the term "and/or" as used herein is merely one type of association that describes an associated object, meaning that three relationships may exist, e.g., a and/or B may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

It should be noted that the terms "upper", "lower", "left", "right", and the like used in the embodiments of the present application are described in terms of the angles shown in the drawings, and should not be construed as limiting the embodiments of the present application. In addition, in this context, it will also be understood that when an element is referred to as being "on" or "under" another element, it can be directly on "or" under "the other element or be indirectly on" or "under" the other element via an intermediate element.

In view of the problems of high incidence rate of urinary incontinence after radical prostatectomy and difficulty in performing the anastomosis operation between the urethra and the bladder after the prostate gland is removed, the present application provides a urethra implant and a urethra implantation assembly to solve the problems in the prior art.

The following further describes a specific implementation of the embodiments of the present application with reference to the drawings of the embodiments of the present application.

The urethral implant 1 of the present embodiment is provided, as shown in fig. 1 and 2, the urethral implant 1 of the present embodiment mainly includes a support tube 12 and anchoring structures 14, and the anchoring structures 14 are respectively provided at opposite ends of the support tube 12.

As shown in fig. 4 to 7, the anchoring structures 14 are used to anchor the bladder neck anastomosis section 21 and the urethra break anastomosis section 22 at the opposite ends of the supporting tube 12, respectively, to provide bridging between the bladder neck anastomosis section 21 and the urethra break anastomosis section 22, thereby providing support and shaping for the bladder neck anastomosis section 21 and the urethra break anastomosis section 22.

Alternatively, the support tube 12 may be made of a malleable material.

Optionally, referring to fig. 1-3, the inner tubular wall of support tube 12 further includes a urethral mucosa layer 122.

Optionally, the urothelium layer 122 comprises a bioabsorbable material, wherein the urothelium layer 122 can be a material that promotes tissue growth and repair, such as porcine bladder extracellular matrix (UB-ECM).

In a specific embodiment, the supporting tube 12 may be a straight tube (refer to fig. 1), and in practice, the supporting tube 12 may be used to bridge between the bladder neck anastomosis section 21 and the urethra broken end anastomosis section 22 by performing a contraction process on the bladder neck anastomosis section 21 to make the opening diameter thereof substantially equal to the opening diameter of the urethra broken end anastomosis section 22. The present embodiment has advantages in that the manufacturing process can be simplified and the manufacturing cost can be reduced.

In another embodiment, the support tube 12 may also be flared (see fig. 2), i.e., the opposite ends of the support tube 12 exhibit a larger opening diameter at one end and a smaller opening diameter at the other end to match the opening diameter of the bladder neck orifice anastomosis section 21 and the opening diameter of the urethra broken end anastomosis section 22, respectively. The advantage of this embodiment is that the supporting tube 12 can be directly bridged between the bladder neck anastomosis section 21 and the urethra fracture anastomosis section 22 without performing the tightening process on the bladder neck anastomosis section 21, thereby simplifying the complexity of the operation and shortening the operation time.

Alternatively, the anchoring structure 14 may include at least one of barbs 142, cilia, and various embodiments of the anchoring structure 14 will be described in detail below with reference to the barbs 142, it being understood that the following embodiments of the barbs 142 are applicable to the cilia.

Optionally, the urethral implant 1 further comprises a sheath 16, as shown in fig. 3, in this embodiment, the anchoring structures 14 (i.e., barbs 142) at the opposite ends of the support tube 12 can be partially fitted in the sheath 16 to facilitate the delivery of the support tube 12 between the bladder neck anastomosis section 21 and the urethra broken end anastomosis section 22.

In one embodiment, the support tube 12 may also be integrally sleeved within the sheath 16 (see fig. 3) to deliver the support tube 12 between the bladder neck anastomosis section 21 and the urethra fracture anastomosis section 22. For example, the supporting tube 12 is integrally sleeved in the sheath 16, and the supporting tube 12 is conveyed to a position between the bladder neck and end anastomosis section 21 and the broken end anastomosis section 22 through the urethra of the patient, and the sheath 16 is removed, so as to perform the anchoring operation on the bladder neck and end anastomosis section 21 and the broken end anastomosis section 22 by means of the exposed anchoring structures 14 (barbs 142).

