CN117838374A - Medical implant - Google Patents

Medical implant Download PDF

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Publication number
CN117838374A
CN117838374A CN202211207237.8A CN202211207237A CN117838374A CN 117838374 A CN117838374 A CN 117838374A CN 202211207237 A CN202211207237 A CN 202211207237A CN 117838374 A CN117838374 A CN 117838374A
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CN
China
Prior art keywords
strut
medical implant
support
struts
connector
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Pending
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CN202211207237.8A
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Chinese (zh)
Inventor
王光辉
解利娜
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Microport Urocare Shanghai Co Ltd
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Microport Urocare Shanghai Co Ltd
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Publication date
Application filed by Microport Urocare Shanghai Co Ltd filed Critical Microport Urocare Shanghai Co Ltd
Priority to CN202211207237.8A priority Critical patent/CN117838374A/en
Priority to PCT/CN2023/113957 priority patent/WO2024066797A1/en
Publication of CN117838374A publication Critical patent/CN117838374A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention provides a medical implant for implantation in a non-vascular lumen, the medical implant being configured to be radially collapsible or expandable, the medical implant comprising a stent body comprising at least four struts, wherein a first strut, a second strut, a third strut and a fourth strut are arranged at intervals along a circumference of the stent body, and each strut is curved in a direction away from a centerline of the stent body; the proximal ends of all the struts are connected, the proximal ends of the first strut, the second strut, the third strut and the fourth strut are distributed on an arc-shaped surface, and the first strut and the fourth strut are respectively positioned at two ends of the arc-shaped surface; the distal ends of all the struts are connected and form a distal end structure of the stent body, and the distal end structure of the stent body is a non-closed annular structure. The medical implant provided by the invention can solve the problems that the contact surface of the bracket and the tissue is large, the tissue is stimulated greatly, and the distal end of the bracket lacks radial support in the prior art.

Description

Medical implant
Technical Field
The invention relates to the technical field of medical equipment, in particular to a medical implant.
Background
Benign prostatic hyperplasia (benign prostatic hyperplasia, BPH) is one of the common diseases of middle-aged and elderly men, and current surgical treatments for BPH include conventional surgical treatments, laser treatments, and minimally invasive interventions. Conventional surgical treatments are currently the primary treatment options, including transurethral prostatectomy (transurethral resection of the prostate, TURP), transurethral prostatectomy (transurethral incision of the prostate, TUIP), and open prostatectomy, where TURP is the "gold standard" of current BPH treatment and other surgical procedures have therapeutic effects similar to or similar to TURP, but with differences in scope and complications. Transurethral prostatectomy (transurethral electro vaporization of the prostate, TUVP) and transurethral bipolar electrosurgery (plasma kinetic resection of prostate, PKRP) are also currently available for use in the surgical treatment of BPH as alternative treatments for TURP or TUIP.
All the above treatments can improve the urinary tract symptoms of BPH patients by more than 70%. However, most of these treatments require general anesthesia, and may have severe bleeding during surgery, and the older patients with obstruction may have poor tolerance, which may cause problems with retrograde ejaculation.
In addition to conventional surgical treatment methods, minimally invasive interventional therapy is also an effective treatment for BPH by introducing a stent, which is used to support the prostate tissue forming channel to effect urination. However, the treatment method has high requirements on the stent, and the stent used in the prior art has the problem that the stent is easy to shift after being implanted for a long time.
Disclosure of Invention
The invention aims to provide a medical implant which solves the problems that the contact surface of a stent and tissue is large, the stimulation to the tissue is large, and the distal end of the stent lacks radial support in the prior art.
To solve the above-mentioned technical problems, the present invention provides a medical implant for implanting a non-vascular channel, the medical implant configured to be radially contractible or expandable, the medical implant comprising a stent body including at least four struts, wherein first, second, third and fourth struts are arranged at intervals in a circumferential direction of the stent body, and each strut is bent in a direction away from a center line of the stent body; the proximal ends of all the struts are connected, the proximal ends of the first strut, the second strut, the third strut and the fourth strut are distributed on an arc-shaped surface, and the first strut and the fourth strut are respectively positioned at two ends of the arc-shaped surface; the distal ends of all the struts are connected and form a distal end structure of the stent body, and the distal end structure of the stent body is a non-closed annular structure.
Further, the distal end of the second strut is connected to the first strut by a first connector, and the distal end of the third strut is connected to the distal end of the fourth strut by a second connector.
