WO2016025019A1

WO2016025019A1 - Tissue fastener in a needle

Info

Publication number: WO2016025019A1
Application number: PCT/US2015/000082
Authority: WO
Inventors: Jeffrey E. Yeung; Teresa T. Yeung
Original assignee: Yeung Jeffrey E; Yeung Teresa T
Priority date: 2014-08-11
Filing date: 2015-08-10
Publication date: 2016-02-18

Abstract

A fastener is made with elastically curved legs containing tissue-gripping elements. The elastically curved legs can be resiliently straightened within a lumen of a needle. A plunger is positioned proximally to the fastener in the lumen. The needle serves two functions: (1) to straighten the elastically curved legs, and (2) to puncture into tissue. The needle is withdrawn from tissue, while the plunger is held stationary to deploy the fastener from the lumen of the needle, allowing the legs to resume curvatures, laterally pressing the tissue-gripping elements to fasten into tissue.

Description

TISSUE FASTENER ΓΝ A NEEDLE

Jeffrey E. Yeung and Teresa T. Yeung CROSS-REFERENCES TO OTHER APPLICATIONS

This is a PCT application claiming priority of US Provisional 62/070,015 filed on August 1 1 , 2014, and US Provisional 62/070,022 filed on August 1 1 , 2014.

FIELD OF INVENTION

This invention is a tissue fastener delivered by a needle into tissue. The needle is punctured into and withdrawn from tissue to anchor the fastener in the tissue.

BACKGROUND

Endoscopic surgery is commonly used to minimize surgical trauma. However, sutures are still needed to fasten or approximate tissues. Conventional suturing is slow and requires surgical space, which hinders or prohibits endoscopic surgeries.

SUMMARY OF INVENTION

A fastener is made with elastically curved legs containing tissue-gripping elements. The elastically curved legs can be resiliently straightened within a lumen of a needle. A plunger is positioned proximal to the fastener in the lumen. The needle serves two functions: (1 ) to straighten the elastically curved legs, and (2) to puncture into tissue. The needle is withdrawn from tissue, while the plunger is held stationary to deploy the fastener from the lumen of the needle to fasten or approximate the tissue.

REFERENCE NUMBER

100 Fastener

101 Elastical ly curved leg

102 Tissue gripping element

103 Distal end of the elastically curved leg

104 Stem

105 Suture, filament, elastic filament, or rubber band

106 Hole in stem

107 Inside or convex surface of the elastically curved leg

108 Needle

109 Needle lumen

1 10 Plunger 1 1 1 Tissue

1 12 Tear or rupture

1 13 Suture knot

1 14 Sleeve

1 15 Distal end of the sleeve with or without tissue manipulating element

1 16 Soft palate

1 1 7 Oropharynx

1 18 Tongue

1 19 Genioglossus muscle

120 Epiglottis

121 Nasal septum

122 Suture-needle

123 Indentation or slit

124 Step of tissue gripping element

125 Base or concave side of elastically curved leg

126 Spring

127 Side arm

128 Tissue support or compress element

129 Slit of the needle

130 Trough, channel or hole between the step and base of the elastically curved leg

131 Ramp or slope between the step and base of the elastically curved leg

132 Sleeve handle

133 Needle handle

134 Plunger handle

135 Proximal end of the elastically curved leg of a proximal fastener

BRIEF DESCRIPTION OF DRAWINGS

Figure 1 shows a fastener 100 with tissue gripping elements 102 on two elastically curved legs 101 in open positions. Proximal portion of the fastener 100 contains a suture 105.

Figure 2 depicts resiiiently straightened elastically curved legs 101 of the fastener 100 in closed positions for insertion into a lumen of a needle.

Figure 3 shows insertion of the fastener 100 with resiiiently straightened legs 101 within the lumen 109 of the needle 108 for tissue puncturing and fastener 100 delivery. Figure 4 shows a flat, smooth, convex or inside surface 107 of the elastically curved leg 101 to allow approximation of both legs 101 during resilient straightening in Figures 2-3.

Figure 5 shows a suture hole or passage 106 in the stem 104 of the fastener 100.

Figure 6 shows deployment of the fastener 100 by holding the plunger 110 stationary while withdrawing the needle 108. The elastically curved legs 101 resume open positions outside the needle 108.

