WO2024105693A1 - A surgical tissue fastener - Google Patents
A surgical tissue fastener Download PDFInfo
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- WO2024105693A1 WO2024105693A1 PCT/IN2023/051054 IN2023051054W WO2024105693A1 WO 2024105693 A1 WO2024105693 A1 WO 2024105693A1 IN 2023051054 W IN2023051054 W IN 2023051054W WO 2024105693 A1 WO2024105693 A1 WO 2024105693A1
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- Prior art keywords
- tissue
- arms
- surgical fastener
- capturing
- pairs
- Prior art date
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- 230000000149 penetrating effect Effects 0.000 claims abstract description 11
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00893—Material properties pharmaceutically effective
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
Definitions
- the present disclosure generally relates to the technical field of surgical instruments, and in particular relates to, a novel surgical tissue fastener for closing wounds.
- Surgical staplers are also used to close wounds.
- Staplers are quick, convenient, and easy to apply.
- Staplers are usually of two types: metals that are non-biodegradable and polymers that are biodegradable.
- Metal wound closure staplers are usually made of stainless steel. Advantages of the same include quick placement, minimal tissue reaction, low risk of infection, and strong wound closure. But metal staples are usually painful and need to be removed as they are not biodegradable. Sometimes it also leaves "rail-road" scars.
- the stapler doesn't have a mechanism for capturing the perfect amount of tissue for the dimension and design of the staple, which many a times, captures a greater or lesser amount of tissue than the ideal. Capturing a greater amount of tissue than the required amount leads to pressure necrosis and subsequent scarring. On the other side, capturing a lesser amount of tissue than ideal may lead to loose closure and subsequent opening and widening of the wound.
- the other issue with the metal skin staplers is that there is no indicator or guidance mechanism to guide the surgeon during the application, which may lead to misaligned wound edges. Because of the design of the metal staple, it poses a significant risk of damaging the tissue while entering them. The biggest drawback is that these staplers lack versatility; there aren't different sizes for different applications.
- Polymeric skin staplers are intuitive, fast, and relatively easy to use. Polymeric staples do not need to be removed as they are biodegradable. The biggest disadvantage of this type of stapler is its significantly lower tensile strength. Moreover, the currently available staples don't have a closed loop to securely capture the tissue. Because of this, it is not suitable for high-tension wound closures. The deeper layer must be closed with some other tension-reducing method in order to use the polymeric staplers. Other disadvantages include high cost, highly inflammatory degradation products, and sometimes protrusion of the staple out of the wound.
- a bi-layer closure refers to closing the wound in two separate layers, first the deep dermis layer and then the superficial layer.
- the deep layer is the more important of the two as it provides the necessary strength to keep the integrity of the wound intact, takes tension off the superficial skin sutures and skin edges, reduces dead space, causes skin edge eversion, gives a better cosmetic outcome, and prevents other wound complications.
- a surgical wound can also be closed by a single-layer closure where, closing only the superficial layer or the deep layer alone or by taking bi-layer equivalent sutures, but it is generally recommended to close surgical wounds in the conventional bi-layer method in moderate- to high-stress wounds. The final decision is taken by the operating surgeon after assessing several parameters of the wound that is to be closed.
- the prior art document US7112214B2 discloses a dynamic bio-absorbable staple for use with a wound in living human tissue having opposed sides, the staple comprising a bio-absorbable staple body including a pair of staple arms operably joined at a shoulder portion by a backspin, each arm further including an elbow portion having an inwardly projecting cleat, the staple arms, the inwardly projecting cleats and the back-span defining an internal tissue capture zone; and each shoulder portion including an interior shoulder angle generally defined by the back-span and the staple arm, the shoulder portion constructed so that the interior shoulder angle is between 70°-100° in the first position at an insertion time, the interior shoulder angle transitioning to between 120°-180° in a second deformed position at a second time after the insertion time in response to lateral forces naturally exerted by the opposing sides of the wound and deformation of at least the shoulder portions of the bio- absorbable staple body caused by polymeric creep and
- tissue fasteners comprising an elongated central member having a proximal end and a distal end and opposed lateral sides, a plurality of frictional engagement elements extending outwardly from each lateral side such that the engagement members on a first lateral side are opposed to the engagement members extending outwardly from the other lateral side, each engagement member having a proximal end, a distal end, and a cross-sectional area, and each engagement member additionally having a distal tip extending from the distal end, wherein the tip has a cross-sectional area that is smaller than the cross-sectional area of the engagement member.
- US7004950B1 relates to a surgical fastener having a tissue spacer at its forward end.
- the spacer is inserted between the lateral sides of a wound to be closed and holds the tissue on the lateral sides of the wound apart while the tines of a staple are driven into the tissue margins and bent around the staple bending surface of the staple anvil to draw the tissue captured between the tines toward each other.
- the tissue spacer has a width greater than the width of the staple bending surface of the anvil and less than the distance between the tines of the staple in an unbent condition, such that when inserted between the lateral sides of the wound, it will space the facing tissue margins of the wound apart, a distance sufficient to provide a metered amount of tissue on the lateral sides of the wound that will be captured between the tines and drawn together as the tines are bent toward each other to close the wound without crushing or overlapping the captured tissue.
- polymeric skin staples are being used for wound closure.
- polymeric staples also have some drawbacks, the biggest drawback of this type of staple is that it has significantly lower tensile strength.
- the currently available staples don't have a closed loop to securely capture the tissue.