Further, the first connecting piece and the second connecting piece are made of elastic materials, and the first connecting piece and the second connecting piece are in a compressed state.
Further, the bracket main body further comprises a fifth strut and a sixth strut, wherein two ends of the fifth strut are respectively connected with the proximal end and the distal end of the first strut; the two ends of the sixth strut are respectively connected with the proximal end and the distal end of the fourth strut.
Further, on an axial projection of the medical implant, a space formed between the fifth and sixth struts is disposed opposite to a space formed between the second and third struts.
Further, all the struts at least comprise a supporting section and a connecting section which are sequentially connected along the proximal end to the distal end, and the distance from the supporting section of the strut to the axis of the medical implant is gradually increased and then gradually decreased along the proximal end to the distal end; the end part of the connecting section of the second support is connected with the end part of the connecting section of the third support; the end part of the connecting section of the first support is connected with the end part of the connecting section of the fifth support to form a first connecting point, one end of the first connecting piece is connected to the first connecting point, and the other end of the first connecting piece is connected to the connecting section of the second support; the end part of the connecting section of the fourth support and the end part of the connecting section of the sixth support are connected to form a second connecting point, one end of the second connecting piece is connected to the second connecting point, and the other end of the second connecting piece is connected to the connecting section of the third support.
Further, the stent body further includes a seventh strut disposed between the second strut and the third strut, the distal ends of the seventh strut, the second strut and the third strut being directly connected.
Further, the medical implant further comprises a third connector through which the proximal ends of all the struts are connected.
Further, the third connecting piece is a U-shaped connecting piece, and the proximal ends of the first pillar, the second pillar, the third pillar and the fourth pillar are fixedly connected with the U-shaped side of the U-shaped connecting piece.
Further, the outer surface of the third connector gradually decreases in size in a distal-to-proximal direction.
Further, the bracket main body is prepared by adopting an integral molding process.
In summary, compared with the prior art, the medical implant provided by the invention has the following advantages:
the medical implant adopts at least four struts to form the bracket main body of the medical implant, the far end and the near end can form an arc-shaped support, the middle part of the bracket main body is arched by each strut, the bracket main body forms a stable shell shape, and the force required for pressing the bracket main body to deform is larger at the moment, so that the supporting force provided for the inner wall of the cavity channel when the implant is implanted to support the inner wall of the cavity channel is larger, and the bracket can provide larger supporting force. The contact area between the stent main body and the inner wall of the cavity is small, so that the problem of large tissue stimulation caused by overlarge contact area between the stent and the tissue in the prior art is avoided, on the other hand, the contact area between the stent and the tissue is small, the compression effect on the prostatic hyperplasia part is better under the action of the stent main body, the ischemic necrosis of the hyperplasia part is caused, the effect of remodelling the tissue structure is achieved, the urethral obstruction is improved, the treatment of the prostatic stenosis can be obviously improved, and the treatment of the prostatic stenosis is immediate or medium-long-term.
Moreover, the far end and the near end of the bracket main body form arc supports, the middle part is designed for each strut arch, the bracket main body is characterized by a shell shape, the middle part is high, the near end and the far end are small, the bracket main body not only accords with physiological anatomical structures, but also has good supporting effect on cavity tissues, has good anchoring effect, and reduces the displacement risk of the bracket.
Meanwhile, the far-end structure of the bracket main body is a non-closed annular structure, radial support can be realized at the far end, the support stability of the whole medical implant is improved, and when the medical implant is implanted into the urethra to treat benign prostatic hyperplasia, the open far-end structure can play a role in circumferentially supporting the internal urethral sphincter, so that the problem that the internal urethral sphincter is difficult to support and open clinically is solved, and a certain contraction function of the internal sphincter can be ensured.
In addition, when the stent main body of the medical implant is implanted into the inner wall of the urethra to support the urethra, the second support column and the third support column are supported near the 11-point clock point and the 1-point clock point of the inner cavity of the urethra, the first support column is supported near the 4-point clock point or the 5-point clock point of the inner cavity of the urethra, the fourth support column is supported near the 7-point clock point or the 8-point clock point, and the position of the 6-point clock point is left, when the medical implant is implanted into the urethra to treat BPH, the 6-point clock position is left, and the middle lobe structure of the prostate tissue is arranged below the 6-point clock position of the inner cavity of the urethra, so that the stent can not press the middle lobe structure of the prostate tissue after being implanted, the influence on ejaculation or sexual life of a patient is reduced, and the life quality and physical and mental health of the patient are remarkably improved.
