CN109984778B - Medical suturing device and suturing system - Google Patents
Medical suturing device and suturing systemDownload PDFInfo
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- CN109984778B CN109984778BCN201711480237.4ACN201711480237ACN109984778BCN 109984778 BCN109984778 BCN 109984778BCN 201711480237 ACN201711480237 ACN 201711480237ACN 109984778 BCN109984778 BCN 109984778B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00628—T-shaped occluders
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0403—Dowels
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0417—T-fasteners
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
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Abstract
Translated fromChinese
Description
Technical Field
The invention relates to the technical field of interventional medical treatment, in particular to a medical suturing device and a suturing system.
Background
Patent foramen ovale is the most common congenital heart abnormality in adults at present, and 20% -25% of patent foramen ovale are incompletely closed in normal people. The patent refers to the field of 'surgical instruments, devices or methods'. Meanwhile, patent foramen ovale is closely related to decompression sickness, migraine and cerebral apoplexy.
In the past, surgical operation is mainly used for treating patent foramen ovale, the success rate of surgical treatment is high, the fatality rate is low, but the trauma is large, and complications such as atrial fibrillation, hydropericardium, postoperative bleeding and wound infection can occur, so that the surgical operation is rarely adopted in recent years. With the development of cardiac catheter technology, patent foramen ovale can be radically treated through interventional therapy. Recent clinical practice has demonstrated that this technique is safe, effective and feasible, capable of permanently closing an open foramen ovale.
The most interventional therapy is to implant an occluder, which generally comprises two net-shaped disks and a connecting piece for connecting the two net-shaped disks, wherein the two net-shaped disks are respectively clamped in the left atrium and the right atrium and block the oval hole passage outlets at the two sides of the atrial septum, and the connecting piece connects the left disk and the right disk together through the oval hole channel to complete the occlusion at the two sides. The plugging device for the oval hole is used for interventional therapy, although chest opening and open heart surgery can be avoided, the surgical risk and the wound area can be greatly reduced, and postoperative recovery is facilitated. However, because the volume of the occluder is large, the atrium has a protruding part which easily causes thrombus, the oval hole is generally a sandwich structure, the occluder can generate large deformation when clamping the atrial septum, the left and right discs can be dislocated, and the dragging force is generated between the two discs, so that the occluder has large deformation and workload, and the overall structure has certain fatigue risk under the motion of heart pulsation.
In the existing mode of sewing by adopting the puncture needle, the puncture assembly is only provided with one needle head, and when sewing, the puncture assembly needs to be punctured once by virtue of the puncture tube, then the puncture tube is bent and punctured once again, namely, the puncture tube not only needs to be bent, but also needs to be pushed twice to puncture, so that the operation is very inconvenient and the required time is long.
Disclosure of Invention
In view of the above, it is necessary to provide a medical suturing apparatus and a suturing system, which are capable of solving the problems of inconvenience and long operation time in the conventional suturing method using a puncture needle.
The utility model provides a medical suturing device, medical suturing device includes the puncture subassembly, the puncture subassembly includes first syringe needle and second syringe needle, the needle point of first syringe needle reaches the needle point of second syringe needle all the time towards the distal end of puncture subassembly extends.
In one embodiment, the medical suturing device further comprises a thread assembly, wherein the thread assembly comprises a suture thread, a first buckle and a second buckle, one end of the suture thread is connected with the first buckle, the other end of the suture thread is connected with the second buckle, the first buckle is connected with the first needle, the second buckle is connected with the second needle, and the suture thread is clamped between the first needle and the second needle.
In one embodiment, the puncture assembly comprises a double-head puncture needle and a thimble, the double-head puncture needle comprises the first needle head and the second needle head, the first needle head is provided with a first cavity and is open at two ends, the second needle head is provided with a second cavity and is open at two ends, the proximal end of the first needle head is connected with the proximal end of the second needle head and keeps the proximal end of the first needle head and the proximal end of the second needle head open, a first opening is arranged at one side of the first needle head opposite to the second needle head, a second opening is arranged on the second needle head opposite to the first opening, the distal end of the first opening extends to the distal end of the first needle head, and the distal end of the second opening extends to the distal end of the second needle head; the thimble comprises a first ejector rod and a second ejector rod, the near end of the first ejector rod is connected with the near end of the second ejector rod, the far end of the first ejector rod extends into the first cavity from the near end of the first needle head, and the far end of the second ejector rod extends into the second cavity from the near end of the second needle head; the first buckle is contained in the first cavity, the second buckle is contained in the second cavity, and the suture line is located between the first opening and the second opening.
In one embodiment, the puncture assembly further comprises a fixing member and an outer tube, the fixing member has a cavity, the proximal end of the fixing member is provided with an opening, the distal end of the outer tube is connected with the proximal end of the fixing member, the inner diameter of the outer tube is larger than the diameter of the opening at the proximal end of the fixing member, the proximal end of the double-headed puncture needle is connected with the distal end of the fixing member, and the proximal end of the thimble is accommodated in the cavity of the fixing member.
In one embodiment, the puncture assembly further comprises a fixed block, the fixed block is accommodated in the cavity of the fixed part, and the proximal end of the thimble is accommodated in the cavity of the fixed part and connected with the distal end of the fixed block.
