WO2024066797A1 - 一种医用植入物 - Google Patents

一种医用植入物 Download PDF

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Publication number
WO2024066797A1
WO2024066797A1 PCT/CN2023/113957 CN2023113957W WO2024066797A1 WO 2024066797 A1 WO2024066797 A1 WO 2024066797A1 CN 2023113957 W CN2023113957 W CN 2023113957W WO 2024066797 A1 WO2024066797 A1 WO 2024066797A1
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WO
WIPO (PCT)
Prior art keywords
pillar
medical implant
stent body
connecting member
distal end
Prior art date
Application number
PCT/CN2023/113957
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English (en)
French (fr)
Inventor
王光辉
解利娜
Original Assignee
微创优通医疗科技（上海）有限公司
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Publication of WO2024066797A1 publication Critical patent/WO2024066797A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/047—Urethrae

Definitions

  • the present invention relates to the technical field of medical equipment, and in particular to a medical implant.
  • Benign prostatic hyperplasia is one of the common diseases in middle-aged and elderly men.
  • surgical treatments for BPH include conventional surgery, laser therapy, and minimally invasive interventional therapy.
  • Conventional surgery is the main treatment method, including transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), and open prostatectomy.
  • TURP is the "gold standard" for the treatment of BPH.
  • the therapeutic effects of other surgical methods are close to or similar to TURP, but the scope of application and complications are different.
  • transurethral electrovaporization of the prostate (TUVP) and transurethral plasma kinetic resection of the prostate (PKRP) can also be used in the surgical treatment of BPH.
  • minimally invasive interventional treatment is also an effective treatment for BPH, which is to introduce a stent to support the prostate tissue to form a channel for urination.
  • this treatment method has high requirements for the stent, and the stents used in the prior art generally have the problem of easy displacement after being implanted for a long time.
  • the object of the present invention is to provide a medical implant to solve the problems in the prior art that the contact surface between the stent and the tissue is large, which causes greater stimulation to the tissue and the distal end of the stent lacks radial support.
  • the present invention provides a medical implant for implanting in a non-vascular cavity.
  • the medical implant is configured to be contractible or expandable in the radial direction
  • the medical implant includes a stent body, and the stent body includes at least four pillars, wherein the first pillar, the second pillar, the third pillar and the fourth pillar are arranged at intervals along the circumference of the stent body, and each pillar is bent in a direction away from the center line of the stent body; the proximal ends of all the pillars are connected, and the proximal ends of the first pillar, the second pillar, the third pillar and the fourth pillar are distributed on an arc surface, and the first pillar and the fourth pillar are respectively located at two ends of the arc surface; the distal ends of all the pillars are connected to 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 distal end of the second pillar is connected to the first pillar via a first connecting member
  • the distal end of the third pillar is connected to the distal end of the fourth pillar via a second connecting member.
  • first connecting member and the second connecting member are made of elastic material, and the first connecting member and the second connecting member are in a compressed state.
  • the stent body also includes a fifth pillar and a sixth pillar, and the two ends of the fifth pillar are respectively connected to the proximal end and the distal end of the first pillar; the two ends of the sixth pillar are respectively connected to the proximal end and the distal end of the fourth pillar.
  • the space formed between the fifth pillar and the sixth pillar is arranged opposite to the space formed between the second pillar and the third pillar.
  • all of the pillars at least include a supporting segment and a connecting segment connected in sequence from the proximal end to the distal end, and the distance from the supporting segment of the pillar to the axis of the medical implant first gradually increases and then gradually decreases in the direction from the proximal end to the distal end;
  • the end of the connecting segment of the second pillar is connected to the end of the connecting segment of the third pillar;
  • the end of the connecting segment of the first pillar is connected to the end of the connecting segment of the fifth pillar to form a first connecting point, one end of the first connecting member is connected to the first connecting point, and the other end is connected to the connecting segment of the second pillar;
  • the end of the connecting segment of the fourth pillar is connected to the end of the connecting segment of the sixth pillar to form a second connecting point, one end of the second connecting member is connected to the second connecting point, and the other end is connected to the connecting segment of the third pillar.
  • the stent body also includes a seventh pillar, and the seventh pillar is arranged between the second pillar and the third pillar, and the distal ends of the seventh pillar, the second pillar and the third pillar are directly connected.
  • the medical implant further comprises a third connecting member, the proximal ends of all the pillars being connected to the third connecting member.
  • the third connecting member is connected.
  • the third connecting member is a U-shaped connecting member, and the proximal ends of the first pillar, the second pillar, the third pillar and the fourth pillar are fixedly connected to the U-shaped side of the U-shaped connecting member.
  • the outer surface size of the third connecting member gradually decreases from the distal end to the proximal end.
  • bracket body is prepared by an integrated molding process.
  • the medical implant provided by the present invention has the following advantages:
  • the medical implant of the present invention uses at least four pillars to form the stent body of the medical implant.
  • the distal end and the proximal end can form an arc support.
  • the middle is arched by each pillar, and the stent body forms a stable shell shape.
  • the force required to compress the stent body to produce deformation is greater. Therefore, when the implant is implanted, the supporting force provided to the inner wall of the cavity is also greater, so that the stent can provide greater supporting force.
  • the contact area between the stent body and the inner wall of the cavity is very small. On the one hand, it avoids the problem of large tissue stimulation caused by the large contact surface between the stent and the tissue in the prior art.
  • the contact area between the stent and the tissue is very small.
  • the compressive effect on the prostate hyperplasia site is better, so that the hyperplasia site is ischemic and necrotic, and the effect of tissue structure remodeling is achieved, urethral obstruction is improved, and the treatment of prostate stenosis can be significantly improved. Whether it is immediate or medium- and long-term, there are obvious effects.
  • the distal and proximal ends of the stent body of the present invention both form arc-shaped supports, with the middle part being an arched design of the pillars.
  • the stent body presents a "shell-shaped" feature, being high in the middle and small at the proximal and distal ends. It not only conforms to the physiological anatomical structure and has a good effect of expanding the cavity tissue, but also has a good anchoring effect, reducing the risk of stent displacement.
  • the distal structure of the stent body is a non-closed annular structure, which can achieve radial support at the distal end, thereby improving the support stability of the entire medical implant.