In addition, the stent main body of the medical implant can be designed by adopting 7 or more struts, after the support points of the implant and the inner wall of the cavity are increased by containing enough struts, the support force of the stent main body on the inner wall of the cavity can be further improved, more support points can circumferentially spread the cavity tissues, when the cavity tissues are piled and pressed, the stent effect is more remarkable, for example, most benign prostatic hyperplasia is caused by prostatic tissue piling and thickening, urethra is extruded, various problems in urination occur, and after the medical implant is implanted into the urethra, the urethra is supported by enough support points, so that not only can the urethra be spread, but also a circumferentially dispersed acting force can be provided for the urethral tissues, the proliferated prostatic tissues pressed by the urethra can be dispersed, and the pressing effect of the proliferated prostatic tissues on the urethra is reduced, so that the treatment effect is better.
In addition, the medical implant can adopt the connecting piece to fold and connect the proximal end of the support column, the connecting piece can be provided with a smooth arc surface, the stimulation to tissues after the stent is implanted is reduced, the outer surface size of the connecting piece can be gradually reduced along the direction from the distal end to the proximal end, the volume of the connecting piece can be further reduced, the stimulation to the tissues is reduced, in addition, the size along the proximal end is reduced, the urination resistance is reduced, and the urinary retention risk is reduced.
In addition, the bracket main body of the medical implant is manufactured by adopting an integral molding process, and has good structural integrity and high reliability.
Drawings
Fig. 1 is a schematic structural view of a medical implant according to an embodiment of the present invention.
Wherein, the reference numerals are as follows:
10-a stent body; a 101-distal structure; 11-a first strut; 12-a second leg; 13-a third strut; 14-fourth struts; 15-fifth struts; 16-sixth struts; 17-seventh struts; 21-a first connector; 22-a second connector; 23-a third connector; 111-a connection section of the first leg; 112-a support section of the first leg; 121-a connecting section of a second strut; 131-a connecting section of a third strut; 141-a connecting section of a fourth strut; 151-a connection section of a fifth strut; 161-the connecting section of the sixth leg.
Detailed Description
A medical implant according to the present invention will be described in further detail with reference to the accompanying drawings and detailed description. The advantages and features of the present invention will become more apparent from the following description.
It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for the purpose of facilitating and clearly aiding in the description of embodiments of the invention. For a better understanding of the invention with objects, features and advantages, refer to the drawings. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the invention to the extent that any modifications, changes in the proportions, or adjustments of the sizes of structures, proportions, or otherwise, used in the practice of the invention, are included in the spirit and scope of the invention which is otherwise, without departing from the spirit or essential characteristics thereof.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and to simplify the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.
In this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
The invention aims to provide a medical implant to solve the problems that the contact surface of a bracket and tissue is large, the stimulation to the tissue is large, and the long-term implantation has a displacement risk in the prior art.
To achieve the above-described idea, the present invention provides a medical implant for implantation in a non-vascular lumen, such as a urethra, for treatment of benign prostatic hyperplasia, as shown in fig. 1, wherein the medical implant is configured to be radially contractible or expandable, and in a natural state, the medical implant is in an expanded state, and in a contracted state under pressure of external force. The following description of the morphology of the medical implant refers to the expanded state of the medical implant in its natural state unless otherwise specified.
The medical implant comprises a bracket main body 10, wherein the bracket main body 10 comprises at least four support posts, the first support post 11, the second support post 12, the third support post 13 and the fourth support post 14 are arranged at intervals along the circumference of the bracket main body 10, and each support post is bent in a direction far away from the center line of the bracket main body 10; the proximal ends of all the struts are connected, the proximal ends of the first strut 11, the second strut 12, the third strut 13 and the fourth strut 14 are distributed on an arc surface, the first strut 11 and the fourth strut 14 are respectively positioned at two ends of the arc surface, the distal ends of all the struts are connected and form a distal end structure 101 of the stent body 10, and the distal end structure 101 of the stent body 10 is a non-closed annular structure.
