WO2016157211A1

WO2016157211A1 - An automated needle holder and suturing device

Info

Publication number: WO2016157211A1
Application number: PCT/IN2016/000077
Authority: WO
Inventors: Hemant Bhansali; Ravi Bhallamudi; Rupesh Ghyar
Original assignee: Indian Institute Of Technology, Bombay
Priority date: 2015-03-27
Filing date: 2016-03-28
Publication date: 2016-10-06

Abstract

The automated needle holder and suturing device comprises an arcuate jaw member(12) comprising a curvature such that the curvature is in correlation with the curvature of a curved needle(10) adapted to be used with the device. It also comprises a slotted guide(13), a rack and pinion assembly in order to engage and disengage the needle mover assembly(16), a piston element(24) adapted to be linearly slide-able and being triggered by at least a trigger assembly(35), a biasing element(26) coupled with the piston element(24), and a laterally located slotted profile(27) in order to guide at least a plunger(28). The biasing element(26) is linearly slide-able as well as angularly displaceable as per the piston element(24) movement. The operative distal end of said biasing element(26) is coupled with the rack element(22).

Description

AN AUTOMATED NEEDLE HOLDER AND SUTURING DEVICE

FIELD OF THE INVENTION:

This invention relates to the field of medical engineering and biomedical engineering. Particularly, this invention relates to the field of medical devices, tools, and equipment. Specifically, this invention relates to an automated needle holder and suturing device. BACKGROUND OF THE INVENTION:

The term, 'suturing', refers to the process of joining two surfaces or edges together along a line by or as if by sewing. In medical parlance, suturing is the joining of tissues with needle and "thread," so that the tissues bind together and heal. The "thread" is actually specialized suture material.

Surgical suture is a medical device used to hold body tissues together after an injury or surgery. Application generally involves using a needle with an attached length of thread. A number of different shapes, sizes, and thread materials have been developed over its millennia of history.

There are two broad classifications of needles: curved and straight. A straight needle can be used without instruments. A curved needle must be handled with forceps and a needle holder.

There are two types of curved needles:

1) Cutting Needle: A cutting needle is used primarily for suturing the skin. It has a very sharp tip with sharp edges, which are needed to pass through the skin. Since you will place primarily skin sutures, you generally will use a cutting needle.

2) Tapered Needle: Tapered needles, or "round-bodied" needles, have a sharp tip with smooth edges and are less traumatic to the surrounding tissues. They are used primarily on the deeper, subcutaneous tissues, blood vessels, and intestinal anastomoses. A tapered needle is not good for simple skin suturing because it is difficult to pass the tapered needle through the skin. Tissue approximation by suturing remained the most reliable, cost-effective method for organs and tissue plane reconstructions. It is said that during suturing, a surgeon should have the ability to instantaneously select the most suitable method of suturing for the operating space available. The surgeon should have advanced knowledge of how the needle holder moves when the method of griping the needle is modified and the arc of the needle.

S Seki (1987) of Okayama University of Japan described the precise and correct method of suturing in open surgery. He experimented extensively for understanding accuracy in open surgery suturing in restricted places. His investigations showed that refinement of surgeons' technique of operation is always ignored. He suggested that improvement of open surgery suturing technique is achievable by avoiding 4 restrictive issues. The first issue is associated with configuration of needle. Understanding the usable part of a ½ or 3/8th circle needle is very much essential. For a 3/8 circle needle, the span of needle is about 135 .Therfore unless suture completes this span, it can not be called a good stitch. For ½ 'circle needle, the suture needs to complete a span of 140°.

The second issue deals with distance between exit or entry point of needle and span of a stitch. Ideal suturing was defined as advancing a needle along its curvature (needle circle) to minimize tissue trauma, while placing the suture with its intended span and tissue bite in the expected place. The points between entry and exit of needle are always determined by the size of the needle and the type of the tissue to be sutured.

The third issue he discusses how the needle should be held in the jaws of Needle Holder. The final issue he talks about is the movement of hand and hence needles though the tissue in either Roll-Pitch-Roll wrist configuration, or the Roll-Pitch- Yaw wrist configuration when the approach angle to the suturing surface is shallow.

Various authors have discussed about ideal suturing in laparoscopic surgery. Z Szabo and A. Cuschieri and Emam T A et al have established various norms of angle and entry of the instruments through the ports and optical angle for better vision. Frede T et al suggested optimal geometry for intracorporeal suturing. Optical angle, Manipulation angle and azimuth angle for perfect suturing are vividly described by G B Hanna et al , Meng W C et al and Frede T et al. The task analysis of the suturing done by various authors was reasonably good. Task analysis revealed that suturing is the longest and most involved of the four basic surgical tasks, followed by tying knots, dissecting tissue, and cutting suture. (Owen, & Baecker, 1994). All the researches in laparoscopic suturing definitely improved the technique. However, the main issues of positioning accuracy remained unsolved. For an effective suturing, and good tissue approximation, the suture line should be always in the centre of the vision.

Available suturing devices has first a semiautomatic device. The prototype of the semiautomatic suturing device was developed by one of the authors (H. Nagai, S. Araki., gynecologist) for use in transfixing sutures in the deep pelvic cavity during open surgery. (Surg Endosc (1999) 13: 191-193). The first-generation semiautomatic suturing device is a forceps type (Maniceps t type I, (Mani Corp., Tochigi, Japan) that can be applied in laparoscopic surgery. However the device was very cumbersome to use.