In one embodiment, the medical suturing device further comprises a first connector through which the proximal end of the first needle and the proximal end of the second needle are connected.
In one embodiment, the medical suturing device further comprises a second connecting piece, and the proximal end of the first ejector rod is connected with the proximal end of the second ejector rod through the second connecting piece.
In one embodiment, the first needle and the second needle are connected in a V shape or a U shape.
In one embodiment, the first needle is parallel to the second needle, and the first ejector rod is parallel to the second ejector rod.
In one embodiment, the first clip is rod-shaped when being constrained in the first cavity and is unfolded in a plane after sliding out of the distal end of the first needle, and the second clip is rod-shaped when being constrained in the second cavity and is unfolded in a plane after sliding out of the distal end of the second needle.
In one embodiment, the puncture assembly comprises a first ejector rod and a second ejector rod connected with the first ejector rod, the first ejector rod is the first needle head, and the second ejector rod is the second needle head; the first buckle is tubular and is sleeved on the first ejector rod, the second buckle is tubular and is sleeved on the second ejector rod.
In one embodiment, the surgical suturing device comprises a first delivery cable and a first sheath, and further comprises the medical suturing device in any one of the above embodiments, wherein the distal end of the first delivery cable is connected with the puncture assembly, and the puncture assembly is accommodated in the first sheath.
In one embodiment, the medical suturing system further comprises a drag assembly, a second delivery cable and a second sheath, the drag assembly comprising a left disc and a third link connected to each other, a proximal end of the third link being connected to a distal end of the second delivery cable, the drag assembly extending through the second sheath from a proximal end of the second sheath and the second sheath extending through the first sheath from a proximal end of the first sheath upon delivery.
In one embodiment, the left disc is linear when being retracted in the second sheath, the left disc is a disc body with a hollow part when not being retracted in the second sheath, and the distal end of the puncture assembly can penetrate through the left disc.
In one embodiment, the third connector comprises a plurality of guide wires, the distal ends of the guide wires are connected with the left disc, and the proximal ends of the guide wires are connected with the distal ends of the second steel delivery cables.
In one embodiment, the guide wires are arranged at intervals or form the third connecting piece through weaving.
In one embodiment, the first sheath has a third lumen and a fourth lumen that are parallel to each other, the medical suturing device extends through the first sheath from the proximal end of the first sheath, and the second sheath extends through the first sheath from the proximal end of the first sheath.
Above-mentioned medical suturing device need not only transfer curved puncture tube, only need propelling movement puncture assembly moreover, need not propelling movement puncture assembly many times repeatedly, can accomplish once sew up required two pinholes, and convenient operation has saved certain operating time.
Drawings
FIG. 1 is a schematic view showing the constitution of a medical suturing system according to example 1;
FIG. 2 is a schematic view showing the construction of a suturing device in the medical suturing system of example 1;
FIG. 3 is a cross-sectional view of the distal end of the suturing device of FIG. 2;
FIG. 4 is a schematic view of the suturing device of FIG. 2 in an overall cross-sectional configuration;
FIG. 5 is a schematic structural view of the tow assembly of embodiment 1 housed in a second sheath;
FIG. 6 is a schematic structural diagram of the trailing assembly in the embodiment 1 after the left disk is released;
FIG. 7 is a schematic diagram of the structure of the tissue at the oval hole in the body;
FIG. 8 is a schematic view of the left disc of example 1 after release in the left atrium;
FIG. 9 is a schematic view of the suturing device puncturing the overlapping area of the atrial wall as the left disk is drawn against the atrial wall in example 1;
FIG. 10 is a schematic view of the trailing assembly of FIG. 9 after retraction;
FIG. 11 is a schematic view showing the suturing device of example 1 snapped behind the left atrium after suturing;
FIG. 12 is a schematic view showing the construction of a double-headed puncture needle in the medical suturing system of example 1;
FIG. 13 is a schematic view showing the construction of a suturing device in the medical suturing system of example 2;
FIG. 14 is a schematic cross-sectional view of FIG. 13;
FIG. 15 is a schematic structural view of the dual headed lancet of FIG. 13;
fig. 16 is a schematic view of a thread assembly in the medical suturing system of example 3.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as a proximal end, and the end farther from the operator is generally referred to as a distal end, and the proximal and distal ends of any component of the medical device are defined according to this principle.
The technical solution of the present invention will be described in further detail with reference to specific examples.
Example 1
Embodiment 1 provides amedical suturing system 10, referring to fig. 1, comprising amedical suturing device 100, afirst delivery cable 200, afirst sheath 300, adrag assembly 400, asecond delivery cable 500, and asecond sheath 600. The proximal end of themedical suturing device 100 is connected to the distal end of thefirst delivery cable 200, the proximal end of thedrag unit 400 is connected to the distal end of thesecond delivery cable 500, thefirst sheath 300 has athird lumen 310 and afourth lumen 320 that are parallel to each other, themedical suturing device 100 passes through thefirst sheath 300 from the proximal end of thefirst sheath 300, thedrag unit 400 passes through thesecond sheath 600 from the proximal end of thesecond sheath 600, and thesecond sheath 600 passes through thefirst sheath 300 from the proximal end of thefirst sheath 300 during delivery.