  • the open distal structure can provide circumferential support for the internal urethral sphincter, thereby solving the problem that the internal sphincter is difficult to support and open in clinical practice, and can also ensure that the internal sphincter has a certain contraction function.
  • the second support and the third support are provided near the positions of the 11 o'clock position and the 1 o'clock position of the inner cavity of the urethra
  • the first support is provided near the positions of the 4 o'clock position or the 5 o'clock position of the inner cavity of the urethra
  • the fourth support is provided near the positions of the 7 o'clock position or the 8 o'clock position of the inner cavity of the urethra, leaving the 6 o'clock position vacant.
  • the 6 o'clock position is vacated, and the middle lobe structure of the prostate tissue is below the 6 o'clock position of the urethral cavity.
  • the stent will not compress the middle lobe structure of the prostate tissue after implantation, reducing the impact on the patient's ejaculation or sexual life, and significantly improving the patient's quality of life and physical and mental health.
  • the stent body of the medical implant of the present invention can be designed with 7 or more pillars. After including enough pillars to increase the supporting points between the implant and the inner wall of the cavity, in addition to further improving the supporting force of the stent body on the inner wall of the cavity, more supporting points can open the cavity tissue in the circumferential direction. When the cavity tissue is piled up and compressed, the effect of the stent will be more significant. For example, most benign prostatic hyperplasia is caused by the hyperplasia of prostate tissue, which leads to the accumulation and thickening of prostate tissue, squeezing the urethra, and causing various problems in urination.
  • the medical implant of the present invention After the medical implant of the present invention is implanted in the urethra, enough supporting points support the urethra, which can not only open the urethra, but also provide a circumferential dispersion force to the urethral tissue, which can disperse the hyperplastic prostate tissue that compresses the urethra, reduce the compression of the urethra by the hyperplastic prostate tissue, and make the treatment effect better.
  • the medical implant of the present invention can use a connector to gather and connect the proximal end of the support.
  • the connector can be provided with a smooth curved surface to reduce the stimulation to the tissue after the stent is implanted, and the outer surface size of the connector can gradually decrease from the distal end to the proximal end, which can further reduce the volume of the connector and reduce the stimulation to the tissue.
  • the reduction in size along the proximal direction can reduce the urination resistance and reduce the risk of urine retention.
  • the stent body of the medical implant of the present invention is manufactured by an integrated molding process, and has good structural integrity and high reliability.
  • FIG1 is a schematic structural diagram of a medical implant according to an embodiment of the present invention.
  • the reference numerals are as follows: 10-stent body; 101-distal end structure; 11-first pillar; 12-second pillar; 13-third pillar; 14-the fourth pillar; 15-the fifth pillar; 16-the sixth pillar; 17-the seventh pillar; 21-the first connecting piece; 22-the second connecting piece; 23-the third connecting piece; 111-the connecting section of the first pillar; 112-the supporting section of the first pillar; 121-the connecting section of the second pillar; 131-the connecting section of the third pillar; 141-the connecting section of the fourth pillar; 151-the connecting section of the fifth pillar; 161-the connecting section of the sixth pillar.
  • the purpose of the present invention is to provide a medical implant to solve the problems in the prior art that the contact surface between the stent and the tissue is large, which causes great stimulation to the tissue and there is a risk of displacement after long-term implantation.
  • the present invention provides a medical implant for implantation in a non-vascular cavity, such as a urethra to treat benign prostatic hyperplasia, wherein the medical implant is configured to be contractible or expandable in the radial direction.
  • a non-vascular cavity such as a urethra to treat benign prostatic hyperplasia
  • the medical implant is configured to be contractible or expandable in the radial direction.
  • the medical implant In a natural state, the medical implant is in a In the expanded state, the medical implant is in a contracted state under the pressure of an 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.
  • the medical implant includes a stent body 10, and the stent body 10 includes at least four pillars, wherein a first pillar 11, a second pillar 12, a third pillar 13 and a fourth pillar 14 are arranged at intervals along the circumference of the stent body 10, and each pillar is bent in a direction away from the center line of the stent body 10; the proximal ends of all the pillars are connected, and the proximal ends of the first pillar 11, the second pillar 12, the third pillar 13 and the fourth pillar 14 are distributed on an arc surface, the first pillar 11 and the fourth pillar 14 are respectively located at two ends of the arc surface, and the distal ends of all the pillars are connected to 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.
  • At least four pillars constitute the stent body of the medical implant, and both the distal end and the proximal end can form an arc support, and the middle is arched by each pillar, and the stent body 10 forms a stable shell shape.
  • the force required to compress the stent body 10 to produce deformation is greater. Therefore, the support force provided to the inner wall of the cavity when the implant is implanted is also greater, so that the stent as a whole can provide greater support force.
  • the stent body 10 supports the inner wall of the cavity through the pillars, and the contact area with the inner wall of the cavity is very small.
  • the contact area between the stent and the tissue is very small.
  • the compressive effect on the prostate hyperplasia part is better, so that the hyperplasia part is ischemic and necrotic, and the effect of tissue structure remodeling is achieved, urethral obstruction is improved, and the treatment of prostate stenosis can be significantly improved, whether it is immediate or medium and long term, there are obvious effects.
  • the "shell-shaped" stent body 10 not only conforms to the physiological anatomical structure, has a good effect on the opening of the cavity tissue, but also has a good anchoring effect, reducing the risk of stent displacement.
  • the distal structure 101 of the stent body is a non-closed annular structure, which can achieve radial support at the distal end, thereby improving the support stability of the entire medical implant.
  • the open distal structure 101 can provide circumferential support for the internal urethral sphincter, thereby solving the problem that the internal sphincter is difficult to support and open in clinical practice, and can also ensure that the internal sphincter has a certain contraction function.
  • the distal end of the second support 12 is connected to the first support 11 via a first connecting member 21, and the distal end of the third support 13 is connected to the distal end of the fourth support 14 via a second connecting member.
  • the distal ends of the struts are connected by two connecting pieces, thereby forming a non-closed annular distal structure 101 of the stent body 10; the provision of the two connecting pieces further strengthens the circumferential support effect of the distal structure 101 on the internal urethral sphincter.
  • both the first connector 21 and the second connector 22 can be made of elastic material, and the first connector 21 and the second connector 22 are in a compressed state.
  • the connector in a compressed state makes it easy to transmit the force generated by the pressure on the inner wall of the urethra to the connection at the distal end of the pillar, thereby increasing the circumferential support force.