In this embodiment, at least four struts form a stent body of the medical implant, the distal end and the proximal end can form an arc-shaped support, the middle of the stent body 10 is arched by each strut, the stent body 10 is formed into a stable shell shape, and the force required for pressing the stent body 10 to deform is larger at this time, so that the supporting force provided for the inner wall of the cavity is larger when the inner wall of the cavity is supported after the implant is implanted, and the whole stent can provide a larger supporting force. The support body 10 supports the inner wall of the cavity through the support column, so that the contact area between the support body and the inner wall of the cavity is small, on one hand, the problem that the support body and the tissue are large in stimulation caused by overlarge contact area in the prior art is avoided, on the other hand, the contact area between the support body and the tissue is small, the compression effect on the hyperplasia part of the prostate is better under the action of the support body 10, the ischemia necrosis of the hyperplasia part is caused, the remodeling effect of a tissue structure is achieved, the urethral obstruction is improved, the treatment of the prostatic stenosis can be remarkably improved, and the treatment has obvious effects whether the treatment is immediate or medium-long. The shell-shaped stent main body 10 not only accords with physiological anatomical structures, has good effect of expanding the cavity tissues, but also has good anchoring effect, and reduces the displacement risk of the stent.
Meanwhile, the far-end structure 101 of the stent main body is a non-closed annular structure, radial support can be realized at the far end, the support stability of the whole medical implant is improved, and when the medical implant is implanted into the urethra to treat benign prostatic hyperplasia, the open-type far-end structure 101 can play a role in circumferentially supporting the internal urethral sphincter, the problem that the internal urethral sphincter is difficult to support and open clinically is solved, and a certain contraction function of the internal sphincter can be ensured.
Further, the distal end of the second strut 12 is connected to the first strut 11 by a first connector 21, and the distal end of the third strut 13 is connected to the distal end of the fourth strut 14 by a second connector 22. In the present embodiment, the distal ends of the struts are connected by two connectors, thereby forming the distal end structure 101 of the non-closed loop structure of the stent body 10; the provision of two connectors further enhances the circumferential support of the internal urethral sphincter by the distal structure 101.
Preferably, the first connecting member 21 and the second connecting member 22 may be made of an elastic material, and the first connecting member 21 and the second connecting member 22 are in a compressed state. The connecting piece in a compressed state enables on one hand that the force generated by the backlog of the inner wall of the urethra of the support column is easy to be transmitted to the connection of the distal end of the support column, the circumferential supporting force is increased, and on the other hand, when the medical implant is prevented from being contracted, the radial distance of the distal end of the support body is increased by the extrusion of the connecting piece and the support column, so that the compression and the storage of the medical implant into the input device are not facilitated. In the embodiment of the present invention, the compression direction of the connector is not limited, and may be bending compression in a direction toward or away from the proximal end or bending compression in a direction toward both sides.
Preferably, the stent body 10 further comprises a fifth strut 15 and a sixth strut 16, both ends of the fifth strut 15 being connected to the proximal and distal ends of the first strut 11, respectively; the sixth leg 16 is connected at both ends to the proximal and distal ends of the fourth leg 14, respectively. Preferably, the fifth strut 15 and the sixth strut 16 may be disposed between the first strut 11 and the fourth strut 14. By adding two struts between the first strut 11 and the fourth strut 14, the support points of the stent main body are more, and more struts can also make the structure of the formed shell-shaped stent main body 10 more stable, so that the overall support effect of the stent main body 10 is improved. It should be clear to a person skilled in the art that more struts may be provided between the first strut 11 and the fourth strut 14, further improving the structural stability and providing a better supporting effect.
Preferably, on an axial projection of the medical implant, a space formed between the fifth strut 15 and the sixth strut 16 is disposed opposite a space formed between the second strut 12 and the third strut 13. Wherein, the axial projection refers to the projection of the medical implant on a plane perpendicular to the axis thereof. Specifically, when the medical implant is implanted in a lumen such as the urethra, on an axial projection of the medical implant, the 12 o 'clock position is located in the space formed between the second leg 12 and the third leg 13, and the 6 o' clock position is located in the space formed between the fifth leg 15 and the sixth leg 16, in time. By the design, the structure of the bracket main body 10 is firmer when the inner wall of the cavity is supported, and the position of 6 o 'clock is vacated, when the medical implant is implanted into the urethra for treating BPH, the position of 6 o' clock is vacated, so that the bracket can not press the middle lobe structure of the prostate tissue after implantation, the influence on ejaculation or sexual life of a patient is reduced, and the life quality of the patient is remarkably improved.
