Method and apparatus for clamping tissue layers and occluding tubular body lumens

• US 10,076,339 B2
• Filed: 05/07/2014
• Issued: 09/18/2018
• Est. Priority Date: 01/11/2011
• Status: Active Grant

• Current Assignee: Amsel Medical Corporation
• Original Assignee: Amsel Medical Corporation
• Inventors: Miller, Arnold, Lilach, Nir
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): Ton, Martin T
• Application Number:
  US14/272,304
• Publication Number:
  US 20140243857A1
• Time in Patent Office: 1,595 Days
• Field of Search: 606158
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/1205 : Introduction devices
• CPC Class Codes: A61B 2017/12054 : Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3413 : guided by ultrasound

Abstract

Apparatus for occluding a space between a first structure and a second structure, said apparatus comprising:

• • an occluder, said occluder comprising a distal implant and a proximal implant, wherein:
    • said distal implant comprises a body and a locking shaft mounted to said body, wherein said body of said distal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the first structure, and further wherein said locking shaft comprises a first locking element for selective connection to said proximal implant and a second locking element for selective connection to an inserter for deploying said occluder; and
    • said proximal implant comprises a body having an opening, wherein said body of said proximal implant comprises a plurality of legs which may assume (i) a diametrically-reduced configuration for disposition within the lumen of a tube, and (ii) a diametrically-expanded configuration for disposition against the second structure, and further wherein said body of said proximal implant comprises a third locking element for selective connection to said first locking element of said distal implant;
    • wherein said locking shaft of said distal implant is slidably receivable within said opening in said body of said proximal implant, and further wherein said first locking element of said distal implant and said third locking element of said proximal implant are selectively engagable with one another so as to hold said distal implant and said proximal implant in fixed position relative to one another.

Claims

1. An apparatus for securing tissue layers together comprising:

a distal implant comprising a distal body, a first locking element, and a plurality of legs which may assume (i) a diametrically-reduced delivery configuration in which it can be passed through at least two tissue layers and (ii) a diametrically-expanded deployed configuration in which the legs are extended radially of the distal body; and

a proximal implant, separate from the distal implant, the proximal implant comprising a proximal body, a second locking element, and a plurality of legs configured to assume (i) a diametrically-reduced delivery configuration and (ii) a diametrically-expanded deployed configuration in which the legs are extended radially of the proximal body;

wherein the implants are connectible together to connect the first locking element and the second locking element, thereby locking the distal implant and the proximal implant together, the radially extended configuration of the legs and the locking elements being constructed and arranged so that when the implants are locked together legs of the proximal and distal implants are interdigitated in the absence of tissue between the implants;

the proximal and distal implants being deployable separately and independently of each other.

2. The apparatus of claim 1, wherein the apparatus comprises a super-elastic material such as nitinol and where the legs of each of the implants self-expand upon release of each implant from its delivery configuration.

3. The apparatus of claim 1, wherein the distal implant legs together form a concave configuration when diametrically expanded, and the proximal implant legs together form a concave configuration when diametrically expanded.

4. The apparatus of claim 3 wherein the implants are arranged so that their concavities face towards each other.

5. The apparatus of claim 1, wherein the tissue layers comprise the opposed walls of a mammalian body lumen.

6. The apparatus of claim 5, wherein when locked together, at least one of the proximal body and the distal body transfixes the tissue layers at a transfixion site.

7. The apparatus of claim 6, wherein the plurality of legs of the distal implant and the plurality of legs of the proximal implant together create an area of compression that circumscribes the transfixion site.

8. The apparatus of claim 1, further comprising a delivery tube comprising a needle or a catheter having a distal outlet opening, wherein the delivery tube contains the distal implant in its diametrically-reduced configuration and the proximal implant in its diametrically-reduced configuration in readiness to be ejected serially from the delivery tube.

9. The apparatus of claim 8, wherein the delivery tube is configured to advance the distal implant in its diametrically-reduced configuration through at least two tissue layers before the distal implant is ejected from the tube.

10. The apparatus of claim 9, further comprising a mechanism for maintaining the position of the distal implant after ejection out of the delivery tube, thereby to enable the delivery tube to be withdrawn proximally to deploy the proximal implant.

11. The apparatus of claim 10, wherein the mechanism comprises a retention member configured to selectively engage with the distal implant to hold the distal implant in place when deployed.

12. The apparatus of claim 11, wherein the retention member is configured to fit axially through a lumen in the distal body, and further comprises a selectively expandable locking region configured to interfere with the lumen of the distal body lumen to maintain the position of the distal implant, the locking region being selectively configurable to a low profile to release the distal implant and enable removal of the retention member through the lumen of the distal body.