  • it can prevent the radial distance at the distal end of the stent body from being increased due to the compression between the connector and the pillar when the medical implant contracts, which is not conducive to the compression and storage of the medical implant into the input device.
  • the compression direction of the connector which can be bent and compressed in a direction close to or away from the proximal end, or bent and compressed in directions on both sides.
  • the stent body 10 further includes a fifth pillar 15 and a sixth pillar 16, and the two ends of the fifth pillar 15 are respectively connected to the proximal end and the distal end of the first pillar 11; the two ends of the sixth pillar 16 are respectively connected to the proximal end and the distal end of the fourth pillar 14.
  • the fifth pillar 15 and the sixth pillar 16 can be arranged between the first pillar 11 and the fourth pillar 14. Adding two pillars between the first pillar 11 and the fourth pillar 14 can make the support points of the stent body more, and more pillars will also make the structure of the "shell-shaped" stent body 10 more stable, and improve the overall support effect of the stent body 10.
  • more pillars can be arranged between the first pillar 11 and the fourth pillar 14 to further improve the stability of the structure and achieve a better support effect.
  • the space formed between the fifth pillar 15 and the sixth pillar 16 is arranged opposite to the space formed between the second pillar 12 and the third pillar 13.
  • the axial projection refers to the projection of the medical implant on a plane perpendicular to its axis. Specifically, when the medical implant is implanted in a cavity such as the urethra, on the axial projection of the medical implant, according to the clock position, the 12 o'clock position is located in the space formed between the second pillar 12 and the third pillar 13, and the 6 o'clock position is located in the space formed between the fifth pillar 15 and the sixth pillar 16.
  • Such a design can make the structure of the stent body 10 more stable when supporting the inner wall of the cavity, and the 6 o'clock position is vacated.
  • the stent will not compress the middle lobe structure of the prostate tissue after implantation, reduce the impact on the patient's ejaculation or sexual life, and significantly improve the patient's quality of life. quantity.
  • the second pillar 12 and the third pillar 13 support the inner wall of the cavity at the 11 o'clock and 1 o'clock positions, respectively, and the first pillar 11, the fourth pillar 14, the fifth pillar 15 and the sixth pillar 16 support the inner wall of the cavity at the 8 o'clock, 7 o'clock, 5 o'clock and 4 o'clock positions, respectively.
  • the 6 o'clock position is vacated to prevent the stent from compressing the middle lobe structure of the prostate tissue.
  • all the pillars at least include a supporting segment and a connecting segment sequentially connected from the proximal end to the distal end.
  • the first pillar 11 includes a connecting segment 111 and a supporting segment 112; the distance from the supporting segment of the pillar to the axis of the medical implant first gradually increases and then gradually decreases from the proximal end to the distal end; the end of the connecting segment 121 of the second pillar 12 is connected to the end of the connecting segment 131 of the third pillar 13; the end of the connecting segment 111 of the first pillar 11 is connected to the end of the connecting segment 151 of the fifth pillar 15 to form a first connecting point, one end of the first connecting member 21 is connected to the first connecting point, and the other end is connected to the connecting segment 121 of the second pillar 12; the end of the connecting segment 141 of the fourth pillar 14 is connected to the end of the connecting segment 161 of the sixth pillar 16 to
  • the first connecting member 21 and the second connecting member 22 serve to interconnect the distal ends of all the pillars to form a non-closed annular structure. On the one hand, it provides radial support force at the distal end of the stent. On the other hand, the connecting member can also realize the transmission of force after the stent is implanted.
  • the stent body 10 further includes a seventh support 17, and the seventh support 17 is disposed between the second support 12 and the third support 13.
  • the distal ends of the seventh support 17, the second support 12 and the third support 13 are directly connected between the second support 12 and the third support 13.
  • Adding a seventh support 17 between the second support 12 and the third support 13 can further increase the support points, so that the support effect of the stent is further enhanced, and the structure is more stable, reducing the risk of displacement of the stent.
  • the stent body 10 includes enough support posts to increase the support points, in addition to the above-mentioned increase in support force, more support points can open the cavity tissue along the circumferential direction.
  • the effect of the stent will be more significant.
  • most benign prostatic hyperplasia is due to the hyperplasia of prostate tissue, which leads to the accumulation and thickening of prostate tissue, squeezing the urethra, and causing various problems in urination.
  • enough support points support the urethra, which can not only open the urethra, It can also provide a circumferential dispersing force to the urethra tissue, disperse the hyperplastic prostate tissue that compresses the urethra, reduce the compressive effect of the hyperplastic prostate tissue on the urethra, and make the treatment effect better.
  • pillars can be added between the second pillar 12 and the first pillar 11, and between the third pillar 13 and the fourth pillar 14 as needed.
  • the medical implant also includes a third connector 23, and the proximal ends of all the pillars are connected by the third connector 23.
  • the third connector 23 may be a U-shaped connector, and the side of the U-shaped connector constitutes 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 the U-shaped connector, such as the proximal ends of each pillar are distributed on the U-shaped arc surface.
  • the proximal ends of the pillars are gathered and connected by a connector, and the connector can be a smooth U-shaped bracket, which can reduce the stimulation of the tissue after the bracket is implanted.
  • the outer surface size of the third connector gradually decreases from the distal end to the proximal end, which can further reduce the volume of the connector and reduce the stimulation to the tissue.
  • the size decreases in the proximal direction, which can reduce the urination resistance and reduce the risk of urine retention.
  • the bracket body can be prepared by an integrated molding process.
  • it can be a tube cutting integrated molding process, which is formed by cutting and bending an elliptical tube or sheet; it can also be integrated by using a heat treatment shaping process for a sheet or strip, and it can also be integrated by using 3D printing technology, powder metallurgy, injection molding and other processes.
  • the bracket body of the present invention can be obtained by connecting strips by welding, splicing, bonding, riveting and other connection methods, which also belongs to the protection scope of the present invention.
  • the medical implant of the present invention is compressed in the sheath of the stent delivery device before implantation, and the implant is delivered to the designated position by pushing, rotating and pulling back the catheter, and plays a role in supporting and dilating the urethra.
  • the prostatic urethra Under the action of the stent, the prostatic urethra is locally ischemic and necrotic and the structure is remodeled, thereby improving urethral obstruction.
