CN111920484B - Puncture outfit adaptable to different patients - Google Patents

Abstract

The invention discloses a puncture outfit capable of adapting to different patients, which comprises a puncture tube assembly, a top shell assembly, an instrument seal and a zero seal, wherein the puncture tube assembly comprises a bottom shell assembly, the instrument seal and the zero seal are clamped between the top shell assembly and the bottom shell assembly and are in a compressed state, and the top shell assembly and the bottom shell assembly are mutually connected to form an integral sealing system; the puncture needle also comprises a puncture needle penetrating through the puncture tube assembly, the inner surface of the first tube tail comprises an inner clamping hook, the shape and the size of the inner clamping hook are designed to be matched with the outer notch, and when the inner clamping hook is aligned with the outer notch, the second hollow tube can axially move relative to the first hollow tube.

Description

Puncture outfit adaptable to different patients

Technical Field

The invention relates to a minimally invasive surgical instrument, in particular to a puncture outfit which can adapt to different patients.

Background

A puncture instrument is a surgical instrument used in minimally invasive surgery (especially hard-tube endoscopic surgery) for establishing an artificial passage into a body cavity. Typically consisting of a spike assembly and a spike. The general clinical use mode is as follows: a small opening is cut on the skin of a patient, the puncture needle penetrates through the puncture tube assembly, and then the puncture needle penetrates through the abdominal wall through the skin opening to enter a body cavity. Once inside the body cavity, the needle is removed, leaving the puncture tube assembly as a passage for instruments into and out of the body cavity.

In the hard tube laparoscopic surgery, a pneumoperitoneum machine is usually adopted to continuously perfuse gas (such as carbon dioxide gas) into the abdominal cavity of a patient and maintain a stable gas pressure (about 13-15 mmHg) so as to obtain a sufficient operation space. The puncture tube assembly typically consists of a hollow tube, a housing, a sealing membrane (also known as an instrument seal) and a zero seal (also known as a self-seal). The puncture tube assembly penetrates from the outside of the body cavity to the inside of the body cavity and is used as a passage for instruments to enter and exit the body cavity. The housing connects the hollow tube, zero seal and sealing membrane into a sealed system. The zero seal generally does not provide a seal for the inserted instrument, but automatically closes and forms a seal when the instrument is removed. The sealing membrane grips the instrument and forms a seal as the instrument is inserted.

When the puncture tube assembly is secured to the abdominal wall of a patient, the hollow tube thereof may be divided into an extracorporeal section (length H1), a body wall section (length H2) and an intracorporeal section (length H3). The length H2 of the body wall segment varies, and when applied to different patients, the abdominal wall thickness varies from patient to patient, e.g., the difference between obese patients and the smaller abdominal wall thickness is greater; the wall section H2 varies for different puncture positions and puncture angles even when used with the same patient. The length H1 of the extracorporeal section cannot be reserved too long or too short, which is inconvenient for inserting the instrument, and especially when the puncture tube component is used as a main operation hole and needs to be repeatedly switched, the puncture tube component is too short which is inconvenient for operating the instrument at different inclination angles. The length H3 of the in-vivo section is not changed greatly generally, and is reserved for 20-30 mm. The length of the hollow tube of the puncture tube assembly in the prior art is fixed, and the requirements of different scene in the field cannot be met.

Disclosure of Invention

In one aspect of the invention, a penetrator adaptable to different patients is provided, comprising a puncture tube assembly including a bottom housing assembly, a top housing, an instrument seal and a zero seal sandwiched between the top housing and the bottom housing assembly in a compressed state, the top housing and the bottom housing assembly being connected to each other to form an integral sealing system; the bottom shell assembly comprises a bottom shell, a first hollow tube and a second hollow tube; the first hollow tube comprises a first tube head and a first tube tail with a first tube wall extending therebetween, and the second hollow tube comprises a second tube head and a second tube tail with a second tube wall extending therebetween; the first pipe head is connected with the bottom shell, and the second pipe head is arranged in the first hollow pipe;

1) the outer surface of the second pipe wall comprises N rings of annular steps, and the annular steps are uniformly distributed on the outer surface of the second pipe wall at equal intervals along the axial direction of the second hollow pipe from the adjacent area of the second pipe head; two adjacent circles of annular steps define a circle of annular groove; the second hollow pipe also comprises an outer notch, and the outer notch cuts off the N circles of annular steps to form a non-closed structure;

2) the inner surface of the first pipe tail comprises an inner clamping hook, the shape and the size of the inner clamping hook are designed to be matched with the outer notch, and when the inner clamping hook is aligned with the outer notch, the second hollow pipe can axially move relative to the first hollow pipe.

In one embodiment, the inner ribs are shaped and dimensioned to mate with the outer female rings, and the inner ribs mate with any outer female ring to form a rotational snap fit that can rotate about the axis of the hollow tube but cannot move axially.

In another scheme, the outer notches comprise a first row of outer notches and a second row of outer notches which are uniformly distributed along the circumferential direction of the second hollow pipe; the inner convex ribs comprise a first inner convex rib and a second inner convex rib which are uniformly distributed along the circumferential direction of the first hollow pipe; the first inner convex rib is matched with the first row of outer gaps in shape and size, and the second inner convex rib is matched with the second row of outer gaps in shape and size.

In another scheme, the outer concave ring comprises m circles of outer clamping grooves, and the m circles of outer clamping grooves can be contracted into the first hollow pipe.

In another scheme, any outer clamping groove can be matched with the inner convex rib to form a rotary buckle; when the inner convex rib and the first outer clamping groove are matched to form rotary buckle matching, the length of the hollow pipe of the bottom shell component is Lt1, and the length is the longest length; when the inner convex rib is matched with the mth outer clamping groove to form rotary buckle matching, the length of the hollow pipe of the bottom shell component is Ltm, and the following relation is met

Ltm-Lt 1-m P2, wherein: lt1 — longest hollow tube length; ltm-the length of the hollow tube when the inner convex rib is matched with the mth outer clamping groove is Ltm; m is the serial number of the rotary buckle matching; p2-spacing of two adjacent external card slots.

