CN117224275A - Hernia repair device and method of use - Google Patents
Hernia repair device and method of use Download PDFInfo
- Publication number
- CN117224275A CN117224275A CN202311196314.9A CN202311196314A CN117224275A CN 117224275 A CN117224275 A CN 117224275A CN 202311196314 A CN202311196314 A CN 202311196314A CN 117224275 A CN117224275 A CN 117224275A
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- Prior art keywords
- hernia repair
- repair device
- hernia
- conveying
- disc
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Classifications
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A40/00—Adaptation technologies in agriculture, forestry, livestock or agroalimentary production
- Y02A40/80—Adaptation technologies in agriculture, forestry, livestock or agroalimentary production in fisheries management
- Y02A40/81—Aquaculture, e.g. of fish
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- Prostheses (AREA)
Abstract
The invention discloses a hernia repair device and a use method thereof, wherein the hernia repair device comprises a device body, the device body comprises a disc body part and a positioning part, the end part of the positioning part is connected to one side surface of the disc body part, the disc body part and the positioning part are of an integrally formed three-dimensional net structure and have shape recovery property, the device body can be deformed into a linear structure, and the device body can be automatically expanded from the linear structure to form a preset three-dimensional net structure by means of the shape recovery property. The hernia repair device is convenient to put the hernia repair device into a hernia ring opening through a conveying device in minimally invasive surgery, reduces surgical incisions, can be unfolded into a preset three-dimensional net structure by means of shape recovery self-expansion after the device body is released, does not need auxiliary tools to assist in unfolding and placing, solves the problem that an existing hernia patch cannot be automatically unfolded in surgery, and simultaneously solves the problem that the existing hernia patch is easy to shift.
Description
Technical Field
The invention relates to the field of medical appliances, in particular to a hernia repair device and a using method thereof.
Background
Hernia refers to a rupture or weakening of the peritoneum supporting an internal organ at a location due to surgical injury or pathology such that the internal organ of the abdominal cavity protrudes from the abdominal cavity to the outside of the abdominal wall through the rupture or weakening site, forming a local tumor. Hernia has a incidence of about 0.36% in our country, accounting for 1.18% over 60 years old, and a new incidence of about 200 tens of thousands of cases per year. The types of hernias can be divided according to the location, such as hernias protruding from the umbilical region, such as umbilical hernias, masses formed from the groin, such as inguinal hernias, and also femoral hernias, leukotrichia hernias, incisional hernias. Once hernia is formed, the hernia can not self-heal, and the walking and normal activities of a patient can be influenced when the hernia is serious, so that serious threat is formed to the health and life of a human body, if the hernia is not treated in time, inflammatory swelling can be caused, hernia is difficult to recover, dangerous situations such as intestinal obstruction and intestinal necrosis occur, the life is endangered, and the hernia must be treated through an operation.
Current methods of treating hernias are performed by hernia repair, including direct suturing and hernia patch repair. The traditional hernia treatment method is to directly suture and repair the tissue at the defect part, and the method has the advantages of high postoperative recurrence rate, serious pain and slow recovery. An ideal method for treating hernia at present is hernia patch repair, namely, a patch material is selected to cover a damaged part to repair a hernia ring, and the method is tension-free hernia repair. Tension-free hernia repair has achieved extensive clinical treatment verification and is considered the safest and effective treatment. Tensionless hernia repair is divided into open hernia repair and laparoscopic hernia repair. The open hernia repair adopts a direct implantation method, which may require a large wound for implantation, and is unfavorable for repairing and beautifying the wound of a patient.
Compared with the open hernia repair, the laparoscopic hernia repair has the main advantages of small wound, only needs to make an incision of 4-6 cm, has light postoperative pain, improves recovery speed, enables patients to move early, and reduces recurrence rate and other complications. To accommodate laparoscopic minimally invasive surgery, the surgeon needs to place a hernia patch from a small incision, and the hernia patch needs to be placed in a rolled configuration into the patient and then deployed within the patient. At present, after some hernia patches enter a patient body in a curled shape, the hernia patches cannot be automatically restored to a preset shape, the hernia patches are difficult to ensure to be automatically unfolded to the original shape of the hernia patches after being placed, the hernia patches can only be unfolded in an auxiliary mode by means of surgical instruments such as forceps and the like, the spreading effect is strong and poor, the surgical effect is possibly affected, and the surgical time is prolonged and the surgical difficulty is increased. And the patch is placed at the hernia, so that the patch is easy to shift during suturing, and the suturing difficulty is increased. Meanwhile, as the repairing materials are soft patches, if the inguinal hernia is large due to the large hernia ring gap, the patches are not supported by tissues after being placed, and the patch is easy to shift and the hernia recurs.