Figure 7 shows partial thickness delivery of the fastener 100 and spreading of the elastically curved legs 101 of their open positions to anchor within tissue 111.

Figure 8 shows two deployed fasteners 100 in tissue 111, adjacent to a tear 112 or rupture 112. The tissue 111 can be a tendon, meniscus, muscle, ligament or other.

Figure 9 shows approximation of the tear 112 or torn tissue 111 by pulling and tying the suture 105 with a knot 113 or slip knot 113 in endoscopic surgery.

Figure 10 shows a counter fastener 100 consisting two opposing fasteners 100 at distal and proximal locations, connected by a suture 105 or filament 105.

Figure 1 1 shows insertion of the counter fastener 100 with the connecting suture 105 in a lumen 109 of a needle 108 with a sliding sleeve 114 and a plunger 110.

Figure 12 shows fastening of the distal fastener 100 by needle 108 puncturing into and withdrawing from distal tissue 111, while holding the plunger 110 stationary.

Figure 13 shows pushing of the proximal portion of the tissue 111 by the sleeve 114 to approximate the tear 112, while withdrawing the needle 108.

Figure 14 shows a tight approximation of torn tissue 111 by the counter fastener 100 to expedite healing. The repair is internal without device exposure to minimize infection.

Figure 15 shows tissue 111 tightening or shortening, depicted as ripples, using the needle 108 pulling in Figure 12 and sleeve 114 pushing technique in Figure 13.

Figure 16 shows apnea caused by airway blockade at oropharynx 117 by soft palate 116.

Figure 17 shows implantation of the counter fasteners 100, as in Figure 15, to tighten, shorten or support the soft palate 116 and relieve apnea.

Figure 18 shows apnea caused by airway blockade in oropharynx 117 by a tongue 118, poorly supported by the weakened or relaxed genioglossus muscle 119.

Figure 19 shows implantation of the counter fastener 100, as in Figure 15, to tighten, shorten or support the genioglossus muscle 119 and the tongue 118 to relieve apnea.

Figure 20 shows a suture-needle 122 at the proximal portion of the suture 105, which is capable of passing through the lumen 109 of the needle 108. Figure 21 shows tissue manipulating elements 115 at the distal end of a sleeve 114. Figure 22 shows a counter fastener 100 connected by a stem 104. The elastically curved legs 101 are in open positions.

Figure 23 shows closed positions of the elastically curved legs 101 for insertion into a lumen of a needle. Fastener 100 in closed positions in Figure 23 is longer than fastener 100 in open positions in Figure 22 for a tight and elastic tissue approximation.

Figure 24 shows insertion of the counter fastener 100 in the lumen 109 of the needle 108 with a plunger 110 proximal to the counter fastener 100.

Figure 25 shows deployment of the counter fastener 100 by holding the plunger 110 stationary while withdrawing the needle 108.

Figure 26 shows a sleeve 114 over the needle 108 housing the counter fastener 100. Figure 27 depicts a curved needle 108 with a flexible sleeve 114 and flexible plunger 110 (not shown) inside the needle 108.

Figure 28 depicts needle 108 punctured into and partially withdrawn from the distal tissue 111, while holding the plunger 110 stationary to deploy the distal fastener 100.

Figure 29 shows approximation of torn tissue 111 by pushing the sleeve 114 and withdrawing the needle 108 simultaneously.

Figure 30 shows a tight approximation of torn or separated tissue 111 by the counter fastener 100 to expedite healing. The repair is within tissue with no device exposure to minimize infection.

Figure 31 shows indentation 123 or slits 123 on the stem 104 for tissue ingrowth and flexibility.

Figure 32 shows tissue manipulating elements 115 on the distal end of the sleeve 114. Figure 33 shows a spring, elastic connector or bridge 126 for elastic tissue

approximation.

Figure 34 shows a side arm 127 extending from the stem 104 of the fastener 100. The side arm 127 contains a tissue support or tissue compressing element 128.

Figure 35 shows a slit 129 opening from the distal lumen 109 of the needle 108. The side arm 127 is sized and configured to slide along the slit 129.