Covidien introduced the SILS™ Stitch Articulating Suturing instrument and is claimed to be most advanced endoscopic automated suturing device. Along with the automated functions of the current Endo Stitch™ instrument, it can rotate 360 ⁰ .However, the biggest disadvantage being the use of T shaped specialised needle which are very thick and can damage the delicate tissue.

Based on the Endo Stitch, a partially automated suturing tool has been developed. With the aid of a DC motor, triggered by a button, one can suture by one-fingered handling.

Another attempt of suturing device is seen in US Patent 7048748 Bl . Where, the claimed product is used for suturing and tying interrupted knots but cannot be used for continuous suturing. In another patent by Lisa Ann; US4373530; the author describes a surgical stitching instrument of forceps-like construction having a pair of arms pivotally interconnected for movement about an axis and respectively terminating in a suture holder which has a needle receiving slot and notches on opposite sides of the slot adapted to receive a suture disposed across the slot .However, the suturing is Not as described by S Saki to be perfect. Timothy N in his patent US 4841888 described a sewing machine for forming stitches in a substrate, for example, in forming stitches in tissue during surgery, comprises a needle for passing thread into the substrate from one side thereof at a first location and for withdrawing the thread from the substrate at a second location spaced from the first location. The needle is removably operable solely from the said one side of the substrate. However, the machine like cloth sewing machine uses a thick special and fixed needle. This definitely is more cumbersome to use in depth and for delicate tissue. In yet other invention for laparoscopic suturing RD 180 device (Innovative Solutions, US), during Suture placement, the initial squeeze of the lever advances the retracted needle forward through the selected tissue placed in the jaw of the device tip; the full squeeze advances the needle into the ferrule attached to its suture held in the device tip's distal end. Release of the lever retracts the needle, which pulls the now engaged ferrule and suture back through the tissue. However, this device uses a straight and specially made needles and sutures. Use of straight needle has but long time is obsolete and the curved needle has shown much superiority over it.

In yet another suturing device for laparoscopic surgery called Endo360 by Paresh C. Shah, MD, chief of laparoscopy at Lenox Hill Hospital, uses specially made curved needle with notches and special curvature of the needle to go through the tissue. The device doesn't explain the basic concept of suturing put forward by S Saki for perfect suturing. Moreover, use of special sutures makes it unusable by majority of surgeons world over for Open and laparoscopic Surgery.

There are certain points to be considered, as follows:

1. Choice of Configuration of Needle

2. Needle Grip and Grasping

3. Movement of Needle

4. Task and Motion Analyses in Surgery

5. Task Constraints

These are explained, below:

1. Choice of Configuration of Needle

Ideal suturing is defined as advancing a needle along its curvature (needle circle) to minimize tissue trauma, while placing the suture with its intended span and tissue bite in the expected place. Therefore, the needle should be chosen keeping the tissue to be sutured in mind. The points between entry and exit of needle is always determined by the size of the needle and the type of the tissue to be sutured.. The exact span of the suturing points; both exit and entry are determined by the span of the needle used.

The span of needle is V2 x radius. Hence half circle needle with a diameter of 29 mm with 90° rotation for suturing will have accuracy of exit at 2 x 29/2 = 20.5 mm or 2 cm. (1) Similarly for a 20 mm needle, the span is 14mm and for a 40 mm needle it is 2.8 cm

The arc of the needle also determines the suturing. For a 3/8 circle needle, suturing span is an arc of 3/8 X360/1 =135°

However, 20 degrees are to be excluded at each end of the needle for insertion and withdrawal, the effective needle range is 95°

To prevent the inadvertent dipping of needle too much in the tissue, the entrance angle should be 95/2 =47°. This angle of entry will allow the needle to move in a natural arc. However, when the tissue was slanted, the effective angle became 35°(2)

For a half circle needle, the suturing span is 180°. If 20 ⁰ are taken off at each end, then the effective arc is 140 ⁰ and entrance angle is 70°

2. Needle Grip and Grasping

During suturing, surgeons should have the ability to instantaneously select the suitable method of suturing for the operating space available. If the entry and exit point of suture needle misses the designated or intended points then the tissue being sutured may become distorted or even torn . If the needle grip is selected with which the needle holder describes a larger arc than the operating space, the suture cannot be completed as it will miss the correct exit point. While understanding the laparoscopic suturing few points should be remembered.

In open surgery during suturing, the surgeons have the ability to select the most suitable method of suturing for the operating space available. Otherwise, the needle may miss the intended exit point and may even teat the tissue. The ability of a surgeon to select the exact size of the needle, a long length of thread and above all, the types of grips for needle holding will spell the success of good suturing. The surgeon also chooses the size and strength of needle holder according to depth of suture line and thickness of the needle and tissue. Even if the suture line is vertical or horizontal, the surgeon is able to change the angle of approach accordingly.

In open surgery, there are 4 types of needle grips possible.

1. Straight grip - where needle plane is at right angle to the plane of needle holder and also to the long axis of the needle holder 2. Oblique grip - where the needle point is shifted towards the tip of the needle holder by 45° and making an angle of 135° with long axis of the needle holder but the needle plane is at right angle to the jaw

3. Rotated grip - where needle plane is rotated forwards by 30- 45 ⁰ towards the tip but the needle plane or transverse axis is in right angle

4. Combined grip is with rotated and oblique grip

All this grips can be adjusted manually, precisely and immediately to suit the suturing in open surgery. Accuracy of suturing will change depending upon the variables.