  • the implant is pulled into the sheath and then removed, thereby improving the urination discomfort symptoms caused by prostatic stenosis.
  • the medical implant provided by the present invention has the following advantages:
  • the medical implant of the present invention uses at least four pillars to form the stent body of the medical implant.
  • the distal end and the proximal end can form an arc support.
  • the middle is arched by each pillar, and the stent body forms a stable shell shape.
  • the force required to compress the stent body to produce deformation is greater. Therefore, when the implant is implanted, the supporting force provided to the inner wall of the cavity is also greater, so that the stent can provide greater supporting force.
  • the contact area between the stent body and the inner wall of the cavity is very small. On the one hand, it avoids the problem of large tissue stimulation caused by the large contact surface between the stent and the tissue in the prior art.
  • the contact area between the stent and the tissue is very small.
  • the compressive effect on the prostate hyperplasia site is better, so that the hyperplasia site is ischemic and necrotic, and the effect of tissue structure remodeling is achieved, urethral obstruction is improved, and the treatment of prostate stenosis can be significantly improved. Whether it is immediate or medium- and long-term, there are obvious effects.
  • the distal and proximal ends of the stent body of the present invention both form arc-shaped supports, with the middle part being an arched design of the pillars.
  • the stent body presents a "shell-shaped" feature, being high in the middle and small at the proximal and distal ends. It not only conforms to the physiological anatomical structure and has a good effect of expanding the cavity tissue, but also has a good anchoring effect, reducing the risk of stent displacement.
  • the distal structure of the stent body is a non-closed annular structure, which can achieve radial support at the distal end, thereby improving the support stability of the entire medical implant.
  • the open distal structure can provide circumferential support for the internal urethral sphincter, thereby solving the problem that the internal sphincter is difficult to support and open in clinical practice, and can also ensure that the internal sphincter has a certain contraction function.
  • the second pillar and the third pillar support the urethral cavity near the 11 o'clock position and the 1 o'clock position
  • the first pillar supports the urethral cavity near the 4 o'clock or 5 o'clock position
  • the fourth pillar supports the urethral cavity near the 7 o'clock or 8 o'clock position, leaving the 6 o'clock position vacant.
  • the stent When the medical implant is implanted into the urethra to treat BPH, since the 6 o'clock position is vacated and the middle lobe structure of the prostate tissue is below the 6 o'clock position of the urethral cavity, the stent will not compress the middle lobe structure of the prostate tissue after implantation, thereby reducing the impact on the patient's ejaculation or sexual life, and significantly improving the patient's quality of life and physical and mental health.