Hernia patches for treating inguinal hernias are typically secured with suture stitches. However, excessive suturing may injure nerve branches, presenting postoperative pain; suture cuts may occur to tissue, which may result in the failure of effective fixation of the hernia patch, and even recurrence of the hernia or other serious complications. At present, the problem of suture in the process of suturing hernia patches is solved by using fewer sutures or no sutures, but the problem of unstable fixation is also brought.
In order to reduce the time of tiling hernia patches, reduce the operation difficulty of operating doctors, shorten the operation time, reduce the operation risk, enhance the treatment effect of the operation, the development designer is required to design a controllable release hernia repair device which can be implanted into a focus part in a minimally invasive intervention operation mode and is self-expanded to develop an intelligent hernia repair device with a proper size, and the hernia repair device has the advantages of small wound, no need of suturing, easiness in fixing, convenience in operation and low recurrence rate.
Disclosure of Invention
The invention aims to overcome the defects that the existing hernia patch in the prior art cannot be automatically unfolded and easily shifted in operation, and provides a hernia repair device and a using method thereof.
The invention solves the technical problems by the following technical scheme:
the utility model provides a hernia repair device, hernia repair device includes the device body, the device body includes disk body portion and location portion, location portion's end connection in one side surface of disk body portion, disk body portion with location portion is integrated into one piece's three-dimensional network structure and has shape recovery nature, the device body can become linear structure when receiving the delivery sheath, the device body can also rely on shape recovery nature follow linear structure self-expanding expansion is the three-dimensional network structure of reservation.
In the scheme, the tray body and the positioning part of the hernia repair device are integrally formed into the three-dimensional net structure and have shape recovery, the device body can be deformed into a linear structure when being taken into the delivery sheath, the hernia repair device can be placed into a hernia ring opening through the delivery device in minimally invasive surgery, the size of an operation incision is reduced, the hernia repair device can be self-expanded and unfolded into a preset three-dimensional net structure by means of shape recovery after the device body is released, other auxiliary tools are not needed to assist in unfolding and placing the hernia repair device, so that the problem that an existing hernia repair patch cannot be automatically unfolded in surgery is solved, meanwhile, when the hernia repair device is used, the tray body corresponds to the abdominal wall side, the positioning part fills a hernia channel, the tray surface of the tray body can play a supporting role at the abdominal wall defect, the positioning part can play a role of enabling the hernia repair device to be self-positioned in the channel formed by air, the combination of the two structures can increase the fitting degree of the hernia repair device and the abdominal wall, the phenomenon that the hernia repair device is easy to outwards bulge and shift after the hernia repair device is placed is avoided, and the problem that the existing hernia repair patch is easy to shift is solved. In addition, the hernia repair device fills the hernia annular opening, can play a role in dispersing and resisting the pressure of the abdominal cavity, can effectively block the hernia channel, and avoids postoperative recurrence, postoperative intestinal obstruction, intestinal necrosis and other adverse conditions.
The tray surface of the tray body is in any shape, and can be selected according to different hernia ring positions and individual conditions, and can be round, oval, round square, round rectangle, round trapezoid, round triangle, square, rectangle, trapezoid, triangle, U-shaped, irregular graph or combination of the above graph.
The radial dimension of the disk body is not smaller than the radial dimension of the positioning part.
In this embodiment, the tray body is adapted to contact the peritoneum during use, thus firmly sealing the cavity formed by the hernia tunnel against re-formation of the hernia tunnel.
Preferably, the inner or outer surface of the three-dimensional net structure is provided with at least one layer of film structure.
In the scheme, the film structure has good cell affinity and histocompatibility, avoids human rejection, and has good anti-adhesion effect.
Preferably, the film structure is a polymer film or a biological film.
In this aspect, the polymer film may be selected from a degradable polymer film and a non-degradable polymer film. The biological membrane is prepared from one or more of human or animal amniotic membrane, basement membrane, pericardium, peritoneum, pleura or visceral submucosa. The biomembrane is an anti-adhesion layer, which can ensure that the hernia repair device is not easy to adhere with the abdominal wall viscera after being placed in a body, thereby avoiding infection recurrence.
Preferably, the device body further comprises a connecting portion, the end portion of the positioning portion is connected to one side surface of the disc portion through the connecting portion, and the radial size of the positioning portion and the radial size of the disc portion are both larger than the radial size of the connecting portion.
In this scheme, thinner connecting portion is favorable to the device body to put into the operation and is released the quotation of back disk body portion and resume to the shape of presetting, also is favorable to the self-adaptation adjustment when locating part and disk body portion dislocation, realizes quick self-positioning. Preferably, the connecting portion is also a three-dimensional net structure. The connection portion may be centered or offset with respect to the tray body.
Preferably, the positioning part has an axisymmetric structure.
In the scheme, the positioning part is arranged into an axisymmetric structure, so that the device body can be conveniently and rapidly positioned in a channel formed by hernia when being automatically unfolded. Preferably, the axisymmetric structure is cylindrical, conical or frustoconical.