For example, the support tube 12 can be placed directly between the bladder neck anastomosis segment 21 and the urethra fracture anastomosis segment 22 through the surgical incision, and the sheath 16 is removed, so as to perform the anchoring operation on the bladder neck anastomosis segment 21 and the urethra fracture anastomosis segment 22 through the exposed anchoring structures 14 (barbs 142).

Alternatively, the barbs 142 of the anchoring structure 14 may be distributed helically (see fig. 8) or uniformly (see fig. 8). But not limited thereto, the barbs 142 of the anchoring structure 14 may also be distributed out of order.

Alternatively, the direction of inclination of each barb 142 in the anchoring structures 14 at the same end may be the same (see fig. 8 or 9) or different (see fig. 10).

Optionally, the angle of inclination of each barb 142 in the anchoring structure 14 is greater than 0 ° and equal to or less than 90 °. Preferably, the inclination angle of each barb 142 is 30 ° or more and 45 ° or less (refer to fig. 11 or fig. 12).

Alternatively, each barb 142 in the anchoring structure 14 may not penetrate the bladder neck anastomosis section 21/urethral severed end anastomosis section 22 (see FIGS. 6 and 7); alternatively, the barbs 142 of the anchoring structure 14 may partially penetrate the bladder neck/end anastomosis segment 21/end anastomosis segment 22; alternatively, each barb 142 in the anchoring structure 14 may penetrate completely through the bladder neck anastomosis 21/urethral severed end anastomosis 22 (see fig. 4 and 5).

In this embodiment, the length of each barb 142 in the anchoring structure 14 is between 0.1mm and 2 mm. For example, the length of each barb 142 that does not penetrate the bladder neck anastomosis section 21/the severed urethra anastomosis section 22 may be set to about 1.5mm, while the length of each barb 142 that completely penetrates the bladder neck anastomosis section 21/the severed urethra anastomosis section 22 may be set to about 2 mm.

Alternatively, the barbs 142 may be distributed over the outer tubular wall of the support tube 12 (see fig. 13), and this structure may facilitate the docking operation between the opposite ends of the support tube 12 and the bladder neck anastomosis section 21 and the urethra fracture anastomosis section 22, respectively, to facilitate the anchoring operation.

In summary, the embodiment of the application provides bridging between the bladder neck anastomosis section and the urethra broken end anastomosis section by using the supporting tube, so that the bladder can be prevented from being directly sutured with the urethra to cause the damage of the human tissue due to the excessive traction.

Furthermore, the urethra implantation assembly of the embodiment of the application can rapidly anchor the two opposite ends of the supporting tube with the bladder neck orifice anastomosis section and the urethra broken end anastomosis section by means of the anchoring structure without executing manual anastomosis operation, thereby greatly reducing the difficulty of the anastomosis operation and effectively shortening the operation time.

In addition, the urethral mucosa layer is arranged on the inner tube wall of the supporting tube, so that the technical effects of resisting and preventing calculus and reducing rejection can be achieved.

The embodiment of the application also provides a urethra implantation assembly, which is suitable for excision and reconstruction of male posterior urethra.

As shown in fig. 14 to 18, the urethral implant set 3 of the present embodiment mainly includes the urethral implant 1 described above in the first embodiment and the prostate implant 4 having the receiving structure 42.

In this embodiment, the urethra implant 1 may be anchored to the bladder neck anastomosis section 21 and the urethra broken end anastomosis section 22 respectively, so as to provide bridging between the bladder neck anastomosis section 21 and the urethra broken end anastomosis section 22, and to provide support and shaping for the bladder neck anastomosis section 21 and the urethra broken end anastomosis section 22, and further, the urethra implant 1 may be accommodated in the accommodating structure 42 of the prostate implant 4, so as to provide support for the prostate implant 4 wrapped on the outer side of the urethra implant 1 to provide support for the cavity formed in the pelvic cavity after the prostate is removed.