There are two suturing fields in laparoscopic surgery

1. Horizontal suturing plane where suture line can be horizontal along X-axis or vertical along Y-axis

2. Vertical or inclined suturing plane by lifting the tissue or bowel with a stay suture or with a grasping or Babcock forceps or anatomically it is in inclined position as in suturing the crurae during approximation of hiatal gap in Nissen's fundoplication or even suturing of peritoneum of anterior abdominal wall in ventral hernia. Again here, the suture line is in horizontal or X-axis or vertical or in Y- axis.

Within each category of vertical suturing, there are two directions of suturing. Either towards or away from the surgeon will determine the ease of suturing.

The display of suture line can also be either non isoplanar display ie horizontal suture line and anatomy of organ as well as surrounding structures displayed as vertical or vice versa by rotation of camera and isoplanar display when anatomy is displayed by correct positioning of camera showing a mirror image. Task performance and task quality decrease markedly in non isoplanar display. Isoplanar display gives the best performance ,better suture placement, less errors and less time required for suturing.

3. Movement of Needle

The range of needle movement depends upon whether the needle is half circled or 3/8 of a circle or a half circle needle is slightly straightened out to get accommodated in reducer sleeve for the ease of introduction.

The range of movement of the needle is defined as full when a half circle needle produces a stitch by entering the tissue at an entrance angle o 45°, then travels through the tissue 180° along its own natural arc and comes out at an exit angle. The entrance angle is the angle between the point of the needle and the tissue entering whereas the exit angle is at the point of needle emergence from the tissue. In the tissue, the needle travels half circle along its natural arc of 180°.

In open surgery, the needle holder is on an average is 6 inches or 18 cm for a needle of 29 mm and the position of the needle holder is parallel to the horizontal surface or tissue plane. However, in open surgery, Seki found that the accuracy of the needle point exiting at a precise point(determined by the span of the needle)as associated with two main manipulations of the needle. The needle gets more deviated from the intended or expected exit point when there was no jiggling or wavering of the needle in the tissue. Without jiggling the surgeons demonstrated a overshoot tendency of the exit point(8) .By having a short grip on the needle, Seki found that in open surgery there was less deviation of needle with greater precision and the force required to drive the needle through was also less and inclining or sloping the tissue (stimulant) increased the precision of exit point.

4. Task and Motion Analyses in Surgery

Suturing is decomposed into seven subtasks: 1) position needle, 2) bite tissue, 3) pull needle through, 4) re-position needle, 5) re-bite tissue, 6) pull needle through, and 7) pull suture through tissue.

A major difference between the expert and novice surgeons seemed to lie in proficiency at grasping the needle and moving it to a desired position and orientation, without slipping or dropping it. For the expert, the needle coming out the first bite of tissue was in a position and orientation very close to that desired, such that less time was required to manipulate it. Using the same needle drivers/holders, a simplified knot can be tied quickly and efficiently with a total of five reach & orient motions, two grasp & holds, two pulls, and one release motion, executed as follows:

1 : position needle

1. reach & orient (needle driver),

2. grasp & hold (needle with driver),

3. reach & orient (needle holder),

2: loop 4. reach & orient (driver with needle),

5. reach & orient (driver with needle),

3: pull through loops 6. reach & orient (needle holder), 7. grasp & hold (suture with holder),

8. pull (suture with holder),

4: pull knot tight 9. pull (suture with driver and holder),

5. Task Constraints

Comparing the four tasks, suturing took the longest time,followed by tying knots, dissecting tissue, and cutting suture. These results may reflect four types of constraints: physical, precision, safety, and visuomotor constraints. Physical constraints are due to the single, small port of entry for each tool, and the crude design of the tool itself. Surgical tools, with a long shaft which extends the reachof the effector from the hand, can reach the operative site through Small incisions, but have reduced degrees of freedom for subsequent .In contrast, the greater number of motions in the subtasks of 'pulling taut the suture' compared to 'pulling taut the tissue' indicates that it is more difficult to grasp suture. This can be explained by examining the precision requirements in the subtasks.

The finding that all the subtasks reduced to the same basic,underlying motions was unexpected. The surgeons' movements with the crude tools were reduced to five elemental manipulation motions:

1. reach & orient,2. grasp & hold/cut, 3. push, 4. pull, and 5. release.

The intention for automated needle holder is to all the subtasks listed above to a one simple task before a knot is taken achieving precision, speed, accuracy and safety.

OBJECTS OF THE INVENTION:

The invention generally relates to suturing of various tissues like pedicle of any organ, tissues, intestines, blood vessels; in open surgery as well as laparoscopically; incorporating self moving ½ circle needle through the tissue at correct angle and depth for the suturing to take effect without any difficult manoeuvres mimicking the steps as is done in surgery to achieve the intended results.

An object of this invention is to provide a device to assist a surgeon in efficiently suturing tissue as a prelude to a surgical operation.

Another object of this invention is to provide a device to assist a surgeon in efficiently suturing tissues such as blood vessels, Intestine, fascias, muscles and vascular pedicles of any size in a fast, accurate and easy manner for junior surgeons and novices to senior and experienced surgeons for both Open as well as laparoscopic Surgery.

Yet another other objective is to facilitate accurate suturing in difficult to reach areas and tissues during the surgery. It simplifies and automates task and motion steps as is understood by task analysis.