Preferably, the tray body has a groove penetrating the tray body, and the groove extends from the edge of the tray body to the center.
In this scheme, the recess is used for supplying spermatic cord or uterus round ligament tissue to pass, avoids interfering, also further assists to improve fixed effect.
Preferably, the end part of the groove, which is close to the center of the disc body part, is connected with a via hole, the via hole is communicated with the groove, and the inner diameter of the via hole is larger than that of the groove.
In this scheme, adopt above-mentioned structure setting, form the structure of binding off at the junction of via hole and recess, when spermatic cord or uterus round ligament tissue inlay in the via hole, the binding off structure is fixed the device body on spermatic cord or uterus round ligament tissue, improves fixed effect, avoids the device to take place to shift. The vias may be circular, oval, rounded square, rounded rectangle, rounded trapezoid, rounded triangle, square, rectangle, trapezoid, triangle, U-shape, or irregular pattern.
Preferably, the device body is integrally formed by winding a single or a plurality of wires.
In the scheme, the device body is manufactured by adopting the process, an integrated three-dimensional net structure is formed, and the device body has shape recovery property, so that the device body can be automatically expanded and unfolded into a preset shape after being released from the delivery sheath.
Preferably, the silk thread is made of metal or polymer.
In the scheme, the device body made of the metal material is a developable hernia repair device under the X-ray equipment, so that the visibility of instruments during operation is improved. The high polymer material comprises degradable high polymer material and non-degradable high polymer material.
The degradable polymeric material may be selected from one or more of polylactic acid, polyglycolic acid, polydioxanone, polycaprolactone, trimethylene carbonate, oxidized regenerated cellulose or polydopamine, or a copolymer of at least two thereof. After the materials are placed into a human body, the materials are gradually degraded and gradually filled by human tissues, so that the final residual quantity of foreign matters in the human body is greatly reduced, the compression on peripheral blood vessels can be gradually reduced, the foreign matter feeling felt by a patient is lightened, the comfort of the patient after operation is improved, and the compliance of the abdominal wall is improved.
The non-degradable high polymer material can be selected from one or more of polyethylene terephthalate, polybutylene succinate, polypropylene, polyethylene, polyvinylidene fluoride, polyvinyl alcohol, zein and polyacrylonitrile, or a copolymer of at least two of the above.
Preferably, the metal material is nickel-titanium memory alloy or biomedical magnesium alloy.
In the scheme, the nickel-titanium memory alloy or biomedical magnesium alloy has a shape memory function, and the device body made of the nickel-titanium memory alloy is convenient for being rapidly and automatically unfolded into a preset shape, and the hernia channel is fully filled. In addition, the nickel-titanium memory alloy or biomedical magnesium alloy also has good cell affinity and tissue compatibility, and avoids the rejection of human bodies.
Preferably, a connecting piece is arranged on the surface of the tray body far away from the positioning part, one end of the connecting piece is connected with the tray body, and the other end of the connecting piece is used for connecting a conveying steel cable. Preferably, the connection is a screw.
In this scheme, the connecting piece sets up on the surface that keeps away from the location portion, and the location portion of being convenient for is released earlier in the operation process, fixes a position in the cavity that hernia formed, then is that disk body portion is released, blocks off the hernia ring mouth. The connecting piece is a threaded piece, so that the steel cable is convenient to convey and is connected with the connecting piece in a threaded manner, and the hernia repair device is released through rotation.
A method of using a hernia repair device as described above, the method comprising the steps of:
s1, conveying the end part of the conveying sheath tube to a preset position.
S2, connecting the hernia repair device to a conveying steel cable in a conveying sheath pipe, and pulling the hernia repair device into the conveying sheath pipe through the movement of the conveying steel cable in the conveying sheath pipe;
s3, pushing the hernia repair device out of the conveying sheath tube through the distal movement of the conveying steel cable;
and S4, connecting the hernia repair device with the conveying steel cable.
In this embodiment, a matched delivery device is required for the hernia repair device, and the delivery device has a delivery sheath and a delivery cable positioned within the delivery sheath.
In step S1, a hole is opened at a corresponding position near the treatment site by a minimally invasive surgery, and then the end of the delivery sheath is delivered to a predetermined position (appropriate position of the human hernia).
In step S2, a delivery cable is provided inside the delivery sheath, and the delivery cable moves inside the delivery sheath. The connecting piece is arranged on the tray body of the hernia repair device, the end part of the conveying steel cable is connected to the connecting piece, and the hernia repair device can be pulled into the conveying sheath through the movement of the conveying steel cable in the conveying sheath due to the fact that the device body can be deformed into a linear structure.
In step S3, the hernia repair device is pushed out of the delivery sheath by moving the delivery cable distally, the positioning part is pushed out of the delivery sheath and released at the appropriate position of the hernia channel, and then the delivery sheath is pulled back proximally to further release the disc part at the appropriate position of the hernia annulus.