Referring also to fig. 2-4, amedical suturing device 100 includes awire assembly 110 and apuncture assembly 120. Thewire assembly 110 includes asuture 111, afirst buckle 112, and asecond buckle 113, and one end of thesuture 111 is connected with thefirst buckle 112 and the other end is connected with thesecond buckle 113. In this embodiment, thefirst buckle 112 is tubular, thesecond buckle 113 is tubular, one end of thesuture 111 is connected to the middle of thefirst buckle 112, and the other end of the suture is connected to the middle of thesecond buckle 113, preferably, the middle of each of thefirst buckle 112 and thesecond buckle 113 is perforated, one end of thesuture 111 is knotted after passing through the hole in the middle of thefirst buckle 112, so as to connect one end of thesuture 111 to thefirst buckle 112, and similarly, the other end of thesuture 111 is knotted after passing through the hole in the middle of thesecond buckle 113, so as to connect the other end of thesuture 111 to thesecond buckle 113. Thefirst buckle 112 and thesecond buckle 113 can be made of cut nickel-titanium alloy, cobalt-chromium alloy, stainless steel 316L, Polytetrafluoroethylene (PTFE) and other pipes, and can also be made of polylactic acid, magnesium, iron, alloy and other absorbable materials, the length of each of thefirst buckle 112 and thesecond buckle 113 is 3mm-8mm, the shape of each of the first buckle and the second buckle can be a straight shape, a Y shape or an X shape, and the separated part of the tail end can be formed by cutting or directly processing the pipes. The diameter of thesuture 111 is 0.1mm-0.5mm, and the length thereof can be determined according to the distance to be sutured, and can be selected from 2mm-8 mm. Thesuture line 111 may be made of the same material as thefirst buckle 112 or thesecond buckle 113, or may be made of PA (nylon) line, PET (polyethylene terephthalate) line, PE (polyethylene) line, or ultra-high molecular weight polyethylene line.
Thepuncture assembly 120 comprises a double-headedpuncture needle 121 and athimble 122, and further comprises a fixedblock 123, afixed piece 124 and anouter tube 125. The double-endedpuncture needle 121 includes afirst needle 1211 and asecond needle 1212, the needle point of thefirst needle 1211 and the needle point of thesecond needle 1212 both extend all the time toward the distal end of thepuncture assembly 120, thefirst needle 1211 has afirst cavity 1213 and both ends open, thesecond needle 1212 has asecond cavity 1214 and both ends open, the proximal end of thefirst needle 1211 is connected with the proximal end of thesecond needle 1212 and keeps both the proximal end of thefirst needle 1211 and the proximal end of thesecond needle 1212 open, one side of thefirst needle 1211 opposite to thesecond needle 1212 is provided with afirst opening 1215, thesecond needle 1212 is provided with a second opening (not shown) opposite to thefirst opening 1215, the distal end of thefirst opening 1215 extends to the distal end of thefirst needle 1211, and the distal end of the second opening extends to the distal end of thesecond needle 1212. Theejector pin 122 comprises afirst ejector rod 1221 and asecond ejector rod 1222, the proximal end of thefirst ejector rod 1221 is connected with the proximal end of thesecond ejector rod 1222, the outer diameter of thefirst ejector rod 1221 is slightly smaller than the inner diameter of thefirst needle 1211, the outer diameter of thefirst ejector rod 1221 is larger than the outer diameter of thefirst buckle 112, the outer diameter of thesecond ejector rod 1222 is slightly smaller than the inner diameter of thesecond needle 1212, the outer diameter of thesecond ejector rod 1222 is larger than the outer diameter of thesecond buckle 113, the distal end of thefirst ejector rod 1221 extends into thefirst cavity 1213 from the proximal end of thefirst needle 1211, and the distal end of thesecond ejector rod 1222 extends into thesecond cavity 1214 from the proximal end of thesecond needle 1212.
During suturing, please refer to fig. 3 again, thefirst buckle 112 is accommodated in thefirst cavity 1213, thesecond buckle 113 is accommodated in thesecond cavity 1214, the outer diameter of thefirst push rod 1221 is larger than the outer diameter of thefirst buckle 112, the outer diameter of thesecond push rod 1222 is larger than the outer diameter of thesecond buckle 113, and thesuture 111 is located between thefirst opening 1215 and the second opening, i.e. thesuture 111 is clamped between thefirst needle 1211 and thesecond needle 1212. Asspike 122 moves distally,first post 1221 pushesfirst catch 112 distally withinfirst cavity 1213 andsecond post 1222 pushessecond catch 113 distally withinsecond cavity 1214, with one end ofsuture 111 moving distally alongfirst aperture 1215 and the other end moving distally along the second aperture.