In another scheme, the length L1 of the first hollow pipe satisfies the relation, 3X Lt1/8 is less than or equal to L1 is less than or equal to Lt1/3,

wherein: lt 1-shortest hollow tube length; l1 — length of first hollow tube;

in yet another aspect, a hollow tube seal is secured to the second tube head, the hollow tube seal comprising an outer sealing cylindrical surface and an inner sealing cylindrical surface defined by a sealing cylinder; the first hollow tube also comprises an inner cylindrical surface, one end of the inner cylindrical surface penetrates through the first tube head, and the other end of the inner cylindrical surface extends to intersect with the inner convex rib; the inner sealing cylindrical surface is in contact with the inner cylindrical surface.

Drawings

For a fuller understanding of the nature of the present invention, reference should be made to the following detailed description taken together with the accompanying figures in which:

fig. 1 is an exploded view of aspike assembly 1;

FIG. 2 is a side projection view of thespike assembly 1;

FIG. 3 is a 2-2 cross-sectional view of thespike assembly 1;

fig. 4 is a simulated schematic view of thepuncture tube assembly 1 secured to the abdominal wall;

FIG. 5 is a perspective schematic view of thebottom housing assembly 40 a;

FIG. 6 is a schematic perspective view of thebottom housing 100;

figure 7 is a projection view of secondhollow tube 300 from the proximal end to the distal end;

figure 8 is a side view of secondhollow tube 300;

figure 9 is a distal to proximal projection view of the firsthollow tube 200;

FIG. 10 is a cross-sectional view 10-10 of FIG. 9;

FIG. 11 is a cross-sectional view of thebottom housing assembly 40 a;

FIG. 12 is an enlarged view 12-12 of FIG. 11;

FIG. 13 is an enlarged view of 13-13 of FIG. 11;

figure 14 is a side view of secondhollow tube 300 a;

FIG. 15 is an enlarged view of 15-15 of FIG. 14;

figure 16 is a distal to proximal projection view of the firsthollow tube 200 a;

FIG. 17 is a cross-sectional view of 17-17 of FIG. 16;

FIG. 18 is a cross-sectional view of thebottom housing assembly 40 b;

FIG. 19 is an enlarged view of 19-19 of FIG. 18;

FIG. 20 is an enlarged view of 20-20 of FIG. 18;

FIG. 21 is a perspective view ofbottom housing 100 b;

fig. 22 is a sectional view of thebottom housing 100 b;

figure 23 is a side view of secondhollow tube 300 b;

FIG. 24 is an enlarged view of 24-24 of FIG. 23;

figure 25 is a distal to proximal projection of the firsthollow tube 200 b;

FIG. 26 is a cross-sectional view 26-26 of FIG. 25;

FIG. 27 is a cross-sectional view of thebottom housing assembly 40 d;

FIG. 28 is an enlarged view of 28-28 of FIG. 27;

FIG. 29 is an enlarged view of 29-29 of FIG. 27;

the same reference numbers will be used throughout the drawings to refer to identical or similar parts or elements.

Detailed Description

Embodiments of the present invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, the disclosure herein is not to be interpreted as limiting, but merely as a basis for the claims and as a basis for teaching one skilled in the art how to employ the present invention. Embodiments of the present disclosure will now be described in detail with reference to the drawings, where for convenience, the party proximal to the operator is defined as the proximal end and the party distal from the operator is defined as the distal end.

Figures 1-3 depict apuncture tube assembly 1 for laparoscopic surgery. Thespike assembly 1 comprises anaxis 2 and, arranged axially in series, atop housing 30, aninstrument seal 10, a zero seal 20 and abottom housing 40. Wherein theinstrument seal 10 and the zero seal 20 are made of a super elastic material such as silicone rubber, etc. Thetop housing 30 and thebottom housing 40 are made of a rigid thermoplastic plastic such as polycarbonate. Theinstrument seal 10 includes a sealinglip 11 defined by a sealingmembrane 17 and a sealing membraneouter flange 19. The zero seal 20 comprises a zeroseal flange 29 and a zeroseal body 27 connected thereto and extending distally, a pair ofseal sheets 21 connected to the zeroseal body 27 and extending distally to form a "duck bill" shaped openable and closable duck bill valve. Thetop housing 30 contains an open puncturetube assembly inlet 31 defined by aproximal housing 37 and anupper retaining ring 33 connected to thetop housing 30 and extending distally. Thebottom housing 40 comprises adistal housing 47, alower retaining ring 43 coupled to thedistal housing 47 and extending proximally, atransition housing 45 coupled to thedistal housing 47 and extending distally to form ahollow tube 50, thehollow tube 50 comprising ahollow tube channel 53 defined by ahollow tube wall 51, thehollow tube wall 51 extending distally and forming ahollow tube lip 55, thehollow tube lip 55 defining an openhollow tube outlet 57. In this example, theinstrument seal 10 and the zero seal 20 are mounted between atop housing 30 and abottom housing 40. Wherein the zeroseal flange 29, the sealant membraneouter flange 19 are sandwiched between thelower retainer ring 43 and theupper retainer ring 33 and are in a compressed state, thetop housing 30 further comprises anattachment post 39 connected to theproximal housing 37 and extending distally, thebottom housing 40 further comprises anattachment hole 49 matching the shape and position of the attachment post, theattachment post 39 and theattachment hole 49 are in an interference fit, thereby connecting thetop housing 30, theinstrument seal 10, the zero seal 20 and thebottom housing 40 into an integral sealing system. In this example the top shell and the bottom shell form a whole through fixed column and fixed orifices interference connection, however, various modes such as threaded connection, rotatory buckle connection, glue bonding can also be adopted.