In step S4, after the hernia repair device is placed in the appropriate position in the hernia tunnel, the connection between the hernia repair device and the delivery wire rope is released, the hernia repair device is released into the tunnel formed by the hernia, and the hernia repair device self-expands to a predetermined three-dimensional mesh structure, filling the hernia tunnel. Compared with laparoscopic hernia repair, the use method has the advantages that the hernia repair patch is not required to be observed through a laparoscope and is assisted by other auxiliary tools to be unfolded and fixed at a proper position, the purpose of rapidly and safely repairing the hernia is achieved, and the operation is convenient, safe and reliable, and the hernia repair operation can be effectively performed.
On the basis of conforming to the common knowledge in the field, the above preferred conditions can be arbitrarily combined to obtain the preferred examples of the invention.
The invention has the positive progress effects that: the tray body part and the positioning part of the hernia repair device are formed into a three-dimensional net structure integrally formed and have shape recovery, the device body can be deformed into a linear structure, the hernia repair device is conveniently placed into a hernia ring opening through a conveying device in minimally invasive surgery, the size of an operation incision is reduced, after the device body is released, the hernia repair device can be self-expanded and unfolded into a preset three-dimensional net structure by means of shape recovery, and other auxiliary tools are not needed to assist in unfolding, placing and fixing the hernia repair device, so that the problems that an existing hernia repair patch cannot be automatically unfolded in surgery and needs to be fixed by a suture line are solved. Meanwhile, when the hernia repair device is used, the disc body corresponds to the abdominal wall side, the locating part fills the hernia channel, the disc surface of the disc body can play a supporting role at the abdominal wall defect opening, the locating part can play a role in enabling the device to be self-located in the hernia formed channel, the combination of the two structures can increase the fitting degree of the hernia repair device and the abdominal wall, the phenomenon that the device is easy to outwards protrude and shift due to the abdominal wall defect after the hernia repair device is placed is avoided, and the problem that the existing hernia repair device is easy to shift is solved. In addition, the hernia repair device can cover the areas needing to be covered on the inner side and the outer side of the abdominal wall, and the hernia ring opening can be filled with the hernia repair device to play a role in dispersing and resisting the pressure of the abdominal cavity, and also play a role in effectively blocking a hernia channel and supporting peritoneum, so that adverse conditions such as postoperative hernia recurrence, intestinal obstruction and intestinal necrosis are avoided. The hernia repair device has the advantages of small wound, no need of suture, easy fixation, convenient operation and low recurrence rate.
Drawings
Fig. 1 is a schematic structural view of a hernia repair device according to embodiment 1 of the present invention (the positioning portion is a cylinder).
Fig. 2 is a schematic structural diagram of a hernia repair device according to embodiment 1 of the present invention (the positioning portion is a truncated cone).
Fig. 3 is a schematic structural view of a hernia repair device according to embodiment 1 of the present invention (the positioning portion is a cone).
Fig. 4 is a schematic structural view of a hernia repair device according to embodiment 1 of the present invention (the positioning portion is cylindrical and is disposed eccentrically with respect to the disc portion).
Fig. 5 is a schematic view showing the disc-shaped structure of the disc body according to embodiment 1 of the present invention.
Fig. 6 is a schematic view of the structure of the tray body of embodiment 1 of the present invention with an elliptical shape.
Fig. 7 is a schematic diagram of a disc body with rounded square shape according to embodiment 1 of the present invention.
Fig. 8 is a schematic structural view of a disc body with rounded triangle shape according to embodiment 1 of the present invention.
Fig. 9 is a schematic structural view of a disc body part with rounded trapezoid shape according to embodiment 1 of the present invention.
Fig. 10 is a schematic view of a disc with grooves in the disc body according to embodiment 1 of the present invention.
Fig. 11 is a schematic view of a disc portion with a circular shape (a via hole is provided in the center of the disc portion) according to embodiment 1 of the present invention.
Fig. 12 is a schematic view of a disc portion with a circular shape (via holes are eccentrically provided in the disc portion) according to embodiment 1 of the present invention.
Fig. 13 is a schematic view showing the structure of the disk body of embodiment 1 of the present invention in an irregular pattern (the opening of the groove faces the long axis direction).
Fig. 14 is a schematic view showing the structure of the disk body of embodiment 1 of the present invention in an irregular pattern (the opening of the groove faces the short axis direction).
Fig. 15 is a schematic structural diagram of the disc body of embodiment 1 of the present invention with irregular patterns (the via holes are U-shaped).
Fig. 16 is a schematic structural view of a hernia repair device according to embodiment 2 of the present invention (the positioning portion is a cylinder).
Fig. 17 is a schematic structural view of a hernia repair device according to embodiment 2 of the present invention (the positioning portion is a truncated cone).