The double-headedpuncture needle 121 may be made of a metal tube of nickel-titanium alloy, cobalt-chromium alloy, stainless steel 316L, etc. by cutting and heat setting, or may be made of a polymer material such as polytetrafluoroethylene by injection molding or machine shaping. The double-headedpuncture needle 121 is preferably made of a nitinol tube because nitinol material has superelasticity and shape memory, and the double-headedpuncture needle 121 made of the nitinol tube is in a compressed state when being constrained in thefirst sheath 300 and can rebound to its original shape after being extended from thefirst sheath 300. The maximum outer diameter of the double-headedpuncture needle 121 is less than or equal to 1.8mm, and the minimum inner diameter is greater than or equal to 0.6 mm. The distance between the distal end of thefirst needle 1211 and the distal end of thesecond needle 1212 is 1.1 to 1.3 times the length of thesuture 111. Thefirst aperture 1215 has a width that is slightly greater than the diameter of thesuture 111 and the second aperture has a width that is also slightly greater than the diameter of thesuture 111. Thespike 122 may be made of the same material as the double-headedneedle 121.
The fixingmember 124 has acavity 1241 and a proximal end provided with anopening 1242, the distal end of theouter tube 125 is connected with the proximal end of the fixingmember 124 by gluing, screwing, welding, etc., and the outer diameter of theouter tube 125 is equal to or slightly smaller than the diameter of theopening 1242 at the proximal end of the fixingmember 124, the proximal end of the two-headedpuncture needle 121 is connected with the distal end of the fixingmember 124, the fixingblock 123 is accommodated in thecavity 1241 of the fixingmember 124, and the proximal end of thethimble 122 is accommodated in thecavity 1241 of the fixingmember 124 and connected with the distal end of the fixingblock 123. The distal end of thefirst delivery cable 200 extends from theproximal opening 1242 of thefastener 124 into thecavity 1241 of thefastener 124 and attaches to the proximal end of thefastener 123, such as by threading, gluing, fitting tight with dimensional tolerances, etc. Theouter tube 125 may be a metal tube or a polymer tube. Thefastener 124 may be formed of an implantable material such as titanium alloy, cobalt-chromium alloy, stainless steel 316L, teflon, or the like. The proximal end of the double-endedneedle 121 and thefastener 124 may be fixedly connected by gluing or tight tolerances. The distal end of theouter tube 125 and the proximal end of thefastener 124 may be connected by threading, gluing, or a tight fit locking. The inner diameter of theouter tube 125 is slightly larger than the outer diameter of thefirst delivery cable 200. Theouter tube 125 may be a braided steel cable, or may be made of other metal materials, such as a flexible wire or catheter made of titanium alloy, cobalt-chromium alloy, stainless steel 316L, etc. The first andsecond delivery cables
The shape of the fixingmember 124 is not limited as long as it can be accommodated in the cavity of thefirst sheath 300. The shape of the fixingblock 123 is not limited as long as it can be accommodated in the fixingmember 124 and slide in the axial direction of the fixingmember 124. The proximal end ofneedle 122 may be coupled to the distal end of mountingblock 123 in a variety of ways. In other embodiments, the proximal end of thefirst push rod 1221 may not be connected to the proximal end of thesecond push rod 1222, and the proximal end of thefirst push rod 1221 and the proximal end of thesecond push rod 1222 may be inserted into the distal end of the fixingblock 123 for connection, which may be threaded, glued, tightly fitted with dimensional tolerance, or the like. In other embodiments, thepuncture assembly 120 may not include afixed block 123, and the distal end of thefirst delivery cable 200 extends from theproximal opening 1242 of the fixingmember 124 into thecavity 1241 of the fixingmember 124 and connects with the proximal end of theneedle 122, as long as the proximal end of theneedle 122 can connect with the distal end of thefirst delivery cable 200 and move distally under the push of thefirst delivery cable 200.
The proximal end of thefirst needle 1211 is connected to the proximal end of thesecond needle 1212 through afirst connector 1217, and the proximal end of thefirst push rod 1221 is connected to the proximal end of thesecond push rod 1222 through the fixingblock 123. In other embodiments, the proximal end of thefirst needle 1211 and the proximal end of thesecond needle 1212 may be directly connected. In other embodiments, the proximal end of thefirst post 1221 and the proximal end of thesecond post 1222 can be directly connected or connected via a second connecting member.
Thefirst needle 1211 and thesecond needle 1212 are connected in a V-shape, and thefirst push rod 1221 and thesecond push rod 1222 are connected in a V-shape. In other embodiments, thefirst needle 1211 is parallel to thesecond needle 1212, and the proximal end of thefirst needle 1211 is connected to the proximal end of thesecond needle 1212 through afirst connector 1217, thefirst needle 1211 and thesecond needle 1212 can be regarded as being connected in a U-shape; thefirst post rod 1221 is parallel to thesecond post rod 1222, the proximal end of thefirst post rod 1221 is connected to the proximal end of thesecond post rod 1222 through a second connecting member, and thefirst post rod 1221 and thesecond post rod 1222 can be regarded as being connected in a U shape.