Still another objective is to facilitate accurate suturing with adequate gripping without slipping in a blood-filled environment

SUMMARY OF THE INVENTION:

According to this invention, there is provided an automated needle holder and suturing device comprising:

an arcuate jaw member with an operative frontal open sector, said arcuate jaw member comprises a curvature defined by a body such that said curvature is in correlation with the curvature of a curved needle adapted to be used with said device, said arcuate jaw member comprises a slotted guide for said curved needle to be located and guided through said slotted guide;

at least a curved needle adapted to be angularly displaced along the slotted guide of the arcuate jaw member;

at least a needle mover assembly adapted to engage with said needle in a frictional manner;

at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said pinion wheel is adapted to move in an axially upwards and downward manner apart from linear engagement with said rack element, said upward and downward movement being provided in order to engage said needle mover assembly and to disengage said needle mover assembly, respectively, and said at least a rack and pinion assembly further characterised, in that, said at least a rack element being adapted to engage with said pinion wheel;

at least a piston element adapted to be linearly slide-able along its longitudinal axis, said piston element being triggered by at least a trigger assembly;

at least a biasing element with an operative proximal end and an operative distal end, said operative proximal end of said biasing element being coupled with said piston element, said biasing element comprises a laterally located slotted profile in order to guide at least a plunger, said biasing element being linearly slide-able as well as angularly displaceable as per said piston element movement, said operative distal end of said biasing element being coupled with said rack element; and

at least a plunger with an operative proximal end and an operative distal end with a pivoting point in between.

Typically, said arcuate jaw member comprises a slotted guide, on its operative top surface, for said curved needle to be located and guided through said slotted guide.

Typically, said arcuate jaw member comprises a slotted guide, on its operative top surface, for said curved needle to be located and guided through said slotted guide, characterised, in that, said slotted guide being defined by a race and / or ball bearings.

Typically, said arcuate jaw member comprises a curvilinear access slot along said arcuate jaw member's operative inner circumference.

Typically, said arcuate jaw member comprises a curvilinear access slot along said arcuate jaw member's operative inner circumference, characterised, in that, said curvilinear access slot is parallel to an already defined slotted guide of said arcuate jaw member.

Typically, said arcuate jaw member comprises a collapsible segmented jaw assembly, characterised, in that the segments comprise at least two lateral opposite facing sector elements and a third sector element located between the at least two lateral opposite facing sector elements, said at least two lateral opposite facing sector elements being collapsible jaws, in that their operative distal ends converge towards each other in response to a collapsing trigger by associated elements of said device.

Typically, said needle mover assembly is a sector element defined in a manner such that its arc-end engages with a pre-defined portion of the curved needle at its tip according to a first engagement cycle and further engages with a pre defined portion of the curved needle at its end according to a second engagement cycle.

Typically, said sector element comprises at least an operative top pincher mechanism and an operative bottom pincher mechanism, said operative top pincher mechanism as well as said bottom pincher mechanism work towards securing a grip on the needle in order to articulate its curvilinear movement (or angular displacement).

Typically, said sector element comprises at least an operative top pincher mechanism and an operative bottom pincher mechanism, said operative top pincher mechanism as well as said bottom pincher mechanism work towards securing a grip on the needle in order to articulate its curvilinear movement (or angular displacement), characterised, in that, said operative bottom pincher mechanism is a still assembly, in that, it is angularly displaceable but does not have any other movement.

Typically, said sector element comprises at least an operative top pincher mechanism and an operative bottom pincher mechanism, said operative top pincher mechanism as well as said bottom pincher mechanism work towards securing a grip on the needle in order to articulate its curvilinear movement (or angular displacement), characterised, in that, said operative top pincher mechanism is angularly displaceable in a first direction correlating with the angular displacement direction of said needle and is also moveable in a manner such that it moves to pinch said needle in said slotted guide from the top in a second angular displacement direction which is a partial roll degree of freedom.

Typically, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said pinion wheel being substantially centrally located with respect to said arcuate jaw member, generally and further being co-axial to said arcuate jaw member.

Typically, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said pinion wheel comprises teeth which are smaller in length than teeth on said rack element in order to ensures that, although, said pinion wheel moves axially upwards or downwards, it does not lose engagement with said rack teeth.

Typically, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, operative rear side of said rack element comprises a slot adapted to receive a boss protruding from said biasing element in order to allow play of movement, said lot length being pre-calculated in terms of allowable linear play. Typically, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said needle mover assembly moves from its initial resting disengaged position to its engaged position by an axial operative upward movement of said pinion wheel.

Typically, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said needle mover assembly comprises a slot at its operative outer side, which slot matches or is at least bigger than width of said curve needle and curvature to ensure slippage-free engagement.

Typically, said device comprises at least a trigger assembly adapted to articulate movement of said needle from its first position to its second diametrically opposite position, said trigger assembly comprises an elongate shaft which linearly displaces in an operative forward and an operative backward direction in response to trigger actions.

Typically, said device comprises at least a trigger assembly adapted to articulate movement of said needle from its first position to its second diametrically opposite position, said trigger assembly comprises an elongate shaft having an operative proximal assembly coupled to a trigger and an operative distal mechanism coupled to said biasing element.

Typically, said piston element being triggered by at least a trigger assembly, in that a first trigger action causes said piston to move in an operative backward direction and a second trigger action causes said piston to move in an operative forward direction

Typically, said plunger being a rocker arm with an intermittent pivoting point about which it rocks operatively upward and operatively downward, in that, its operative proximal end engages with a pre-defined profile slotted in said cam.

