Office Action 1: Non-Final Rejection (2024-12-17)
Rejection types: 103 - Obviousness, Double Patenting

CLAIMS:
Listing of Claims

Amendments to the ClaimsThis listing of claims will replace all prior versions and listings of claims in the application:

1\. (Canceled)

2\. (New) A method for cutting a transverse carpal ligament in a patient, the method comprising:
advancing a distal end of a shaft of a soft tissue cutting device into a carpal tunnel in the patient;
depressing a balloon activation lever on a handle of the soft tissue cutting device, to activate a bellows in the handle and thus inflate two balloons on either side of the shaft, the shaft extending from the handle;
deploying a blade out of the shaft, between the two balloons, to cut the transverse carpal ligament;
moving the blade back inside the shaft;
deflating the two balloons; and
removing the shaft of the soft tissue cutting device from the patient.

3\. (New) The soft tissue cutting method of claim 2, further comprising:
before advancing the distal end of the shaft, priming the soft tissue cutting device by filling, via a fill port on the handle the two balloons with a gas or a fluid; and
allowing the balloon activation lever to move to an extended position to cause the gas or the fluid to move from the two balloons into the bellows.

4\. (New) The soft tissue cutting method of claim 2, wherein deploying the blade and moving the blade comprises sliding a slider along the handle of the soft tissue cutting device, wherein the slider is coupled with the blade.

5\. (New) The soft tissue cutting method of claim 2, further comprising verifying placement of the distal end of the shaft of the soft tissue cutting device with respect to one or more anatomical structures before inflating the two balloons.

6\. (New) The soft tissue cutting method of claim 2, wherein the two balloons expand radially outwardly from the shaft and are located on a distal portion of the shaft, at or near a working end of the blade.

7\. (New) The soft tissue cutting method of claim 2, wherein deploying the blade out of the shaft comprises moving a slider button coupled with a proximal end of the blade along the handle to cause the blade to slide along a blade guideway within the shaft and thus cause a blade working end to protrude out of a slot on the shaft.

8\. (New) The soft tissue cutting method of claim 2, wherein depressing the balloon activation lever on the handle unlocks the blade to enable it to be deployed.

9\. (New) The soft tissue cutting method of claim 2, further comprising locking the balloon activation lever in a locked position via a spring-biased button on the balloon activation lever, to lock the two balloons in an inflated state.

10\. (New) The soft tissue cutting method of claim 9, further comprising releasing the spring-biased button before deflating the two balloons.