The draggingassembly 400 is used for dragging the tissue of the position to be sutured, so that the tissue of the position to be sutured can not be excessively deformed to influence the suturing effect when the puncturingassembly 120 punctures. Referring also to fig. 5-6, thedrag assembly 400 includes aleft disc 410 and athird link 420 connected to each other, the proximal end of thethird link 420 is connected to the distal end of thesecond delivery cable 500, and thedrag assembly 400 extends through thesecond sheath 600 from the proximal end of thesecond sheath 600. Theleft disc 410 has elasticity and shape memory, theleft disc 410 is linear when being constrained in the second sheath 600 (see fig. 5), theleft disc 410 is a disc when not being constrained in the second sheath 600 (see fig. 6), preferably, theleft disc 410 is a disc with a hollow part when not being constrained in thesecond sheath 600, and the distal end of the double-headedpuncture needle 121 can penetrate through theleft disc 410. The overall shape of theleft disc 410 can be circular, square, diamond, etc., and the shape is not limited, and the hollow shape on theleft disc 410 is not limited, as long as the distal end of the double-headedpuncture needle 121 can penetrate through theleft disc 410. Thethird linkage 420 comprises a plurality ofguide wires 421, the distal ends of theguide wires 421 are connected to theleft plate 410, and the proximal ends of theguide wires 421 are connected to the distal ends of the seconddelivery wire cables 500. The plurality ofguide wires 421 are arranged at intervals to form a third connectingmember 420. In other embodiments, the plurality ofwires 421 form thethird connector 420 by braiding.
Theleft disc 410 may be formed from a nitinol tube that is cut and then heat set. The two ends of the third connectingmember 420 can be welded, knotted by knitting, glued, etc. to the distal ends of theleft disc 410 and the second conveyingcable 500, respectively. Theguide wire 421 is a flexible metal wire, such as a nickel-titanium wire, a stainless steel wire, a PET wire, a PA wire, a PTFE wire, a PE wire, or an ultra-high molecular weight polyethylene wire, and therefore has good flexibility, can be bent at will, has a certain strength, and can bear a sheath pulling force of more than 40N.
In the present embodiment, thefirst sheath 300 with two cavities is used to separate themedical suturing device 100 and the draggingassembly 400, so as to avoid the inconvenience and risk caused by the mutual interference between the two in thefirst sheath 300. In other embodiments, thefirst sheath 300 can also be a single lumen tube, after themedical suturing device 100 is connected to thefirst delivery cable 200, themedical suturing device 100 passes through thefirst sheath 300 from the proximal end of thefirst sheath 300, and after the draggingassembly 400 is connected to thesecond delivery cable 500 and is constrained in the cavity of thesecond sheath 600, thesecond sheath 600 passes through thefirst sheath 300 from the proximal end of thefirst sheath 300.
In other embodiments, themedical suturing system 10 may not include the trailingassembly 400 and thesecond delivery cable 500, and themedical suturing device 100 may be attached to thefirst delivery cable 200 and delivered through thefirst sheath 300 to reach the target tissue in the body to suture the target tissue.
For example, themedical suturing device 100 is not limited to the treatment of patent foramen ovale. Referring to fig. 7, a block diagram is a schematic diagram of the structure of the tissue in the body of the patent foramen ovale, and two atrial walls at the patent foramen ovale have an overlapping region, and the two atrial walls can be sutured together by suturing the overlapping region with themedical suturing device 100, so as to block the blood shunt at the patent foramen ovale.
Referring to fig. 8-11, the sewing process includes the following steps:
1. the distal end of thefirst delivery cable 200 is passed through the opening in the proximal end of thefastener 124 and connected to the proximal end of theanchor block 123; threading afirst clasp 112 from the distal end of thefirst needle 1211 into thefirst cavity 1213, threading asecond clasp 113 from the distal end of thesecond needle 1212 into thesecond cavity 1214, and positioning thesuture 111 between thefirst aperture 1215 and the second aperture; thereafter, the distal end of thepuncture assembly 120 is threaded into thethird lumen 310 from the proximal end of thefirst sheath 300 and pushed to the distal end of thefirst sheath 300;
2. extending a second sheath 600 (not shown) with a conical sheath core from the proximal end of thefirst sheath 300 into thefourth cavity 320 of thefirst sheath 300 and pushing it to the distal end of thefirst sheath 300, and the distal end of the sheath core extending from the distal end of thesecond sheath 600;
3. after the femoral vein puncture is performed by means of a bronchoscope or the like, the distal end of thefirst sheath 300 is delivered to the right atrium; pushing out the sheath core and thesecond sheath 600 from the distal end of thefirst sheath 300, so that the sheath core and thesecond sheath 600 are inserted into the foramen ovale to the left atrium; withdrawing the sheath core;
4. connecting the distal end of thesecond delivery cable 500 to the proximal end of thethird link 420; then, the proximal end of thesecond sheath 600 of theleft disc 410 is inserted into the cavity of thesecond sheath 600, and theleft disc 410 is pushed to the distal end of thesecond sheath 600; extending thesecond sheath 600 from the proximal end of thefirst sheath 300 into thefourth lumen 320, and advancing thesecond sheath 600 to the distal end of thefirst sheath 300;
5. pushing thesecond sheath 600 distally so that the proximal end of the compressedleft disc 410 protrudes beyond the distal end of thefirst sheath 300; withdrawing thesecond sheath 600 to gradually push the compressedleft disc 410 out of the cavity of thesecond sheath 600 for release, wherein the releasedleft disc 410 is in an expanded shape; thesecond delivery cable 500 is pulled slowly proximally to bring theleft disc 410 against the foramen ovale; fixing thesecond transport cable 500 such that thesecond transport cable 500 does not move relative to the sheath;