Referring to fig. 3 and 4, when thepuncture tube assembly 1 penetrates from the outside of the body cavity to the inside of the body cavity, as a passage for the instruments to enter and exit the body cavity, a pneumoperitoneum machine is generally used to continuously perfuse the body cavity of the patient with gas (such as carbon dioxide gas) and maintain a stable gas pressure (about 13-15 mmHg) so as to obtain a sufficient operation space. When no external instrument is inserted, the pair of sealingsheets 21 of the zero seal 20 is closed, and the zero seal 20 forms a zero seal assembly with thelower fixing ring 43, thetransition housing 45 and thehollow tube 50, preventing gas in the body cavity from leaking to the outside of the body through the puncture tube assembly. When the external instrument is inserted, the external instrument opens the zero seal, gas in the body cavity can flow to the area between the zero seal and the sealing membrane through the zero seal, but the sealinglip 11 tightens the instrument, preventing gas from leaking through the sealing membrane. In this example, the sealing membrane and the zero seal are in direct contact and form a non-removable sealing system, however, the sealing membrane and the zero seal may not be in direct contact, and two separate and quick-release instrument seal assemblies and zero seal assemblies may be formed. For example, CN201610630336.5 entitled "a crimp-type piercer sealing system" discloses a structure comprising an instrument sealing assembly (first sealing assembly) and a zero sealing assembly (second sealing assembly). It will be appreciated by those skilled in the art that there are numerous implementations of the instrument seal and zero seal disclosed in the prior art, such as the four-lobed instrument seal assembly disclosed in US8029475, such as the pleated instrument seal assembly disclosed in US7789861, such as the instrument seal assembly comprising a woven cloth disclosed in US6482181, such as the four-lobed zero seal disclosed in US5443452, such as the duckbill zero seal disclosed in US8034032, and the like. Other disclosed instrument seals, zero seals and slight adaptations of their housings may be used in place of the instrument seals, zero seals, top housing, bottom housing, etc. described herein.

Referring to fig. 4, when thepuncture tube assembly 1 is secured to the abdominal wall of a patient, thehollow tube 50 thereof can be divided into an extracorporeal section (length H1), a body wall section (length H2) and an intracorporeal section (length H3). The length H2 of the body wall segment varies, and when applied to different patients, the abdominal wall thickness varies from patient to patient, such as obese patients and the smaller abdominal wall thickness varies greatly; the wall section H2 varies for different puncture positions and puncture angles even when used with the same patient. The length H1 of the extracorporeal section cannot be reserved too long or too short, which is inconvenient for inserting the instrument, and especially when the puncture tube component is used as a main operation hole and needs to be repeatedly switched, the puncture tube component is too short which is inconvenient for operating the instrument at different inclination angles. The length H3 of the in-vivo section is not changed greatly generally, and is reserved for 20-30 mm. The length of thehollow tube 50 of thespike assembly 1 is fixed and cannot meet the requirements of different field situations.

Fig. 5-11 depict an improvedbottom housing assembly 40a comprising abottom housing 100, a firsthollow tube 200 and a secondhollow tube 300. Referring first to fig. 5-6, thebottom housing 100 includes adistal housing 47 with alower retaining ring 43 connected to thedistal housing 47 and extending proximally; thetransition housing 45 is connected at one end to the distal housing and at its other end extends to form a hollowtube mounting wall 46, said hollowtube mounting wall 46 extending proximally and being connected to a hollowtube retaining wall 44, said hollowtube retaining wall 44 defining the bottom housing throughhole 41.

Referring to fig. 7-8, the secondhollow tube 300 comprises asecond tip 310 and asecond tube end 330 and a secondhollow tube wall 320 extending therebetween. The inner surface of the second hollow tube wall defines a hollow channel and the outer surface thereof comprises an outercylindrical surface 370 having adiameter Dw 1. The outer surface of the second hollow pipe wall comprises N (N is more than or equal to 10) circles of outerconvex rings 340, and the outerconvex rings 340 are uniformly distributed on the outer surface of the second hollow pipe wall at equal intervals along the axial direction of the second hollow pipe from the adjacent area of the second pipe head. Two adjacent circles ofmale rings 340 define a circle offemale rings 350; the second hollow tube further comprises anouter notch 360, and the outer notch cuts off the N rings of outer convex rings to form an unsealed ring structure. In this example, theouter indentations 360 comprise two aligned rows of first and second rows ofouter indentations 361, 362 circumferentially distributed about the second hollow tube dividing each annular step into a first set ofouter collar portions 341 and a second set ofouter collar portions 342. However, three, four or more rows of outer indentations may be included.

Referring to fig. 9-10, the firsthollow tube 200 comprises afirst tip 210 and afirst tail 230 with a firsthollow tube wall 220 extending therebetween. The inner surface of thefirst tube end 230 includes aninner lug 250, theinner lug 250 being shaped and dimensioned to mate with theouter notch 360, the second hollow tube being axially movable relative to the first hollow tube when theinner lug 250 is aligned with theouter notch 360. The firsthollow tube 200 also includes an innercylindrical surface 229 having a diameter Dn1, the innercylindrical surface 229 extending through thefirst stub 210 at one end and extending into intersection with theinner ledge 250 at the other end. In this example, theinner lugs 250 comprise two sets of inner lugs, a firstinner lug 251 and a secondinner lug 252, circumferentially distributed along the first hollow tube, the firstinner lug 251 matching the shape and size of the first row ofouter notches 361, and the secondinner lug 252 matching the shape and size of the second row ofouter notches 362. However, theinner lugs 250 may be grouped into three, four or more groups. Whether grouped, theinner lugs 250 are shaped and sized to mate with theouter notches 360, and the second hollow tube is axially movable relative to the first hollow tube when theinner lugs 250 are aligned with theouter notches 360.

Referring to fig. 11-12, thefirst cartridge 210 is coupled to thebottom housing 100. In this example, the outer surface offirst tip 210 matches the shape and size of hollowtube mounting wall 46, and in one embodiment,first tip 210 and hollowtube mounting wall 46 are glued together. In another alternative, the outer surface of thefirst cartridge 210 is fixed to the inner wall of thehollow tube stopper 44 as a whole by interference fit.

Referring to fig. 11 and 13, the head of the second hollow tube is mounted inside the first hollow tube. Theinner lugs 250 are shaped and dimensioned to mate with the outer female rings 350, and the mating of theinner lugs 250 with either outerfemale ring 350 provides a rotational snap fit that is rotatable about the hollow tube axis but not axially movable.

As shown in fig. 11-12, thebottom housing assembly 40a further comprises ahollow tube seal 500 mounted to the second stub, thehollow tube seal 500 comprising an outer sealing cylindrical surface 520 having a diameter Dt3 defined by asealing cylinder 510 and an inner sealingcylindrical surface 530 having a diameter Dt 4. In one embodiment, theinner sealing cylinder 530 is mounted outside the outercylindrical surface 370 and secured with glue; the outer cylindrical sealing surface 520 is an interference fit with the innercylindrical surface 229.