- Most biodegradable polymeric staples are not able to capture the tissue from deep inside the skin layer. This may result in loose connections between the tissue, which may not be able to handle the pressure and increase the chances of the wound opening. Because of this, it is not suitable for high-tension wound closures. The deeper layer must be closed with some other tension-reducing method in order to use the polymeric staplers.
- Other disadvantages include high cost, highly inflammatory degradation products, and sometimes protrusion of the staple out of the wound.
- the primary objective of the invention is to develop a surgical fastener that provides a safe and effective means for closing wounds.
- Another objective of the invention is to develop a surgical fastener that offers enhanced tensile strength compared to conventional surgical fasteners.
- Another objective of the invention is to develop a surgical fastener that can be easily configured to achieve desired degradation period.
- Another objective of the invention is to develop a surgical fastener that is capable of fastening tissue so that they cannot be slipped easily.
- Another objective of the invention is to develop a surgical fastener with a unique characteristic shape that allows the surgical fastener to have more surface area for capturing the tissue than sutures and any other alternatives, thus exerting less pressure on the tissue and thus, lessen the chances of pressure necrosis of the tissue.
- Another objective of the invention is to develop a surgical fastener that causes eversion of wounds, results in an enhanced cosmetic outcome, and prevents the inversion of the wounds and related complications.
- Another objective of the invention is to develop a surgical fastener that penetrates a tissue without any assistance from metal pins or needles, thereby eliminating the need for a separate mechanism to penetrate the tissue.
- Another objective of the invention is to develop a surgical fastener that has significant growth-promoting and anti-bacterial properties to promote significant healing and prevent infections.
- Another objective of the invention is to develop a surgical fastener that has antiinflammatory properties to prevent granulomatous tissue formation and causes a lesser inflammatory response than sutures and polymeric bio-absorbable fasteners.
- Yet another objective of the invention is to develop a surgical fastener in which plastic deformation is evenly distributed across the deformed length of the arms of the surgical fastener and is not localized at a single point.
- Further objective of the invention is to develop a surgical fastener that prevents accelerated single-point stress corrosion and single-point failure of the staple while also providing uniform degradation across the length and better integrity of the surgical fastener.
- the present disclosure proposes a surgical tissue fastener.
- the following presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key/critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.
- the present disclosure aims to solve the technical problem of providing a novel surgical fastener that provides a safe and effective technique to capture and fasten the dermal tissue for closing wounds.
- the invention provides a surgical fastener that offers enhanced tensile strength compared to conventional surgical fasteners.
- the surgical fastener provides easy load transfer and uniform stress distribution across the edges of the tissue, thereby removing stress from the skin edges.
- the surgical fastener is capable of capturing the tissue relative to the fastener's size to avoid complications.
- the surgical fastener can be easily tweaked to achieve the desired degradation period.
- the surgical fastener causes eversion of the wounds, results in an enhanced cosmetic outcome, and prevents the inversion of the wounds and related complications.
- the surgical fastener comprises two tissue-capturing zones opposite to each other significantly in a same plane.
- Each tissue-capturing zone is formed by a pair of arms.
- Each arm of the pairs of arms having two or more segments.
- at least two arms of the pairs of arms from either or the same tissue-capturing zone are connected at their respective bases, thereby forming a dual-axis symmetry substantially in the same plane in an ideal unfastened condition.
- the one or more segments of the arms of the pairs of arms in the same tissue-capturing zone are configured to move towards each other for penetrating and capturing the tissue in their respective tissue-capturing zones when the surgical fastener undergoes plastic deformation upon receiving forces by a surgical fastening device.
- the plastic deformation of the surgical fastener is evenly distributed across the deformed length of each arm of the pairs of arms instead of a localized single point.
- each arm of the pairs of arms comprise a sharp penetrative tip, which is configured to penetrate into the tissue.
- the sharp penetrative tips of the arms of the pairs of arms in the same tissue-capturing zones are configured to face inwardly towards each other, forming a gap through which the tissue enters into the respective tissue-capturing zones.
- At least one segment of the arms of the pair of arms in each tissue-capturing zone comprise a shape of at least one of, a straight configuration, an inwardly curved configuration or an outwardly curved configuration.
- the surgical fastener is made of a composition that contains biodegradable metal or metals in the form of an alloy.
- FIG. 1 illustrates a top view of a surgical fastener, in accordance to an example embodiment of the invention.
- FIG. 2 illustrates a top view of the surgical fastener before applying to dermal tissue, in accordance to an example embodiment of the invention.
- FIG. 3 illustrates a top view of the surgical fastener in a deformed state after applying to the dermal tissue, in accordance to an example embodiment of the invention.
- FIG. 4 illustrates a side view of a wound eversion after applying the surgical fastener to the dermal tissue, in accordance to an example embodiment of the invention.
- FIG. 5 illustrates a bottom view of the closed wound after applying the surgical fastener to the dermal tissue, in accordance to an example embodiment of the invention.
- FIG. 6 illustrates a top view of the closed wound after applying the surgical fastener to the dermal tissue, in accordance to an example embodiment of the invention.
- FIGs. 7A-7J illustrate schematic views of the surgical fastener in various configurations, in accordance to an example embodiment of the invention.
- FIG. 1 refers to a top view of a surgical fastener 100.
- the surgical fastener 100 offers enhanced tensile strength compared to conventional staples.
- the surgical fastener 100 provides easy load transfer and uniform stress distribution across the wound, thereby removing stress from the skin edges.