OFFICE ACTION:
DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,004,884 B2 in view of Barnes et al. (US 20160081710 A1)
Regarding claim 2, ‘884 discloses: A method for cutting a transverse carpal ligament in a patient (Col. 12 lines 51-52), the method comprising: advancing a distal end of a shaft of a soft tissue cutting device into a carpal tunnel in the patient (Col. 12 lines 53-54); depressing a balloon activation lever on a handle of the soft tissue cutting device, to activate a bellows in the handle and thus inflate two balloons (Col. 12 lines 57-59 discloses depressing a balloon activation lever on a handle of the soft tissue cutting device to activate a bellows in the handle and inflate “at least one balloon”); deploying a blade along the shaft (Col. 12 lines 65-66), between the two balloons, to cut the transverse carpal ligament (Col. 12 lines 65-66); deflating the two balloons (Col. 13 lines 1-3); and removing the shaft of the soft tissue cutting device from the patient (Col. 13 line 4).
‘884 doesn’t directly disclose:
the two balloons are on either side of the shaft;
the shaft extends from the handle;
the blade is deployed from the shaft between the two balloons;
moving the blade back inside the shaft.
Barnes discloses a similar device for cutting a transverse carpal ligament in a patient (para. [0050]), including a shaft 20 of a soft tissue cutting device 10 and two balloons that extend on either side of the shaft (para. [0089]); the shaft extends from a handle 16 (Fig. 1); the blade 26 is deployed from the shaft between the two balloons (para. [0086]; Fig. 5); moving the blade back inside the shaft (i.e., after the procedure; para. [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘884 with Barnes such that ‘884 has two balloons on either side of the shaft and the blade is deployed from inside the shaft for purposes of positioning the device within the carpal tunnel region and to extend the “safe zone” such that any tendons or nerves are moved away from the device such that only the transverse carpal ligament is cut and not nearby at-risk structures (para. [0090]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA  to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US 20160081710 A1) in view of Voellmicke et al. (US 2004/0034276 A1).
Regarding claim 2, Barnes discloses a method for cutting a transverse carpal ligament in a patient (para. [0050]), the method comprising: advancing a distal end of a shaft 20 of a soft tissue cutting device 10 into a carpal tunnel in the patient (para. [0082], [0096]); depressing a balloon activation lever 18 on a handle 16 of the soft tissue cutting device (Fig. 1), inflate two balloons (i.e., 34a, 34b) on either side of the shaft (para. [0089]), the shaft extending from the handle (Fig. 1); deploying a blade 26 out of the shaft (para. [0086]), between the two balloons (Fig. 5), to cut the transverse carpal ligament (para. [0086]); moving the blade back inside the shaft (para. [0099]); deflating the two balloons (para. [0101]); and removing the shaft of the soft tissue cutting device from the patient (para. [0101]).
Barnes also discloses an inflation device that can be any desired device including a syringe to inflate (para. [0148]).
Barnes doesn’t directly disclose a bellows in the handle that is activated to allow fluid to flow through.
In the same field of endeavor, namely devices for controlling fluid flow through a medium, Voellmicke discloses the interchangeability of syringes and bellows such that instead of using syringes to force fluid through the system, an expandable bellows 502 is provided (para. [0063]; Figs. 7A-7C).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Barnes to have a bellows in the handle that may be actuated to allow fluid to flow through for purposes of controlling the inflation and deflation of the balloons from the handle assembly by controlling the fluid flow (paras. [0063], [0065]).
Regarding claim 4, Barnes and Voellmicke disclose the soft tissue cutting method of claim 2. Barnes also discloses deploying the blade and moving the blade comprises sliding a slider 270 along the handle of the soft tissue cutting device (para. [0140]), wherein the slider is coupled with the blade (para. [0140]).
Regarding claim 5, Barnes and Voellmicke disclose the soft tissue cutting method of claim 2. Barnes also discloses verifying placement of the distal end of the shaft of the soft tissue cutting device with respect to one or more anatomical structures before inflating the two balloons (para. [0098]).
Regarding claim 6, Barnes and Voellmicke disclose the soft tissue cutting method of claim 2. Barnes also discloses the two balloons expand radially outwardly from the shaft and are located on a distal portion of the shaft, at or near a working end of the blade (paras. [0066], [0068]).
Regarding claim 7, Barnes and Voellmicke disclose the soft tissue cutting method of claim 2. Barnes also discloses deploying the blade out of the shaft comprises moving a slider button coupled with a proximal end of the blade (para. [0140]) along the handle to cause the blade to slide along a blade guideway 28 within the shaft (paras. [0082], [0087], [0088]) and thus cause a blade working end to protrude out of a slot on the shaft (para. [0087], [0088]; the active position).
Regarding claim 8, Barnes and Voellmicke disclose the soft tissue cutting method of claim 2. Barnes also discloses depressing the balloon activation lever on the handle unlocks the blade to enable it to be deployed (para. [0170] discloses a safety mechanism that prevents the blades from contacting tissue based on the balloons to prevent unwanted cutting; see also paras. [0096]-[0097]).
Regarding claim 9, Barnes and Voellmicke disclose the soft tissue cutting method of claim 2. Barnes also discloses comprising locking the balloon activation lever in a locked position via a spring-biased button (para. [0164] discloses a compression mechanism 332 with a spring 372 (see also para. [0158]); para. [0153] discloses various actuators including a push button and para. [0170] discloses any mechanism of activation disclosed which would include the push button) on the balloon activation lever, to lock the two balloons in an inflated state (para. [0170]; para. [0077] also discloses a mechanism that activates the balloons and Fig. 1 shows a push mechanism).
Regarding claim 10, Barnes and Voellmicke disclose the soft tissue cutting method of claim 9. Barnes also discloses comprising releasing the spring-biased button before deflating the two balloons (para. [0170]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes and Voellmicke as applied to claim 2 and further in view of Anderson et al (US 2007/0213616 A1).
Regarding claim 3, Barnes and Voellmicke disclose the soft tissue cutting method of claim 2. Barnes also discloses filling each of the balloons with gas or fluid through a conduit to inflate the balloons and deflating the balloons by removing the gas or fluid (para. [0092]-[0095]). Barnes also discloses that inflating and deflating the balloons is accomplished by utilizing a control mechanism on the handle (para. [0077]). Barnes doesn’t directly disclose: before advancing the distal end of the shaft, priming the soft tissue cutting device by filling, via a fill port on the handle the two balloons with a gas or a fluid; and allowing the balloon activation lever to move to an extended position to cause the gas or the fluid to move from the two balloons into the bellows.
In the same field of endeavor, namely systems and methods for arteriotomy localization, Anderson discloses before advancing the distal end of the shaft, priming the soft tissue cutting device (para. [0107]).
The combination of Barnes and Voellmicke with Anderson would disclose before advancing the distal end of the shaft, priming the soft tissue cutting device by filling, via a fill port on the handle the two balloons with a gas or a fluid; and allowing the balloon activation lever to move to an extended position to cause the gas or the fluid to move from the two balloons into the bellows.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Barnes to have the priming step as disclosed by Anderson for purposes of preparing the device to be used in the body (para. [0107]).
Conclusion