Thehollow tube seal 500 is made of a thermoset elastomer or a thermoplastic elastomer. In one embodiment, the outer cylindrical sealing surface 520 is an interference fit with the innercylindrical surface 229. Sufficient extrusion force is formed between the outer sealing cylindrical surface 520 and the innercylindrical surface 229 to form a rotating peak force F1, a rotating outer force F2 is applied to the first hollow tube and the second hollow tube, and when F2 is less than or equal to F1, the first hollow tube and the second hollow tube do not generate relative rotation displacement; when F2 > F1, the first and second hollow tubes can be relatively rotationally displaced, thereby rotationally disengaging the rotational snap-fit from each other until the second hollow tube is axially movable, i.e., active, relative to the first hollow tube when theinner lugs 250 are aligned with theouter notches 360. Reasonable interference is selected through an experimental method, and the material and the hardness of the hollowtube sealing element 500 are reasonably selected, so that the rotation peak force F1 is controlled in a comfortable and safe range, and in a specific scheme, F1 is more than or equal to 10N and less than or equal to 20N. When F1 is less than 10N, the safety factor for preventing the first hollow pipe and the second hollow pipe from generating accidental relative rotation is not high enough; when F1 > 20N, the operation comfort of rotating the first hollow tube and the second hollow tube relative to each other is not good enough.

In one embodiment, the second hollow tube comprises N rings ofmale rings 340, and two adjacent rings ofmale rings 340 define one ring offemale rings 350, i.e. the second hollow tube comprises N-1 rings of female rings. And M circles of the outer concave rings in the N-1 circles of the outer concave rings can be contracted into the first hollow pipe to be matched with the inner convex lug to form rotary buckle matching, wherein M < (N-1), which is called M circles of outer clamping grooves, and the first, second … … and M circles of outer clamping grooves are sequentially arranged from the far end to the near end. And N-1-m circles of the N-1 circles of the outer concave rings can not be contracted into the first hollow pipe and can not participate in forming the rotary buckle fit. The convex-concave alternate structure consisting of the N circles of convex rings and the N-1 circles of concave rings is beneficial to increasing the fixed friction force of the hollow tube on the abdominal wall of the patient. And the convex-concave alternate structure formed by the M +1 circles of the outer convex rings and the M circles of the outer clamping grooves can also be used for adjusting the length of the hollow pipe.

When the inner lug is matched with the first outer clamping groove, the length of the hollow tube of the bottom shell component is Lt1, namely the longest length; when the inner lug is matched with the second outer clamping groove, the distance between two adjacent annular grooves is P2, and the length of the hollow pipe of the bottom shell component isLt 2; by analogy, when the inner lug is matched with the mth outer clamping groove, the length of the hollow pipe of the bottom shell component is Ltm. The width of each outer clamping groove is P1, the distance between every two adjacent outer clamping grooves is P2, and the length Ltm of the hollow tube satisfies the following relation: Ltm-Lt 1-m P2

It will be appreciated by those skilled in the art that when thebottom housing assembly 40a is substituted for thebottom housing 40 in thepuncture tube assembly 1 to form a new puncture tube assembly 1a (not shown) for laparoscopic surgery, the surgeon may rotate the first and second hollow tubes relative to each other to align the inner lugs with the outer notches of the second hollow tube, thereby disengaging the rotating catches, depending on the thickness of the abdominal wall of the patient, the position and angle of puncture of the puncture tube assembly, and the personal handling habits; moving the second hollow tube into position and rotating the second hollow tube to form a rotating snap fit changes the overall length of the hollow tube of the spike assembly. The fixed depth of the puncture tube assembly in the abdominal wall is further adjusted, so that the external section (length H1), the body wall section (length H2) and the internal section (length H3) of the puncture tube assembly are arranged ideally.

The length setting of the firsthollow tube 200 has a greater impact on the ease of use of the spike assembly 1a in situ, and in one aspect, the length L1 of the firsthollow tube 200 satisfies the relationship: l1 is not less than 3 × Lt1/8 and not more than Lt1/3, and m × P2 is less than L1.

When L1 is larger than 3/8 of Lt1, the puncture tube assembly in the shortest state is inconvenient to use, and the lengths of the body wall segment (long H2) and the body interior segment (long H3) are insufficient. When L1 is less than 1/3 of Lt1, L1 is too short and the adjustable extension length of the puncture assembly is not significant enough.

Fig. 14-20 depict an improvedbottom housing assembly 40b comprisingbottom housing 100, firsthollow tube 200a andsecond sleeve 300 a. Referring first to fig. 18-19, thebottom housing 100 includes adistal housing 47 with alower retaining ring 43 connected to thedistal housing 47 and extending proximally;transition housing 45 is connected at one end to the distal housing and at its other end extends to form acannula mount wall 46,cannula mount wall 46 extending proximally and being connected to cannula stopwall 44, cannula stopwall 44 defininglower housing throughbore 41.

Referring now to fig. 14-15, secondhollow tube 300a comprisessecond tip 310a andsecond tail 330 and secondhollow tube wall 320a extending therebetween. The inner surface of the second hollow tube wall defines a hollow channel and the outer surface thereof comprises an outercylindrical surface 370 having adiameter Dw 1. The outer surface of the second hollow pipe wall comprises N (N is more than or equal to 10)annular steps 340a, and theannular steps 340a are uniformly distributed on the outer surface of the second hollow pipe wall at equal intervals along the axial direction of the second hollow pipe from the adjacent area of the second pipe head. Two adjacent rings ofannular steps 340a define a ring ofannular grooves 350 a. Theannular step 340a comprises arotational section 347a and arotational axis 301a, wherein therotational axis 301a coincides with the axis of the hollow tube. Referring to fig. 15 and 20, the rotatedsection 347a includes a proximalbeveled edge 345a forming a proximal angle ANG1 with the axis ofrotation 301a and a distalbeveled edge 349a forming a distal angle ANG2 with the axis ofrotation 301 a. In one design, therotational section 347a includes a wedge shape that tapers from a distal end to a proximal end. In a specific implementation scheme, ANG1 is more than or equal to 90 degrees and less than or equal to 135 degrees, ANG1 is more than or equal to 15 degrees and less than or equal to 45 degrees, and the angle arrangement is favorable for reducing the abdominal wall puncture force and increasing the resistance of the puncture tube assembly to be pulled out from the abdominal wall in the process of penetrating through the abdominal wall to establish a puncture channel. The second hollow tube further comprises anouter notch 360a, and the outer notch cuts off the N circles of annular steps to form an unsealed ring structure. In this example, theouter notches 360a comprise two aligned rows ofouter notches 361a and 362a (not shown) evenly distributed circumferentially along the second hollow tube, which divide each ring of annular step into a first group ofannular step portions 341a and a second group ofannular step portions 342 a. However, three, four or more rows of outer indentations may be included.