6. pushing thefirst delivery cable 200 distally to align the distal end of the double-endedpuncture needle 121 with the portion of the foramen ovale to be sutured until the needle ends of thefirst needle 1211 and thesecond needle 1212 completely penetrate the atrial septum; fixing the first conveyingwire rope 200 so as not to move with respect to thefirst sheath 300;
7. pushing thesecond sheath 600 distally through the foramen ovale; withdrawing the seconddelivery wire cable 500 such that theleft disc 410 is constricted within the cavity of thesecond sheath 600; thereafter, withdrawing thesecond sheath 600 out of the body;
8. pushing the first conveyingcable 200 to the far end, the far end of the first conveyingcable 200 driving thefixing block 123 and theejector pin 122 to move to the far end synchronously, at this time, the far end of thefirst ejector rod 1221 pushing thefirst buckle 112 to move towards the end of thefirst needle 1211 in thefirst cavity 1213, the far end of thesecond ejector rod 1222 pushing thesecond buckle 113 to move towards the end of thesecond needle 1212 in thesecond cavity 1214, and meanwhile, thesuture 111 moving to the far end between thefirst buckle 112 and thesecond buckle 113 along with the movement of thefirst buckle 112 and thesecond buckle 113; after the distal end of thefirst buckle 112 is pushed out of thefirst cavity 1213 and the distal end of thesecond buckle 113 is pushed out of thesecond cavity 1214, the double-headedpuncture needle 121 is withdrawn after pushing theouter tube 125 proximally, at this time, both thefirst buckle 112 and thesecond buckle 113 remain in the left atrium and hang on the atrial wall, and most of thesuture thread 111 remains in the right atrium, thereby suturing the two atrial walls together at the foramen ovale;
9. withdrawing theouter tube 125 to constrict thepuncture assembly 120 within thefirst sheath 300; thefirst sheath 300, thepuncture device 120 and thefirst delivery cable 200, which are bundled in thefirst sheath 300, are withdrawn from the body, thereby completing a suture.
It should be noted that the same operation may be used to sew anotherthread assembly 110 to the overlapping area to enhance the tightness of the seam between the two sheets of membrane. The number of the repeated operations can be determined according to actual needs, and the number of the requiredwire assemblies 110 is also determined according to the number of the repeated operations.
Referring to fig. 12, the length of thesuture 111 is D, the distance between the distal end of thefirst needle 1211 and the distal end of thesecond needle 1212 is D, and since thesuture 111 is located between thefirst needle 1211 and thesecond needle 1212 and is linear, D is smaller than D, thesuture 111 is tightened between two puncture points after suturing, thereby ensuring the suturing effect. It will be appreciated that by adjusting the angle betweenfirst needle 1211 andsecond needle 1212, and the initial installed position ofsuture 111 betweenfirst needle 1211 andsecond needle 1212, the tightness ofsuture 111 between the two puncture points can be adjusted.
Themedical suturing device 100 of example 1 can simply and quickly perform an in vivo suturing operation by the cooperation of thepuncture assembly 120 and thethread assembly 110 by an interventional suturing means, thereby avoiding an open chest operation for treating a patent foramen ovale, greatly reducing operation risks and wound area, and facilitating postoperative recovery. Secondly, thesuture line 111 does not need to be knotted in vivo, thereby reducing the operation difficulty, saving the operation time and relieving the pain of the patient. Third, after suturing, only thewire assembly 110 is left in the body, and because thewire assembly 110 has a small volume, the risk of complications of the implant in the body can be greatly reduced, the surrounding tissues can not be damaged, and because thesuture 111 bears a small tensile force, the risk of fatigue failure is also low.
Example 2
The same portions of the embodiment 2 as those of the embodiment 1 are not described again, but please refer to fig. 13-14, where thefirst buckle 712 is tubular, thesecond buckle 713 is tubular, one end of thesuture 711 is connected to the middle of thefirst buckle 712, the other end of the suture is connected to the middle of thesecond buckle 713, the outer diameter of thefirst push rod 7221 is smaller than the inner diameter of thefirst buckle 712, the outer diameter of thesecond push rod 7222 is smaller than the inner diameter of thesecond buckle 713, so that the distal end of thefirst push rod 7221 can extend into the cavity of thefirst buckle 712, the distal end of thesecond push rod 7222 can extend into the cavity of thesecond buckle 713, the distal end of thefirst push rod 7221 is needle-head-shaped, and the distal end of thesecond push rod 7222 is needle-head-shaped. That is, the distal end of thefirst plunger 7221 has the same function as thefirst needle 1211 in the first embodiment, and the distal end of thesecond plunger 7222 has the same function as thesecond needle 1212 in the first embodiment, and it can be understood that thefirst plunger 7221 is the solidfirst needle 7211 in the present embodiment, and thesecond plunger 7222 is the solidsecond needle 7212 in the present embodiment.
Further, thefirst needle 7211 is not provided with afirst opening 1215, thesecond needle 7212 is not provided with a second opening, the outer diameter of thefirst catch 712 is larger than or equal to the inner diameter of thefirst needle 7211, the outer diameter of thesecond catch 713 is larger than or equal to the inner diameter of thesecond needle 7212, the proximal end of thefirst catch 712 is closer to the distal end of the medical suturing device than the distal end of thefirst needle 7211, and the proximal end of thesecond catch 713 is closer to the distal end of the medical suturing device than the distal end of thesecond needle 7212.