- the surgical fastener 100 is capable of capturing the required amount of the tissue relative to the size to avoid complications.
- the surgical fastener 100 can be easily tweaked to achieve the desired degradation profile.
- the surgical fastener 100 can be used to close wounds.
- Epidermis is the uppermost layer of skin and acts as a waterproof barrier.
- the epidermis is 0.1 mm to 0.3 mm thick on average.
- Dermis is below the epidermis and has tough connective tissue, mainly elastin, hair follicles, sweat glands, melanocytes, and some other protective cells.
- the dermis has an average thickness of at least 1 mm-3 mm.
- the dermis layer is the toughest and is responsible for the strength and the integrity of the skin. As the dermis layer is the main stress-bearing layer, most wound closure techniques involve the dermis layer for wound closure.
- the surgical fastener 100 is fastened in the dermis layer using a surgical fastening device, for example, a surgical stapler.
- the surgical fastener 100 comprises two tissue-capturing zones (102, 104) opposite to each other significantly in the same plane.
- Each tissuecapturing zone (102, 104) is formed by a pair of arms (106A, 106B, 108A, and 108B).
- Each arm of the pairs of arms (106A, 106B, 108A, and 108B) having two or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B).
- the at least two arms (106A, 106B, 108A, and 108B) of the pairs of arms (106A, 106B, 108A, and 108B) from either or the same tissue-capturing zone (102, 104) are connected at their respective bases, thereby forming a dual-axis symmetry substantially in the same plane in an ideal unfastened condition.
- the portions of the surgical fastener 100 are mirror images of each other through both the horizontal and vertical planes, which are formed by a horizontal axis X and a vertical axis Y, passing through the center point 110 of the surgical fastener 100 when seen from the top in a standard orientation as shown in FIG. 1.
- the surgical fastener 100 is made of a composition that contains biodegradable metal or metals in the form of an alloy.
- FIG. 2 refers to a top view of the surgical fastener 100 before applying to the tissue.
- at least one segment (112B, 113B, 114B, and 115B) of each arm of the pairs of arms (106A, 106B, 108A, and 108B) comprises a sharp penetrative tip (116A, 116B, 118A, and 118B), which is configured to penetrate into the tissue (12, 14).
- the sharp penetrative tips (116A, 116B, 118A, and 118B) of the arms of the pairs of arms (106A, 106B, 108A, and 108B) in the same tissue-capturing zones (102, 104) are configured to face inwardly towards each other, forming a gap through which the tissue (12, 14) enters into the respective tissue-capturing zones (102, 104).
- FIG. 3 refers to a top view of the surgical fastener 100 in a deformed state after applying to the tissue.
- the one or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the arms of the pairs of arms (106A, 106B, 108A, and 108B) in the same tissuecapturing zone (102, 104) are configured to move towards each other for penetrating and capturing the tissue (12, 14) in their tissue-capturing zones (102, 104) when the surgical fastener 100 undergoes plastic deformation upon receiving forces by the surgical fastening device.
- the plastic deformation of the surgical fastener 100 is evenly distributed across the deformed length of each arm of the pairs of arms (106A, 106B, 108A, and 108B) instead of a localized single point.
- the surgical fastener 100 is capable of capturing optimal amounts of the tissue (12, 14) in their respective tissue-capturing zones (102, 104), which provides high tensile strength for holding the wound.
- the one or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the arms of the pairs of arms (106A, 106B, 108A, and 108B) in the same tissue-capturing zone (102, 104) make a closed loop by which the tissue (12, 14) are held in place.
- FIGs. 4-6 refer to a side view, a bottom view and a top view of a closed wound after applying the surgical fastener 100 to the tissue.
- the surgical fastener 100 leads to eversion of the wound edges to provide superior cosmetic outcomes after surgery while also preventing inversion of the wound edges, as shown in FIGs. 4-6.
- the surgical fastener 100 allows easy load transfer and uniform stress distribution across the wound, which also removes the stress from the skin edges.
- FIGs. 7A-7J refer to the schematic views of the surgical fastener 100 in various configurations.
- the at least one segment (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the arms of the pair of arms (106A, 106B, 108A, and 108B) in each tissue-capturing zone (102, 104) comprises a shape of at least one of, a straight configuration, an inwardly curved configuration, or an outwardly curved configuration.
- At least two arms of said pairs of arms (106A, 106B, 108A, and 108B) from either or the same tissue-capturing zone (102, 104) are connected at their respective bases and are connected to the rest of the fastener by a bridge like structure.
- each arm of the pairs of arms (106A, 106B, 108A, and 108B) has three segments.
- at least one segment of the arms of the pairs of arms (106A, 106B, 108A, and 108B) has constant radius curvature.
- the surgical fastener 100 closes the wound edges and allows the wound to heal by degrading gradually over time. This allows greater flexibility and versatility for the surgical fastener 100 to be used in different shapes. The surgical fastener 100 is better suited for different types of tissue and surgical procedures.
- the novel surgical fastener 100 captures and fastens the dermal tissue to close the wounds.
- the surgical fastener 100 provides easy load transfer and uniform stress distribution across the wound, thereby removing stress from the skin edges.
- the surgical fastener 100 is capable of capturing the required amount of tissue (12, 14) relative to its size to avoid complications.
- the surgical fastener 100 can be easily tweaked to achieve the desired degradation profile.
- the surgical fastener 100 is capable of fastening the tissue (12, 14) so that it cannot be easily slipped.