APPLICANT REBUTTAL: REMARKS
Claims 2-11 are pending and claims 2-10 stand rejected by the Office Action of
December 17, 2024. This Response amends claims 2-10 and adds new claim 11. The claim amendments and added claim add no new matter. For example, support for the claim amendments may be found in paragraphs [0046] and [0073]. Applicant respectfully requests reexamination and reconsideration of pending claims 2-11.
Drawing Amendments
With this paper, Figures 10-13 are being replaced with Figures 10-13 on the attached Replacement Sheets. In Figures 10-13, the reference numeral 216 is being replaced with the reference numeral 220. No new matter is added. Applicant respectfully requests entry of amended Figures 10-13.
Double Patenting Re
j
ection
Claim 2 is rejected on the ground of non-statutory double patenting, as allegedly being unpatentable over claim 1 of U.S. Patent No. 12,004,884, in view of Barnes et al. (U.S. 2016/0081710). Applicant will address any future non-statutory double patenting rejection, if one may be applied to the currently amended claims.
Claim Re
j
ections Under 35 U.S.C.
&
Claims 2 and 4-10 stand rejected under 35 U.S.C. § 103, as allegedly being unpatentable over U.S. Patent Publication 2016/0081710 ("Barnes"), in view of U.S. Patent Publication 2004/0034276 ("Voellmicke"). Claim 3 stands rejected under 35 U.S.C. § 103, as allegedly being unpatentable over Barnes and Voellmicke and further in view of U.S. Patent Publication 2007/0213616 ("Anderson"). Applicant respectfully traverses these rejections.
As currently amended, claim 2 is directed to a method for cutting a transverse carpal
ligament. The method includes steps of activating a locking mechanism on the balloon activation lever to lock the two balloons in an inflated state and unlocking the locking mechanism. The cited Barnes, Voellmicke, and Anderson references all fail to teach or suggest at least the step of activating a locking mechanism on the balloon activation lever to lock the two balloons in an
inflated state. Although Barnes does teach a locked position and an unlocked position, he does not teach the specific method step of activating a locking mechanism on the balloon activation lever to lock the two balloons in an inflated state. Therefore, even if Barnes and Voellmicke could be combined, the method of claim 2 would not be achieved. Anderson does not remedy this shortcoming and is not relevant to claim 2.
At least for these reasons, Applicant respectfully submits that claim 2 and all dependent claims are patentable over Barnes, Voellmicke, and Anderson. Applicant thus respectfully requests withdrawal of the rejections of claims 2-10 under 35 U.S.C. § 103.
Conclusion