Typically, said plunger being a rocker arm with an intermittent pivoting point about which it rocks operatively upward and operatively downward, in that, its operative operative distal end being configured to move in correlation with the defined slot profile of said cam. Typically, said device comprises at least a gear, at least a clutch, and at least a spacer; coaxially located on a pin, said pin being substantially co-axial with said arcuate jaw assembly and stemming from a portion of said device which encloses said biasing element, said rack element, and said pinion wheel, said pin also being used to hold said pinion wheel in a co-axial manner.

Typically, said device comprises at least a link extending from a gear, said link being coupled at one end to said gear and at its other end to said sector element, characterised, in that, said link enabling frictional engagement of said sector element with said needle and further disenabling frictional engagement with said sector element in response to trigger actions, and particularly in response to upward movement of pinion wheel and downward movement of pinion wheel, respectively.

Typically, a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein said biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a first path defined by a first half of the slotted profile in response to pressing a first trigger action, thereby articulating movement of said needle mover assembly from its first position (where it is engaged with the tip of said needle which is located in the outside half of said arcuate jaw assembly) and to its second position (where it is still engaged with the tip of said needle which is now located in the inside half of said arcuate jaw assembly), and wherein said curved needle traverses from its first position (outside half of said arcuate jaw assembly) to its diagonally opposite second position (inside half of said arcuate jaw assembly).

Typically, a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a first path defined by a first half of the slotted profile in response to releasing a first trigger action, thereby articulating movement of said needle mover assembly from its second position (where it is now disengaged near the tip of said needle which is located in the inside half of said arcuate jaw assembly) and to its first position (where it shall now engage with the rear of said needle which is now located in the inside half of said arcuate jaw assembly), in a direction of travel which is opposite to the direction of needle travel), and wherein said curved needle remains stationary.

Typically, a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein said biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a second path defined by a second half of the slotted profile in response to pressing a second trigger action, thereby articulating movement of said needle mover assembly from its first position (where it is engaged with the rear of said needle which is located in the inside half of said arcuate jaw assembly) and to its second position (where it is still engaged with the rear of said needle which is now located in the outside half of said arcuate jaw assembly), and wherein said curved needle traverses from its second position (inside half of said arcuate jaw assembly to its diagonally opposite first position (outside half of said arcuate jaw assembly).

Typically, a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a second path defined by a second half of the slotted profile in response to releasing a second trigger action, thereby articulating movement of said needle mover assembly from its second position (where it is now disengaged near the rear of said needle which is located in the outside half of said arcuate jaw assembly) and to its first position (where it shall now engage with the tip of said needle which is now located in the outside half of said arcuate jaw assembly), in a direction of travel which is opposite to the direction of needle travel, and wherein said curved needle remains stationary.

Typically, said trigger assembly is a spring loaded trigger assembly.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

The invention will now be described in relation to the accompanying drawings, in which:

Figures 1 to 9 illustrate various views of the automated needle holder and suturing device; Figure 10 illustrates a slotted profile of a biasing element of the automated needle holder and suturing device;

Figure 11 illustrates an isometric close-up view of one embodiment of the automated needle holder and suturing device;

Figure 12 illustrates an isometric close-up view of an alternative embodiment of the automated needle holder and suturing device; and

Figures 13 and 14 illustrate the collapsible jaw assembly of the automated needle holder and suturing device.

DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

According to this invention, there is provided an automated needle holder and suturing device.

Figures 1 to 9 illustrate various views of the automated needle holder and suturing device.

Figure 10 illustrates a slotted profile of a biasing element of the automated needle holder and suturing device.

Figure 1 1 illustrates an isometric close-up view of one embodiment of the automated needle holder and suturing device.

Figure 12 illustrates an isometric close-up view of an alternative embodiment of the automated needle holder and suturing device.

In accordance with an embodiment of this invention, there is provided an arcuate jaw member (12) with an operative frontal open sector. The arcuate jaw member comprises a curvature defined by a body such that the curvature is in correlation with the curvature of a curved needle (10) adapted to be used with the device of this invention. The open sector, typically, is relatively lesser than a semicircle. The arcuate jaw member provides a slotted guide (13) (Figure 1 1), on its operative top surface, for the curved needle to be located and guided through the slot. This slotted guide may be defined by a race and / or ball bearings (14). The needle is adapted to be angularly displaced along the slotted guide of the arcuate jaw member. The needle angularly traverses to complete a full circular path in two discrete steps. These steps are in synchronisation in response to two trigger actions which form a part of the device of this invention.

In at least an alternative embodiment, the arcuate jaw member (12') further comprises a curvilinear access slot (15) (Figure 12) along the arcuate jaw member's operative inner circumference. This is parallel to the already defined slotted guide of the arcuate jaw member.

In at least an additional embodiment of this invention, the arcuate jaw assembly is a collapsible segmented jaw assembly (40), in that the segments (41, 43, 45)) comprise at least two lateral opposite facing sector elements (41 , 43) and a third sector element (45) located between the at least two lateral opposite facing sector elements. These at least two lateral opposite facing sector elements are collapsible jaws, in that their operative distal ends converge towards each other in response to a collapsing trigger by associated elements of this device. This allows the arcuate jaw assembly to reach a smaller diameter so that it can enter ports of the human body, which ports are smaller in diameter than the operational diameter of the arcuate jaw assembly of this invention.

In response to a first trigger action, in at least one embodiment of this invention, the needle (10) traverses angularly to be displaced from its first position to its second diametrically opposite position (as seen through Figures 1 , 2, and 3 in the accompanying drawings).