In this embodiment, the distal end of thefirst needle 7211 may be left as a needle in embodiment 1 or may not be left as a needle, and the distal end of thesecond needle 7212 may be left as a needle in embodiment 1 or may not be left as a needle. It is also understood that in other embodiments,first needle 7211 andsecond needle 7212 may be omitted.
In the medical suturing device according to example 2, the suturing principle is as follows: delivering the distal end of the medical suturing device through thefirst sheath 300 to the foramen ovale in the right atrium; withdrawing thefirst sheath 300 to extend the distal end of the medical suturing device from thefirst sheath 300; advancingfirst delivery cable 200 distally so that the needle end offirst plunger 7221 and the needle end ofsecond plunger 7222 penetrate the atrial septum untilfirst catch 712 andsecond catch 713 fully enter the left atrium; keeping the position of the fixing member with respect to the foramen ovale constant, thefirst delivery cable 200 is withdrawn to move the fixingmember 723 proximally to the proximal end of the fixing member, at this time, thefirst catch 712 and thesecond catch 713 naturally fall into the left atrium, thereby completing the suturing operation, and the suturing effect is the same as that of embodiment 1.
Referring to fig. 15, the length of thesuture 711 is D, the distance between the distal end of thefirst ejector pin 7221 and the distal end of thesecond ejector pin 7222 is D, and thesuture 711 is linearly positioned between thefirst ejector pin 7221 and thesecond ejector pin 7222, so that D is smaller than D, and after suturing, thesuture 711 is tightened between two puncture points to ensure suturing effect. It will be appreciated that by adjusting the angle between thefirst push rod 7221 and thesecond push rod 7222, and the initial installation position of thesuture 711 between thefirst push rod 7221 and thesecond push rod 7222, the tightness of thesuture 711 between the two puncture points can be adjusted.
Example 3
The same parts of embodiment 3 as embodiment 1 are not described again, but the differences are mainly that thefirst buckle 812 is rod-shaped when being constrained in the first cavity and is unfolded in a plane after sliding out from the distal end of the first needle (see fig. 16), and thesecond buckle 813 is rod-shaped when being constrained in the second cavity and is unfolded in a plane after sliding out from the distal end of the second needle (see fig. 16). The shape of the first andsecond catches
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (16)
1. The medical suturing device is characterized by comprising a puncture assembly, wherein the puncture assembly comprises a first needle head and a second needle head, and the needle point of the first needle head and the needle point of the second needle head both extend towards the far end of the puncture assembly all the time;
the medical suturing device further comprises a wire assembly, the wire assembly comprises a suturing wire, a first buckle and a second buckle, one end of the suturing wire is connected with the first buckle, the other end of the suturing wire is connected with the second buckle, the first needle is provided with a first cavity and two end openings, the second needle is provided with a second cavity and two end openings, the first buckle is contained in the first cavity, the second buckle is contained in the second cavity, and the suturing wire is clamped between the first needle and the second needle.
2. The medical suturing device of claim 1, wherein the puncture assembly comprises a double-ended puncture needle and a spike, the double-ended puncture needle comprising the first needle and the second needle, the proximal end of the first needle being connected to and maintaining open both the proximal end of the first needle and the proximal end of the second needle, the first needle being provided with a first opening on a side opposite the second needle, the second needle being provided with a second opening opposite the first opening, the distal end of the first opening extending to the distal end of the first needle, the distal end of the second opening extending to the distal end of the second needle; the thimble comprises a first ejector rod and a second ejector rod, the near end of the first ejector rod is connected with the near end of the second ejector rod, the far end of the first ejector rod extends into the first cavity from the near end of the first needle head, and the far end of the second ejector rod extends into the second cavity from the near end of the second needle head; and the suture is positioned between the first aperture and the second aperture.
3. The medical suturing device of claim 2, wherein the puncture assembly further comprises a fixing member and an outer tube, the fixing member has a cavity and a proximal end having an opening, the distal end of the outer tube is connected to the proximal end of the fixing member, the inner diameter of the outer tube is larger than the diameter of the opening of the proximal end of the fixing member, the proximal end of the double-ended puncture needle is connected to the distal end of the fixing member, and the proximal end of the needle is received in the cavity of the fixing member.
4. The medical suturing device of claim 3, wherein the puncture assembly further comprises a fixed block, the fixed block is received within the cavity of the fixed member, and the proximal end of the needle is received within the cavity of the fixed member and is connected to the distal end of the fixed block.
5. The medical suturing device of claim 2, further comprising a first connector through which the proximal end of the first needle is connected to the proximal end of the second needle.
6. The medical suturing device of claim 5, further comprising a second connector, wherein the proximal end of the first push rod is connected to the proximal end of the second push rod via the second connector.
7. The medical suturing device of any one of claims 1-6, wherein the first needle is V-shaped or U-shaped attached to the second needle.
8. The medical suturing device of claim 6, wherein the first needle is parallel to the second needle, and the first plunger is parallel to the second plunger.
9. The medical suturing device of claim 2, wherein the first clip is rod-shaped when captured within the first lumen and expands flat upon sliding out of the distal end of the first needle, and wherein the second clip is rod-shaped when captured within the second lumen and expands flat upon sliding out of the distal end of the second needle.