CITED REFERENCE SUMMARIES: Ref US20070213616A1: Claims:
An arteriotomy targeting catheter, comprising: an arteriotomy targeting aid coupled to the catheter and adapted to detect the location of an arteriotomy; and one or more beacons coupled to the catheter proximal to the arteriotomy targeting aid.
an arteriotomy targeting aid coupled to the catheter and adapted to detect the location of an arteriotomy; and
one or more beacons coupled to the catheter proximal to the arteriotomy targeting aid.
The catheter of claim 1 , wherein the arteriotomy targeting aid comprises an inflatable balloon.
The catheter of claim 2 , wherein the balloon comprises an elastic polymeric material.
The catheter of claim 3 , wherein the soft elastic polymeric material is selected from the group consisting of one or more of a polyamide, a polyamide blend, a polyethylene, a polyethylene terephthalate, a polyurethane, a polyamide, and a polyamide blend.
The catheter of claim 4 , wherein the polyamide blend is PBAX.
The catheter of claim 2 , wherein the durometer of the balloon material is between 20A and 90D.
The catheter of claim 6 , wherein the durometer of the balloon material is between 80 A and 65 D.
The catheter of claim 7 , wherein the durometer of the balloon material is 90 A.
The catheter of claim 1 , wherein the arteriotomy targeting aid comprises a mechanical expansible device.
The catheter of claim 1 , wherein the arteriotomy targeting aid comprises an arteriotomy locating sensor.
The catheter of claim 10 , wherein the arteriotomy locating sensor comprises a temperature sensor.
The catheter of claim 11 , wherein the temperature sensor is a thermistor.
The catheter of claim 10 , wherein the arteriotomy locating sensor comprises a flow measurement sensor.
The catheter of claim 10 , wherein the arteriotomy locating sensor comprises an optical sensor.
The catheter of claim 10 , wherein the arteriotomy locating sensor comprises an impedance sensor.
The catheter of claim 10 , wherein the arteriotomy locating sensor comprises a Doppler sensor.
The catheter of claim 1 , wherein the beacon comprises an ultrasonic transmitter.
The catheter of claim 1 , wherein the beacon comprises a radio frequency transmitter.
The catheter of claim 1 , wherein the beacon comprises a magnetic field generator.
A method of determining the location of a therapeutic site in a body, comprising: inserting a catheter into the body, wherein the catheter comprises a targeting aid; and manipulating the catheter such that the targeting aid is adjacent to or at the therapeutic site.
inserting a catheter into the body, wherein the catheter comprises a targeting aid; and
manipulating the catheter such that the targeting aid is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the therapeutic site is an arteriotomy.
The method of claim 20 , wherein manipulating the catheter comprises moving the catheter until a Doppler signal from the targeting aid determines that the targeting aid is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises a temperature sensor and manipulating the catheter comprises moving the catheter until the temperature sensor indicates that it is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises a fluid flow detector and manipulating the catheter comprises moving the catheter until the fluid flow detector indicates that it is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises an optical sensor and manipulating the catheter comprises moving the catheter until the optical sensor indicates that it is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises a pressure sensor and manipulating the catheter comprises moving the catheter until the pressure sensor indicates that it is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises an impedance sensor and manipulating the catheter comprises moving the catheter until the impedance sensor indicates that it is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises a force detector and manipulating the catheter comprises moving the catheter until the force detector indicates that it is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises a mechanically expansive device and the method comprises expanding the mechanically expansive device and moving the catheter until the device is adjacent to or at the therapeutic site.
The method of claim 20 , wherein the targeting aid comprises an inflatable balloon and the method comprises inflating the balloon and moving the catheter until the balloon is adjacent to or at the therapeutic site.
The method of claim 20 , wherein: the therapeutic site is an arteriotomy created by an introducer sheath inserted into an artery; inserting the catheter into the body comprises inserting the catheter and targeting aid through the lumen of the introducer sheath past the arteriotomy and into the artery; and manipulating the catheter comprises retracting the catheter such that the targeting aid approaches the arteriotomy.