In response to a second trigger action, in at least one embodiment of this invention, the needle (10) traverses angularly to be displaced from its second position back to its first diametrically opposite (original) position (as seen through Figures 3 and 4 in the accompanying drawings). Thus, two trigger actions complete one stitch cycle for a needle; one stitch cycle being entering a tissue and exiting a tissue. In accordance with another embodiment of this invention, there is provided a needle mover assembly (16) adapted to engage with the needle in a frictional manner.

In at least one embodiment, the needle mover assembly (16) is a sector element defined in a manner such that its arc-end engages with a pre-defined portion of the curved needle at its tip according to a first engagement cycle and further engages with a pre defined portion of the curved needle at its end according to a second engagement cycle. The needle mover assembly moves from its initial resting disengaged position to its engaged position by an axial operative upward movement of a pinion wheel. In its engaged position, it imparts pressure on to the needle, laterally, to enable friction locking of the needle against the inner circumference of the arcuate jaw member. The needle mover assembly comprises a slot at its operative outer side, which slot matches or is at least bigger than needle width and curvature to ensure slippage-free engagement.

In at least one other embodiment, the needle mover assembly (16) is a sector element comprising at least an operative top pincher mechanism (21) and an operative bottom pincher mechanism (23). Both, the operative top pincher mechanism as well as the bottom pincher mechanism work towards securing a grip on the needle in order to articulate its curvilinear movement (or angular displacement). Typically, the operative bottom pincher mechanism is a still assembly, in that, it is angularly displaceable but does not have any other movement. Typically, the operative top pincher mechanism is angularly displaceable in a first direction correlating with the angular displacement direction of the needle and is also moveable in a manner such that it moves to pinch the needle in the slotted guide from the top in a second angular displacement direction which is a partial roll degree of freedom.

In accordance with yet another embodiment of this invention, there is provided a pinion wheel (18). The pinion wheel is substantially centrally located with respect to the arcuate jaw member, generally. The pinion wheel is co-axial to the arcuate jaw member. The pinion wheel moves in an axially upwards and downward manner, too, apart from the linear engagement with a rack element. This upward and downward movement is to engage the needle mover assembly (16) and to disengage the needle mover assembly.

In accordance with still another embodiment of this invention, there is provided a rack element (22) adapted to engage with the pinion wheel (18). The pinion wheel comprises teeth which are smaller in length than the teeth on the rack element. This ensures that, although, the pinion moves axially upwards or downwards, it does not lose engagement with the rack teeth. The operative rear side of the rack element comprises a slot (32) (as seen in Figure 8 of the accompanying drawings) adapted to receive a boss (34) (as seen in Figure 8 of the accompanying drawings) protruding from the biasing element in order to allow play of movement. The slot length is pre-calculated in terms of allowable linear play.

In accordance with an additional embodiment of this invention, there is provided a piston element (24) adapted to be linearly slide-able along its longitudinal axis. The piston element is triggered by a trigger assembly (35) (Figures 13 and 14), in that a first trigger action causes the piston to move in an operative backward direction and a second trigger action causes the piston to move in an operative forward direction.

In accordance with yet an additional embodiment of this invention, there is provided a biasing element (26) with an operative proximal end and an operative distal end. The operative proximal end of the biasing element is coupled with the piston element (24). The biasing element comprises a laterally located slotted profile (27) (clearly seen in Figure 10 of the accompanying drawings) in order to guide further assemblies. The biasing element is linearly slide-able as per the piston element movement. The operative distal end of the biasing element is coupled with the rack element.

In accordance with still an additional embodiment of this invention, there is provided a plunger (28) with an operative proximal end and an operative distal end with a pivoting point in between. In other words, the plunger is a rocker arm with an intermittent pivoting or rocking point about which it rocks operatively upward and operatively downward. The operative proximal end engages with a pre-defined profile slotted in the cam. The plunger, in general, and the operative distal end of the plunger, specifically, moves in correlation with the defined slot profile of the cam.

In accordance with another additional embodiment of this invention, there is provided a trigger assembly (35) adapted to articulate movement of the needle as disclosed above, i.e. from its first position to its second diametrically opposite position. The trigger assembly comprises an elongate shaft which linearly displaces in an operative forward and an operative backward direction in response to trigger actions. This elongate shaft has an operative proximal assembly coupled to a trigger and an operative distal mechanism coupled to the biasing element (26).

In accordance with yet another additional embodiment of this invention, there is provided a gear (37), a clutch (38), and a spacer (39); coaxially located on a pin (40). The pin is substantially co-axial with the arcuate jaw assembly and stems from a portion of the device which encloses the biasing element, the rack, and the pinion. The pin is also used to hold the pinion wheel (18) in a co-axial manner, as disclosed above.

In accordance with still another additional embodiment of this invention, there is provided a link (42) extending from the gear (37). This link is advantageously coupled with the sector element, in that, the link enables frictional engagement of the sector element with the needle and further disenabling frictional engagement with the sector element in response to trigger actions, and particularly in response to upward movement of pinion wheel and downward movement of pinion wheel, respectively.

Referring to Figure 10 of the accompanying drawings, the slotted profile of the biasing element (26) is clearly shown and marked with reference numerals A, A', B, and B'. The steps of working are explained below:

Starting from rest, the plunger is at point A'. At this time, the needle is in the outside half of the arcuate jaw assembly. The piston is completely extended. The plunger is completely extended. The trigger is completely extended and is in its natural resting position.