Figure 36 shows a stem 104 of a fastener 100 containing two side arms 127, sized and configured to slide along two slits of a needle (not shown).

Figure 37 shows tacking, fastening or repairing torn tissue 111 by approximating the tear 112 between side arms 127 and tissue gripping elements 102 of the fastener 100. Figure 38 shows troughs 130 between steps 124 and base 125 of the elastically curved legs 101 for hooking the tissue 111 and relieving stress during straightening of the elastically curved leg 101.

Figure 39 shows ramps 131 for strengthening the interface and spreading the stress between the steps 124 and the base 125 during transformation from open to closed positions.

Figure 40 shows handle 132 of the sleeve 114, handle 133 of the needle 108 and handle 134 of the plunger 110.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Figure 1 shows a fastener 100 with at least two elastically curved legs 101 in open positions or curved positions. The elastically curved legs 101 contain tissue gripping elements 102 on concave sides 125 of the curvatures. The tissue gripping elements 102 contain steps 124. The steps 124 of the tissue gripping elements 102 of the fastener 100 face proximally to resist proximal movement or migration. The concave side 125 of the curvature can be called a base 125 for the tissue gripping elements 102. A convex side or inside portion 107 of the curvature is generally smooth or flat. In the open positions of the elastically curved legs 101, the distal ends 103 are spread apart from each other. In the open position, the elastic leg 101 can have more than one curvature. Location and degree of the curvature of the leg 101 of the fastener 100 can vary. Curvatures of the legs 101 can also be asymmetrical or not in mirror image to each other. Proximal portion of the fastener 100 contains a stem 104 holding a suture 105 or filament 105.

Figure 2 depicts resilient straightening of the elastically curved legs 101, approximating the inside portions 107 of the elastically curved legs 101 of the fastener 100. The resiliently straightened positions are the closed positions of the elastically curved legs 101. In the closed positions, the distal ends 103 approximate, close or abut together. The step 124 of the tissue gripping element 102 and the base 125 of the elastically curved leg 101 form an angle. The angle is between 120 degree and 30 degree. The preferred angle is between 100 degree and 80 degree for strong tissue gripping or anchoring. Cross-section of the fastener 100 in the closed position as shown in Figure 2 can be circular, elliptical, square or other shape. Spacing between tissue gripping elements 102 can vary. For soft and fragile tissue, closely spaced tissue gripping elements 102 provide high anchoring strength. On the other hand, for firm tissue, greater spacing between gripping elements 102 may be required to embed, sink or lodge the tissue gripping elements 102 into a firm tissue. In addition, distal tissue gripping elements 102 near the distal end 103 of the elastically curved legs 101 as shown in Figure 1 provide the most tissue anchoring power. Spacing between tissue gripping elements 102 near the distal end 103 can be closer or less than spacing between tissue gripping elements 102 near the stem 104 for uniform compressive grips to optimize fastening strength in various tissues.

Figure 3 shows insertion of the fastener 100 in closed positions into a lumen 109 of a needle 108 for tissue puncturing and fastener 100 delivery. The suture 105 and a plunger 110 are also inserted in the lumen 109 of the needle 108, proximal to the fastener 100. Cross-section of the lumen 109 is sized and configured to house the fastener 100 with the elastically curved legs 101 in the closed positions.

Figure 4 shows a smooth or flat inside surface 107 of the elastically curved leg 101 to allow close approximation during resilient straightening of both legs 101 to form the closed positions as shown in Figures 2-3, for fitting within the lumen 109 of the needle 108. The inside surface 107 of the elastically curved leg 101 in the open position is smooth, flat or convex. Figure 5 shows a suture hole or passage 106 in the stem 104 of the fastener 100 and a stack of tissue gripping elements 102.

Figure 6 shows deployment of the fastener 100 by holding the plunger 110 stationary while withdrawing the needle 108. The resiliently straightened legs 101 slide out from the lumen 109, resume the curvatures of the elastically curved legs 101 to spread or push the tissue gripping elements 102 laterally or outwardly, transforming the legs 101 from closed to the open positions. The needle 108 in Figure 6 has a numeric scale or color zone to indicate depth of needle puncture, visible by an endoscope. The metallic needle 108 is also visible under fluoroscope or ultrasound for needle guidance. After proper placement of the needle 108, safe deployment of the fastener 100 is through needle withdrawal, not advancement. Figure 7 shows partial thickness delivery of the fastener 100. Opening of the elastically curved legs 101 presses or embeds the tissue gripping elements 102 laterally into tissue 111 to firmly anchor the suture 105 by the fastener 100. The fastener 100 delivery is convenient, requiring little surgical time and almost no surgical space for suture 105 attachment.