the therapeutic site is an arteriotomy created by an introducer sheath inserted into an artery;
inserting the catheter into the body comprises inserting the catheter and targeting aid through the lumen of the introducer sheath past the arteriotomy and into the artery; and
manipulating the catheter comprises retracting the catheter such that the targeting aid approaches the arteriotomy.
The method of claim 31 , wherein the introducer sheath is retracted simultaneously with retraction of the catheter.
The method of claim 31 , wherein the targeting aid comprises an inflatable balloon and wherein the balloon is inflated after insertion of the catheter and prior to retracting the catheter.
The method of claim 31 , further comprising applying compression above the arteriotomy.
A method of determining the location of a therapeutic site in a body relative to a therapeutic applicator, comprising: inserting a targeting catheter into the body; identifying the location of the therapeutic site using the targeting catheter; and determining the position of the targeting catheter relative to the therapeutic applicator.
inserting a targeting catheter into the body;
identifying the location of the therapeutic site using the targeting catheter; and
determining the position of the targeting catheter relative to the therapeutic applicator.
The method of claim 35 , wherein the therapeutic site is an arteriotomy.
The method of claim 35 , further comprising aligning the therapeutic applicator with the therapeutic site based on the relative position of the targeting catheter.
The method of claim 35 , wherein determining the position of the targeting catheter relative to the therapeutic applicator comprises using triangulation.
The method of claim 38 , wherein the triangulation is based on magnetic fields.
The method of claim 38 , wherein the triangulation is based on acoustic signals.
The method of claim 40 , wherein the triangulation is based on an acoustic time-of-flight determination.
The method of claim 35 , wherein determining the position of the targeting catheter relative to the therapeutic applicator comprises transmitting an ultrasound signal from a transmitter located on the catheter to multiple receivers located on the therapeutic applicator.
The method of claim 42 , wherein the transmitter comprises a piezoelectric cylinder.
The method of claim 42 , wherein determining the position of the targeting catheter relative to the therapeutic applicator comprises determining the acoustic time-of-flight from the transmitter to the receivers.
The method of claim 35 , wherein determining the position of the targeting catheter relative to the therapeutic applicator comprises transmitting ultrasound signals from multiple transmitters located on the therapeutic applicator to a receiver located on the catheter.
Ref US20160081710A1: Claims:
A soft tissue cutting device, comprising: (a) a shaft having a top surface, two side surfaces and a bottom surface, wherein the shaft extends along a longitudinal axis; (b) a shaft opening that extends for a distance along the longitudinal axis; (c) a blade that extends through and withdraws from the shaft opening; and (d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft.
(a) a shaft having a top surface, two side surfaces and a bottom surface, wherein the shaft extends along a longitudinal axis;
(b) a shaft opening that extends for a distance along the longitudinal axis;
(c) a blade that extends through and withdraws from the shaft opening; and
(d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft.
The soft tissue cutting device of claim 1 wherein the one or more balloons includes a lateral balloon that expands radially outwardly from one of the two side surfaces.
The soft tissue cutting device of claim 1 wherein the one or more balloons includes a dorsal balloon that expands radially outwardly from the bottom surface.
The soft tissue cutting device of claim 1 wherein the one or more balloons includes a first lateral balloon that expands radially outwardly from one of the two side surfaces, a second lateral balloon that expands radially outwardly from another of the two side surfaces, and a dorsal balloon that expands radially outwardly from the bottom surface.
The soft tissue cutting device of claim 1 wherein the shaft opening extends longitudinally along the top surface and the blade has a top cutting edge that extends in a direction parallel to the longitudinal axis, and wherein the top cutting edge is housed within the shaft when the device is in an inactive position and the top cutting edge extends upwardly through the shaft opening when the device is in an active position.