Referring to fig. 16-17, the firsthollow tube 200a includes afirst tip 210 and afirst tail 230a with a firsthollow tube wall 220 extending therebetween. The inner surface of thefirst tube end 230a includes aninner hook 250a, theinner hook 250a is shaped and dimensioned to mate with theouter notch 360a, and the second hollow tube is axially movable relative to the first hollow tube when theinner hook 250a is aligned with theouter notch 360 a. The firsthollow tube 200 further comprises an innercylindrical surface 229, one end of the innercylindrical surface 229 extends through thefirst ferrule 210 and the other end extends to intersect theinner hook 250 a. In this example, theinner hooks 250a include two sets of inner hooks, namely a firstinner hook 251a and a secondinner hook 252a, which are circumferentially and uniformly distributed along the first hollow pipe, the firstinner hook 251a matches with the shape and size of the first row ofouter notches 361a, and the secondinner hook 252a matches with the shape and size of the second row of outer notches 362 a. However, theinner hooks 250a may be divided into three, four or more groups. Regardless of the grouping, theinner hooks 250a are shaped and sized to mate with theouter notches 360a, and the second hollow tube is axially movable relative to the first hollow tube when theinner hooks 250a are aligned with theouter notches 360 a.

Referring to fig. 18-19,first tip 210 of firsthollow tube 200a is connected tobottom housing 100. In this example, the outer surface offirst tip 210 matches the shape and size of hollowtube mounting wall 46, and in one embodiment,first tip 210 and hollowtube mounting wall 46 are glued together. Alternatively, the exterior offirst cartridge 210 is secured as a unit by interference with the interior wall of hollowtube mounting wall 46.

Referring to fig. 18 and 20, the proximal end of the secondhollow tube 300a is mounted inside the firsthollow tube 200 a. Theinner hooks 250a are shaped and dimensioned to mate with theannular recesses 350a, and theinner hooks 250a mate with any one of theannular recesses 350a to form a rotating snap fit that is rotatable about the hollow tube axis but not axially movable.

Similarly, thebottom housing assembly 40b also includes ahollow tube seal 500 mounted to the second tube head. In one version, the inner sealingcylindrical surface 530 of thetube seal 500 is mounted on the outside of the outercylindrical surface 370 and secured with glue; the outer cylindrical sealing surface 520 is an interference fit with the innercylindrical surface 229. In one embodiment, the outer cylindrical sealing surface 520 is an interference fit with the innercylindrical surface 229. Sufficient extrusion force is formed between the outer sealing cylindrical surface 520 and the innercylindrical surface 229 to form a rotating peak force F1, a rotating outer force F2 is applied to the first hollow tube and the second hollow tube, and when F2 is less than or equal to F1, the first hollow tube and the second hollow tube do not generate relative rotation displacement; when F2 is greater than F1, the first hollow tube and the second hollow tube can generate relative rotation displacement, so that the rotation snap fit is mutually rotated and separated, and when theinner clamping hook 250a is aligned with theouter notch 360a, the second hollow tube can axially move relative to the first hollow tube, namely, the movable state is obtained. Reasonable interference is selected experimentally, and thehollow tube seal 500 material and hardness are chosen so that the peak rotational force F1 is controlled to be within a comfortable and safe range.

In one embodiment, the secondhollow tube 300a comprises N rings ofannular steps 340a, and two adjacent rings ofannular steps 340a define one ring ofannular groove 350a, i.e., the second hollow tube comprises N-1 rings ofannular grooves 350 a. And M rings of annular grooves in the N-1 rings of annular grooves can be contracted into the first hollow tube to be matched with the inner lug to form rotary buckle matching, wherein M < (N-1), which is called M rings of outer clamping grooves, and the first, second … … and M rings of outer clamping grooves are sequentially arranged from the far end to the near end. And N-1-m rings of annular grooves in the N-1 rings of annular grooves can not be contracted into the first hollow pipe and can not participate in forming the rotary buckle fit. The convex-concave alternate structure consisting of the N circles of annular steps and the N-1 circles of annular grooves is beneficial to increasing the fixed friction force of the hollow tube on the abdominal wall of a patient. And the convex-concave alternate structure formed by the M +1 ring of annular steps and the M ring of external clamping grooves can also be used for adjusting the length of the hollow pipe.

When the inner lug is matched with the first outer clamping groove, the length of the hollow tube of the bottom shell component is Lt1, namely the longest length; when the inner lug is matched with the second outer clamping groove, the distance between two adjacent annular grooves is P2, and the length of the hollow pipe of the bottom shell component isLt 2; by analogy, when the inner lug is matched with the mth outer clamping groove, the length of the hollow pipe of the bottom shell component is Ltm. The width of each outer clamping groove is P1, the distance between every two adjacent outer clamping grooves is P2, and the length Ltm of the hollow tube satisfies the following relation: Ltm-Lt 1-m P2

It will be appreciated by those skilled in the art that when thebottom housing assembly 40b is substituted for thebottom housing 40 in thepuncture tube assembly 1 to form a new puncture tube assembly 1b (not shown) for laparoscopic surgery, the surgeon may rotate the first and second hollow tubes relative to each other to align the inner lugs with the outer notches of the second hollow tube, thereby disengaging the rotating catches, depending on the thickness of the abdominal wall of the patient, the position and angle of puncture of the puncture tube assembly, and the personal handling habits; moving the second hollow tube into position and rotating the second hollow tube to form a rotating snap fit changes the overall length of the hollow tube of the spike assembly. The fixed depth of the puncture tube assembly in the abdominal wall is further adjusted, so that the external section (length H1), the body wall section (length H2) and the internal section (length H3) of the puncture tube assembly are arranged ideally.