Alternatively, there may be no direct contact between the urethral implant 1 (i.e., the outer sidewall of the support tube 12) and the receiving structure 42 (see fig. 14), i.e., a gap is left between the outer sidewall of the support tube 12 and the sidewall of the receiving structure 42.

Alternatively, the urethral implant 1 (i.e., the support tube 12) and the receiving structure 42 can be in direct contact, in which case, the urethral implant assembly 3 can further include an alignment structure 32 disposed on the receiving structure 42 and/or the support tube 12 for providing positional alignment between the prostate implant 4 and the urethral implant 1 to facilitate smooth performance of the procedure.

In this embodiment, the alignment structure 32 can include a first protrusion 321 disposed on the receiving structure 42 of the prostate implant 4, as shown in fig. 16.

Specifically, the position alignment between the prostate implant 4 and the urethral implant 1 can be rapidly achieved by embedding the first protruding part 321 at the gap between the bladder neck anastomosis section 21 and the urethral stump anastomosis section 22.

In another embodiment, the alignment structure 32 may comprise a concave portion 322 disposed on the receiving structure 42 of the prostate implant 4 and a second convex portion 323 disposed on the support tube 12 of the urethral implant 1 (see fig. 17 and 18).

Specifically, the second protruding portion 323 of the supporting tube 12 can be protruded out from the gap between the bladder neck anastomosis section 21 and the urethra broken end anastomosis section 22 and be clamped into the recessed portion 322 of the accommodating structure 42, so as to quickly achieve the position alignment between the prostate implant 4 and the urethra implant 1.

In summary, the urethra implantation assembly provided by the embodiment of the present application can not only provide protection for the urethra implant by further combining the urethra implant with the prostate implant, but also provide support for the cavity formed in the pelvic cavity after the prostate is removed by means of the prostate implant, so as to enhance the recovery of the urine control function.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A urethral implant, comprising:

supporting a tube; and

anchoring structures provided at opposite ends of the support tube;

2. The urethral implant according to claim 1, wherein the support tube is made of a malleable material.

3. The urethral implant of claim 1, wherein the inner tubular wall of the support tube comprises a urethral mucosa layer.

4. The urethral implant according to claim 3, wherein the urethral mucosa layer comprises a bioabsorbable material comprising porcine bladder extracellular matrix.

5. The urethral implant according to claim 1, wherein the support tube is of a cylindrical or trumpet shape.

6. The urethral implant of claim 1, wherein the anchoring structures comprise at least one of barbs, cilia.

7. The urethral implant of claim 6, wherein each of the barbs or cilia in the anchoring structure are in one of a spiral distribution, a uniform distribution, and a random distribution.

8. The urethral implant of claim 6, wherein the barbs or cilia in the anchoring structures are angled in the same or different directions.

9. The urethral implant of claim 6, wherein each of the barbs or cilia in the anchoring structure is inclined at an angle greater than 0 ° and equal to or less than 90 °.

10. The urethral implant of claim 9, wherein each of the barbs or cilia is inclined at an angle of greater than or equal to 30 ° and less than or equal to 45 °.

11. The urethral implant according to claim 6, wherein each of the barbs in the anchoring structure can penetrate none, part, or all of the bladder neck/severed urethra anastomosis segments;

12. The urethral implant according to claim 6, wherein the barbs also extend over the outer tubular wall of the support tube.

13. The urethral implant according to claim 1, further comprising a sheath, wherein the anchoring structure portion of the support tube or the support tube as a whole is nestable within the sheath to facilitate delivery of the support tube between the bladder neck anastomosis and the urethral stump anastomosis.

14. A urethral implant assembly for use in the resected reconstruction of the male posterior urethra, said urethral implant assembly comprising:

the urethral implant of any one of claims 1 to 13; and

a prostate implant having a receiving structure;

15. The urethral implant assembly of claim 14, further comprising alignment structure provided to the receiving structure and/or the support tube for providing positional alignment between the prostate implant and the urethral implant.

16. The urethral implant assembly of claim 14,

the alignment structure comprises a convex part arranged on the accommodating structure; or