Source: http://www.google.co.uk/patents/US9743970
Timestamp: 2017-11-18 10:29:22
Document Index: 80415897

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61']

Patent US9743970 - Anatomical location markers and methods of use in positioning sheet-like ... - Google Patents
A tissue marker assembly which can be useful with an implant delivery system for delivering a sheet-like implant is disclosed. The tissue marker assembly can include a delivery sleeve with a tissue marker slidably disposed within a lumen therethrough. A proximal handle can be coupled to the tissue marker...http://www.google.co.uk/patents/US9743970?utm_source=gb-gplus-sharePatent US9743970 - Anatomical location markers and methods of use in positioning sheet-like materials during surgery
Publication number US9743970 B2
Application number US 14/933,774
Also published as US9204940, US9314314, US20130172920, US20130245707, US20160051300, WO2013101641A2, WO2013101641A3
Publication number 14933774, 933774, US 9743970 B2, US 9743970B2, US-B2-9743970, US9743970 B2, US9743970B2
Patent Citations (494), Non-Patent Citations (19), Classifications (12)
US 9743970 B2
1. A method of marking a location of a biceps tendon, the method comprising:
observing the biceps tendon on an articular side of a supraspinatus tendon; and
inserting a tissue marker through the supraspinatus tendon so that a distal end of the tissue marker emerges on the articular side of the supraspinatus tendon,
wherein the tissue marker does not pierce the biceps tendon;
a delivery sleeve extending from a proximal end to a distal end and having a lumen extending through at least a portion of the delivery sleeve;
wherein the tissue marker is slidably disposed within the lumen of the delivery sleeve;
wherein the tissue marker includes a plurality of flexible arms located at a distal end of the tissue marker, the flexible arms constrained by the delivery sleeve is a delivery state and the flexible arms projecting outward from a distal end of the tissue marker in a deployed state.
2. The method of claim 1, wherein the distal end of the tissue marker emerges on the articular side of the supraspinatus tendon adjacent the biceps tendon.
deploying the flexible arms of the tissue marker from inside the delivery sleeve on the articular side of the supraspinatus tendon.
4. The method of claim 1, wherein when the tissue marker comprises: a shaft extending from a proximal end to a distal end; and
the plurality of flexible arms located at the distal end of the shaft,
wherein the plurality of flexible arms extend laterally away from the shaft in the deployed state.
positioning the flexible arms of the tissue marker on the articular side of the supraspinatus tendon in the deployed state.
6. A method of marking a location on a supraspinatus tendon for placement of a sheet-like implant, the method comprising:
inserting a first tissue marker through the supraspinatus tendon at a first point; and
inserting a second tissue marker through the supraspinatus tendon at a second point spaced away from the first point,
positioning a sheet-like implant on a bursal side of the supraspinatus tendon such that an edge of the sheet-like implant is aligned with the first and second points.
7. The method of claim 6, wherein the first tissue marker and the second tissue marker are inserted while viewing an articular side of the supraspinatus tendon.
8. The method of claim 6, wherein the first tissue marker and the second tissue marker are inserted through the supraspinatus tendon so a distal end of each of the first and second tissue markers emerges from an articular side of the supraspinatus tendon adjacent a biceps tendon.
9. The method of claim 8, wherein the first tissue marker and the second tissue marker do not pierce a biceps tendon.
attaching the sheet-like implant to the supraspinatus tendon with one or more fasteners, wherein the one or more fasteners do not pierce the biceps tendon.
11. The method of claim 6, wherein each of the first tissue marker and the second tissue marker comprise:
a plurality of flexible arms located at the distal end of the shaft,
wherein the plurality of flexible arms extend laterally away from the shaft in a deployed state.
12. The method of claim 11, wherein after inserting each of the first and second tissue markers through the supraspinatus tendon, the first and second tissue markers are deployed so that each of the plurality of flexible arms abuts the supraspinatus tendon on an articular side of the supraspinatus tendon.