The length setting of the firsthollow tube 200a has a greater impact on the convenience of the needle cannula assembly 1b in situ, and preferably, the length L1 of the firsthollow tube 200a satisfies the relationship:

3*Lt1/8≤L1≤Lt1/3，m*P2＜L1

when L1 is larger than 3/8 of Lt1, the puncture tube assembly in the shortest state is inconvenient to use, and the lengths of the body wall segment (long H2) and the body interior segment (long H3) are insufficient. When L1 is less than 1/3 of Lt1, L1 is too short and the adjustable extension length of the puncture assembly is not significant enough.

Fig. 21-22 depict yet another modified bottom housing assembly 40c (not shown) comprising abottom housing 100b, a secondhollow tube 300a and ahollow tube seal 500. The bottom housing assembly 40c is connected to the first hollow tube only differently than thebottom housing assembly 40 b. Briefly, thebottom housing assembly 40b is formed by separating thebottom housing 100 and the firsthollow tube 200a into two parts that are injection molded and then joined together. In the bottom housing assembly 40c, the bottom housing and the first hollow tube are integrally connected and injection molded by a single mold to form a single part. In one embodiment, the bottom housing 100c comprises adistal housing 47, and thelower retaining ring 43 is connected to thedistal housing 47 and extends proximally; thetransition housing 45 is connected at one end to the distal housing and extends at its other end to form a hollowtube mounting wall 46, said hollowtube mounting wall 46 extending distally to form a firsthollow tube 200 b. The firsthollow tube 200b includes afirst tip 210b and afirst tail 230a with a firsthollow tube wall 220 extending therebetween. The inner surface of thefirst tube end 230a includes aninner hook 250a, theinner hook 250a is shaped and dimensioned to mate with theouter notch 360a, and the second hollow tube is axially movable relative to the first hollow tube when theinner hook 250a is aligned with theouter notch 360 a. The firsthollow tube 200b also includes an innercylindrical surface 229, the innercylindrical surface 229 extending across the hollowtube mounting wall 46 at one end and extending across theinner hook 250a at the other end. In this example, theinner hooks 250a include two sets of inner hooks, namely a firstinner hook 251a and a secondinner hook 252a, which are circumferentially and uniformly distributed along the first hollow pipe, the firstinner hook 251a matches with the shape and size of the first row ofouter notches 361a, and the secondinner hook 252a matches with the shape and size of the second row of outer notches 362 a. However, theinner hooks 250a may be divided into three, four or more groups. Regardless of the grouping, theinner hooks 250a are shaped and sized to mate with theouter notches 360a, and the second hollow tube is axially movable relative to the first hollow tube when theinner hooks 250a are aligned with theouter notches 360 a.

In the bottom housing assembly 40c, the proximal end of the secondhollow tube 300a is mounted inside the firsthollow tube 200 b. Theinner hooks 250a are shaped and dimensioned to mate with theannular recesses 350a, and theinner hooks 250a mate with any one of theannular recesses 350a to form a rotating snap fit that is rotatable about the hollow tube axis but not axially movable. Theinner sealing cylinder 530 of thetube seal 500 is mounted outside theouter cylinder 370 and fixed with glue; the outer cylindrical sealing surface 520 is an interference fit with the innercylindrical surface 229. The manner of installation and the principle of operation of the second hollow tube and tube seal of the bottom housing assembly 40c are substantially the same and therefore will not be described in further detail.

23-27 depict a modifiedbottom housing assembly 40d that includes abottom housing 100, a first hollow tube 200c and asecond sleeve 300 b. Referring first to fig. 23-24, secondhollow tube 300b comprisessecond tip 310b andsecond tail 330 with secondhollow tube wall 320b extending therebetween. The inner surface of the second hollow tube wall defines a hollow channel and the outer surface thereof comprises an outercylindrical surface 370 having adiameter Dw 1. The outer surface of the second hollow pipe wall comprises a plurality of circles of outwardconvex ring teeth 340b, and the outwardconvex ring teeth 340b are uniformly distributed on the outer surface of the second hollow pipe wall at equal intervals along the axial direction of the second hollow pipe from the adjacent area of the second pipe head. Two adjacent circles of outerconvex ring teeth 340b define a circle of outerring tooth grooves 350 b. The outwardlyconvex ring tooth 340b comprises a rotational cross-section 347b and arotational axis 301b, wherein therotational axis 301b coincides with the axis of the hollow tube. Referring to fig. 23 and 24, the rotated section 347b includes a proximal beveled edge 345b forming a proximal angle ANG1 with the axis ofrotation 301b and a distal beveled edge 349b forming a distal angle ANG2 with the axis ofrotation 301 b. In one design, the rotational section 347b includes a wedge shape that tapers from a distal end to a proximal end. The convex ring teeth and the outer ring tooth grooves which are alternately arranged in the convex-concave mode form sawtooth-shaped anti-skidding textures, and the fixing friction force of the hollow pipe on the abdominal wall of a patient can be increased. In a specific implementation scheme, ANG1 is more than or equal to 90 degrees and less than or equal to 135 degrees, ANG1 is more than or equal to 15 degrees and less than or equal to 45 degrees, and the angle arrangement is favorable for reducing the abdominal wall puncture force and increasing the resistance of the puncture tube assembly to be pulled out from the abdominal wall in the process of penetrating through the abdominal wall to establish a puncture channel. The second hollow tube further comprises anouter notch 360b, and the outer notch cuts off the N circles of outer convex ring teeth to form an unsealed ring structure. In this example, theouter notches 360b comprise a first row ofouter notches 361b, a second row of outer notches 362b (not shown), a third row of outer notches 363b (not shown) and a fourth row of outer notches 362b (not shown) which are uniformly distributed along the circumferential direction of the second hollow tube, and are aligned in four rows, and the four rows of outer notches divide each circle of the outer convex ring teeth into a first set of outer convexring teeth portions 341b, a second set of outer convexring teeth portions 342b, a third set of outer convex ring teeth portions 343b (not shown) and a fourth set of outer convex ring teeth portions 344b (not shown).