The trigger is first pressed fully. The plunger moves relatively from point A' to point A to point B. The trigger is spring loaded. While the plunger moves relatively from point A' to point A, second spring gets compressed, piston retracts, biasing element retracts. When the biasing element reaches point A, it engages with the rack element at its piston end. The plunger rocks about its pivoting point, in that, its distal portion is lifted upwards. This enables movement of gear on the teeth of the rack. The link opens up to push the needle mover assembly. The needle mover assembly moves up and compresses the needle against the race of the arcuate jaw assembly. First spring gets compressed. Further ahead, while the plunger moves from point A to point B, the piston retracts further, the biasing element retracts further, and the rack starts retracting, thereby moving the pinion. The pinion starts angularly displacing, which, in turn angularly displaces the spacer, clutch, and link, thereby angularly displacing the needle mover assembly which is frictionally engaged with the needle. Therefore, the needle starts angularly displacing along the inner race of the arcuate jaw assembly due to compression. The plunge is in rocker position at point A. The needle mover assembly moves to its second diametrically opposite position (i.e. inside half of the arcuate jaw assembly).

The trigger is now released. The plunger moves relatively from point B to point B' to point A'. While the plunger moves relatively from point B to point B', second spring gets released, plunger which was is rocked position of point B, moves from point B to point B'. The piston moves further ahead, the biasing element moves further ahead. The rack element is steady. The biasing element moves in the slot of rack, freely. The rocker arm rocks downwards. Consequentially, the gear, the spacer, and the clutch move downwards. The link retracts as it has not engaging force acting upon it. The needle mover assembly angularly displaces to its original position. First spring is released. The biasing element is engaged with the rack element at its gear end. While the plunger moves relatively from point B' to point A', the piston moves further ahead and second spring is released (decompressed). As the biasing element moves further, the rack element moves further. The gear angularly displaces and the needle mover assembly angularly displaces without needle by 180 degrees (anticlockwise). The needle is in the inner half of the arcuate jaw assembly.

One stitch = 2 triggers = 2*relative movement of plunger across slotted profile(point A' - point A - point B - point B' - point A').

Further, springs are advantageously located in the assembly to aid certain pre-defined actions.

While this detailed description has disclosed certain specific embodiments of the present invention for illustrative purposes, various modifications will be apparent to those skilled in the art which do not constitute departures from the spirit and scope of the invention as defined in the following claims, and it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

Claims

Claims,

1. An automated needle holder and suturing device comprising:

2. An automated needle holder and suturing device as claimed in claim 1 wherein, said arcuate jaw member comprises a slotted guide, on its operative top surface, for said curved needle to be located and guided through said slotted guide.

3. An automated needle holder and suturing device, said arcuate jaw member comprises a slotted guide, on its operative top surface, for said curved needle to be located and guided through said slotted guide, characterised, in that, said slotted guide being defined by a race and / or ball bearings.

4. An automated needle holder and suturing device as claimed in claim 1 wherein, said arcuate jaw member comprises a curvilinear access slot along said arcuate jaw member's operative inner circumference.

5. An automated needle holder and suturing device as claimed in claim 1 wherein, said arcuate jaw member comprises a curvilinear access slot along said arcuate jaw member's operative inner circumference, characterised, in that, said curvilinear access slot is parallel to an already defined slotted guide of said arcuate jaw member.

6. An automated needle holder and suturing device as claimed in claim 1 wherein, said arcuate jaw member comprises a collapsible segmented jaw assembly, characterised, in that the segments comprise at least two lateral opposite facing sector elements and a third sector element located between the at least two lateral opposite facing sector elements, said at least two lateral opposite facing sector elements being collapsible jaws, in that their operative distal ends converge towards each other in response to a collapsing trigger by associated elements of said device.

7. An automated needle holder and suturing device as claimed in claim 1 wherein, said needle mover assembly is a sector element defined in a manner such that its arc-end engages with a pre-defined portion of the curved needle at its tip according to a first engagement cycle and further engages with a pre defined portion of the curved needle at its end according to a second engagement cycle.

8. An automated needle holder and suturing device as claimed in claim 1 wherein, said sector element comprises at least an operative top pincher mechanism and an operative bottom pincher mechanism, said operative top pincher mechanism as well as said bottom pincher mechanism work towards securing a grip on the needle in order to articulate its curvilinear movement (or angular displacement).

9. An automated needle holder and suturing device as claimed in claim 1 wherein, said sector element comprises at least an operative top pincher mechanism and an operative bottom pincher mechanism, said operative top pincher mechanism as well as said bottom pincher mechanism work towards securing a grip on the needle in order to articulate its curvilinear movement (or angular displacement), characterised, in that, said operative bottom pincher mechanism is a still assembly, in that, it is angularly displaceable but does not have any other movement.

10. An automated needle holder and suturing device as claimed in claim 1 wherein, said sector element comprises at least an operative top pincher mechanism and an operative bottom pincher mechanism, said operative top pincher mechanism as well as said bottom pincher mechanism work towards securing a grip on the needle in order to articulate its curvilinear movement (or angular displacement), characterised, in that, said operative top pincher mechanism is angularly displaceable in a first direction correlating with the angular displacement direction of said needle and is also moveable in a manner such that it moves to pinch said needle in said slotted guide from the top in a second angular displacement direction which is a partial roll degree of freedom.

1 1. An automated needle holder and suturing device as claimed in claim 1 wherein,, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said pinion wheel being substantially centrally located with respect to said arcuate jaw member, generally and further being co-axial to said arcuate jaw member.

12. An automated needle holder and suturing device as claimed in claim 1 wherein, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said pinion wheel comprises teeth which are smaller in length than teeth on said rack element in order to ensures that, although, said pinion wheel moves axially upwards or downwards, it does not lose engagement with said rack teeth.