- the surgical fastener 100 with a unique shape allows the surgical fastener 100 to have more surface area for capturing the tissue (12, 14) than sutures or any other alternatives, thus exerting less pressure on the tissue (12, 14) and lessens the chances of pressure necrosis of the tissue (12, 14).
- the surgical fastener 100 causes the eversion of the wound, results in an enhanced cosmetic outcome, and prevents the inversion of the wound and related complications.
- the surgical fastener 100 penetrates the tissue (12, 14) without any assistance from metal pins or needles, thereby eliminating the need for a separate mechanism to penetrate the tissue (12, 14).
- the surgical fastener 100 has significant growth-promoting and anti-bacterial properties to promote healing and prevent infections.
- the surgical fastener 100 has antiinflammatory properties to prevent granulomatous tissue formation and causes a lesser inflammatory response than sutures and polymeric bio-absorbable fasteners.
- the surgical fastener 100 prevents accelerated single-point stress corrosion and single-point failure of the surgical fastener 100 while also providing uniform degradation across the deformed length of the surgical fastener 100.
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Abstract
The present disclosure proposes a surgical fastener (100) for wound closure. The surgical fastener (100) comprises two tissue-capturing zones (102, 104) opposite each other significantly in the same plane. Each tissue-capturing zone (102, 104) is formed by a pair of arms (106A, 106B, 108A, and 108B). At least two arms of the pairs of arms (106A, 106B, 108A, and 108B) from the same tissue-capturing zone (102, 104) are connected at their respective bases, thereby forming a dual-axis symmetry substantially in the same plane in an ideal unfastened condition. Each arm of the pairs of arms (106A, 106B, 108A, and 108B) having two or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B), which are moved towards each other for penetrating and capturing tissue (12, 14) in their respective tissue-capturing zones (102, 104) when the surgical fastener (100) undergoes plastic deformation upon receiving forces by a surgical fastening device.
Description
A Surgical Tissue Fastener
DESCRIPTION:
Field of the invention:
[0001] The present disclosure generally relates to the technical field of surgical instruments, and in particular relates to, a novel surgical tissue fastener for closing wounds.
Background of the invention:
[0002] When an opening in tissue is created either through an intentional incision or an accidental wound or laceration, biological healing of the opening commences through the approximation of the tissue on either side of the wound. The ideal wound closure method should cause precise approximation along the skin edges, provide adequate strength to the wound, maintain uniform tensile strength along the wound, provide good eversion of the skin edges, provide good cosmetic results, and minimize wound complications like strangulation and necrosis of the tissue, infection of the wound, wound dehiscence, etc.
[0003] Wound closures are usually done with sutures, staplers, adhesives, or strips. Closure with sutures is generally time-consuming, tedious, and not easy to perform, for certain closure techniques. Another disadvantage of using a suture is possible strangulation and necrosis of tissue due to the high pressure exerted by the relatively small surface area of the suture and over-tightening of the suture in order to tie the suture snugly. Sutures are of two types: non-biodegradable and biodegradable. The disadvantages of using biodegradable sutures include very early loss of tensile strength of the sutures, inflammation by the degradation products of the suture, and subsequent granulomas in the tissue. The non- biodegradable sutures need to be removed after some days; if kept for longer periods, they may lead to scarring of the tissue.
[0004] Surgical staplers are also used to close wounds. Staplers are quick, convenient, and easy to apply. Staplers are usually of two types: metals that are non-biodegradable and polymers that are biodegradable. Metal wound closure staplers are usually made of stainless steel. Advantages of the same include quick placement, minimal tissue reaction, low risk of infection, and strong wound closure. But metal staples are usually painful and
need to be removed as they are not biodegradable. Sometimes it also leaves "rail-road" scars.
[0005] The biggest disadvantage of the same is that the stapler doesn't have a mechanism for capturing the perfect amount of tissue for the dimension and design of the staple, which many a times, captures a greater or lesser amount of tissue than the ideal. Capturing a greater amount of tissue than the required amount leads to pressure necrosis and subsequent scarring. On the other side, capturing a lesser amount of tissue than ideal may lead to loose closure and subsequent opening and widening of the wound. The other issue with the metal skin staplers is that there is no indicator or guidance mechanism to guide the surgeon during the application, which may lead to misaligned wound edges. Because of the design of the metal staple, it poses a significant risk of damaging the tissue while entering them. The biggest drawback is that these staplers lack versatility; there aren't different sizes for different applications.
[0006] Polymeric skin staplers are intuitive, fast, and relatively easy to use. Polymeric staples do not need to be removed as they are biodegradable. The biggest disadvantage of this type of stapler is its significantly lower tensile strength. Moreover, the currently available staples don't have a closed loop to securely capture the tissue. Because of this, it is not suitable for high-tension wound closures. The deeper layer must be closed with some other tension-reducing method in order to use the polymeric staplers. Other disadvantages include high cost, highly inflammatory degradation products, and sometimes protrusion of the staple out of the wound.
[0007] Further, adhesives and strips are non-penetrative alternatives for wound closure. But the biggest problem lies in its mechanism of approximating the wound edges. The wound edges are kept in place by a passive bridge created by the adhesive or the strip. It doesn't actively penetrate the tissue to make a closed loop. Hence, the tissue can't be securely captured and kept in place in moderate- to high-tension wounds. That's why this method of closure is reserved only for the superficial layer, where wound tension is minimal or almost non-existent. Another problem with adhesive and strips is that sometimes they elicit a
strong immune reaction to the adhesive used. Also, sometimes the adhesive gets rubbed off and weakens the closure.