Fig. 18 is a schematic structural view of a hernia repair device according to embodiment 2 of the present invention (the positioning portion is a cone).
Fig. 19 is a schematic structural view of a hernia repair device according to embodiment 2 of the present invention (the positioning portion is cylindrical and is disposed eccentrically with respect to the disc portion).
Fig. 20 is a schematic structural view of a hernia repair device according to embodiment 2 of the present invention (the positioning portion is a cylinder, and the connecting portion is eccentrically disposed with respect to the disc portion).
Fig. 21 is a flowchart of a method of using the hernia repair device according to embodiment 1 of the present invention.
Reference numerals illustrate:
device body 1
Tray body 11
Groove 111
Via 112
Connecting piece 113
Positioning part 12
Connection part 13
Radial direction 100
Detailed Description
The invention will now be more fully described by way of example only and with reference to the accompanying drawings, but the invention is not thereby limited to the scope of the examples described.
Example 1
As shown in fig. 1-15, the embodiment discloses a hernia repair device, which comprises a device body 1, wherein the device body 1 comprises a tray body 11 and a positioning portion 12, the end of the positioning portion 12 is connected to one side surface of the tray body 11, and the tray body 11 and the positioning portion 12 are of an integrally formed three-dimensional net structure and have shape recovery, namely shape memory. The device body 1 can be deformed into a linear structure when the sheath is taken in, and the device body 1 can be automatically expanded from the linear structure into a predetermined three-dimensional net structure by means of shape recovery.
In this embodiment, the tray body 11 and the positioning portion 12 of the hernia repair device are formed as an integrally formed three-dimensional mesh structure and have shape recovery, the device body 1 can be deformed into a linear structure, so that the hernia repair device can be conveniently placed into a hernia ring opening by a conveying device in a minimally invasive operation, the size of an operation incision is reduced, and after the device body 1 is released, the hernia repair device can be self-expanded and unfolded into a preset three-dimensional mesh structure by means of shape recovery without other auxiliary tools to assist in unfolding and placing the hernia repair device, so that the problem that an existing hernia repair patch cannot be automatically unfolded in the operation is solved. Meanwhile, when the hernia repair device is used, the disc body 11 corresponds to the abdominal wall side, the locating part 12 fills the hernia channel, the disc surface of the disc body 11 can play a supporting role at the abdominal wall defect, the locating part 12 can play a role in enabling the device to be self-located in the hernia formed channel, the combination of the two structures can increase the fitting degree of the hernia repair device and the abdominal wall, the phenomenon that the device is easy to outwards protrude and shift due to the abdominal wall defect after the hernia repair device is placed is avoided, and the problem that the existing hernia repair device is easy to shift is solved. In addition, the hernia repair device fills the hernia annular opening, can play a role in dispersing and resisting the pressure of the abdominal cavity, can effectively block the hernia channel, and avoids postoperative recurrence, postoperative intestinal obstruction, intestinal necrosis and other adverse conditions.
Because the hernia repair device is of a three-dimensional net structure, after being released, the hernia repair device can be self-expanded and unfolded to be in a preset shape, and the disc body 11 and the positioning part 12 can cover the areas which need to be covered on the inner side and the outer side of the abdominal wall respectively, so that the hernia repair device does not need other auxiliary tools to help the hernia repair device to be unfolded and positioned on the hernia ring, and the problem that the hernia recurrence rate is increased due to the fact that the existing hernia repair patch cannot be unfolded and positioned by itself, and then the hernia ring and a hernia channel are not sufficiently covered is avoided. Meanwhile, the hernia repair device has simpler operation process, small operation incision and can only pass through the conveying sheath.
The disk body of the hernia repair device can play a role in supporting the peritoneum, and the position of the device is automatically adjusted after the positioning part is arranged in a hernia channel through the three-dimensional structure of the positioning part and is fixed in the hernia channel, so that hernia recurrence caused by device displacement is effectively prevented.
Because the hernia repair device is self-expanded into a preset shape through shape recovery, the positioning part is unfolded and is propped against the wall surface of the hernia channel to realize the function of self-positioning, and suture and fixation are not needed, so that the problems that nerve branches are possibly injured, postoperative pain is caused, tissues are possibly cut to lose effective fixation, hernia recurrence or other serious complications are even caused when suture is used for suturing are avoided, the operation time is shorter, the operation incision is smaller, and the device is fixed more firmly.
As shown in fig. 5 to 15, the disk surface of the disk body 11 is of any shape, and a suitable disk surface shape can be selected according to different hernia ring positions and individual conditions, and can be approximated to a circle, an ellipse, a rounded square, a rounded rectangle, a rounded trapezoid, a rounded triangle, a square, a rectangle, a trapezoid, a triangle, a U-shape, an irregular pattern, or a combination of the above patterns.