13. An automated needle holder and suturing device as claimed in claim 1 wherein, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, operative rear side of said rack element comprises a slot adapted to receive a boss protruding from said biasing element in order to allow play of movement, said lot length being pre-calculated in terms of allowable linear play.

14. An automated needle holder and suturing device as claimed in claim 1 wherein, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said needle mover assembly moves from its initial resting disengaged position to its engaged position by an axial operative upward movement of said pinion wheel.

15. An automated needle holder and suturing device as claimed in claim 1 wherein, said at least a rack and pinion assembly comprises at least rack element and at least a pinion wheel, characterised, in that, said needle mover assembly comprises a slot at its operative outer side, which slot matches or is at least bigger than width of said curve needle and curvature to ensure slippage-free engagement.

16. An automated needle holder and suturing device as claimed in claim 1 wherein, said device comprises at least a trigger assembly adapted to articulate movement of said needle from its first position to its second diametrically opposite position, said trigger assembly comprises an elongate shaft which linearly displaces in an operative forward and an operative backward direction in response to trigger actions.

17. An automated needle holder and suturing device as claimed in claim 1 wherein, said device comprises at least a trigger assembly adapted to articulate movement of said needle from its first position to its second diametrically opposite position, said trigger assembly comprises an elongate shaft having an operative proximal assembly coupled to a trigger and an operative distal mechanism coupled to said biasing element.

18. An automated needle holder and suturing device as claimed in claim 1 wherein, said piston element being triggered by at least a trigger assembly, in that a first trigger action causes said piston to move in an operative backward direction and a second trigger action causes said piston to move in an operative forward direction

19. An automated needle holder and suturing device as claimed in claim 1 wherein, said plunger being a rocker arm with an intermittent pivoting point about which it rocks operatively upward and operatively downward, in that, its operative proximal end engages with a pre-defined profile slotted in said cam.

20. An automated needle holder and suturing device as claimed in claim 1 wherein, said plunger being a rocker arm with an intermittent pivoting point about which it rocks operatively upward and operatively downward, in that, its operative operative distal end being configured to move in correlation with the defined slot profile of said cam.

21. An automated needle holder and suturing device as claimed in claim 1 wherein, said device comprises at least a gear, at least a clutch, and at least a spacer; coaxially located on a pin, said pin being substantially co-axial with said arcuate jaw assembly and stemming from a portion of said device which encloses said biasing element, said rack element, and said pinion wheel, said pin also being used to hold said pinion wheel in a co-axial manner.

22. An automated needle holder and suturing device as claimed in claim 1 wherein, said device comprises at least a link extending from a gear, said link being coupled at one end to said gear and at its other end to said sector element, characterised, in that, said link enabling frictional engagement of said sector element with said needle and further disenabling frictional engagement with said sector element in response to trigger actions, and particularly in response to upward movement of pinion wheel and downward movement of pinion wheel, respectively.

23. An automated needle holder and suturing device as claimed in claim 1 wherein, a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein said biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a first path defined by a first half of the slotted profile in response to pressing a first trigger action, thereby articulating movement of said needle mover assembly from its first position (where it is engaged with the tip of said needle which is located in the outside half of said arcuate jaw assembly) and to its second position (where it is still engaged with the tip of said needle which is now located in the inside half of said arcuate jaw assembly), and wherein said curved needle traverses from its first position (outside half of said arcuate jaw assembly) to its diagonally opposite second position (inside half of said arcuate jaw assembly).

24. An automated needle holder and suturing device as claimed in claim 1 wherein, wherein a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a first path defined by a first half of the slotted profile in response to releasing a first trigger action, thereby articulating movement of said needle mover assembly from its second position (where it is now disengaged near the tip of said needle which is located in the inside half of said arcuate jaw assembly) and to its first position (where it shall now engage with the rear of said needle which is now located in the inside half of said arcuate jaw assembly), in a direction of travel which is opposite to the direction of needle travel), and wherein said curved needle remains stationary.

25. An automated needle holder and suturing device as claimed in claim 1 wherein, wherein a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein said biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a second path defined by a second half of the slotted profile in response to pressing a second trigger action, thereby articulating movement of said needle mover assembly from its first position (where it is engaged with the rear of said needle which is located in the inside half of said arcuate jaw assembly) and to its second position (where it is still engaged with the rear of said needle which is now located in the outside half of said arcuate jaw assembly), and wherein said curved needle traverses from its second position (inside half of said arcuate jaw assembly to its diagonally opposite first position (outside half of said arcuate jaw assembly).

26. An automated needle holder and suturing device as claimed in claim 1 wherein, wherein a single suture or a single stitch is effected by a first trigger action and a second trigger action, cumulatively, and wherein biasing element comprises a slotted profile, characterised, in that, said profile characterises motion of said plunger, in that, said plunger is relatively guided by said profile such that it traverses a second path defined by a second half of the slotted profile in response to releasing a second trigger action, thereby articulating movement of said needle mover assembly from its second position (where it is now disengaged near the rear of said needle which is located in the outside half of said arcuate jaw assembly) and to its first position (where it shall now engage with the tip of said needle which is now located in the outside half of said arcuate jaw assembly), in a direction of travel which is opposite to the direction of needle travel, and wherein said curved needle remains stationary.

27. An automated needle holder and suturing device as claimed in claim 1 wherein, said trigger assembly is a spring loaded trigger assembly.