Preferably, as shown in fig. 1, in the embodiment of the present invention, the second support column 12 and the third support column 13 support the inner wall of the lumen at 11 o 'clock and 1 o' clock, respectively, and the first support column 11, the fourth support column 14, the fifth support column 15 and the sixth support column 16 support the inner wall of the lumen at 8 o 'clock, 7 o' clock, 5 o 'clock and 4 o' clock, respectively, after the medical implant of the present invention is implanted in the lumen. At this point, the 6 o' clock position is left free to prevent the stent from pressing against the middle lobe structure of the prostate tissue.
Specifically, the medical implant provided by the invention comprises at least a support section and a connection section which are sequentially connected along a proximal end to a distal end, and taking a first support 11 as an example, the first support 11 comprises a connection section 111 and a support section 112; the distance from the support section of the support column to the axis of the medical implant is gradually increased and then gradually decreased along the direction from the proximal end to the distal end; the end of the connecting section 121 of the second strut 12 is connected with the end of the connecting section 131 of the third strut 13; the end of the connecting section 111 of the first pillar 11 is connected with the end of the connecting section 151 of the fifth pillar 15 to form a first connecting point, one end of the first connecting piece 21 is connected to the first connecting point, and the other end is connected to the connecting section 121 of the second pillar 12; the end of the connecting section 141 of the fourth strut 14 is connected with the end of the connecting section 161 of the sixth strut 16 to form a second connection point, and one end of the second connecting member 22 is connected to the second connection point, and the other end is connected to the connecting section 131 of the third strut 13. In the solution of this embodiment, the first connecting element 21 and the second connecting element 22 serve to interconnect the distal ends of all the struts together, forming a non-closed annular structure, providing radial support forces at the distal ends of the stent on the one hand, and enabling the transmission of forces after stent implantation on the other hand.
As a preferred solution of the present invention, the stand body 10 further includes a seventh pillar 17, the seventh pillar 17 is disposed between the second pillar 12 and the third pillar 13, and a seventh pillar 17 is added between the second pillar 12 and the third pillar 13 by directly connecting the distal ends of the seventh pillar 17, the second pillar 12 and the third pillar 13, so that the supporting point can be further increased, the supporting effect of the stand is further enhanced, the structure is also more stable, and the displacement risk of the stand is reduced. In addition, after the stent body 10 contains enough struts to increase supporting points, besides the supporting force can be improved, more supporting points can be used for expanding the cavity tissues along the circumferential direction, after the cavity tissues are piled and pressed, the effect of the stent is more remarkable, for example, most benign prostatic hyperplasia is caused by the piling and thickening of the prostatic tissues, the urethra is extruded, various problems in urination occur, after the medical implant of the embodiment is implanted into the urethra, the urethra is supported by the enough supporting points, not only the urethra can be expanded, but also a circumferential dispersing acting force can be provided for the urethral tissues, the proliferated prostatic tissues pressing the urethra can be dispersed, and the pressing effect of the proliferated prostatic tissues on the urethra is reduced, so that the treatment effect is better.
It should be noted that one skilled in the art may also add more struts between the second strut 12 and the third strut 13 to further increase the support force of the stent body 10, to increase the structural integrity and stabilizing effect. Further, between the second pillar 12 and the first pillar 11, the third pillar 13 and the fourth pillar 14 may be added as needed.
Further, the medical implant further comprises a third connecting member 23, wherein the proximal ends of all the struts are connected by the third connecting member 23. The third connecting member 23 may be a U-shaped connecting member, and the side surfaces of the U-shaped connecting member form the above-mentioned arc surface, that is, the arc surface in this embodiment is U-shaped, and the proximal ends of the first pillar 11, the second pillar 12, the third pillar 13 and the fourth pillar 14 are connected by a U-shaped connecting member, for example, the proximal ends of the pillars are distributed on the arc surface of the U-shape. The connecting piece is used for furling and connecting the proximal ends of the struts, and the connecting piece can be a smooth U-shaped bracket, so that the stimulation to tissues after the bracket is implanted can be reduced. Further, the outer surface of the third connector is gradually reduced in size in the direction from the distal end to the proximal end, which may further reduce the volume of the connector, reduce irritation to tissue, and further reduce the size in the direction from the proximal end, which may reduce the urinary resistance and reduce the risk of urinary retention.