Referring to fig. 25-26, the firsthollow tube 200b comprises afirst tip 210 and afirst tail 230b with a firsthollow tube wall 220 extending therebetween. The inner surface of thefirst tube end 230b includes an inner tab 250b, the inner tab 250b being shaped and dimensioned to mate with theouter notch 360b, the second hollow tube being axially movable relative to the first hollow tube when the inner tab 250b is aligned with theouter notch 360 b. The firsthollow tube 200 also includes an innercylindrical surface 229, the innercylindrical surface 229 extending through thefirst tip 210 at one end and extending to intersect the inner protrusion 250b at the other end. In this example, the inner protrusions 250b comprise fourinner protrusions 251b, 252b, 253b and 254b distributed circumferentially around the first hollow tube. The firstinner tab 251b matches the shape and size of the firstouter row notch 361b, the secondinner tab 252b matches the shape and size of the second outer row notch 362b, the thirdinner tab 253b matches the shape and size of the third outer row notch 363b, and the fourthinner tab 254b matches the shape and size of the fourth outer row notch 364 b. Regardless of the grouping, the inner tab 250b is shaped and dimensioned to mate with theouter notch 360b, and the second hollow tube is axially movable relative to the first hollow tube when the inner tab 250b is aligned with theouter notch 360 b.

Referring to fig. 26-28, the inner boss 250b includes a plurality of rings ofinner ring teeth 260b, theinner ring teeth 260b being evenly spaced along the axial direction of the first hollow tube on the inner surface of the inner boss 250 b. Two adjacent rings ofinner ring teeth 260b define a ring of innerring teeth slots 270 b. Referring to fig. 27-29, thefirst stub 210 of the firsthollow tube 200b is connected to thebottom housing 100 and the proximal end of the secondhollow tube 300b is mounted inside the firsthollow tube 200 b. Theinner ring teeth 260b are shaped and dimensioned to mate with the outerring teeth slots 350b, and the innerring teeth slots 270b are shaped and dimensioned to mate with theouter ring teeth 340b to form a rotating snap fit that can rotate about the hollow tube axis but cannot move axially.

Similarly, thebottom housing assembly 40d also includes ahollow tube seal 500 mounted to the second stub. In one version, the inner sealingcylindrical surface 530 of thetube seal 500 is mounted on the outside of the outercylindrical surface 370 and secured with glue; the outer cylindrical sealing surface 520 is an interference fit with the innercylindrical surface 229. In one embodiment, the outer cylindrical sealing surface 520 is an interference fit with the innercylindrical surface 229. Sufficient extrusion force is formed between the outer sealing cylindrical surface 520 and the innercylindrical surface 229 to form a rotating peak force F1, a rotating outer force F2 is applied to the first hollow tube and the second hollow tube, and when F2 is less than or equal to F1, the first hollow tube and the second hollow tube do not generate relative rotation displacement; when F2 > F1, the first and second hollow tubes can be relatively rotationally displaced, thereby rotationally disengaging the rotational snap-fit from each other until the second hollow tube is axially displaced relative to the first hollow tube, i.e., active, when the inner tab 250b is aligned with theouter notch 360 b. Reasonable interference is selected experimentally, and thehollow tube seal 500 material and hardness are chosen so that the peak rotational force F1 is controlled to be within a comfortable and safe range.

In one embodiment, the inner cam 250b includes X number ofinner cam teeth 260b and X-1 number ofinner cam teeth 270 b. In a specific scheme, X is more than or equal to 3 and less than or equal to 5. When X < 3, the matching length of the first and second sleeves is not tight enough and smooth, and when X > 5, the matching length is too long, thereby reducing the total length (displacement) of the axial expansion and contraction of the first and second hollow tubes.

In yet another embodiment, the addendum diameter Dd of the outer ring tooth and the dedendum diameter Dg of the outer ring tooth socket satisfy the relationship: 0.3mm (Dd-Dg)/2 mm (0.5 mm). When the outer convex ring teeth are smaller than 0.3mm, the requirements on manufacturing precision and matching precision of the outer convex ring teeth are high, the friction force of the anti-skid textures formed by the outer convex ring teeth and the outer ring tooth grooves wrapped on the abdominal wall wound of a patient is insufficient, and when (Dd-Dg)/2 is larger than 0.5mm, in order to ensure enough strength, the outer diameter of the sleeve needs to be increased, so that the damage of the puncture wound is increased, and meanwhile, when the anti-skid textures formed by the outer convex ring teeth and the outer ring tooth grooves are wrapped on the abdominal wall wound of the patient, the ring teeth with the height exceeding 0.5 easily cause additional damage to the wound.

Similarly, when thebottom housing assembly 40d replaces thebottom housing 40 in thepuncture tube assembly 1 to form a new puncture tube assembly 1d (not shown in the figures) for laparoscopic surgery, the surgeon can relatively rotate the first hollow tube and the second hollow tube to align the inner protrusion with the outer notch of the second hollow tube according to the thickness of the abdominal wall of the patient, the position and puncture angle of the puncture tube assembly, personal operation habits and the like, so that the rotary buckle is disengaged; moving the second hollow tube into position and rotating the second hollow tube to form a rotating snap fit changes the overall length of the hollow tube of the spike assembly. The fixed depth of the puncture tube assembly in the abdominal wall is further adjusted, so that the external section (length H1), the body wall section (length H2) and the internal section (length H3) of the puncture tube assembly are arranged ideally.

Various methods of rotational snap-fitting and telescoping of the first and second hollow tubes have been shown above. In order to facilitate the alignment of the outer notch and the inner convex block (inner clamping hook) in the adjusting process, in one scheme, a first hollow tube and a second hollow tube are made of transparent materials, and the matching position can be seen by naked eyes; in another scheme, an alignment mark is arranged on the outer surface of the first pipe tail, and when the outer notch is aligned with the alignment mark, the outer notch is aligned with the inner convex block (inner clamping hook).