[0008] The traditional methods for wound closure are bi-layer closure or single-layer closure. A bi-layer closure refers to closing the wound in two separate layers, first the deep dermis layer and then the superficial layer. The deep layer is the more important of the two as it provides the necessary strength to keep the integrity of the wound intact, takes tension off the superficial skin sutures and skin edges, reduces dead space, causes skin edge eversion, gives a better cosmetic outcome, and prevents other wound complications. A surgical wound can also be closed by a single-layer closure where, closing only the superficial layer or the deep layer alone or by taking bi-layer equivalent sutures, but it is generally recommended to close surgical wounds in the conventional bi-layer method in moderate- to high-stress wounds. The final decision is taken by the operating surgeon after assessing several parameters of the wound that is to be closed.
[0009] Many prior art documents disclose the wound closure fastener. The prior art document US7112214B2 discloses a dynamic bio-absorbable staple for use with a wound in living human tissue having opposed sides, the staple comprising a bio-absorbable staple body including a pair of staple arms operably joined at a shoulder portion by a backspin, each arm further including an elbow portion having an inwardly projecting cleat, the staple arms, the inwardly projecting cleats and the back-span defining an internal tissue capture zone; and each shoulder portion including an interior shoulder angle generally defined by the back-span and the staple arm, the shoulder portion constructed so that the interior shoulder angle is between 70°-100° in the first position at an insertion time, the interior shoulder angle transitioning to between 120°-180° in a second deformed position at a second time after the insertion time in response to lateral forces naturally exerted by the opposing sides of the wound and deformation of at least the shoulder portions of the bio- absorbable staple body caused by polymeric creep and adsorption of the bio-absorbable staple body in the living human tissue.
[0010] Another prior art document, US20200390441A1, relates to tissue fasteners, comprising an elongated central member having a proximal end and a distal end and
opposed lateral sides, a plurality of frictional engagement elements extending outwardly from each lateral side such that the engagement members on a first lateral side are opposed to the engagement members extending outwardly from the other lateral side, each engagement member having a proximal end, a distal end, and a cross-sectional area, and each engagement member additionally having a distal tip extending from the distal end, wherein the tip has a cross-sectional area that is smaller than the cross-sectional area of the engagement member.
[0011] Yet another prior art document, US7004950B1, relates to a surgical fastener having a tissue spacer at its forward end. The spacer is inserted between the lateral sides of a wound to be closed and holds the tissue on the lateral sides of the wound apart while the tines of a staple are driven into the tissue margins and bent around the staple bending surface of the staple anvil to draw the tissue captured between the tines toward each other. The tissue spacer has a width greater than the width of the staple bending surface of the anvil and less than the distance between the tines of the staple in an unbent condition, such that when inserted between the lateral sides of the wound, it will space the facing tissue margins of the wound apart, a distance sufficient to provide a metered amount of tissue on the lateral sides of the wound that will be captured between the tines and drawn together as the tines are bent toward each other to close the wound without crushing or overlapping the captured tissue.
[0012] The aforementioned prior arts are similar developments related to the field of the present invention. But there are many drawbacks to the available inventions for the surgical tissue fastener. The conventional surgical staplers are in traditional shapes made with metal material, which are painful for the patients during the wound healing period. Also, if the surgical tissue fasteners are not biodegradable, it is necessary to remove the fastener from the skin layer after the period of wound healing. Furthermore, the use of conventional fasteners also leaves scars on the outermost layer of the skin.
[0013] To overcome the drawbacks, polymeric skin staples are being used for wound closure. Although polymeric staples also have some drawbacks, the biggest drawback of this type of staple is that it has significantly lower tensile strength. Moreover, the currently
available staples don't have a closed loop to securely capture the tissue. Most biodegradable polymeric staples are not able to capture the tissue from deep inside the skin layer. This may result in loose connections between the tissue, which may not be able to handle the pressure and increase the chances of the wound opening. Because of this, it is not suitable for high-tension wound closures. The deeper layer must be closed with some other tension-reducing method in order to use the polymeric staplers. Other disadvantages include high cost, highly inflammatory degradation products, and sometimes protrusion of the staple out of the wound.
[0014] All the available wound closure inventions, like staplers, adhesives, strips, and similar products, are only capable of closing the superficial layer. While the deep layer in moderate- to high-stress wounds is closed by sutures only.
[0015] Therefore, there is a need for a novel surgical fastener that has improved properties over existing wound closure techniques to provide a safe and effective means of closing surgical wounds. There is also a need for a surgical fastener that is made of a biodegradable material that offers an enhanced balance of strength, biocompatibility, and biodegradability. There is also a need for a surgical fastener that has a unique design and desired mechanical properties which is suitable for closing the deep layer in conventional bilayer wound closures or can act as a single-layer wound closure technique, without the disadvantages of currently available wound closure modalities.
Objectives of the invention:
[0016] The primary objective of the invention is to develop a surgical fastener that provides a safe and effective means for closing wounds.
[0017] Another objective of the invention is to develop a surgical fastener that offers enhanced tensile strength compared to conventional surgical fasteners.
[0018] Another objective of the invention is to develop a surgical fastener that allows easy load transfer and uniform stress distribution across the wound and removes the stress from the skin edges.
[0019] Another objective of the invention is to develop a surgical fastener that is capable of capturing the required amount of tissue relative to the fastener's size to avoid complications.