The radial dimension of the disk portion 11 is not smaller than the radial dimension of the positioning portion 12. The disk 11 is adapted to contact the peritoneum and deform into a disk, which firmly seals the cavity formed by the hernia passages, preventing re-formation of the hernia passages. The radial dimension is the dimension in the radial direction 100.
The inner or outer surface of the three-dimensional network is provided with at least one layer of film structure (not shown in the figures). The film structure has good cell affinity and histocompatibility, avoids human rejection, and has good anti-adhesion effect.
The film structure is a biological film or a polymer film.
The biological membrane is prepared from one or more of human or animal amniotic membrane, basement membrane, pericardium, peritoneum, pleura or visceral submucosa. The biomembrane is an anti-adhesion layer, which can ensure that the hernia repair device is not easy to adhere with the abdominal wall viscera after being placed in a body, thereby avoiding infection recurrence.
The polymer film can be made of degradable polymer material and non-degradable polymer material.
The degradable polymeric material may be selected from one or more of polylactic acid, polyglycolic acid, polydioxanone, polycaprolactone, trimethylene carbonate, oxidized regenerated cellulose or polydopamine, or a copolymer of at least two thereof. After the materials are placed into a human body, the materials are gradually degraded and gradually filled by human tissues, so that the final residual quantity of foreign matters in the human body is greatly reduced, the compression on peripheral blood vessels can be gradually reduced, the problem that a patient feels foreign matters is solved, the comfort of the patient after operation is improved, and the compliance of the abdominal wall is improved.
The non-degradable high polymer material can be selected from one or more of polyethylene terephthalate, polybutylene succinate, polypropylene, polyethylene, polyvinylidene fluoride, polyvinyl alcohol, zein and polyacrylonitrile, or a copolymer of at least two of the above.
As shown in fig. 1-4, the positioning portion 12 has an axisymmetric structure, so that when the device body 1 is automatically deployed, the three-dimensional mesh structure abuts against the wall surface of the hernia tunnel, thereby being rapidly positioned in the hernia tunnel. Preferably, the axisymmetric structure is cylindrical, conical or frustoconical.
As shown in fig. 10-15, the tray body 11 is provided with a groove 111 penetrating the tray body 11 along a direction perpendicular to the radial direction 100, the groove 111 extends from the edge of the tray body 11 to the center, and the groove 111 is used for allowing spermatic cord or circular uterine ligament tissue to pass through, so that interference is avoided, and the fixing effect of the device is further improved.
As shown in fig. 11 to 15, the end of the groove 111 near the center of the disc 11 is connected with a via 112, the via 112 communicates with the groove 111, the inner diameter of the via 112 is larger than the inner diameter of the groove 111, and a closing-up structure is formed at the joint of the via 112 and the groove 111. When the spermatic cord or the circular uterine ligament tissue is embedded in the through hole 112, the closing-in structure fixes the device body 1 on the spermatic cord or the circular uterine ligament tissue, so that the fixing effect is improved, and the displacement is avoided. The vias 112 may be circular, oval, rounded square, rounded rectangle, rounded trapezoid, rounded triangle, square, rectangle, trapezoid, triangle, U-shape, or irregular pattern.
As shown in fig. 1 to 4, a connecting member 113 is provided on a surface of the tray body 11 remote from the positioning portion 12, one end of the connecting member 113 is connected to the tray body 11, and the other end of the connecting member 113 is used for connecting a conveying wire rope. The connecting member 113 is provided on a surface remote from the positioning portion 12 so that during surgery, the positioning portion 12 is released first and positioned in the cavity formed by the hernia, and then the tray portion 11 is released to close the hernia annulus. Preferably, the connector 113 is a threaded member that facilitates threading of the delivery cable to the connector 113 and release of the hernia repair device by rotation.
In other alternative implementations, the connector may be integrally formed with the device body, and the delivery cable may be replaced with other delivery members or controls.
The device body 1 is formed by winding a single wire into a whole, forms an integrated three-dimensional net structure and has shape recovery property, so that the device body 1 can be automatically expanded and unfolded into a preset shape after being released from a delivery sheath.
In other embodiments, the device body 1 may be integrally formed by winding a plurality of wires.
The silk thread is made of high polymer material. The device body 1 made of the silk thread made of the high polymer material can ensure that the hernia repair device is not easy to adhere with the abdominal wall viscera after being placed in a body, thereby avoiding infection or complications. Of course, the silk thread made of the polymer material can be made of degradable or non-degradable polymer material.
The hernia repair device is made of completely degradable materials, and the materials are gradually degraded and gradually filled by human tissues along with the extension of the implantation time, so that the final residual quantity of foreign matters in the body is greatly reduced, the postoperative comfort of a patient is improved, and the compliance of the abdominal wall is improved.