13. The apparatus of claim 10 further comprising a push rod engageable with the proximal end of the proximal implant to maintain the position of the proximal implant proximally of the tissue layers while the delivery tube is withdrawn to deploy the proximal implant.

14. The apparatus of claim 13 wherein the mechanism for maintaining the position of the distal implant comprises a retention member configured to selectively engage with the distal implant to hold the distal implant whereby the retention member and the push rod can be manipulated to draw the deployed proximal and distal implants toward each other to lock them together.

15. The apparatus of claim 10 wherein the mechanism for maintaining the position of the distal implant comprises a locking tube secured to the distal implant body and extending in a proximal direction, the proximal end of the locking tube having a first portion of an interlock mechanism;

a distal implant retention tube having proximal and distal ends with a second portion of the interlock mechanism at the distal end, the first and second portions of the interlock mechanism being mateable to releasably connect with each other, the proximal end of the distal implant retention tube being receivable through and extending proximally of the lumen in the body of the proximal implant, the interlock mechanism enabling the position of the distal implant to be maintained while the delivery tube is withdrawn proximally.

16. The apparatus of claim 15 where the first and second portions of the interlock mechanism are complementary and separable from each other.

17. The apparatus of claim 16 further comprising a supplemental lock for the interlock mechanism to temporarily prevent separation of the portions of the interlock mechanism.

18. The apparatus of claim 17 wherein the supplemental lock comprises an elongate wire removably disposed in the lumen of the distal implant delivery tube and passing through the interlock mechanism to engage the interlock mechanism and prevent separation of the portions of the interlock mechanism.

19. The apparatus of claim 1 wherein the distal implant further comprises:

an axially deformable tubular body having proximal and distal ends and a plurality of circumferentially spaced longitudinal slits formed between the ends, the slits defining strips that, when the tubular body is axially deformed, will bend and extend radially outward to define the legs of the distal implant;

a locking tube having proximal and distal ends and secured at its distal end to and extending proximally of the distal-end of the tubular body, the proximal end of the locking tube being receivable in the tubular proximal end of the distal implant;

each of the locking tube and the proximal end of the distal body having third locking elements configured to lock the proximal end of the distal implant to the locking tube with its legs radially extended.

20. The apparatus of claim 1 further comprising:

the proximal implant comprising a proximal tube having proximal and distal ends, the distal end of the proximal tube having a plurality of longitudinally extending slits extending through the distal end of the proximal tube and defining a plurality of distally extending legs having free distal ends, the proximal tube being formed from a material having a shape memory in which the legs extend radially outward about the proximal tube axis, the legs being confinable into a tubular shape within a delivery tube in readiness to self-expand when released from the delivery tube, the proximal portion of the proximal tube having a locking element.

21. The apparatus of claim 20 further comprising:

the distal implant comprising a distal tube having proximal and distal ends, the proximal end of the distal tube having a plurality of longitudinally extending slits extending through the proximal end of the distal tube and defining a plurality of proximally extending legs having free proximal ends, the distal tube being formed from a material having a shape memory in which the legs extend radially outward about the distal tube axis, the legs being confinable into a tubular shape within a delivery tube in readiness to self-expand when released, the distal implant having a proximal portion having a locking element engageable with the locking element of the proximal implant to lock the proximal and distal implants together.

22. The apparatus of claim 1 further comprising:

the distal implant comprising a distal tube formed from a material having a shape memory and having proximal and distal ends with a plurality of circumferentially spaced, longitudinally extending slits formed between its ends that define a plurality of radially extendable legs, the legs being extendible radially outward about the distal tube axis in response to axial compression of the ends of the distal tube, the legs having a tubular shape memory,

a locking tube attached to and extending proximally from the distal portion of the distal tube and being receivable in the proximal end of the distal tube when the distal tube is axially compressed, the locking tube and the proximal portion of the locking tube having cooperative locking elements to secure the distal implant in an axially compressed configuration in which the legs extend radially.

23. The apparatus of claim 22 further comprising:

the proximal portion of the locking tube being receivable in the tube of the proximal implant, the locking tube having an additional locking element engageable with the locking element of the proximal implant.

24. The apparatus of claim 1 wherein the legs have free ends and, when deployed, the legs can engage tissue substantially along the length of the legs.

25. The apparatus of claim 1 wherein the locking elements are disposed on the implant bodies and are independent of the legs.

26. The apparatus of claim 1 wherein the proximal implant is deployable only after the distal implant has been deployed.

27. The apparatus of claim 1 wherein the distal implant can be deployed externally on the distal side of the tissue layers and the proximal implant can be deployed externally on the proximal side of the tissue layers.

28. The apparatus of claim 1 wherein the bodies of the implants are less than about 18 gauge.