[0020] Another objective of the invention is to develop a surgical fastener that can be easily configured to achieve desired degradation period.
[0021] Another objective of the invention is to develop a surgical fastener that is capable of fastening tissue so that they cannot be slipped easily.
[0022] Another objective of the invention is to develop a surgical fastener with a unique characteristic shape that allows the surgical fastener to have more surface area for capturing the tissue than sutures and any other alternatives, thus exerting less pressure on the tissue and thus, lessen the chances of pressure necrosis of the tissue.
[0023] Another objective of the invention is to develop a surgical fastener that causes eversion of wounds, results in an enhanced cosmetic outcome, and prevents the inversion of the wounds and related complications.
[0024] Another objective of the invention is to develop a surgical fastener that penetrates a tissue without any assistance from metal pins or needles, thereby eliminating the need for a separate mechanism to penetrate the tissue.
[0025] Another objective of the invention is to develop a surgical fastener that has significant growth-promoting and anti-bacterial properties to promote significant healing and prevent infections.
[0026] Another objective of the invention is to develop a surgical fastener that has antiinflammatory properties to prevent granulomatous tissue formation and causes a lesser inflammatory response than sutures and polymeric bio-absorbable fasteners.
[0027] Yet another objective of the invention is to develop a surgical fastener in which plastic deformation is evenly distributed across the deformed length of the arms of the surgical fastener and is not localized at a single point.
[0028] Further objective of the invention is to develop a surgical fastener that prevents accelerated single-point stress corrosion and single-point failure of the staple while also providing uniform degradation across the length and better integrity of the surgical fastener.
Summary of the invention:
[0029] The present disclosure proposes a surgical tissue fastener. The following presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key/critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.
[0030] In order to overcome the above deficiencies of the prior art, the present disclosure aims to solve the technical problem of providing a novel surgical fastener that provides a safe and effective technique to capture and fasten the dermal tissue for closing wounds.
[0031] According to one aspect, the invention provides a surgical fastener that offers enhanced tensile strength compared to conventional surgical fasteners. The surgical fastener provides easy load transfer and uniform stress distribution across the edges of the tissue, thereby removing stress from the skin edges. The surgical fastener is capable of capturing the tissue relative to the fastener's size to avoid complications. The surgical fastener can be easily tweaked to achieve the desired degradation period. The surgical fastener causes eversion of the wounds, results in an enhanced cosmetic outcome, and prevents the inversion of the wounds and related complications.
[0032] In one embodiment herein, the surgical fastener comprises two tissue-capturing zones opposite to each other significantly in a same plane. Each tissue-capturing zone is
formed by a pair of arms. Each arm of the pairs of arms having two or more segments. In one embodiment herein, at least two arms of the pairs of arms from either or the same tissue-capturing zone are connected at their respective bases, thereby forming a dual-axis symmetry substantially in the same plane in an ideal unfastened condition.
[0033] In one embodiment herein, the one or more segments of the arms of the pairs of arms in the same tissue-capturing zone are configured to move towards each other for penetrating and capturing the tissue in their respective tissue-capturing zones when the surgical fastener undergoes plastic deformation upon receiving forces by a surgical fastening device. In one embodiment herein, the plastic deformation of the surgical fastener is evenly distributed across the deformed length of each arm of the pairs of arms instead of a localized single point.
[0034] In one embodiment herein, at least one segment of each arm of the pairs of arms comprise a sharp penetrative tip, which is configured to penetrate into the tissue. The sharp penetrative tips of the arms of the pairs of arms in the same tissue-capturing zones are configured to face inwardly towards each other, forming a gap through which the tissue enters into the respective tissue-capturing zones.
[0035] In one embodiment herein, at least one segment of the arms of the pair of arms in each tissue-capturing zone comprise a shape of at least one of, a straight configuration, an inwardly curved configuration or an outwardly curved configuration.
[0036] In one embodiment herein, the surgical fastener is made of a composition that contains biodegradable metal or metals in the form of an alloy.
[0037] Further, objects and advantages of the present invention will be apparent from a study of the following portion of the specification, the claims, and the attached drawings.
Detailed description of drawings:
[0038] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate an embodiment of the invention, and, together with the description, explain the principles of the invention.
[0039] FIG. 1 illustrates a top view of a surgical fastener, in accordance to an example embodiment of the invention.
[0040] FIG. 2 illustrates a top view of the surgical fastener before applying to dermal tissue, in accordance to an example embodiment of the invention.
[0041] FIG. 3 illustrates a top view of the surgical fastener in a deformed state after applying to the dermal tissue, in accordance to an example embodiment of the invention.
[0042] FIG. 4 illustrates a side view of a wound eversion after applying the surgical fastener to the dermal tissue, in accordance to an example embodiment of the invention.
[0043] FIG. 5 illustrates a bottom view of the closed wound after applying the surgical fastener to the dermal tissue, in accordance to an example embodiment of the invention.
[0044] FIG. 6 illustrates a top view of the closed wound after applying the surgical fastener to the dermal tissue, in accordance to an example embodiment of the invention.
[0045] FIGs. 7A-7J illustrate schematic views of the surgical fastener in various configurations, in accordance to an example embodiment of the invention.
Detailed invention disclosure:
[0046] Various embodiments of the present invention will be described in reference to the accompanying drawings. Wherever possible, the same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps.
[0047] The present disclosure has been made with a view toward solving the problem with the prior art described above, and it is an object of the present invention to provide a novel surgical fastener that provides a safe and effective technique to capture and fasten the tissue.