The soft tissue cutting device of claim 5 wherein the blade is coupled to a blade balloon elevator, wherein the blade balloon elevator inflates to extend the top cutting edge upward through the shaft opening and deflates to retract the top cutting edge downward through the shaft opening.
The soft tissue cutting device of claim 1 wherein the shaft opening extends longitudinally along the top surface and two side surfaces, and the blade has a distal cutting edge that extends in a direction perpendicular to the longitudinal axis, and wherein the distal cutting edge is housed within the shaft when the device is in an inactive position and the distal cutting edge extends distally through the shaft opening when the device is in an active position.
The soft tissue cutting device of claim 1 wherein the device includes a proximal end configured as a single-hand handpiece including one or more controls for activating movement of the blade and inflation and deflation of the one or more balloons, wherein the one or more controls can be activated using a single hand.
The soft tissue cutting device of claim 1 wherein the top surface includes a plurality of suction openings.
The soft tissue cutting device of claim 1 wherein the soft-tissue cutting device is a transverse carpal ligament cutting device.
A transverse carpal ligament cutting device, comprising: (a) a shaft having a top surface, two side surfaces and a bottom surface; (b) a shaft opening that extends for a distance along the top surface; (c) a blade having a top cutting edge; and (d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft; wherein the top cutting edge is housed within the shaft and the one or more balloons are deflated when the device is in an inactive position and wherein the top cutting edge extends upwardly through the shaft opening and the one or more balloons are inflated when the device is in an active position.
(a) a shaft having a top surface, two side surfaces and a bottom surface;
(b) a shaft opening that extends for a distance along the top surface;
(c) a blade having a top cutting edge; and
(d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft;
wherein the top cutting edge is housed within the shaft and the one or more balloons are deflated when the device is in an inactive position and wherein the top cutting edge extends upwardly through the shaft opening and the one or more balloons are inflated when the device is in an active position.
The transverse carpal ligament cutting device of claim 11 further comprising a plurality of suction holes along the top surface.
The transverse carpal ligament cutting device of claim 11 wherein the one or more balloons includes a lateral balloon that expands radially outwardly from one of the two side surfaces.
The transverse carpal ligament cutting device of claim 11 wherein the one or more balloons includes a dorsal balloon that expands radially outwardly from the bottom surface.
The transverse carpal ligament cutting device of claim 11 wherein the one or more balloons includes a first lateral balloon that expands radially outwardly from one of the two side surfaces a second lateral balloon that expands radially outwardly from another of the two side surfaces, and a dorsal balloon that expands radially outwardly from the bottom surface.
The transverse carpal ligament cutting device of claim 11 wherein the blade is coupled to a blade balloon elevator, wherein the blade balloon elevator inflates to extend the top cutting edge upward through the shaft opening and deflates to retract the top cutting edge downward through the shaft opening.
The transverse carpal ligament cutting device of claim 11 wherein the device includes a proximal end configured as a single-hand handpiece including one or more controls for activating movement of the blade and inflation and deflation of the one or more balloons, wherein the one or more controls can be activated using a single hand.
A transverse carpal ligament cutting device, comprising: (a) a shaft having a top surface, two side surfaces and a bottom surface; (b) a shaft opening that extends for a distance along the top wall and two side surfaces; (c) a blade having a distal cutting edge; and (d) one or more balloons coupled to the shaft that expand radially outwardly from the shaft; wherein the distal cutting edge is housed within the shaft and the one or more balloons are deflated when the device is in an inactive position and wherein the distal cutting edge extends distally through the shaft opening and the one or more balloons are inflated when the device is in an active position.
(b) a shaft opening that extends for a distance along the top wall and two side surfaces;
(c) a blade having a distal cutting edge; and
wherein the distal cutting edge is housed within the shaft and the one or more balloons are deflated when the device is in an inactive position and wherein the distal cutting edge extends distally through the shaft opening and the one or more balloons are inflated when the device is in an active position.