13. A method of implanting a sheet-like implant on a supraspinatus tendon using tissue markers, the method comprising:
inserting a first tissue marker from a bursal side of the supraspinatus tendon so a distal end of the first tissue marker emerges on an articular side of the supraspinatus tendon adjacent a biceps tendon;
inserting a second tissue marker from the bursal side of the supraspinatus tendon so a distal end of the first tissue marker emerges on the articular side of the supraspinatus tendon adjacent the biceps tendon spaced away from the first tissue marker;
positioning a sheet-like implant on the bursal side of the supraspinatus tendon;
aligning an edge of the sheet-like implant with the first tissue marker and the second tissue marker; and
attaching the sheet-like implant to the supraspinatus tendon with a plurality of fasteners.
14. The method of claim 13, wherein each of the first tissue marker and the second tissue marker comprise:
positioning the flexible arms of the first and second tissue markers on the articular side of the supraspinatus tendon in the deployed state.
a first delivery sleeve slidably disposed over the first tissue marker while inserting the first tissue marker through the supraspinatus tendon; and
a second delivery sleeve slidably disposed over the second tissue marker while inserting the second tissue marker through the supraspinatus tendon.
the first delivery sleeve constrains the plurality of flexible arms of the first tissue marker in a delivery state while inserting the first tissue marker through the supraspinatus tendon; and
the second delivery sleeve constrains the plurality of flexible arms of the second tissue marker in a delivery state while inserting the second tissue marker through the supraspinatus tendon.
attaching the sheet-like implant to bone.
This application is a continuation of U.S. application Ser. No. 13/889,832, filed May 8, 2013, which is a continuation of U.S. application Ser. No. 13/722,940, filed Dec. 20, 2012, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/581,631 filed on Dec. 29, 2011, the disclosures of each incorporated herein by reference.
The present disclosure is related to the following commonly assigned applications, the disclosures of which are incorporated herein by reference: U.S. Provisional Application No. 61/443,169 filed on Feb. 15, 2011; U.S. Provisional Application No. 61/581,628 filed on Dec. 29, 2011; and U.S. Provisional Application No. 61/581,629 filed on Dec. 29, 2011.
A tissue marker can include an elongate shaft defining a longitudinal direction having a plurality of flexible arms projecting outward from the shaft proximate a distal end thereof. The arms can include nitinol members. Further, the tissue marker can be part of a tissue marker assembly that includes a delivery sleeve having a lumen therethrough. The delivery sleeve can be a needle-like shaft having a tissue penetrating distal end in some embodiments. The tissue marker is slidably disposed within the lumen of the delivery sleeve with the lumen walls flexing the aims to extend generally longitudinally and fit therein.
FIG. 1B depicts the marker 308 as removed from the delivery sleeve 302. The distal portion of the marker 308 includes a plurality of longitudinally extending arms 312 which are formed into the marker 308 or attached to the distal end of the marker. These arms 312 are better depicted in the illustrations of FIGS. 1C and 1D. When unconstrained, as when the arms 312 are outside of the lumen of the delivery sleeve, the flexible arms project outward from the shaft proximate a distal end thereof, as shown in FIG. 1D. However, when the marker 308 is within the delivery sleeve 302, the lumen walls flex and constrain the arms to extend generally longitudinally and fit therein. In the deployed state outside the delivery sleeve 302, the arms retain the marker's position in tissue, yet can be pulled out without any significant effect on the tissue because the arms will flex to extend generally longitudinally as they are pulled through the tissue. In some embodiments, the arms are made of an elastic or superelastic material which can include metals or polymers, for example flexible nitinol members. The marker can include at least three, and in some embodiments four or more aims to more securely engage the tissue. The proximal handle can also include means for selectively coupling and decoupling the tissue marker and delivery sleeve to allow easier insertion of the combined assemblies into tissue. Further, the delivery sleeve and marker can be kept in slidable longitudinal engagement throughout the procedure. In this embodiment, the delivery sleeve can be retracted to deploy the flexible arms, then when the procedure is complete, the delivery sleeve can be pushed distally relative to the marker to flex the arms and move them to a position within the lumen of the delivery sleeve.