The degradable polymeric material may be selected from one or more of polylactic acid, polyglycolic acid, polydioxanone, polycaprolactone, trimethylene carbonate, oxidized regenerated cellulose or polydopamine, or a copolymer of at least two thereof. After the materials are placed into a human body, the materials are gradually degraded and gradually filled by human tissues, so that the final residual quantity of foreign matters in the human body is greatly reduced, the compression on peripheral blood vessels can be gradually reduced, the problem that a patient feels foreign matters is solved, the comfort of the patient after operation is improved, and the compliance of the abdominal wall is improved.
The hernia repair device is made of the non-degradable material, and the three-dimensional net structure has excellent mechanical strength, good flexibility, good biocompatibility and histocompatibility in the implantation period, and can well assist tissue remodeling.
The non-degradable high polymer material can be selected from one or more of polyethylene terephthalate, polybutylene succinate, polypropylene, polyethylene, polyvinylidene fluoride, polyvinyl alcohol, zein and polyacrylonitrile, or a copolymer of at least two of the above.
The hernia repair device is formed by jointly knitting the non-degradable monofilament and the degradable monofilament, so that the overall weight is reduced after the degradation of the degradable monofilament, the foreign body sensation of a patient is reduced, in addition, the mesh area of the hernia repair device is enlarged after the degradation of the degradable monofilament, thereby being more beneficial to the growth of abdominal wall tissues, reinforcing the abdominal wall tissues, facilitating the passage of macrophages and reducing the occurrence of inflammation.
The silk thread is made of metal material. The device body 1 made of the metal silk thread is a developable hernia repair device under the X-ray equipment, thereby increasing the visibility of the instrument during operation.
Preferably, the metal material is nickel-titanium memory alloy or biomedical magnesium alloy. The device body 1 made of nickel-titanium memory alloy or biomedical magnesium alloy has a shape memory function, is convenient for the device body 1 to be rapidly and automatically unfolded into a preset shape, and fully fills the hernia channel. In addition, the nickel-titanium memory alloy or biomedical magnesium alloy also has good cell affinity and tissue compatibility, and avoids the rejection of human bodies.
As shown in fig. 21, the embodiment also discloses a method for using the hernia repair device, which comprises the following steps:
s1, conveying the end part of the conveying sheath tube to a preset position.
In step S1, a hole is opened at a corresponding position near the treatment site by a minimally invasive surgery, and then the end of the delivery sheath is delivered to a predetermined position (appropriate position of the human hernia).
In use of the hernia repair device, a delivery device having a delivery sheath and a delivery cable positioned within the delivery sheath is required.
S2, connecting the hernia repair device to a conveying steel cable in the conveying sheath, and pulling the hernia repair device into the conveying sheath by moving the conveying steel cable in the conveying sheath.
In step S2, a delivery cable is provided inside the delivery sheath, and the delivery cable moves inside the delivery sheath. The plate body 11 of the hernia repair device is provided with a connecting member 113, the end of the delivery wire rope is connected to the connecting member 113, and the hernia repair device can be pulled into the delivery sheath by the movement of the delivery wire rope in the delivery sheath, since the device body 1 can be deformed into a linear structure.
And S3, pushing the hernia repair device out of the delivery sheath by moving the delivery steel cable to the distal end.
In step S3, the hernia repair device is pushed out of the delivery sheath by moving the delivery cable distally, the positioning portion 12 is pushed out of the delivery sheath and released in the appropriate position of the hernia tunnel, and then the delivery sheath is pulled back proximally to further release the tray portion 11 in the appropriate position of the hernia annulus.
And S4, connecting the hernia repair device with the conveying steel cable.
In step S4, after the hernia repair device is placed in the appropriate position in the hernia tunnel, the connection between the hernia repair device and the delivery cable is released, and the delivery cable is released from the threaded connection 113 by rotating the delivery cable, so that the hernia repair device is released in the tunnel formed by the hernia, and the hernia repair device self-expands to a predetermined three-dimensional mesh structure to fill the hernia tunnel. Compared with laparoscopic hernia repair, the use method has the advantages that the hernia repair patch is not required to be unfolded and fixed at a proper position by being observed through a laparoscope and other auxiliary tools, the purpose of rapidly and safely repairing the hernia is achieved, the operation time is short, the operation is convenient, the safety and reliability are realized, and the hernia repair operation can be effectively performed.
The hernia repair device can be tightly attached to abdominal wall tissues after hernia is unfolded, fills up a hernia channel, can play a role in stopping bleeding rapidly, prevents leakage of body fluid at an incision, and is beneficial to postoperative healing and hernia recurrence prevention. Moreover, the hernia repair device has the advantages of simple preparation method, low cost, large-scale production and excellent product performance. The self-expandable three-dimensional net structure of the hernia repair device can strengthen the stability of the hernia repair device and avoid the hernia recurrence caused by the displacement of the hernia repair device.