[0048] According to an example embodiment of the invention, FIG. 1 refers to a top view of a surgical fastener 100. In one embodiment herein, the surgical fastener 100 offers enhanced tensile strength compared to conventional staples. The surgical fastener 100 provides easy load transfer and uniform stress distribution across the wound, thereby removing stress from the skin edges. The surgical fastener 100 is capable of capturing the required amount of the tissue relative to the size to avoid complications. The surgical fastener 100 can be easily tweaked to achieve the desired degradation profile. In one embodiment herein, the surgical fastener 100 can be used to close wounds.
[0049] Epidermis is the uppermost layer of skin and acts as a waterproof barrier. The epidermis is 0.1 mm to 0.3 mm thick on average. Dermis is below the epidermis and has tough connective tissue, mainly elastin, hair follicles, sweat glands, melanocytes, and some other protective cells. The dermis has an average thickness of at least 1 mm-3 mm. The dermis layer is the toughest and is responsible for the strength and the integrity of the skin. As the dermis layer is the main stress-bearing layer, most wound closure techniques involve the dermis layer for wound closure. The surgical fastener 100 is fastened in the dermis layer using a surgical fastening device, for example, a surgical stapler.
[0050] In one embodiment herein, the surgical fastener 100 comprises two tissue-capturing zones (102, 104) opposite to each other significantly in the same plane. Each tissuecapturing zone (102, 104) is formed by a pair of arms (106A, 106B, 108A, and 108B). Each arm of the pairs of arms (106A, 106B, 108A, and 108B) having two or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B). In one embodiment herein, the at least two arms (106A, 106B, 108A, and 108B) of the pairs of arms (106A, 106B, 108A, and 108B) from either or the same tissue-capturing zone (102, 104) are connected at their respective bases, thereby forming a dual-axis symmetry substantially in the same plane in an ideal unfastened condition.
[0051] In one embodiment herein, the portions of the surgical fastener 100 are mirror images of each other through both the horizontal and vertical planes, which are formed by a horizontal axis X and a vertical axis Y, passing through the center point 110 of the surgical fastener 100 when seen from the top in a standard orientation as shown in FIG. 1. In one embodiment herein, the surgical fastener 100 is made of a composition that contains biodegradable metal or metals in the form of an alloy.
[0052] According to an example embodiment of the invention, FIG. 2 refers to a top view of the surgical fastener 100 before applying to the tissue. In one embodiment herein, at least one segment (112B, 113B, 114B, and 115B) of each arm of the pairs of arms (106A, 106B, 108A, and 108B) comprises a sharp penetrative tip (116A, 116B, 118A, and 118B), which is configured to penetrate into the tissue (12, 14). The sharp penetrative tips (116A, 116B, 118A, and 118B) of the arms of the pairs of arms (106A, 106B, 108A, and 108B) in the same tissue-capturing zones (102, 104) are configured to face inwardly towards each other, forming a gap through which the tissue (12, 14) enters into the respective tissue-capturing zones (102, 104).
[0053] According to an example embodiment of the invention, FIG. 3 refers to a top view of the surgical fastener 100 in a deformed state after applying to the tissue. In one embodiment herein, the one or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the arms of the pairs of arms (106A, 106B, 108A, and 108B) in the same tissuecapturing zone (102, 104) are configured to move towards each other for penetrating and capturing the tissue (12, 14) in their tissue-capturing zones (102, 104) when the surgical fastener 100 undergoes plastic deformation upon receiving forces by the surgical fastening device. In one embodiment herein, the plastic deformation of the surgical fastener 100 is evenly distributed across the deformed length of each arm of the pairs of arms (106A, 106B, 108A, and 108B) instead of a localized single point.
[0054] In one embodiment herein, the surgical fastener 100 is capable of capturing optimal amounts of the tissue (12, 14) in their respective tissue-capturing zones (102, 104), which provides high tensile strength for holding the wound. In one embodiment herein, the one or
more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the arms of the pairs of arms (106A, 106B, 108A, and 108B) in the same tissue-capturing zone (102, 104) make a closed loop by which the tissue (12, 14) are held in place.
[0055] According to an example embodiment of the invention, FIGs. 4-6 refer to a side view, a bottom view and a top view of a closed wound after applying the surgical fastener 100 to the tissue. The surgical fastener 100 leads to eversion of the wound edges to provide superior cosmetic outcomes after surgery while also preventing inversion of the wound edges, as shown in FIGs. 4-6. In one embodiment herein, the surgical fastener 100 allows easy load transfer and uniform stress distribution across the wound, which also removes the stress from the skin edges.
[0056] According to another embodiment of the invention, FIGs. 7A-7J refer to the schematic views of the surgical fastener 100 in various configurations. In other embodiments, the at least one segment (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the arms of the pair of arms (106A, 106B, 108A, and 108B) in each tissue-capturing zone (102, 104) comprises a shape of at least one of, a straight configuration, an inwardly curved configuration, or an outwardly curved configuration. In another embodiment, at least two arms of said pairs of arms (106A, 106B, 108A, and 108B) from either or the same tissue-capturing zone (102, 104) are connected at their respective bases and are connected to the rest of the fastener by a bridge like structure. In another embodiment, each arm of the pairs of arms (106A, 106B, 108A, and 108B) has three segments. In another embodiment, at least one segment of the arms of the pairs of arms (106A, 106B, 108A, and 108B) has constant radius curvature. The surgical fastener 100 closes the wound edges and allows the wound to heal by degrading gradually over time. This allows greater flexibility and versatility for the surgical fastener 100 to be used in different shapes. The surgical fastener 100 is better suited for different types of tissue and surgical procedures.