As best seen in FIG. 3E, a first arm 120 and a second arm 122 can be seen extending distally from the delivery shaft 130. First arm 120 and second aim 122 are both part of an implant spreader assembly 124. Implant spreader assembly 124 may be used to carry a sheet-like implant to a location within the human body. Implant spreader assembly 124 may also be used to unfold the sheet-like implant so that the sheet-like implant covers a treatment site within the body.
As previously stated, the implant delivery system 60 can be used to deliver any sheet-like implant. A tendon repair implant 50 may comprise, for example, various sheet-like structures without deviating from the spirit and scope of the present detailed description. In some useful embodiments, the sheet-like structure may comprise a plurality of fibers. The fibers may be interlinked with one another. When this is the case, the sheet-like structure may comprise a plurality of apertures comprising the interstitial spaces between fibers. Various processes may be used to interlink the fibers with one another. Examples of processes that may be suitable in some applications including weaving, knitting, and braiding. In some embodiments, the sheet-like structure may comprise a laminate including multiple layers of film with each layer of film defining a plurality of micro-machined or formed holes. The sheet-like structure of the tendon repair implant may also comprise a reconstituted collagen material having a porous structure. Additionally, the sheet-like structure of the tendon repair implant may also comprise a plurality of electro-spun nanofiber filaments forming a composite sheet. Additionally, the sheet-like structure may comprise a synthetic sponge material that defines a plurality of pores. The sheet-like structure may also comprise a reticulated foam material. Reticulated foam materials that may be suitable in some applications are available from Biomerix Corporation of Fremont, Calif. which identifies these materials using the trademark BIOMATERIAL™. The sheet-like structure may be circular, oval, oblong, square, rectangular, or other shape configured to suit the target anatomy. Various attachment elements may be used to fix tendon repair implant 50 to distal tendon 28 without deviating from the spirit and scope of this detailed description. Examples of attachment elements that may be suitable in some applications include sutures, tissue anchors, bone anchors, and staples. In the embodiment of FIG. 6, sheet-like implant 50 is affixed to distal tendon 28 by a plurality of tendon staples 51. Sheet-like implant 50 is affixed to humerus 14 by a plurality of bone staples 52. Details of exemplary tendon staples may be found in commonly assigned co-pending application: U.S. application Ser. No. 12/684,774 filed Jan. 8, 2010; U.S. application Ser. No. 12/729,029 filed Mar. 22, 2010; U.S. application Ser. No. 12/794,540 filed Jun. 4, 2010; U.S. application Ser. No. 12/794,551 filed on Jun. 4, 2010; U.S. application Ser. No. 12/794,677 filed on Jun. 4, 2010; and U.S. Application No. 61/443,180 filed on Feb. 15, 2011, the disclosures of which are incorporated herein by reference. Exemplary bone staples are described in commonly assigned applications: U.S. Application No. 61/577,626 filed Dec. 19, 2011; U.S. Application No. 61/577,632 filed Dec. 19, 2011 and U.S. Application No. 61/577,635 filed Dec. 19, 2011, the disclosures of which are incorporated herein by reference. Exemplary staples in many of the above applications may be used for anchoring in both soft tissue and in bone.
With the front edge location of the implant delineated, the next step in one method of the present disclosure is placement and attachment of the guidewire. As illustrated in FIG. 8G, with the width of the implant selected for the tendon known, the first fixed point is located a distance D plus an additional distance X in the posterior direction from the line identified by the two markers 308. In some embodiments the distance D is one-half of the width of the implant plus a distance X of about 2 mm. in the posterior direction from the line defined by the two markers 308. Further, the longitudinal distance between an implant mounted on the delivery system used and the guidewire port on the delivery shaft is known. In the illustrated method, using one representative delivery system, it is known that the longitudinal location of the first fixed point should be at the insertion point. As the implant is delivered, it will then extend proximally down the aim of the patient from the line defined by the insertion point by about 5 mm, which assures the implant extends over the point of insertion and is affixed to the humeral head 24. As illustrated in FIG. 8G, a guidewire 172 having a screw 183 for a tissue retention member is placed at the identified first fixed point.