When using the hernia repair device, there are two methods of use, one is to push the protruding hernia sac and the peritoneum back together, i.e. the device is located extraperitoneum for hernia repair, and the other is to push the protruding hernia sac back to its original position, the peritoneum remains the protruding position, and the device is located intraperitoneally for hernia repair. The disc surface of the disc body 11 of the hernia repair device corresponds to the abdominal wall side, the locating part 12 fills the hernia channel, the disc surface with larger size can play a role in supporting the abdominal wall defect, and the locating part 12 with axisymmetric structure can play a role in enabling the device to be self-located in the channel formed by the hernia. The through hole 112 on the tray body 11 can be buckled with the spermatic cord or the circular uterine ligament tissue to assist in functioning as a fixing device and can avoid the traction obstruction of the hernia repair device on the spermatic cord or the circular uterine ligament tissue.
Example 2
As shown in fig. 16 to 20, this embodiment is substantially the same as embodiment 1 except that: the device body 1 further comprises a connecting portion 13, wherein the end portion of the positioning portion 12 is connected to one side surface of the disc portion 11 through the connecting portion 13, and the radial dimension of the positioning portion 12 and the radial dimension of the disc portion 11 are larger than the radial dimension of the connecting portion 13. The radial dimension is the dimension in the radial direction 100.
The thinner connecting part 13 is beneficial to the recovery of the disk surface of the disk body 11 to a preset shape when the device body 1 is placed in an operation and released, and is also beneficial to the self-adaptive adjustment when the positioning part 12 and the disk body 11 are misplaced, so that the quick self-positioning is realized. Preferably, the connecting portion 13 is also a three-dimensional net structure. The connection portion 13 may be centered or offset with respect to the tray body 11.
In the description herein, it should be understood that the terms "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate or are based on the orientation or positional relationship shown in the drawings, merely to facilitate describing the invention and simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention.
While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that this is by way of example only, and the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the principles and spirit of the invention, but such changes and modifications fall within the scope of the invention.
Claims (10)
1. The hernia repair device is characterized by comprising a device body, wherein the device body comprises a disc body and a positioning part, the end part of the positioning part is connected to one side surface of the disc body, the disc body and the positioning part are of an integrally formed three-dimensional net structure and have shape recovery, the device body can be deformed into a linear structure when being taken in a delivery sheath, and the device body can be automatically expanded from the linear structure by means of the shape recovery to form a preset three-dimensional net structure.
2. The hernia repair device according to claim 1, wherein the radial dimension of the disc portion is not less than the radial dimension of the locating portion.
3. The hernia repair device according to claim 1, wherein the inner or outer surface of the three-dimensional mesh structure is provided with at least one layer of film structure;
preferably, the film structure is a polymer film or a biological film.
4. The hernia repair device according to claim 1, wherein the device body further comprises a connection portion, wherein an end of the positioning portion is connected to a side surface of the disc portion through the connection portion, and wherein the radial dimension of the positioning portion and the radial dimension of the disc portion are both greater than the radial dimension of the connection portion.
5. The hernia repair device according to claim 1, wherein the locating section is of axisymmetric structure.
6. The hernia repair device according to claim 1, wherein the tray body has a recess extending therethrough from an edge of the tray body toward a center thereof.
7. The hernia repair device according to claim 6, wherein an end of the recess adjacent the center of the tray body is connected with a via, the via communicating with the recess, the via having an inner diameter greater than an inner diameter of the recess.
8. The hernia repair device according to claim 1, wherein the device body is integrally formed by winding a single or multiple filaments;
preferably, the silk thread is made of metal or polymer;
preferably, the metal material is nickel-titanium memory alloy or biomedical magnesium alloy.
9. The hernia repair device according to claim 1, wherein a connector is provided on a surface of the tray body remote from the positioning portion, one end of the connector is connected to the tray body, and the other end of the connector is connected to a conveying wire rope;
preferably, the connecting member is a screw member.
10. A method of using a hernia repair device according to any one of claims 1-9, wherein the method comprises the steps of:
s1, conveying the end part of a conveying sheath tube to a preset position;
s2, connecting the hernia repair device to a conveying steel cable in a conveying sheath pipe, and pulling the hernia repair device into the conveying sheath pipe through the movement of the conveying steel cable in the conveying sheath pipe;
s3, pushing the hernia repair device out of the conveying sheath tube through the distal movement of the conveying steel cable;
and S4, connecting the hernia repair device with the conveying steel cable.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311196314.9A CN117224275A (en) | 2023-09-15 | 2023-09-15 | Hernia repair device and method of use |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311196314.9A CN117224275A (en) | 2023-09-15 | 2023-09-15 | Hernia repair device and method of use |
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| CN117224275A true CN117224275A (en) | 2023-12-15 |
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| CN202311196314.9A Pending CN117224275A (en) | 2023-09-15 | 2023-09-15 | Hernia repair device and method of use |
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| CN (1) | CN117224275A (en) |
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