Figure 8 shows two deployed fasteners 100 in tissue 111, adjacent to a tear or rupture

112. The tissue can be a tendon, meniscus, muscle, ligament or other. Tendon is made with parallel oriented collagen fibers. Repairing torn tendon with suture is challenging, due to ripping of suture between parallel collagen fibers. Excessive suturing hinders sliding and operation of the tendon. Tissue gripping elements of the fastener 100 press and grip the collagen fibers of the tendon for strong anchoring strength. Figure 9 shows approximation of the tear 112 or torn tissue 111 by pulling and tying the suture 105 with a knot 113 or slip knot 113 for endoscopic surgery.

Figure 10 shows a counter fastener 100 by joining two opposing fasteners 100 at distal and proximal locations. The elastically curved legs 101 are in open positions. The steps 124 of the tissue gripping elements 102 of the distal fastener 100 face proximaliy, while the steps 124 of the tissue gripping elements 102 of the proximal fastener 100 face distally. The distal fastener 100 resists proximal movement or migration; and the proximal fastener 100 resists distal movement or migration. A suture 105 or filament 105 connects the stems 104 of the distal and proximal fasteners 100. Figure 1 1 shows insertion of the counter fastener 100 with the connecting suture 105 into a lumen 109 of a needle 108. A plunger

110 is inserted into the lumen 109 from the proximal end of the needle 108 adjacent and proximal to the fastener 100. A sleeve 114 is placed to slide over the needle 108.

The needle 108 is used to puncture into tissue 111. The needle 108 is then partially withdrawn, while the plunger 110 is held stationary, as shown in Figures 1 1 - 12 to deploy the distal fastener 100 into the distal tissue 111. The steps 124 of the tissue gripping elements 102 of the proximal fastener 100 face distally, as shown in Figure 10. The lumen 109 of the needle 108 restricts the elastically curved legs 101 of the proximal fastener 100 from opening. The restriction creates friction between the needle 108 and gripping elements 102 of the proximal fastener 100 in the needle 108. The friction between the elastic legs 101 and the needle allows surgeon to pull the tissue 111 proximaliy by pulling the needle 108, as shown in Figure 12. The sleeve 114 is used to push the proximal tissue

111 distally or inwardly, as shown in Figure 13. Needle 108 withdrawing and sleeve 114 pushing can be done simultaneously to approximate the distal and proximal tissue 111, and to deploy the proximal fastener 100 for a tight tissue 111 repair, as shown in Figure 14. Tight approximation of torn tissue 111 by the counter fasteners 100 expedites healing or tissue attachment. In addition, the suture 105 or filament 105 between distal and proximal fasteners 100 can be elastic, as a rubber band, to keep a tight tissue 111 approximation. Tissue repair using the counter fastener 100 is internal, without device exposure to minimize infection.

Figure 15 shows tissue 111 tightened or shortened, depicted as ripples by using the needle 108 pulling in Figure 12 and sleeve 114 pushing technique in Figure 13. Figure 16 shows sleep apnea caused by airway blockade at oropharynx 117 by soft palate 116. Figure 17 shows implantation of the counter fasteners 100, as shown in Figure 15, to tighten, shorten or support the soft palate 116 for relieve apnea. The counter fastener 100 is concealed within the soft palate 116 to minimize infection. Figure 18 shows apnea caused by airway blockade in oropharynx 117 by a tongue 118, poorly supported by the weakened or relaxed genioglossus muscle 119. Figure 19 shows implantation of the counter fastener 100, as shown in Figure 15, to tighten, shorten or support the genioglossus muscle 119 and the tongue 118 for relieve apnea. Several counter fasteners 100 may be needed to relieve apnea from weakened muscle 119 of the tongue 118. The counter fasteners 100 are also concealed within the genioglossus muscle 119 and the tongue 118 to minimize infection.