  • the stent body of the medical implant of the present invention can be designed with 7 or more pillars. After including enough pillars to increase the supporting points between the implant and the inner wall of the cavity, in addition to further improving the supporting force of the stent body on the inner wall of the cavity, more supporting points can support the cavity tissue along the circumferential direction. When the cavity tissue is piled up and compressed, the effect of the stent will be more significant. For example, most benign prostatic hyperplasia is caused by the proliferation of prostate tissue, which leads to the accumulation and thickening of prostate tissue, squeezing the urethra and causing various problems in urination.
  • the medical implant of the present invention After the medical implant of the present invention is implanted into the urethra, enough supporting points support the urethra, which can not only open the urethra, but also provide a circumferential dispersion force to the urethral tissue, which can disperse the proliferative prostate tissue that compresses the urethra, reduce the compression of the prostate tissue on the urethra, and make the treatment effect better.
  • the medical implant of the present invention can use a connector to gather and connect the proximal end of the support.
  • the connector is provided with a smooth curved surface to reduce the stimulation to the tissue after the stent is implanted, and the outer surface size of the connector can gradually decrease from the distal end to the proximal end, which can further reduce the volume of the connector and reduce the stimulation to the tissue.
  • the reduction in size along the proximal direction can reduce the urination resistance and reduce the risk of urine retention.
  • the stent body of the medical implant of the present invention is manufactured by an integrated molding process, and has good structural integrity and high reliability.

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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

本发明提供一种医用植入物，用于植入非血管腔道，所述医用植入物被配置为沿径向可收缩或扩张，所述医用植入物包括支架主体，所述支架主体包括至少四根支柱，其中，第一支柱、第二支柱、第三支柱和第四支柱沿所述支架主体的周向间隔布置，且各支柱均向远离支架主体中心线的方向弯曲；所有所述支柱的近端相连，且第一支柱、第二支柱、第三支柱和第四支柱的近端分布在一弧形面上，第一支柱和第四支柱分别位于所述弧形面的两端；所有所述支柱的远端相连且形成支架主体的远端结构，所述支架主体的远端结构为非封闭式的环状结构。本发明提供的一种医用植入物，可以解决现有技术中支架与组织接触面较大对组织刺激较大且支架远端缺乏径向支撑的问题。

Description

一种医用植入物 技术领域
本发明涉及医疗设备技术领域，特别涉及一种医用植入物。
背景技术
良性前列腺增生(benign prostatic hyperplasia，BPH)是中老年男性常见疾病之一，目前BPH的外科治疗包括常规手术治疗、激光治疗以及微创介入治疗。常规手术治疗是目前主要的治疗手段，其包括经尿道前列腺电切术(transurethral resection of the prostate，TURP)、经尿道前列腺切开术(transurethral incision of the prostate，TUIP)以及开放性前列腺摘除术，其中，TURP则是目前BPH治疗的“金标准”，其他外科手术方法的治疗效果与TURP接近或相似，但适用范围和并发症有所差别。作为TURP或TUIP的替代治疗手段，经尿道前列腺电汽化术(transurethral electro vaporization of the prostate，TUVP)和经尿道前列腺双极电切术(plasma kinetic resection of prostate，PKRP)目前也可应用于BPH的外科治疗中。
所有上述各种治疗手段均能够改善BPH患者70％以上的尿路症状。但这些治疗方法大部分需要全麻，手术过程中可能会较为严重的出血现象，而且年龄较大的梗阻患者耐受度较弱，上述治疗方法可能会引起患者逆射精的问题。
除常规的手术治疗方法外，微创介入治疗也是BPH的一种有效治疗手段，该方法是通过引入支架，利用支架支撑前列腺组织形成通道实现排尿。但该治疗方法对支架的要求较高，现有技术中使用的支架普遍存在植入时间久后容易出现移位的问题。
发明内容
本发明的目的在于提供一种医用植入物，以解决现有技术中支架与组织接触面较大对组织刺激较大且支架远端缺乏径向支撑的问题。