In an embodiment of the present invention, the bracket main body may be prepared by an integral molding process. For example, the pipe cutting integrated forming process can be adopted, and the pipe is cut and bent to form by an oval pipe or a sheet; the sheet material or the strip material and the like can be integrally formed by adopting a heat treatment shaping process, and the sheet material or the strip material and the like can be integrally formed by adopting a 3D printing technology, powder metallurgy, injection molding and other processes. In addition, it is also conceivable for those skilled in the art that the stent body of the present invention may be obtained by connecting the bands or the like by means of welding, splicing, bonding, riveting or the like, and is also within the scope of the present invention.
The medical implant is compressed in a sheath tube of a stent conveying device before being implanted, the implant is conveyed to a designated position through pushing, rotating and back pulling of a catheter, and the effects of supporting and expanding urethra are achieved.
In summary, compared with the prior art, the medical implant provided by the invention has the following advantages:
the medical implant adopts at least four struts to form the bracket main body of the medical implant, the far end and the near end can form an arc-shaped support, the middle part of the bracket main body is arched by each strut, the bracket main body forms a stable shell shape, and the force required for pressing the bracket main body to deform is larger at the moment, so that the supporting force provided for the inner wall of the cavity channel when the implant is implanted to support the inner wall of the cavity channel is larger, and the bracket can provide larger supporting force. The contact area between the stent main body and the inner wall of the cavity is small, so that the problem of large tissue stimulation caused by overlarge contact area between the stent and the tissue in the prior art is avoided, on the other hand, the contact area between the stent and the tissue is small, the compression effect on the prostatic hyperplasia part is better under the action of the stent main body, the ischemic necrosis of the hyperplasia part is caused, the effect of remodelling the tissue structure is achieved, the urethral obstruction is improved, the treatment of the prostatic stenosis can be obviously improved, and the treatment of the prostatic stenosis is immediate or medium-long-term.
Moreover, the far end and the near end of the bracket main body form arc supports, the middle part is designed for each strut arch, the bracket main body is characterized by a shell shape, the middle part is high, the near end and the far end are small, the bracket main body not only accords with physiological anatomical structures, but also has good supporting effect on cavity tissues, has good anchoring effect, and reduces the displacement risk of the bracket.
Meanwhile, the far-end structure of the bracket main body is a non-closed annular structure, radial support can be realized at the far end, the support stability of the whole medical implant is improved, and when the medical implant is implanted into the urethra to treat benign prostatic hyperplasia, the open far-end structure can play a role in circumferentially supporting the internal urethral sphincter, so that the problem that the internal urethral sphincter is difficult to support and open clinically is solved, and a certain contraction function of the internal sphincter can be ensured.
In addition, when the stent main body of the medical implant is implanted into the inner wall of the urethra to support the urethra, the second support column and the third support column are supported near the 11-point clock point and the 1-point clock point of the inner cavity of the urethra, the first support column is supported near the 4-point clock point or the 5-point clock point of the inner cavity of the urethra, the fourth support column is supported near the 7-point clock point or the 8-point clock point, and the position of the 6-point clock point is left, when the medical implant is implanted into the urethra to treat BPH, the 6-point clock position is left, and the middle lobe structure of the prostate tissue is arranged below the 6-point clock position of the inner cavity of the urethra, so that the stent can not press the middle lobe structure of the prostate tissue after being implanted, the influence on ejaculation or sexual life of a patient is reduced, and the life quality and physical and mental health of the patient are remarkably improved.
In addition, the stent main body of the medical implant can be designed by adopting 7 or more struts, after the support points of the implant and the inner wall of the cavity are increased by containing enough struts, the support force of the stent main body on the inner wall of the cavity can be further improved, more support points can circumferentially spread the cavity tissues, when the cavity tissues are piled and pressed, the stent effect is more remarkable, for example, most benign prostatic hyperplasia is caused by prostatic tissue piling and thickening, urethra is extruded, various problems in urination occur, and after the medical implant is implanted into the urethra, the urethra is supported by enough support points, so that not only can the urethra be spread, but also a circumferentially dispersed acting force can be provided for the urethral tissues, the proliferated prostatic tissues pressed by the urethra can be dispersed, and the pressing effect of the proliferated prostatic tissues on the urethra is reduced, so that the treatment effect is better.