Figure 20 shows a thin suture-needle 122 at the proximal end of the suture 105. After deployment of the fastener 100 in tissue, the suture-needle 122 is capable of passing through the lumen 109 during withdrawal of the needle 108 from the tissue. The suture- needle 122 can be used to attach other tissue, graft or medical device. Figure 21 shows tissue manipulating elements 115 at the distal end of a sleeve 114. The tissue manipulating elements 115 allow the surgeon to grip, position or rotate tissue for surgical repair.

Figure 22 shows a counter fastener 100 containing a distal and a proximal fastener 100 connected by a stem 104. The elastically curved legs 101 are in open positions. Figure 23 shows closed positions of the elastically curved legs 101 for insertion into a lumen of a needle. Length of the counter fastener 100 in open positions as shown in Figure 22 is shorter than length of the counter fastener 100 in closed positions as shown in Figure 23. Due to fastener 100 shortening in tissue, the counter fastener 100 provides compressive and/or elastic tissue approximation to expedite healing or re-attachment. The steps 124 of the tissue gripping elements 102 of the distal fastener 100 face proximally, while the steps 124 of the tissue gripping elements 102 of the proximal fastener 100 face distally. The distal fastener 100 resists proximal movement or migration; and the proximal fastener 100 resists distal movement or migration.

Figure 24 shows insertion of the counter fastener 100 in the lumen 109 of the needle 108 with a plunger 110 proximal to the counter fastener 100. Figure 25 shows deployment of the counter fastener 100 by holding the plunger 110 stationary while withdrawing the needle 108. The resiliently straightened legs 101 resume the elastic curvatures for tissue fastening. Multiple counter fasteners 100 can be loaded in the needle 108 in series to deploy one counter fastener 100 at a time through sequential needle 108 withdrawals with the stationary plunger 110. Figure 26 shows the counter fastener 100 in closed positions within the lumen 109 of the needle 108. A plunger 110 is inserted adjacent and proximal to the fastener 100. A sleeve 114 slides over the needle 108 for tissue manipulation and approximation. The needle 108 can be curved, as shown in Figure 27, to accommodate surgical location or position. The sleeve 114 and plunger 110 can be flexible to position tissue and deploy the fastener 100.

Figure 28 shows needle 108 punctured into and withdrawn from distal tissue 111, while holding the plunger 110 stationary to deploy the distal fastener 100. Figure 29 shows approximation of torn tissue 111 by pushing the sleeve 114 and withdrawing the needle 108 simultaneously. Figure 30 shows a tight approximation of torn or separated tissue 111 by the counter fastener 100 to expedite healing. The repair is within tissue with no device exposure to minimize infection.

Figure 31 shows indentations or slits 123 on the stem 104 for tissue ingrowth and flexibility. Figure 32 shows tissue manipulating elements 115 on the distal end of the sleeve 114. Tissue can be twisted or repositioned by the sleeve 114. The tissue

manipulating elements 115 can be a step or other shape to assist surgery. Figure 33 shows a spring, elastic connector or bridge 126 for elastic tissue approximation.

The fastener 100 can be used as a tissue fastening tack. Figure 34 shows a side arm 127 extending from the stem 104 of the fastener 100. Location of the side aim 127 is preferred to be proximal and perpendicular to the plane of the elastically curved legs 101 in their open positions. The side arm 127 contains a tissue support 128 or tissue compressing element 128. The tissue compressing element 128 can have spikes, ridges, grippers or other tissue interacting element. Figure 35 shows a slit 129 opening from the distal lumen 109 of the needle 108. The side arm 127 is sized and configured to slide along the slit 129 for insertion into and exiting from the lumen 109 of the needle 108. The needle 108 is used to puncture into a tissue or torn tissue. Needle 108 puncturing is stopped by the tissue compressing element 128 when reaching the surface of the tissue. The fastener 100 is deployed by withdrawing the needle 108, while holding the plunger 110 stationary to tack down the torn tissue 111. Multiple fasteners 100 with side arms 127 and tissue

compressing elements 128 can be loaded in series into the needle 108 with a long slit 129 to fasten the torn tissue 111 with multiple fasteners 100.