为解决上述技术问题，本发明提供一种医用植入物，用于植入非血管腔 道，所述医用植入物被配置为沿径向可收缩或扩张，所述医用植入物包括支架主体，所述支架主体包括至少四根支柱，其中，第一支柱、第二支柱、第三支柱和第四支柱沿所述支架主体的周向间隔布置，且各支柱均向远离支架主体中心线的方向弯曲；所有所述支柱的近端相连，且第一支柱、第二支柱、第三支柱和第四支柱的近端分布在一弧形面上，第一支柱和第四支柱分别位于所述弧形面的两端；所有所述支柱的远端相连且形成支架主体的远端结构，所述支架主体的远端结构为非封闭式的环状结构。
进一步的，所述第二支柱的远端与所述第一支柱通过第一连接件连接，所述第三支柱的远端与所述第四支柱的远端通过第二连接件连接。
进一步的，所述第一连接件和所述第二连接件采用弹性材料制成，所述第一连接件和所述第二连接件处于压缩状态。
进一步的，所述支架主体还包括第五支柱和第六支柱，所述第五支柱的两端分别与所述第一支柱的近端和远端连接；所述第六支柱的两端分别与所述第四支柱的近端和远端连接。
进一步的，在所述医用植入物的轴向投影上，所述第五支柱和所述第六支柱之间形成的空间与所述第二支柱和所述第三支柱之间形成的空间相对设置。
进一步的，所有所述支柱均至少包括沿近端向远端依次连接的支撑段和连接段，所述支柱的支撑段到所述医用植入物的轴线的距离沿近端向远端的方向先逐渐增大后逐渐减小；所述第二支柱的连接段的端部与第三支柱的连接段的端部连接；所述第一支柱的连接段的端部与第五支柱的连接段的端部连接形成第一连接点，所述第一连接件的一端连接于所述第一连接点上，另一端连接于所述第二支柱的连接段上；所述第四支柱的连接段的端部与第六支柱的连接段的端部连接形成第二连接点，所述第二连接件的一端连接于所述第二连接点上，另一端连接于所述第三支柱的连接段上。
进一步的，所述支架主体还包括第七支柱，所述第七支柱设置于所述第二支柱和所述第三支柱之间，所述第七支柱、所述第二支柱和所述第三支柱的远端直接连接。
进一步的，所述医用植入物还包括第三连接件，所有所述支柱的近端通 过所述第三连接件连接。
进一步的，所述第三连接件为U形连接件，所述第一支柱、第二支柱、第三支柱和第四支柱的近端与所述U形连接件的U形侧固定相连。
进一步的，所述第三连接件的外表面尺寸沿远端向近端的方向逐渐减小。
进一步的，所述支架主体采用一体成型工艺制备得到。
综上所述，与现有技术相比，本发明提供的一种医用植入物具有以下优点：
本发明的医用植入物采用至少四根支柱组成医用植入物的支架主体，远端和近端均可构成弧形支撑，中间由各支柱拱起，支架主体形成稳定的贝壳形状，此时压迫支架主体产生形变所需要的力更大，因此，植入物植入后对腔道内壁进行支撑时提供给腔道内壁的支撑力也更大，使得支架可以提供更大的支撑力。而且支架主体与腔道内壁的接触面积很小，一方面避免了现有技术中支架与组织接触面过大而带来对组织刺激较大的问题，另一方面，支架与组织接触面积很小，在支架主体的作用下，对前列腺增生部位的压迫性效果更好，使增生部位缺血坏死，起到组织结构重塑的效果，改善尿道梗阻，可显著改善前列腺狭窄的治疗，无论是即刻还是中长期，都有明显的效果。
而且，本发明的支架主体的远端和近端均构成弧形支撑，中间为各支柱拱起式设计，支架主体呈现“贝壳形”的特征，中间高，近端和远端小，不仅符合生理的解剖结构，对腔道组织的撑开效果好，而且具有很好的锚定效果，减少支架的移位风险。
同时，支架主体的远端结构为非封闭式的环状结构，可以在远端实现径向支撑，提高整个医用植入物的支撑稳定性，而且，当该医用植入物植入尿道治疗良性前列腺增生时，开放式的远端结构可以起到对尿道内括约肌的周向支撑作用，解决临床上内括约肌难以支撑打开的问题，并且还能保证内括约肌有一定的收缩功能。
另外，本发明的医用植入物的支架主体在植入尿道支撑尿道内壁时，在尿道内腔中，第二支柱和第三支柱在尿道内腔的11点时钟点位和1点时钟点位的位置附近进行支撑，第一支柱在尿道内腔的4点或5点时钟点位附近，第四支柱在7点或8点时钟点位的位置附近进行支撑，空出了6点时钟点位 的位置，当医用植入物植入尿道治疗BPH时，由于6点钟位置被空出，而尿道内腔的6点钟位置下方是前列腺组织的中叶结构，这样支架在植入后就不会压迫前列腺组织的中叶结构，减少对患者射精或性生活的影响，显著提高患者的生活质量和身心健康。
另外，本发明的医用植入物的支架主体可以采用7根或更多的支柱设计，包含足够多的支柱增加植入物与腔道内壁的支撑点位后，除可以进一步提高支架主体对腔道内壁的支撑力外，更多的支撑点位可以将腔道组织沿周向撑开，当腔道组织出现堆积压迫后，支架的效果将更加显著，例如大部分良性前列腺增生是由于前列腺组织增生导致前列腺组织堆积增厚，挤压尿道，出现排尿方面的各种问题，本发明的医用植入物植入尿道后，足够多的支撑点位支撑尿道，不仅可以撑开尿道，还能给尿道组织提供一个沿周向的分散作用力，可以将压迫尿道的增生后的前列腺组织分散开，减少增生后的前列腺组织对尿道的压迫作用，使得治疗效果更佳。
并且，本发明的医用植入物可以采用连接件对支柱近端进行收拢连接，连接件可以设有光滑的弧形面，减少支架植入后对组织的刺激，并且连接件的外表面尺寸可以沿远端向近端的方向逐渐减小，可进一步减小连接件的体积，减少对组织的刺激，此外沿近端方向尺寸减小，可以减少排尿阻力，减少尿潴留风险。
此外，本发明的医用植入物的支架主体采用一体成型工艺制成，结构完整性好，可靠性高。
附图说明
图1本发明一实施方式中的一种医用植入物的结构示意图。
其中，附图标记如下：
10-支架主体；101-远端结构；11-第一支柱；12-第二支柱；13-第三支柱；
14-第四支柱；15-第五支柱；16-第六支柱；17-第七支柱；21-第一连接件；22-第二连接件；23-第三连接件；111-第一支柱的连接段；112-第一支柱的支撑段；121-第二支柱的连接段；131-第三支柱的连接段；141-第四支柱的连接段；151-第五支柱的连接段；161-第六支柱的连接段。
具体实施方式
以下结合附图和具体实施方式对本发明提出的一种医用植入物作进一步详细说明。根据下面说明，本发明的优点和特征将更清楚。
需要说明的是，附图采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施方式的目的。为了使本发明的目的、特征和优点能够更加明显易懂，请参阅附图。须知，本说明书所附图式所绘示的结构、比例、大小等，均仅用以配合说明书所揭示的内容，以供熟悉此技术的人士了解与阅读，并非用以限定本发明实施的限定条件，故不具技术上的实质意义，任何结构的修饰、比例关系的改变或大小的调整，在不影响本发明所能产生的功效及所能达成的目的下，均应仍落在本发明所揭示的技术内容能涵盖的范围内。
在本发明的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
在本文中，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
本发明的目的在于提供一种医用植入物，以解决现有技术中支架与组织接触面较大对组织刺激较大且长期植入有移位风险的问题。
为实现上述思想，如图1所示，本发明提供了一种医用植入物，用于植入非血管腔道，例如可以植入尿道以治疗良性前列腺增生，其中，所述医用植入物被配置为沿径向可收缩或扩张，在自然状态下，所述医用植入物处于 扩张状态，在外力压迫积压下，所述医用植入物处于收缩状态。以下对于所述医用植入物的形态描述，若无特殊说明，均是指所述医用植入物在自然状态下的扩张状态。