The transverse carpal ligament cutting device of claim 18 wherein the one or more balloons includes a lateral balloon that expands radially outwardly from one of the two side surfaces.
The transverse carpal ligament cutting device of claim 18 wherein the one or more balloons includes a dorsal balloon that expands radially outwardly from the bottom surface.
The soft tissue cutting device of claim 18 wherein the one or more balloons includes a first lateral balloon that expands radially outwardly from one of the two side surfaces a second lateral balloon that expands radially outwardly from another of the two side surfaces, and a dorsal balloon that expands radially outwardly from the bottom surface.
The transverse carpal ligament cutting device of claim 18 wherein the device includes a proximal end configured as a single-hand handpiece including one or more controls for activating movement of the blade and inflation and deflation of the one or more balloons, wherein the one or more controls can be activated using a single hand.
A transverse carpal ligament cutting device, comprising: (a) a shaft having a top surface, two side surfaces and a bottom surface; (b) a shaft opening that extends for a distance along the top wall; (c) a blade having a blade working end, wherein the blade working end includes a cutting edge that faces the proximal end of the device; and (d) a blade guideway within the shaft, wherein the blade working end moves along the blade guideway.
(b) a shaft opening that extends for a distance along the top wall;
(c) a blade having a blade working end, wherein the blade working end includes a cutting edge that faces the proximal end of the device; and
(d) a blade guideway within the shaft, wherein the blade working end moves along the blade guideway.
The transverse carpal ligament cutting device of claim 23 wherein the blade working end is configured as a hook, wherein the hook includes an inner cutting edge that faces the proximal end of the device.
The transverse carpal ligament cutting device of claim 23 wherein the blade working end includes a blade pin, wherein the blade pin moves within the blade guideway.
The transverse carpal ligament cutting device of claim 23 wherein the blade guideway includes a distal guideway end, a distal incline, a plateau, a proximal incline and a proximal guideway end.
The transverse carpal ligament cutting device of claim 26 wherein when the blade working end is positioned at the distal guideway end, the cutting edge is housed within the shaft.
The transverse carpal ligament cutting device of claim 26 wherein when the blade working end is positioned along the plateau, the blade working end extends through the shaft opening such that the cutting edge is exposed.
The transverse carpal ligament cutting device of claim 26 wherein when the blade working end is positioned at the proximal guideway end, the cutting edge is housed within the shaft.
The transverse carpal ligament cutting device of claim 26 wherein the device further includes one or more balloons coupled to the shaft that expand radially outwardly from the shaft.
A soft tissue cutting device, comprising: (a) a shaft having a plurality of surfaces; (b) a shaft opening that extends for a distance along one of the plurality of surfaces; (c) a blade that extends through and withdraws from the shaft opening; and (d) an inflation device, a conduit and a balloon, wherein the balloon is coupled to the conduit and the conduit is couple to the inflation device and wherein the balloon expands radially outwardly from the shaft.
(a) a shaft having a plurality of surfaces;
(b) a shaft opening that extends for a distance along one of the plurality of surfaces;
(d) an inflation device, a conduit and a balloon, wherein the balloon is coupled to the conduit and the conduit is couple to the inflation device and wherein the balloon expands radially outwardly from the shaft.
The soft tissue cutting device of claim 31 wherein the conduit includes a plurality of openings and the balloon is positioned so the plurality of openings open to an inside of the balloon.
The soft tissue cutting device of claim 31 wherein the balloon includes a fixed portion and an expandable portion, wherein the fixed portion directly connects to the conduit and the expandable portion does not contact the conduit and expands freely of the conduit.
The soft tissue cutting device of claim 33 wherein the conduit includes a plurality of openings and the balloon is positioned so the plurality of openings open to an inside of the expandable portion.
The soft tissue cutting device of claim 31 wherein the inflation device is housed within a handle at a proximal end of the soft tissue cutting device.
The soft tissue cutting device of claim 31 wherein the device includes a first balloon, a first conduit, a seco
[Truncated to input limit]