Figure 36 shows a stem 104 of a fastener 100 containing two side arms 127, sized and configured to slide along two slits 129 of a needle 108 (not shown). The needle 108 is used to puncture into a torn tissue. The side arms 127 and tissue compressing elements 128 stop the needle 108 from further advancing into tissue 111. The needle 108 is then withdrawn, while holding the plunger 110 stationary to deploy the fastener 100 for tacking or repairing the torn tissue 111. Figure 37 shows a tight approximation of a tear 112 between tissue gripping elements 102 and the side arm 127 and/or tissue compressing element 128 of the fastener 100. Figure 23 shows that the length of the fastener 100 in the closed or straightened position is longer than the length of the fastener 100 in the open or curved position. After tissue fastening by the fastener 100 in Figure 22, the tissue is compressed by the shortened fastener 100 for a tight approximation, as shown in Figure 30. Similarly, the fastener 100 in Figure 35 is delivered into tissue 111 in closed positions of the elastically curved legs 101. After fastener 100 deployment, the elastically curved legs 101 resume the curvatures, pressing the tissue gripping elements laterally into tissue. As a result, length of the fastener 100 is shortened, drawing the distal tissue 111 toward the proximal tissue 111 for a tight approximation of the tear 112 as shown in Figure 37. The open position can be called the tissue gripping position, and the closed position can be called the delivery position of the elastically curved leg 101. The open position can also be called the curved position, and the closed position can also be called the resilientiy straightened position.

Figure 38 shows troughs 130 between steps 124 and base 125 of the elastically curved leg 101. The troughs 130 at the steps 124 form hooks, capable of embedding into tissue to enhance gripping power. The troughs 130 also relieve or spread stress during transition from open to closed position of the elastically curved leg 101. Stress on material of the fastener 100 is high between the steps 124 and the base 125 during transition or transformation from elastically curved to resilientiy straightened positions. The troughs 130 between the steps 124 and the base 125 allow relatively rigid materials for forming, molding, printing, stamping or machining the fasteners 100.

Figure 39 shows ramps 131 between the steps 124 and the base 125 in a longitudinal view of a section of the fastener 100 in the closed position. Shape transformation from elastically curved or open position to resilientiy straightened or closed position creates stress, especially at the interface between the steps 124 and the base 125 of the elastically curved legs 101. The ramps 131 spread the stress and strengthen the vulnerable junctions during the shape transformation. In addition, the force of elastic opening of the curved legs 101 may be stronger with the ramps 131 between the steps 124 and the base 125 to press the tissue gripping elements laterally into tissue for firm anchoring. The ramps 131 between the steps 124 and the base 125 also allow a wide range of materials with various flexural modulus for forming, molding, printing, stamping or machining the fasteners 100.

Figure 40 shows handle 132 of the sleeve 114, handle 133 of the needle 108 and handle 134 of the plunger 110, where partial plunger 110 is within the needle 108 and partial needle 108 is within the sleeve 114. The needle handle 133 can be engaged or linked to a trigger. Single pulling of the trigger withdraws the needle 108 to deliver one fastener 100 from the lumen 109 of the needle 108. The plunger 110 can be anchored stationary in the delivery device with the trigger. Multiple fasteners 100 can be inserted into the lumen 109 of the needle 108 in series. The sleeve 114 and sleeve handle 132 slide freely along the needle 108 to facilitate tissue attachment or repair.

The fastener 100 can be coated with biocompatible polymers, such as polyurethane, polytetrafluoroethylene, silicon, polyethylene or other material. For additional biological and surgical benefits, the fastener 100 can also be coated with adhesive, lubricant, growth factor, nutrient, buffering agent, collagen, hydroxyapatite, analgesic, sealant, blood clotting, antibiotic, anti-inflammatory drug, other medication, water repellent, radiopaque agent,

MRI contrast or echogenic agents. All materials should be able to withstand sterilization by gamma, electron beam, autoclave, ETO, plasma or UV light to prevent infection.