In addition, the medical implant can be connected with the proximal end of the support column in a furling way by adopting the connecting piece, the connecting piece is provided with a smooth arc surface, the stimulation to tissues after the stent is implanted is reduced, the outer surface size of the connecting piece can be gradually reduced along the direction from the distal end to the proximal end, the volume of the connecting piece can be further reduced, the stimulation to the tissues is reduced, in addition, the size along the proximal end direction is reduced, the urination resistance is reduced, and the urinary retention risk is reduced.
In addition, the bracket main body of the medical implant is manufactured by adopting an integral molding process, and has good structural integrity and high reliability.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any changes and modifications made by those skilled in the art in light of the above disclosure are intended to fall within the scope of the appended claims. It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims (11)

1. A medical implant for implantation in a non-vascular tract, the medical implant being configured to be radially collapsible or expandable, the medical implant comprising a stent body comprising at least four struts, wherein,
the first support column, the second support column, the third support column and the fourth support column are arranged at intervals along the circumferential direction of the support body, and each support column is bent in a direction away from the center line of the support body;
the proximal ends of all the struts are connected, the proximal ends of the first strut, the second strut, the third strut and the fourth strut are distributed on an arc-shaped surface, and the first strut and the fourth strut are respectively positioned at two ends of the arc-shaped surface;
the distal ends of all the struts are connected and form a distal end structure of the stent body, and the distal end structure of the stent body is a non-closed annular structure.
2. A medical implant according to claim 1, wherein the distal end of the second leg is connected to the first leg by a first connector and the distal end of the third leg is connected to the distal end of the fourth leg by a second connector.
3. A medical implant according to claim 2, wherein said first connector and said second connector are made of an elastic material, said first connector and said second connector being in a compressed state.
4. A medical implant according to claim 2, wherein the stent body further comprises a fifth strut and a sixth strut, both ends of the fifth strut being connected to the proximal and distal ends of the first strut, respectively; the two ends of the sixth strut are respectively connected with the proximal end and the distal end of the fourth strut.
5. A medical implant according to claim 4, wherein the space formed between the fifth and sixth struts is arranged opposite the space formed between the second and third struts in an axial projection of the medical implant.
6. A medical implant according to claim 4, wherein all the struts comprise at least a support section and a connecting section which are connected in sequence from the proximal end to the distal end, the distance from the support section of the strut to the axis of the medical implant increasing and then decreasing in the proximal end to the distal end direction;
the end part of the connecting section of the second support is connected with the end part of the connecting section of the third support;
the end part of the connecting section of the first support is connected with the end part of the connecting section of the fifth support to form a first connecting point, one end of the first connecting piece is connected to the first connecting point, and the other end of the first connecting piece is connected to the connecting section of the second support;
the end part of the connecting section of the fourth support and the end part of the connecting section of the sixth support are connected to form a second connecting point, one end of the second connecting piece is connected to the second connecting point, and the other end of the second connecting piece is connected to the connecting section of the third support.
7. The medical implant of claim 1, wherein the stent body further comprises a seventh strut disposed between the second strut and the third strut, the distal ends of the seventh strut, the second strut and the third strut being directly connected.
8. A medical implant according to claim 1, further comprising a third connector, wherein the proximal ends of all of the struts are connected by the third connector.
9. The medical implant of claim 8, wherein said third connector is a U-shaped connector, and wherein the proximal ends of said first, second, third and fourth struts are fixedly connected to the U-shaped sides of said U-shaped connector.
10. A medical implant according to claim 8, wherein the outer surface of the third connector member tapers in size in the distal to proximal direction.
11. A medical implant according to any one of claims 1 to 10, wherein the stent body is produced by an integral moulding process.
CN202211207237.8A 2022-09-30 2022-09-30 Medical implant Pending CN117838374A (en)

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PCT/CN2023/113957 WO2024066797A1 (en) 2022-09-30 2023-08-21 Medical implant

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Publication number Priority date Publication date Assignee Title
US9789293B2 (en) * 2010-06-24 2017-10-17 Boston Scientific Scimed, Inc. Stents with bladder retention members
DK3328317T3 (en) * 2015-07-29 2022-12-19 Butterfly Medical Ltd RETRACTION AND/OR SUPPORT OF PERIURETHRAL TISSUE
BR122023027338A2 (en) * 2017-12-06 2024-02-20 Butterfly Medical Ltd. UROLOGIC IMPLANT WITH EXTRACTION HANDLE AND/OR ARCHED LIMBS
CN114917057A (en) * 2022-06-22 2022-08-19 北京普润医疗器械有限公司 Intervention support system

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