10. The medical suturing device of claim 1, wherein the puncture assembly comprises a first push rod and a second push rod connected to the first push rod, the first push rod being the first needle and the second push rod being the second needle; the first buckle is tubular and is sleeved on the first ejector rod, the second buckle is tubular and is sleeved on the second ejector rod.
11. A medical suturing system comprising a first delivery cable and a first sheath, and further comprising the medical suturing device of claim 1, wherein the distal end of the first delivery cable is connected to a puncture assembly, and wherein the puncture assembly is received within the first sheath.
12. The medical suturing system of claim 11, further comprising a drag assembly, a second delivery cable, and a second sheath, the drag assembly comprising an interconnected left disc and a third link, a proximal end of the third link being connected to a distal end of the second delivery cable, the drag assembly extending through the second sheath from a proximal end of the second sheath and the second sheath extending through the first sheath from a proximal end of the first sheath during delivery.
13. The medical suturing system of claim 12, wherein the left disc is linear when collapsed within the second sheath, wherein the left disc is a hollow disc when not collapsed within the second sheath, and wherein the distal end of the puncture assembly is capable of penetrating the left disc.
14. The medical suturing system of claim 12, wherein the third connector comprises a plurality of guide wires, a distal end of the guide wires being connected to the left disc, and a proximal end of the guide wires being connected to a distal end of the second delivery cable.
15. The medical suturing system of claim 14, wherein the guide wires are spaced apart or woven to form the third link.
16. The medical suturing system of any one of claims 12-15, wherein the first sheath has third and fourth lumens that are parallel to one another, the medical suturing device extending through the first sheath from a proximal end of the first sheath, and the second sheath extending through the first sheath from a proximal end of the first sheath.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711480237.4ACN109984778B (en) | 2017-12-29 | 2017-12-29 | Medical suturing device and suturing system |
| PCT/CN2018/121735WO2019128776A1 (en) | 2017-12-29 | 2018-12-18 | Medical suturing device and suturing system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711480237.4ACN109984778B (en) | 2017-12-29 | 2017-12-29 | Medical suturing device and suturing system |
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| CN109984778A CN109984778A (en) | 2019-07-09 |
| CN109984778Btrue CN109984778B (en) | 2022-02-22 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201711480237.4AActiveCN109984778B (en) | 2017-12-29 | 2017-12-29 | Medical suturing device and suturing system |
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| CN (1) | CN109984778B (en) |
| WO (1) | WO2019128776A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020183399A1 (en)* | 2019-03-11 | 2020-09-17 | Bfkw, Llc | Single member intraluminal device and method of fixation |
| CN114224411A (en)* | 2021-12-17 | 2022-03-25 | 青岛九远医疗科技有限公司 | Meniscus suturing instrument with good stability |
| CN116138822A (en)* | 2022-12-29 | 2023-05-23 | 先健科技(深圳)有限公司 | suturing device |
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| CN1292665A (en)* | 1998-03-09 | 2001-04-25 | 苏图诺有限公司 | A suturing device for closing an opening in a blood vessel |
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| CN106456153A (en)* | 2014-02-28 | 2017-02-22 | 塞特里克斯有限公司 | Devices and methods for closing openings in body tissue |
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| JP5030797B2 (en)* | 2005-02-07 | 2012-09-19 | アイビー スポーツ メディシン、エルエルシー | System and method for fully internal suture fixation of implant placement and soft tissue repair |
| US20100113873A1 (en)* | 2008-11-06 | 2010-05-06 | Takayuki Suzuki | Suturing device and suturing system |
| JP5738039B2 (en)* | 2011-03-31 | 2015-06-17 | 日本コヴィディエン株式会社 | Medical suture tool |
| JP5749563B2 (en)* | 2011-05-17 | 2015-07-15 | 日本コヴィディエン株式会社 | Medical suture tool |
| BR112014004618A2 (en)* | 2011-08-30 | 2017-03-21 | Mellon Medical B V | surgical suture apparatus |
| JP5946335B2 (en)* | 2012-06-18 | 2016-07-06 | 日本コヴィディエン株式会社 | Medical suture tool |
| US10245021B2 (en)* | 2013-10-08 | 2019-04-02 | Applied Medical Technology, Inc | Magnetic U-stitch device |
- 2017
- 2017-12-29CNCN201711480237.4Apatent/CN109984778B/enactiveActive
- 2018
- 2018-12-18WOPCT/CN2018/121735patent/WO2019128776A1/ennot_activeCeased
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1292665A (en)* | 1998-03-09 | 2001-04-25 | 苏图诺有限公司 | A suturing device for closing an opening in a blood vessel |
| JP2006025934A (en)* | 2004-07-13 | 2006-02-02 | Jms Co Ltd | Biological suture tool |
| CN106456153A (en)* | 2014-02-28 | 2017-02-22 | 塞特里克斯有限公司 | Devices and methods for closing openings in body tissue |
| CN106806015A (en)* | 2015-11-30 | 2017-06-09 | 先健科技(深圳)有限公司 | Intracavitary administration pipe guide |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2019128776A1 (en) | 2019-07-04 |
| CN109984778A (en) | 2019-07-09 |
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