[0057] Numerous advantages of the present disclosure may be apparent from the discussion above. In accordance with the present disclosure, the novel surgical fastener 100 captures and fastens the dermal tissue to close the wounds. The surgical fastener 100 provides easy load transfer and uniform stress distribution across the wound, thereby
removing stress from the skin edges. The surgical fastener 100 is capable of capturing the required amount of tissue (12, 14) relative to its size to avoid complications. The surgical fastener 100 can be easily tweaked to achieve the desired degradation profile.
[0058] The surgical fastener 100 is capable of fastening the tissue (12, 14) so that it cannot be easily slipped. The surgical fastener 100 with a unique shape allows the surgical fastener 100 to have more surface area for capturing the tissue (12, 14) than sutures or any other alternatives, thus exerting less pressure on the tissue (12, 14) and lessens the chances of pressure necrosis of the tissue (12, 14). The surgical fastener 100 causes the eversion of the wound, results in an enhanced cosmetic outcome, and prevents the inversion of the wound and related complications. The surgical fastener 100 penetrates the tissue (12, 14) without any assistance from metal pins or needles, thereby eliminating the need for a separate mechanism to penetrate the tissue (12, 14).
[0059] The surgical fastener 100 has significant growth-promoting and anti-bacterial properties to promote healing and prevent infections. The surgical fastener 100 has antiinflammatory properties to prevent granulomatous tissue formation and causes a lesser inflammatory response than sutures and polymeric bio-absorbable fasteners. The surgical fastener 100 prevents accelerated single-point stress corrosion and single-point failure of the surgical fastener 100 while also providing uniform degradation across the deformed length of the surgical fastener 100.
[0060] It will readily be apparent that numerous modifications and alterations can be made to the processes described in the foregoing examples without departing from the principles underlying the invention, and all such modifications and alterations are intended to be embraced by this application.
Claims
1. A surgical fastener (100), comprising: two tissue-capturing zones (102, 104) opposite to each other significantly in the same plane, wherein said each tissue-capturing zone (102, 104) is formed by a pair of arms (106A, 106B, 108A, and 108B), wherein each said arm of said pairs of arms (106A, 106B, 108A, and 108B) having two or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B), wherein at least two arms (106A, 106B, 108A, and 108B) of said pairs of arms (106A, 106B, 108A, and 108B) from either or the same tissue-capturing zone (102, 104) are connected at their respective bases, thereby forming a dual-axis symmetry substantially in the same plane in an ideal unfastened condition, wherein said one or more segments (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the said arms of the said pairs of arms (106A, 106B, 108A, and 108B) in the same tissue-capturing zone (102, 104) are configured to move towards each other for penetrating and capturing tissue (12, 14) in their respective tissue-capturing zones (102, 104) when said surgical fastener (100) undergoes plastic deformation upon receiving forces by a surgical fastening device.
2. The surgical fastener (100) as claimed in claim 1, wherein at least one segment (112B,
113B, 114B, and 115B) of each said arm of the said pairs of arms (106A, 106B, 108A, and 108B) comprise a sharp penetrative tip (116A, 116B, 118A, and 118B), which is configured to penetrate into the tissue (12, 14).
3. The surgical fastener (100) as claimed in claim 2, wherein the sharp penetrative tips (116A, 116B, 118A, and 118B) of said arms of the said pairs of arms (106A, 106B, 108A, and 108B) in the same tissue-capturing zones (102, 104) are configured to face inwardly towards each other, forming a gap through which the tissue (12, 14) enters into the respective tissue-capturing zones (102, 104).
he surgical fastener (100) as claimed in claim 1, wherein said plastic deformation of the surgical fastener (100) is evenly distributed across the deformed length of each arm of the said pairs of arms (106A, 106B, 108A, and 108B) instead of a localized single point. he surgical fastener (100) as claimed in claim 1, wherein at least one segment (112A, 112B, 113A, 113B, 114A, 114B, 115A, and 115B) of the arms of the pair of arms (106A,
106B, 108A, and 108B) in each tissue-capturing zone (102, 104) comprise a shape of at least one of, a straight configuration, an inwardly curved configuration or an outwardly curved configuration. he surgical fastener (100) as claimed in claim 1, wherein at least two arms of said pairs of arms (106A, 106B, 108A, and 108B) from either or the same tissue-capturing zone
(102, 104) are connected at their respective bases and are connected to the rest of the fastener by a bridge like structure. he surgical fastener (100) as claimed in claim 1, wherein said surgical fastener (100) is made of a composition that contains biodegradable metal or metals in the form of an alloy.
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110087277A1 (en) * | 2009-10-08 | 2011-04-14 | Tyco Healthcare Group Lp | Shape Memory Fasteners And Method Of Use |
US20120305629A1 (en) * | 2002-06-17 | 2012-12-06 | Tyco Healthcare Group Lp | Annular Support Structures |
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Publication number | Priority date | Publication date | Assignee | Title |
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US20120305629A1 (en) * | 2002-06-17 | 2012-12-06 | Tyco Healthcare Group Lp | Annular Support Structures |
US20110087277A1 (en) * | 2009-10-08 | 2011-04-14 | Tyco Healthcare Group Lp | Shape Memory Fasteners And Method Of Use |
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