Those skilled in the art will readily appreciate that the spike assembly also requires a mating spike. The puncture needle penetrates through the puncture tube assembly to form a puncture outfit, then the puncture outfit and the puncture outfit penetrate through the abdominal wall through an incision arranged on the abdominal wall of a patient in advance to enter a body cavity, and then the puncture needle is taken away, and the hollow tube is used as a passage for instruments to enter and exit the body cavity. The introducer needle generally includes a handle portion, a shaft portion and a distal portion. For example, CN201611125444.3 entitled "improved bladeless visual puncture needle" is incorporated herein by reference, which is the puncture needle disclosed in the chinese invention application filed on 12/9/2016. The puncture tube assembly formed by the telescopic bottom shell assembly can be contracted into the shortest length Lt0 at the initial position, is matched with the improved non-knife visual puncture needle to form a puncture device for penetrating the abdominal wall, and the puncture needle is taken away, then the first hollow tube and the second hollow tube are relatively rotated, so that the fixed depth of the puncture tube assembly on the abdominal wall is adjusted, and the external section (long H1), the body wall section (long H2) and the internal section (long H3) of the puncture tube assembly are ideally arranged. A retractable puncture needle can also be designed to match the retractable puncture tube assembly.

Many different embodiments and examples of the invention have been shown and described. The individual embodiments each contain typically different distinguishing features, which can be interchanged or superimposed on one another. One of ordinary skill in the art can adapt the methods and apparatus described herein by making appropriate modifications without departing from the scope of the invention. Several modifications have been mentioned, and other modifications will occur to those skilled in the art. The scope of the invention should, therefore, be determined with reference to the appended claims, and not be construed as limited to the details of structure, materials, or acts shown and described in the specification and drawings.

Claims (5)

1. A puncture instrument adaptable to different patients, comprising a puncture tube assembly comprising a bottom housing assembly, and further comprising a top housing, an instrument seal and a zero seal sandwiched between the top housing and the bottom housing assembly and in a compressed state, the top housing and the bottom housing assembly being connected to each other to form an integral sealing system; still include the pjncture needle that runs through the puncture tube subassembly, its characterized in that:

1) the bottom housing assembly comprises a bottom housing, a first hollow tube and a second hollow tube; the first hollow tube comprises a first tube head and a first tube tail with a first tube wall extending therebetween, and the second hollow tube comprises a second tube head and a second tube tail with a second tube wall extending therebetween; the first pipe head is connected with the bottom shell, and the second pipe head is arranged in the first hollow pipe; the bottom housing assembly is made of a polycarbonate material;

2) the outer surface of the second pipe wall comprises N rings of annular steps, and the annular steps are uniformly distributed on the outer surface of the second pipe wall at equal intervals along the axial direction of the second hollow pipe from the adjacent area of the second pipe head; two adjacent circles of annular steps define a circle of annular groove; the second hollow pipe also comprises an outer notch, and the outer notch cuts off the N circles of annular steps to form a non-closed structure;

3) the inner surface of the first pipe tail comprises an inner clamping hook, the shape and the size of the inner clamping hook are designed to be matched with the outer notch, and when the inner clamping hook is aligned with the outer notch, the second hollow pipe can axially move relative to the first hollow pipe;

4) the inner clamping hook comprises an X ring, wherein X is more than or equal to 3 and less than or equal to 5, so that the matching lengths of the first hollow pipe and the second hollow pipe are matched tightly and stably;

5) further comprising a hollow tube seal secured to the second ferrule, the hollow tube seal comprising an outer sealing cylindrical surface and an inner sealing cylindrical surface defined by a sealing cylinder; the first hollow tube also comprises an inner cylindrical surface, one end of the inner cylindrical surface penetrates through the first tube head, and the other end of the inner cylindrical surface extends to intersect with the inner clamping hook; the inner sealing cylindrical surface is in contact with the inner cylindrical surface; the hollow tube sealing element is made of a thermosetting elastomer or a thermoplastic elastomer material, the contact between the inner sealing cylindrical surface and the inner cylindrical surface is in interference fit with extrusion force to form a rotation peak force F1, and F1 is more than or equal to 10N and less than or equal to 20N; the rotating external force F2 is exerted on the first hollow tube and the second hollow tube, and when F2 is not more than F1, the first hollow tube and the second hollow tube do not generate relative rotation displacement; when F2 is larger than F1, the first hollow tube and the second hollow tube generate relative rotation displacement.

2. The puncture instrument according to claim 1, wherein: the shape and size of the inner hook are designed to be matched with the annular groove, and the inner hook and any annular groove are mutually matched to form rotary buckle fit which can rotate around the axis of the hollow pipe and cannot move axially.

3. The puncture instrument according to claim 2, wherein: the annular step comprises a rotary section and a rotary shaft, wherein the rotary shaft is coincident with the axis of the hollow tube; the rotational section comprises a wedge shape that tapers from a distal end to a proximal end.

4. A puncture instrument according to claim 3, characterized in that: the section of revolution includes proximal hypotenuse and distal hypotenuse, proximal hypotenuse and rotation axis form proximal contained angle ANG1, distal hypotenuse and rotation axis 301a form distal contained angle ANG2, wherein ANG1 is ≦ 90 ≦ 135, ANG1 is ≦ 45 for 15.

5. A puncture instrument according to claim 3, characterized in that: the annular groove comprises m circles of outer clamping grooves, and the m circles of outer clamping grooves can be contracted into the first hollow pipe.

6. The puncture instrument according to claim 5, wherein: any outer clamping groove can be matched with the inner clamping hook to form a rotary buckle; when the inner clamping hook and the first outer clamping groove are matched to form rotary buckle matching, the length of the hollow pipe of the bottom shell component is Lt1, and the hollow pipe is the longest length; when the inner clamping hook is matched with the mth outer clamping groove to form rotary buckle matching, the length of the hollow pipe of the bottom shell component is Ltm, and the following relations are satisfied:

Ltm=Lt1-m*P2

wherein:

lt1 — longest hollow tube length;

ltm-the length of the hollow tube when the inner hook is matched with the mth outer slot is Ltm;

m is the serial number of the rotary buckle matching;

p2-spacing of two adjacent external card slots.

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