A wide range of materials can be used to fabricate the fastener 100. Material used for the fastener 100 should have flexural modulus less than 3,000 MPa, the preferred flexural modulus is 1 ,500 MPa. Flexural modulus of the fastener 100 is between 3,000 MPa and 700 MPa. Biocompatible polymers, such as polypropylene, polyethylene, poly-ether-ether- ketone (PEEK), acetal resin, polysulfone or polycarbonate are possible candidates. For biodegradable capability, the fastener 100 can be made with polylactate, polyglycolic, poly(lactide-co-glycolide), polycaprolactone, trimethylene carbonate or combinations of these materials. Many of these degradable polymers are used in US FDA approved products. Degradable polymers, such as polydioxanone, polyanhydride, trimethylene carbonate, poly-beta-hydroxybutyrate, polyhydroxyvalerate, poly-gama-ethyl-glutamate, poly(DTH iminocarbonate), poly(bisphenol A iminocarbonate), poly-ortho-ester, polycyanoacrylate or polyphosphazene can also be used. For strength, durability and elasticity, nickel-titanium alloy, spring-tempered stainless steel or other metallic material can be used.

The suture 105 can be permanent or biodegradable, braided or monofilament, elastic or fixed length. The suture 105 can also be metallic for strength and durability. The plunger 110, needle 108 and sleeve 114 can be made with stainless steel, titanium, nickel titanium, other alloy or polymer, including PEEK. For visibility under fluoroscope or CT, barium sulfate or other radiopaque agent can be added into the polymer for making the plunger 110, needle 108 and sleeve 114. The plunger 110, needle 108 and sleeve 114 can be coated with lubricant, antibiotic, blood clotting, radiopaque agent or echogenic agent. For hard-to-reach surgical sites, the needle 108 can be made curved or elastic to gain accessibility for the surgeon. To accommodate the curvature of the needle 108, the sleeve 114 and plunger 110 can be made with elastic material, such as nickel titanium, polypropylene, polyethylene, PEEK or other flexible material.

The fastener 100 can be used to widen urethra within prostate to treat benign prostatic hyperplasia. The fastener 100 can be used to support bladder neck to treat stress urinary incontinence. The fastener 100 can be used to treat sleep apnea. The fastener 100 can be used to approximate tissue 111.

It is to be understood that the present invention is by no means limited to the particular constructions disclosed herein and/or shown in the drawings, but also includes any other modification, changes or equivalents within the scope of the claims. Many features have been listed with particular configurations, curvatures, options, and embodiments. Any one or more of the features described may be added to or combined with any of the other embodiments or other standard devices to create alternate combinations and embodiments.

It should be clear to one skilled in the art that the current embodiments, materials, constructions, methods, tissues or surgical procedures are not the only uses for which the invention may be used. It has been foreseen that the fastener 100, plunger 110, needle 108 and sleeve 114 can be applied in other surgical and non-surgical purposes. In fact, the fastener 100 can be used to fasten pictures on walls or machine parts prone to loosening. Different materials, constructions, methods or designs for the fastener 100, plunger 110, needle 108 and sleeve 114 can be substituted and used. Nothing in the preceding description should be taken to limit the scope of the present invention. The full scope of the invention is to be determined by the appended claims.

Claims

What is claimed is:

1 . A fastener deployable from a needle, comprising:

a needle comprises a distal portion, proximal portion and a lumen,

a first leg formed of an elastic material, wherein said first leg having a curved position and a resiliently straightened position,

a first plurality of tissue gripping elements located on a concave side of said first leg when said first leg is in said curved position,

a second leg formed of an elastic material, wherein said second leg having a curved position and a resiliently straightened position,

a second plurality of tissue gripping elements located on a concave side of said second leg when said second leg is in said curved position,

wherein said first and second legs in said resiliently straightened positions are sized and configured to fit in said lumen of said needle,

and wherein said needle further comprises a plunger in said lumen, and wherein said plunger extends from said proximal portion of said needle.

2. The fastener of claim 1 , wherein said first leg further comprises a first proximal end, wherein said second leg further comprises a second proximal end,

and wherein said first and second proximal ends comprise a stem.

3. The fastener of claim 2, wherein said stem comprises a suture.

4. The fastener of claim 1 , wherein said first leg further comprises a first convex surface when said first leg is in said curved position,

wherein said second leg further comprises a second convex surface when said second leg is in said curved position,

and wherein said first and second convex surfaces are generally smooth or flat.