所述医用植入物包括支架主体10，所述支架主体10包括至少四根支柱，其中，第一支柱11、第二支柱12、第三支柱13和第四支柱14沿所述支架主体10的周向间隔布置，且各支柱均向远离支架主体10中心线的方向弯曲；所有所述支柱的近端相连，且第一支柱11、第二支柱12、第三支柱13和第四支柱14的近端分布在一弧形面上，第一支柱11和第四支柱14分别位于所述弧形面的两端，所有所述支柱的远端相连且形成支架主体10的远端结构101，所述支架主体10的远端结构101为非封闭式的环状结构。
在本实施例中，至少四根支柱组成医用植入物的支架主体，远端和近端均可构成弧形支撑，中间由各支柱拱起，支架主体10形成稳定的贝壳形状，此时压迫支架主体10产生形变所需要的力更大，因此，植入物植入后对腔道内壁进行支撑时提供给腔道内壁的支撑力也更大，使得支架整体可以提供更大的支撑力。而且支架主体10通过支柱对腔道内壁进行支撑，与腔道内壁的接触面积很小，一方面避免了现有技术中支架与组织接触面过大而带来对组织刺激较大的问题，另一方面，支架与组织接触面积很小，在支架主体10的作用下，对前列腺增生部位的压迫性效果更好，使增生部位缺血坏死，起到组织结构重塑的效果，改善尿道梗阻，可显著改善前列腺狭窄的治疗，无论是即刻还是中长期，都有明显的效果。而且“贝壳形”的支架主体10不仅符合生理的解剖结构，对腔道组织的撑开效果好，而且具有很好的锚定效果，减少支架的移位风险。
同时，支架主体的远端结构101为非封闭式的环状结构，可以在远端实现径向支撑，提高整个医用植入物的支撑稳定性，而且，当该医用植入物植入尿道治疗良性前列腺增生时，开放式的远端结构101可以起到对尿道内括约肌的周向支撑作用，解决临床上内括约肌难以支撑打开的问题，并且还能保证内括约肌有一定的收缩功能。
进一步的，所述第二支柱12的远端与所述第一支柱11通过第一连接件21连接，所述第三支柱13的远端与所述第四支柱14的远端通过第二连接件 22连接。在本实施例中，通过两个连接件来连接支柱的远端，从而形成所述支架主体10的非封闭式的环状结构的远端结构101；两个连接件的设置进一步加强远端结构101对尿道内括约肌的周向支撑作用。
优选的，所述第一连接件21和所述第二连接件22均可以采用弹性材料制成，所述第一连接件21和所述第二连接件22处于压缩状态。压缩状态的连接件一方面使得支柱受尿道内壁积压产生的力易于传到至支柱远端的连接上，加大周向支撑力，另一方面，可以避免医用植入物收缩时，连接件与支柱挤压增加支架主体远端的径向距离，导致不利于医用植入物压缩收纳进输入装置中。在本发明的实施方式中，对连接件的压缩方向并不作额外的限定，可以是向靠近或远离近端的方向弯曲压缩，也可以是向两侧的方向弯曲压缩。
优选的，所述支架主体10还包括第五支柱15和第六支柱16，所述第五支柱15的两端分别与所述第一支柱11的近端和远端连接；所述第六支柱16的两端分别与所述第四支柱14的近端和远端连接。优选的，所述第五支柱15和所述第六支柱16可以设置于所述第一支柱11和所述第四支柱14之间。在第一支柱11和第四支柱14之间增加两个支柱，可以使支架主体的支撑点位更多，更多的支柱也会使组成的“贝壳形”支架主体10的结构更加稳固，提高支架主体10的整体支撑效果。本领域技术人员应当明了的是，在所述第一支柱11和所述第四支柱14之间还可以设置更多的支柱，进一步提高结构的稳固性，起到更好的支撑效果。
优选的，在所述医用植入物的轴向投影上，所述第五支柱15和所述第六支柱16之间形成的空间与所述第二支柱12和所述第三支柱13之间形成的空间相对设置。其中，所述轴向投影是指所述医用植入物在一垂直于其轴线的平面上的投影。具体来说，当医用植入物植入腔道例如尿道中后，在所述医用植入物的轴向投影上，按时钟点位，12点钟位置位于所述第二支柱12和所述第三支柱13之间形成的空间内，6点钟位置位于所述第五支柱15和所述第六支柱16之间形成的空间内。这样的设计，可以使支架主体10在支撑腔道内壁时，结构更加稳固，并且空出了6点钟的位置，当医用植入物植入尿道治疗BPH时，由于6点钟位置被空出，这样支架在植入后就不会压迫前列腺组织的中叶结构，减少对患者射精或性生活的影响，显著提高患者的生活质 量。
优选的，如图1所示，在本发明的实施方案中，当本发明的医用植入物植入腔道后，所述第二支柱12和第三支柱13分别在11点和1点钟位置支撑腔道内壁，第一支柱11、第四支柱14、第五支柱15和第六支柱16分别在8点、7点、5点和4点钟位置支撑腔道内壁。此时，6点钟位置被空出，以防止支架压迫前列腺组织的中叶结构。
具体来说，本发明提供的所述医用植入物，所有所述支柱均至少包括沿近端向远端依次连接的支撑段和连接段，以第一支柱11为例，所述第一支柱11包括连接段111和支撑段112；所述支柱的支撑段到所述医用植入物的轴线的距离沿近端向远端的方向先逐渐增大后逐渐减小；所述第二支柱12的连接段121的端部与第三支柱13的连接段131的端部连接；所述第一支柱11的连接段111的端部与第五支柱15的连接段151的端部连接形成第一连接点，所述第一连接件21的一端连接于所述第一连接点上，另一端连接于所述第二支柱12的连接段121上；所述第四支柱14的连接段141的端部与第六支柱16的连接段161的端部连接形成第二连接点，所述第二连接件22的一端连接于所述第二连接点上，另一端连接于所述第三支柱13的连接段131上。本实施例的方案中，第一连接件21和第二连接件22起到将所有支柱的远端互连在一起的作用，形成一非封闭式的环状结构，一方面在支架远端提供径向支撑力，另一方面，连接件还可以实现支架植入后力的传递。
作为本发明的优选方案，所述支架主体10还包括第七支柱17，所述第七支柱17设置于所述第二支柱12和所述第三支柱13之间，所述第七支柱17、所述第二支柱12和所述第三支柱13的远端直接连接在第二支柱12和第三支柱13之间增加一根第七支柱17，可以进一步增加支撑点位，使得支架的支撑效果进一步增强，同时结构也更加稳固，减少支架的移位风险。此外，支架主体10包含足够多的支柱增加支撑点位后，除上述提到的可以提高支撑力外，更多的支撑点位可以将腔道组织沿周向撑开，当腔道组织出现堆积压迫后，支架的效果将更加显著，例如大部分良性前列腺增生是由于前列腺组织增生导致前列腺组织堆积增厚，挤压尿道，出现排尿方面的各种问题，本实施例的医用植入物植入尿道后，足够多的支撑点位支撑尿道，不仅可以撑开尿道， 还能给尿道组织提供一个沿周向的分散作用力，可以将压迫尿道的增生后的前列腺组织分散开，减少增生后的前列腺组织对尿道的压迫作用，使得治疗效果更佳。
应当注意的是，本领域技术人员在第二支柱12和第三支柱13之间，还可以增加更多的支柱，以进一步提高支架主体10的支撑力，提高结构完整性和稳定效果。并且，在第二支柱12与第一支柱11之间，第三支柱13与第四支柱14之间，均可以根据需要增加支柱。
进一步的，所述医用植入物还包括第三连接件23，所有所述支柱的近端通过所述第三连接件23连接。其中，所述第三连接件23可以为U形连接件，U形连接件的侧面构成上述弧形面，即本实施例中弧形面为U形，第一支柱11、第二支柱12、第三支柱13和第四支柱14的近端通过U形连接件相连，如各支柱的近端间隔分布在U形的弧形面上。采用连接件对支柱近端进行收拢连接，并且连接件可以为光滑的U形支架，可以减少支架植入后对组织的刺激。进一步的，所述第三连接件的外表面尺寸沿远端向近端的方向逐渐减小，这可以进一步减小连接件的体积，减少对组织的刺激，此外向近端方向尺寸减小，可以减少排尿阻力，减少尿潴留风险。