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US20140046347 5 Aug 2013 13 Feb 2014 W. L. Gore & Associates, Inc. Devices, systems and methods for engaging tissue
1 Alexander et al., "Ligament and tendon repair with an absorbable polymer-coated carbon fiber stent," Bulletin of the Hospital for Joint Diseases Orthopedic Institute, vol. 46(2), pp. 155-173, Fall 1986.
2 Bahler et al., "Trebecular bypass stents decrease intracular pressure in cultured himan anterior segments," Am. J. Opthalmology, vol. 138(6), pp. 988-994, Dec. 2004.
3 Chamay et al., "Digital contracture deformity after implantation of a silicone prosthesis: Light and electron microscopic study", The Journal of Hand Surgery, vol. 3(3), pp. 266-270, May 1978.
4 D'Ermo et al. "Our results with the operation of ab extemo", Opthalmologica, vol. 168, pp. 347-355, (year of pub. sufficiently earlier than effective US filing date and any foreign priority date) 1971.
5 France et al., "Biomechanical evaluation of rotator cuff fixation methods", The American Journal of Sports Medicine, vol. 17(2), pp. 176-181, Mar.-Apr. 1989.
6 Goodship et al., "An assessment of filamentous carbon fibre for the treatment of tendon injury in the horse", vol. 106, pp. 217-221, Mar. 8, 1980.
7 Hunter et al., "Flexor-tendon reconstruction in severely damaged hands", The Journal of Bone and Joint Surgery (American Volume), vol. 53-A(5), pp. 329-358, Jul. 1971.
8 Johnstone et al., "Microsurgery of Schlemm's canal and the human aqueous outflow system", Am. J. Opthalmology, vol. 76 (6), pp. 906-917, Dec. 1973.
9 Kowalsky et al., "Evaluation of suture abrasion against rotator cuff tendon and proximal humerus bone", Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 24(3), pp. 329-334, Mar. 2008.
10 Lee et al., "Aqueous-venous and intraocular pressure. Preliminary report of animal studies", Investigative Ophthalmology, vol. 5(1), pp. 59-64, Feb. 1966.
11 Maepea et al., "The pressure in the episcleral veins, Schlemm's canal and the trabecular meshwork in monkeys: Effects of changes in intraocular pressure", Exp. Eye Res., vol. 49, pp. 645-663, Oct. 1989.
12 Nicolle et al., "A silastic tendon prosthesis as an adjunt to flexor tendon grafting . . .", British Journal of Plastic Surgery, vol. 22(3-4), pp. 224-236, (year of pub. sufficiently earlier than effective US filing date and any foreign priority date) 1969.
13 Rubin et al., "The use of acellular biologic tissue patches in foot and ankle surgery", Clinics in Podiatric Medicine and Surgery, vol. 22, pp. 533-552, Oct. 2005.
14 Schultz, "Canaloplasty procedure shows promise for open-angle glaucoma in European study", Ocular Srugery News, pp. 34-35, Mar. 1, 2007.
15 Spiegel et al., "Schlemm's canal implant: A new method to lower intraocular pressure in patients with POAG", Ophthalmic Surgery and Lasers, vol. 30(6), pp. 492-494, Jun. 1999.
16 Stetson et al., "Arthroscopic treatment of partial rotator cuff tears", Operative Techniques in Sports Medicine, vol. 12, Issue 2, pp. 135-148, Apr. 2004.
17 Valdez et al., "Repair of digital flexor tendon lacerations in the horse, using carbon fiber implants", JAYMA, vol. 177(5), pp. 427-435, Sep. 1, 1980.
18 Wikipedia, the free encyclopedia, "Rotator cuff tear" downloaded from <http://en.wikipedia.org/wiki/Rotator-cuff-tear> on Dec. 6, 2012, 14 pages.
19 Wikipedia, the free encyclopedia, "Rotator cuff tear" downloaded from <http://en.wikipedia.org/wiki/Rotator—cuff—tear> on Dec. 6, 2012, 14 pages.
International Classification A61B90/00, A61B17/88, A61B17/00, A61B17/22
Cooperative Classification A61B2090/3991, A61B90/39, A61B2090/3908, A61B2017/22044, A61B2017/22047, A61B17/88, A61B2017/0046, A61B2017/00867