5. The fastener of claim 3, wherein said suture comprises a second stem.

6. The fastener of claim 5, wherein said second stem comprises:

a third leg formed of an elastic material, wherein said third leg having a

position and a resiliently straightened position, a third plurality of tissue gripping elements located on a concave side of said third leg when said third leg is in said curved position,

a fourth leg formed of an elastic material, wherein said fourth leg having a curved position and a resiliently straightened position,

a fourth plurality of tissue gripping elements located on a concave side of said fourth leg when said fourth leg is in said curved position,

and wherein said third and fourth legs in said resiliently straightened positions are sized and configured to fit in said lumen of said needle.

7. The fastener of claim 1 , wherein said needle further comprises a sleeve, sized and configured to slide over said needle.

8. The fastener of claim 7, wherein said sleeve comprises a distal end, and wherein said distal end comprises at least one tissue manipulating element.

9. The fastener of claim 1 , wherein said needle further comprises a scale or color zone.

10. The fastener of claim 3, wherein said suture comprises a second needle.

1 1. The fastener of claim 2, wherein said stem further comprises:

a third leg formed of an elastic material, wherein said third leg having a curved

position and a resiliently straightened position,

a third plurality of tissue gripping elements located on a concave side of said third leg when said third leg is in said curved position,

12. The fastener of claim 1 , wherein said needle is curved, and wherein said plunger is flexible.

13. The fastener of claim 2, wherein said stem further comprises at least one side arm, wherein said needle further comprises at least one slit opening from said distal portion of said needle,

wherein said at least one side arm is sized and configured to fit and slide in said at least one slit,

and wherein said least one side arm comprises at least one tissue support element.

14. The fastener of claim 1 , wherein said first and second legs further comprise troughs or channels between said pluralities of tissue gripping elements and said concave sides, thereby said pluralities of tissue gripping elements form hooks.

15. The fastener of claim 6, wherein said third and fourth legs further comprise troughs or channels between said pluralities of tissue gripping elements and said concave sides, thereby said pluralities of tissue gripping elements form hooks.

16. The fastener of claim 1 1 , wherein said third and fourth legs further comprise troughs or channels between said pluralities of tissue gripping elements and said concave sides, thereby said pluralities of tissue gripping elements form hooks.

17. The fastener of claim 1 , wherein said first and second legs further comprise ramps or slopes between said pluralities of tissue gripping elements and said concave sides, thereby said ramps spread stress from said resiliently straightened positions.

18. The fastener of claim 6, wherein said third and fourth legs further comprise ramps or slopes between said pluralities of tissue gripping elements and said concave sides, thereby said ramps spread stress from said resiliently straightened positions.

19. The fastener of claim 1 1 , wherein said third and fourth legs further comprise ramps or slopes between said pluralities of tissue gripping elements and said concave sides, thereby said ramps spread stress from said resiliently straightened positions.

20. The fastener of claim 1 has flexural modulus between 3,000 MPa and 700 MPa.

21 . The fastener of claim 1 , wherein said pluralities of tissue gripping elements form angles with said concave sides, and wherein said angles are between 120 degree and 30 degrees.

22. The fastener of claim 6, wherein said pluralities of tissue gripping elements form angles with said concave sides, and wherein said angles are between 120 degree and 30 degrees.

23. The fastener of claim 1 1 , wherein said pluralities of tissue gripping elements form angles with said concave sides, and wherein said angles are between 120 degree and 30 degrees.

24. The fastener of claim 1 , wherein said proximal portion of said needle comprises a handle, and wherein said handle comprises a trigger.

25. The fastener of claim 1 , wherein said needle comprises more than one fastener in said lumen.

26. The fastener of claim 1 further comprises a third leg formed of an elastic material, wherein said third leg having a curved position and a resiliently straightened position,

and a third plurality of tissue gripping elements located on a concave side of said third leg when said third leg is in said curved position.

27. The fastener of claim 6 further comprises a fifth leg formed of an elastic material, wherein said fifth leg having a curved position and a resiliently straightened position,

and a fifth plurality of tissue gripping elements located on a concave side of said fifth leg when said fifth leg is in said curved position.