在本发明的实施例中，所述支架主体可以采用一体成型工艺制备得到。例如可以是管材切割一体成型工艺，通过椭圆管材或片材切割弯曲成型；还可以对片材或者带材等采用热处理定型工艺进行一体成型，还可以利用3D打印技术、粉末冶金、注射成型等工艺进行一体成型。除此之外，本领域技术人员还可以想到的是，采用焊接、拼接、粘接、铆接等连接方式将带材等进行连接也可以得到本发明的支架主体，也属于本发明的保护范畴。
本发明的医用植入物植入前被压缩在支架输送装置的鞘管中，通过导管推送、旋转和后拉将植入物送到指定位置，并起到支撑、扩张尿道的作用，在支架的作用下，前列腺尿道局部缺血坏死和结构重塑，从而改善尿道梗阻，5-7天后，通过将植入物拉进鞘管后取出，达到改善前列腺狭窄引起的排尿不适症状。
综上所述，与现有技术相比，本发明提供的一种医用植入物具有以下优点：
本发明的医用植入物采用至少四根支柱组成医用植入物的支架主体，远端和近端均可构成弧形支撑，中间由各支柱拱起，支架主体形成稳定的贝壳形状，此时压迫支架主体产生形变所需要的力更大，因此，植入物植入后对腔道内壁进行支撑时提供给腔道内壁的支撑力也更大，使得支架可以提供更大的支撑力。而且支架主体与腔道内壁的接触面积很小，一方面避免了现有技术中支架与组织接触面过大而带来对组织刺激较大的问题，另一方面，支架与组织接触面积很小，在支架主体的作用下，对前列腺增生部位的压迫性效果更好，使增生部位缺血坏死，起到组织结构重塑的效果，改善尿道梗阻，可显著改善前列腺狭窄的治疗，无论是即刻还是中长期，都有明显的效果。
而且，本发明的支架主体的远端和近端均构成弧形支撑，中间为各支柱拱起式设计，支架主体呈现“贝壳形”的特征，中间高，近端和远端小，不仅符合生理的解剖结构，对腔道组织的撑开效果好，而且具有很好的锚定效果，减少支架的移位风险。
同时，支架主体的远端结构为非封闭式的环状结构，可以在远端实现径向支撑，提高整个医用植入物的支撑稳定性，而且，当该医用植入物植入尿道治疗良性前列腺增生时，开放式的远端结构可以起到对尿道内括约肌的周向支撑作用，解决临床上内括约肌难以支撑打开的问题，并且还能保证内括约肌有一定的收缩功能。
另外，本发明的医用植入物的支架主体在植入尿道支撑尿道内壁时，在尿道内腔中，第二支柱和第三支柱在尿道内腔的11点时钟点位和1点时钟点位的位置附近进行支撑，第一支柱在尿道内腔的4点或5点时钟点位附近，第四支柱在7点或8点时钟点位的位置附近进行支撑，空出了6点时钟点位的位置，当医用植入物植入尿道治疗BPH时，由于6点钟位置被空出，而尿道内腔的6点钟位置下方是前列腺组织的中叶结构，这样支架在植入后就不会压迫前列腺组织的中叶结构，减少对患者射精或性生活的影响，显著提高患者的生活质量和身心健康。
另外，本发明的医用植入物的支架主体可以采用7根或更多的支柱设计，包含足够多的支柱增加植入物与腔道内壁的支撑点位后，除可以进一步提高支架主体对腔道内壁的支撑力外，更多的支撑点位可以将腔道组织沿周向撑 开，当腔道组织出现堆积压迫后，支架的效果将更加显著，例如大部分良性前列腺增生是由于前列腺组织增生导致前列腺组织堆积增厚，挤压尿道，出现排尿方面的各种问题，本发明的医用植入物植入尿道后，足够多的支撑点位支撑尿道，不仅可以撑开尿道，还能给尿道组织提供一个沿周向的分散作用力，可以将压迫尿道的增生后的前列腺组织分散开，减少增生后的前列腺组织对尿道的压迫作用，使得治疗效果更佳。
并且，本发明的医用植入物可以采用连接件对支柱近端进行收拢连接，连接件设有光滑的弧形面，减少支架植入后对组织的刺激，并且连接件的外表面尺寸可以沿远端向近端的方向逐渐减小，可进一步减小连接件的体积，减少对组织的刺激，此外沿近端方向尺寸减小，可以减少排尿阻力，减少尿潴留风险。
此外，本发明的医用植入物的支架主体采用一体成型工艺制成，结构完整性好，可靠性高。
上述描述仅是对本发明较佳实施方式的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。显然，本领域的技术人员可以对发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包括这些改动和变型在内。

Claims (13)

  1. 一种医用植入物，用于植入非血管腔道，其特征在于，所述医用植入物被配置为沿径向可收缩或扩张，所述医用植入物包括支架主体，所述支架主体包括至少四根的支柱，其中，
    第一支柱、第二支柱、第三支柱和第四支柱沿所述支架主体的周向间隔布置，且各支柱均向远离支架主体中心线的方向弯曲；
    所有所述支柱的近端相连，且第一支柱、第二支柱、第三支柱和第四支柱的近端分布在一弧形面上，第一支柱和第四支柱分别位于所述弧形面的两端；
    所有所述支柱的远端相连且形成支架主体的远端结构，所述支架主体的远端结构为非封闭式的环状结构。
  2. 根据权利要求1所述的医用植入物，其特征在于，所述第二支柱的远端与所述第一支柱通过第一连接件连接，所述第三支柱的远端与所述第四支柱的远端通过第二连接件连接。
  3. 根据权利要求2所述的医用植入物，其特征在于，所述第一连接件和所述第二连接件采用弹性材料制成，所述第一连接件和所述第二连接件处于压缩状态。
  4. 根据权利要求2所述的医用植入物，其特征在于，所述支架主体还包括第五支柱和第六支柱，所述第五支柱的两端分别与所述第一支柱的近端和远端连接；所述第六支柱的两端分别与所述第四支柱的近端和远端连接。
  5. 根据权利要求4所述的医用植入物，其特征在于，在所述医用植入物的轴向投影上，所述第五支柱和所述第六支柱之间形成的空间与所述第二支柱和所述第三支柱之间形成的空间相对设置。
  6. 根据权利要求4所述的医用植入物，其特征在于，所有所述支柱均至少包括沿近端向远端依次连接的支撑段和连接段，所述支柱的支撑段到所述医用植入物的轴线的距离沿近端向远端的方向先逐渐增大后逐渐减小；
    所述第二支柱的连接段的端部与第三支柱的连接段的端部连接；
    所述第一支柱的连接段的端部与第五支柱的连接段的端部连接形成第一 连接点，所述第一连接件的一端连接于所述第一连接点上，另一端连接于所述第二支柱的连接段上；
    所述第四支柱的连接段的端部与第六支柱的连接段的端部连接形成第二连接点，所述第二连接件的一端连接于所述第二连接点上，另一端连接于所述第三支柱的连接段上。
  7. 根据权利要求1所述的医用植入物，其特征在于，所述支架主体还包括第七支柱，所述第七支柱设置于所述第二支柱和所述第三支柱之间，所述第七支柱、所述第二支柱和所述第三支柱的远端直接连接。
  8. 根据权利要求1所述的医用植入物，其特征在于，还包括第三连接件，所有所述支柱的近端通过所述第三连接件连接。
  9. 根据权利要求8所述的医用植入物，其特征在于，所述第三连接件为U形连接件，所述第一支柱、第二支柱、第三支柱和第四支柱的近端与所述U形连接件的U形侧固定相连。
  10. 根据权利要求8所述的医用植入物，其特征在于，所述第三连接件的外表面尺寸沿远端向近端的方向逐渐减小。
  11. 根据权利要求8所述的医用植入物，其特征在于，所述第三连接件设有光滑的U形的弧形面，所述第一支柱、第二支柱、第三支柱和第四支柱的近端间隔分布在所述U形的弧形面上。
  12. 根据权利要求1所述的医用植入物，其特征在于，所述支架主体形成稳定的贝壳形状。
  13. 根据权利要求1-12任一项所述的医用植入物，其特征在于，所述支架主体采用一体成型工艺制备得到。
PCT/CN2023/113957 2022-09-30 2023-08-21 一种医用植入物 WO2024066797A1 (zh)

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